TPW

PAEDIATRICS

Volume 14 n No. 3 n May-june 2023 Published by Muhammad Masud. 51, Kalabagan 1st Lane (Ground floor) Dhaka-1205, Bangladesh, Tel/Fax: +88 02 58155677 n Printing: Image Printing & Packaging 3 Purana Paltan, Dhaka. IMPORTANT: Every care is taken to ensure the accuracy of the information given in this journal but no responsibility is accepted for any error and/or omissions. Editor/ publisher is not responsible in any way for views/comments expressed herein. AMR 27 Global News 28 Research Update 52 Concern 59 Fake Drug 68 Neuro Development 73 Drug Safety 74 Red Alert 75 Pharmacovigilance 79 Advisor, International Affairs Prof. Dr. Moshe Szyf GlaxoSmithKline & James McGill Professor Dept. of Pharmacology & Therapeutics McGill University Medical School Montreal, Quebec Canada Pharmaceutical Advisor Abu Nayeem Saifur Rahman Medical Advisor Dr. R. M. Samiul Hasan Media Advisor Dr. Sajal Ashfaque Dr. SMG Saklayen Russel Dr. Saleh Mahmood Tusher Editor Muhammad Masud Executive Editor S A Nadeem managing editor Sandip Kumar Saha Associate Editor Humayera Kabir Hana Business Editor Md. Shahjahan Research Editor Prof. Dr. Md. Moklesur Rahman Sarker graphics editor Munir Hussein head of marketing Faisal Ahmmed Marketing Md. Shohag Hossen Circulation Md. Sikander Md. Bashar Computer Graphics Md. Aftabul Islam Production Mati Ar Manush Editorial/Business Office 51, Kalabagan 1st Lane (Ground floor) Dhaka-1205, Bangladesh E-mail: [email protected] Prof. Dr. ABM Abdullah UGC Professor, BSMMU Personal Physician to Hon’ble Prime Minister Prof. Dr. Mohammod Shahidullah Department of Neonatology BSMMU, Dhaka Prof. M.A. Salam Founder President & CEO Urology & Transplant Foundation of Bangladesh Dhaka board of Advisors National Prof. Brig. (Rtd.) Abdul Malik Founder & President National Heart Foundation, Dhaka National Prof. Dr. A K Azad Khan President Diabetic Association of Bangladesh & Chairman Board of Trustees Bangladesh University of Health Sciences (BUHS), Dhaka Prof. Dr. TA Chowdhury Professor, Dept. of Obstetrics & Gynaecology BIRDEM, Dhaka Prof. Dr. Abdul Ghani Ex-Chairman Dept. of Pharmacy, University of Dhaka Prof. Dr. Harun-Ur-Rashid Founder & Chief Consultant Kidney Fundation Hospital & Research Institute, Dhaka Did You Know 84 Pediatrics Update 86 Facts on Fingertips 89 Technology 90 FDA Approvals 93 Registration Rules 96 Course and Conferences 98 Upcoming Event 99 News New Arrivals 5, DGDA News 18, FIP News 21, WHO News 22, News 23 Interview Prof. Dr. Mohammod Shahidullah (PRL)31 Prof. Md. Abid Hossain Mollah 35 Prof. Dr. Md. Abdul Mannan 39 Prof. Dr. Md. Jahangir Alam 43 Dr. Kazi Naushad Un Nabi 51 Prof. Mohammed Hanif 55 CONTENTS Exclusive Mr. SM Shafiuzzaman 16 Face to Face Mohammad Ziauddin 48 Prof. Dr. Md. Selimuzzaman 61 Prof. S. K. Banik 65 Prof. Dr. Sanjoy Kumer Dey 71 Prof. Iffat Ara Shamsad 77 Prof. Dr. Syed Shafi Ahmed Muaz 81

NEW ARRIVALS Acme THE PHARMA WORLD 7 Brand Name: Gavisus Generic Name: Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate Strength: 250mg + 133.5mg + 80mg Dosage Form: Chewable Tablet Indications: Gastric reflux, heartburn, flatulence associated with gastric reflux, heartburn during pregnancy Brand Name: Rebreath Generic Name: Revefenacin INN Strength: 175 mcg (3 ml) Dosage Form: Nebulizer Solution Indications: Treatment of chronic obstructive pulmonary disease (COPD). Biopharma Brand Name: Alerfast 180 Brand Name: Alerfast 180 Generic Name: Fexofenadine Hydrochloride Strength: 180 mg Dosage Form: Tablet Indications: Sneezing, itching, watery or red eyes and itchy eyes, blocked or runny Nose. Brand Name: Magnolax Generic Name: Magnesium Hydroxide & Liquid Paraffin Strength: Magnesium Hydroxide BP 300 mg & Liquid Paraffin BP 1.25ml/5ml Dosage Form: Oral Emulsion Indications: Constipation, pediatric constipation, improper bowel movement, colonoscopy and endoscopy, hernia and piles, elderly and bed ridden patients, pre and post-operative conditions & bowel clearance before radioscopy. Brand Name: Biokof Generic Name: Butamirate Citrate Strength: Butamirate Citrate INN 7.5 mg/ 5 ml Dosage Form: Syrup Indications: Dry Cough (Non-productive cough), Acute Cough of any etiology and throat irritation, cough due to bronchospasm, inflammation & lower respiratory tract infections.

THE PHARMA WORLD 9 Brand Name: Pulmobi Generic Name: Pirfenidone Strength: 267 mg, 534 mg & 801 mg Dosage Form: Tablet Indications: Idiopathic Pulmonary Fibrosis (IPF). Brand Name: Zinga B Generic Name: Zinc Sulphate & Vitamin B Complex Strength: Zinc 10 mg, Thiamine 5 mg, Riboflavin 2 mg, Pyridoxine 2 mg & Nicotinamide 20 mg Dosage Form: Syrup Indications: Poor immunity, loss of appetite, growth retardation, infection & wound healing. Brand Name: Fivita Z Generic Name: Iron polymaltose complex, folic acid, Vitamin B complex & Zinc Strength: Iron Polymaltose complex 47 mg, Folic Acid 0.5 mg, Thiamine 5 mg, Riboflavin 2 mg, Pyridoxine 2 mg, Nicotinamide 20 mg & Zinc Sulphate 61.80 mg Dosage Form: Capsule Indications: Dietary supplement, Iron, Folic Acid & Zinc deficiency, Vitamin-B deficiency especially during pregnancy & lactation. Eskayef Everest Brand Name: PG CR Generic Name: Pregabalin Strength: 82.5 mg, 165 mg Dosage Form: Extended Release Tablet Indications: Neuropathic pain associated with diabetic peripheral neuropathy, Postherpetic neuralgia. Brand Name : Fenidone Generic Name: Pirfenidone Strength: 267mg, 801mg Dosage Form: Tablet Indications: Idiopathic Pulmonary Fibrosis (IPF). Brand Name: Osimatab Generic Name: Osimertinib Strength: 80 mg & 40 mg Dosage Form: Oral (FilmCoated Tablet) Indications: in first-line, adjuvant or metastatic setting in EGFR mutationpositive, non-squamous non-small cell lung cancer. Brand Name: Lulifast Generic Name: Luliconazole INN Strength: 1% Dosage Form: Cream Indications:Treatment of interdigital Tinea pedis, Tinea cruris, Tinea corporis & Pityriasis Versicolor caused by the organisms Trichophyton rubrum, Epidermophyton floccosum & Malassezia spp.

Indications: Treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. Brand Name: Q-fit XR 50 Generic Name: Quetiapine Fumarate BP Strength: 50 mg Dosage Form: Film-coated tablet Indications: Treatment of functional symptoms of Schizophrenia, Bipolar disorder, Major depressive disorder. Brand Name: Flosure Generic Name: Tamsulosin Hydrochloride Strength: 0.4 mg Dosage Form: Film-coated tablet Indications: Treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH) Brand Name: Egshel-D Generic Name: Calcium (Eggshell Source) + Vitamin D3 Strength: 500 mg + 200 IU Dosage Form: Tablet Indications: Treatment & prevention of osteoporosis, osteomalacia, rickets, tetany & pseudo hypoparathyroidism. Also suggested use as a dietary supplement where calcium intake may be inadequate; (during pregnancy, lactation, postmenopausal women and the aged) Brand Name: Egshel-DX Generic Name: Calcium (Eggshell Source) + Vitamin D3 Strength: 600 mg + 400 IU Dosage Form: Tablet Indications: Treatment & prevention of osteoporosis, osteomalacia, rickets, tetany & pseudo hypoparathyroidism. Also suggested use as a dietary supplement where calcium intake may be inadequate; (during pregnancy, lactation, postmenopausal women and the aged) Brand Name: Pirfinex Generic Name: Pirfenidon Strength: 267 mg Dosage Form: Film-coated tablet Indications: Treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF). Goodman Brand Name: Empastar Generic Name: Empagliflozine INN Strength: 10 mg & 25 mg Dosage Form: Tablet Indications: Type-2 diabetes mellitus. Brand Name: Litam Generic Name: Levetiracetam USP Strength: 250mg & 500mg Dosage Form: Tablet Indications: Partial seizures, myoclonic & tonic-clonic seizures. Brand Name: Nafinex Generic Name: Naftifine Hydrochloride USP Strength: 2% Dosage Form: Cream 10 THE PHARMA WORLD

THE PHARMA WORLD 11 Hamdard Brand Name: Fevimol Plus Generic Name: Paracetamol BP+Caffeine USP Strength: 500 mg + 65 mg Dosage Form: Tablet Indications: Fever, pain, headache, toothache, migraine, common colds & flu, menstrual pain, rheumatic & muscular pain etc. Brand Name: Branula Generic Name: Brahmi Rasayan Dosage From: 225 ml Syrup Composition: Each 5 ml Branula syrup containsBacopa monnieri 1.21 g, Asparagus racemosus 0.30 g, Withania somnifera 15.74 mg, Elettaria cardamomum 15.74 mg, Cinnamomum zeylanicum 15.74 mg, Syzygium aromaticum 15.74 mg & other ingredients Q.S. Indications: Loss of memory, lack of concentration, dementia, age associated memory impairment (AAMI) & alzheimer’s disease. Brand Name: Hamdard Balm Generic Name: Marham Ajeeb Dosage From: 20 g Ointment Composition: Each gram ointment containsCinnamomum camphora 200 mg, Menthol 200 mg & Thymol 100 mg. Indications: Headache, pain, backache, sprain, sciatica, insect bites & cuts. Brand Name: Hamdard Bhringaraj Generic Name: Mahabhringaraj Taila Dosage From: 130 ml Hair Oil Composition: Each 5 ml oil contains- Sesamum indicum 5.63 g, Eclipta alba 22.54 ml, Rubia cordifolia 0.17 g, Prunus cerasoides 0.17 g, Symplocos racemosa 0.17 g, Pterocarpus santalinus 0.17 g, Red Ochre 0.17 g, Sida cordifolia 0.17 g, Curcuma longa 0.17 g, Berberis aristata 0.17 g, Mesua ferrea 0.17 g, Callicarpa macrophylla 0.17 g, Hibiscus mutabilis 0.17 g and Ichnocarpus frutescens 0.17 g. Indications: Hair fall, premature graying of hair, dandruff, headache and insomnia. Brand Name: Amlasia Generic Name: Amalaki Rasayan Dosage From: 450 ml Syrup Composition: Each 5 ml contains as extractPhyllanthus emblica Juice) 3.03 ml, Piper longum 0.12 g & Honey 0.36 g. Indications: Hyperacidity, dyspepsia, flatulence, heartburn, anorexia, anaemia, heart disease & jaundice.

THE PHARMA WORLD 13 Brand Name: Ihram Generic Name: Glycerin neem soap Dosage From: 100 G Composition: Neem Oil, Vitamin E, Glycerin & Tea Tree Oil. Indications: Dry Skin, acne, pimple, eczema and psoriasis. Brand Name: Ispa Plus Generic Name: Isabgul Spicy Dosage From: 20 Sachets Composition: Each Sachet contains- Plantago ovata (husk) 3 g, Cassia angustifolia 1 g and other excipient Q.S. Indications: Constipation, piles, IBS, hyperlipidemia and powel regulation for bed ridden patient. Brand Name: Kulzam Generic Name: Aab-e-Hayat Dosage From: 15 ml Drop Composition: Each 5 ml contains- Camphor 1.61 g, Thymol 0.81 g, Menthol 0.40 g, Eucalyptus oil 0.52 ml, Pine oil 0.26 ml, Caraway oil 0.26 ml, Anisi oil 0.19 ml and Tincture of ginger 0.19 ml. Indications: Respiratory tract & lung infection, pneumonia, catarrh, cough & cold, headache, cuts, insect’s bite and different type of pains & rheumatism. Composition: Each gram ointment contains – Azadirachta indica 88.88 mg, Delphinium denudatum 5.55 mg, Pinus longifolia 22.22 mg, Curcuma longa 44.44 mg, Cedrus deodara 44.44 mg, Glycyrrhiza glabra 44.44 mg, Lawsonia inermis 44.44 mg, Lamp-black 44.44 mg, Acacia arabica 88.88 mg, Onosma echioides 88.88 mg and Sesamum indicum oil 0.89 ml. Indications: Skin infection, minor cuts, infected ulcers or wounds, inflammation & skin diseases. Brand Name: Hamdard Basak Generic Name: Vasakarista Dosage From: 100 ml Syrup Composition: Each 5ml contains as extract- Adhatoda vasica 0.68g, Piper longum 0.14g, Vitis vinifera 0.14 g, Honey 3.47g, Woodfordia fruticosa 1.14g, Terminalia chebula 73.24mg, Glycyrrhiza glabra 6.78mg, Saussurea hypoleuca 6.78mg, Acorus calamus 6.78mg, Zingiber officinale 6.78mg, Piper nigrum 6.78mg, Syzygium aromaticum 6.78mg, Elettaria cardamomum 6.78mg, Cinnamomum tamala 6.78mg, Cinnamomum zeylanicum 6.78mg, Rhus succedanea 6.78mg & Myrica nagi6.78mg. Indications: Dry irritable cough, allergic & smoker’s cough, hoarseness of voice & sore throat, asthma and respiratory tract infection. Incepta Brand Name: Prulax 1mg Generic Name: Prucalopride Dosage Form: Tablet Strength: 1 mg Indications: Chronic idiopathic constipation. Brand Name: Nystaderm Cream Generic Name: Nystatin and Chlorhexidine Dosage Form: Cream Strength: Nystatin 2% and Chlorhexidine Hydrochloride 1% Indications: Ringworm, Athlete’s foot, infected nappy rash. Brand Name: Neement Generic Name: Marham Neem Dosage From: 20g Ointment

THE PHARMA WORLD 15 Navana Brand Name: MegaMag Generic Name: Magnesium Oxide BP Strength: 365 mg. Dosage Form: Tablet Indications: Relieving the symptoms of magnesium deficiency, muscle, nervous system & leg cramps treatment, constipation & Indigestion, high blood pressure during pregnancy (Pre-eclampsia, Eclampsia), Diabetes, Regulation of calcium balance through its effect on the parathyroid gland. Brand Name: Somalax Generic Name: Carisoprodol USP Strength: 250 mg. Dosage Form: Tablet Indications: Indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. Brand Name: Naviscon Generic Name: Sodium Alginate BP+Sodium Bicarbonate BP + Calcium Carbonate USP Strength: 250 mg + 133.5 mg + 80 mg. Dosage Form: Chewable Tablet Indications: Indicated for the treatment of heartburn, heartburn in pregnancy, dyspepsia associated with gastric reflux, hiatus hernia, reflux esophagitis, regurgitation and all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux. Brand Name: Onaseron ODT 8 Generic Name: Ondansetron Dosage Form: Tablet Strength: 8mg Indications: Postoperative Nausea-Vomiting (PONV), nausea-vomiting in gastroenteritis, nauseavomiting in pregnancy. Nipro JMI One Pharma Brand Name: Palorid Generic Name: Prucalopride INN Strength: 1 mg, 2 mg Dosage Form: Tablet Indications: Chronic idiopathic constipation (CIC). Brand Name: Sulafate Generic Name: Sucralfate USP Strength: 1g/5ml Dosage Form: Oral Suspension Indications: Duodenal ulcer, gastric ulcer & chronic gastritis. Brand Name: Bilbest Generic Name: Bilastine INN Strength: 20mg & 12.5mg /5ml Dosage Form: Tablet & Syrup Indications: Allergic rhino-conjunctivitis (seasonal and perennial) and urticaria. Brand Name: Zacort Generic Name: Deflazacort INN Strength: 6 mg, 24 mg, 30 mg & 6 mg/5 ml Dosage Form: Tablet & Oral Suspension Indications: Bronchial asthma, auto immune disease, allergic reaction & rheumatoid arthritis. Brand Name: Lovapres Plus Generic Name: Amlodipine+Olmesartan Strength: 5mg+20mg, 5mg+40mg Dosage Form: Film-coated tablet Indication: Hypertension.

THE PHARMA WORLD 17 Pharmasia Brand Name:Exilant Generic Name: Dexlansoprazole Strength: 30 mg & 60 mg Dosage Form: Capsule Indications: Healing of erosive esophagitis (EE), maintenance of healed EE, Relief of heartburn and symptomatic non-erosive GERD. Brand Name: Prestorin Generic Name: Rosuvastatin Strength: 5 mg & 10 mg Dosage Form: Tablet Indications: Heterozygous hypercholesterolemia (Familial and Non familial), homozygous hypercholesterolemia (Familial), mixed dyslipidemia (Fredrickson Type IIa and IIb), primary prevention of cardiovascular disease. Brand Name: Enofiz Generic Name: Sodium Bicarbonate + Citric Acid+ Sodium Carbonate Strength: (2.32gm + 2.18gm + 0.50gm)/5 gm Sachet Dosage Form: Powder Indications: Hyperacidity, indigestion, heartburn, flatulence Brand Name: Waxnil Generic Name: Sodium Bicarbonate Strength: 50 mg/ml Dosage Form: Ear Drops Indication: Indicated as an aid to soften and in the removal of hardened ear wax from the ear canal. Brand Name: Tryptin Plus Generic Name: Amitriptyline and Chlordiazepoxide Strength: 12.5 mg and 5 mg Dosage Form: Tablet Indication: For the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. Brand Name: Meget Generic Name: Megestrol Acetate Strength: 160 mg Dosage Form: Tablet Indication: For the treatment of certain hormone dependent neoplasms, such as breast cancer. Also indicated in male or female patients Brand Name: Zif-A Generic Name: Ferrous Ascorbate, Folic Acid and Zinc Sulfate Monohydrate Brand Name: Reluciba Generic Name: Relugolix Strength: 120 mg Dosage Form: Tablet Indication: Indicated for the treatment of adult patients with advanced prostate cancer. Brand Name: Dermasol Plus Generic Name: Clobetasol Propionate and Salicylic Acid Strength: 0.5 mg & 30 mg Dosage Form: Ointment Indication: Psoriasis, Chronic atopic dermatitis, neurodermatitis (lichen simplex chronicus), Lichen planus, Eczema (including nummular eczema, hand eczema, Brand Name: B-9 Generic Name: Folic Acid Strength: 2.5 mg/5 ml Dosage Form: Oral Solution Indication: Folic acid deficiency, Megaloblastic anemia and in anemias of nutritional origins, pregnancy, infancy or childhood. Strength: Ferrous Ascorbate equivalent to Elemental Iron 48 mg, Folic Acid 0.50 mg and Zinc Sulfate Monohydrate equivalent to Zinc 22.5 mg. Dosage Form: Tablet Indication: Prophylaxis of iron deficiency especially for supplementation of Zinc, Iron and Folic Acid during pregnancy and anemia. for the treatment of anorexia, cachexia or weight loss secondary to metastatic cancer. eczematous dermatitis), Dyshidrosis (pompholyx), Seborrheic dermatitis of scalp, Ichthyosis vulgaris and other ichthyotic conditions. Square

EXCLUSIVE “Many pharma companies made substantial investment for upgrading the manufacturing facility with advanced technology” Mr. SM Shafiuzzaman Secretary General, BAPI Would you please tell us about the present status of Bangladesh Pharmaceutical Industry? After the promulgation of Drug Control Ordinance 1982, the pharmaceutical Industry achieved tremendous success in changing the dimension of the pharma industry. I am confident that the transition has opened a new era for the pharma industry of Bangladesh as a whole. The pharma industry is now capable of producing world class medicines and after meeting 98% of local demand of medicines, Bangladesh is now exporting a wide range of pharma finished products to more than 150 countries of the world, including regulatory markets of the Europe, USA and Australia. The commendable progress made by the pharma industry paved the way for self-sufficiency in pharmaceuticals. To reduce the dependency on import, the renowned pharma companies are now producing inhalers, vaccines locally. Many pharma companies made substantial investment for upgrading the manufacturing facility with advanced technology and state of the art equipment to meet the global demand. How do you foresee the situation of our industry after LDC graduation? Are you prepared for it? As an impact of LDC graduation, Bangladesh will no longer be entitled to use the exemption which was previously enjoyed as an LDC and providing patent protection to pharma products became mandatory. As a result, the cost of medicine will be increased which would definitely create sufferings for millions of people of Bangladesh. Although to overcome the challenges of LDC graduation, the Government of Bangladesh faced the challenges boldly and initiated some positive steps for preparing ground for Smooth Transition Strategy (STS). In this respect, the External Resources Division (ERD) and the Ministry of Finance has constituted a Joint Task Team. We shall have to go a long way to overcome the negative impact of LDC graduation on the pharma industry. To accomplish the objective, the Government, and all other related organizations like Chamber of Commerce & Trade Bodies and NGO’s are working relentlessly and we hope for a fruitful result. When do you expect our API Park to run in full capacity to meet the domestic requirement of raw materials? We hope that the API Park will run in full swing the within a short period. At present, 15 manufacturing companies are producing API’s & 4 API plot owners have already set up their respec18 THE PHARMA WORLD

tive factories at the API Park Project and other manufacturing companies started setting up R&D unit at API Industrial Park. Where do we stand so far the export of medicine is concerned? The Pharmaceutical companies have earned wide reputation for exporting world class pharma products to more than 150 countries of the world and day by day export growth is increasing. This is no doubt encouraging for Pharma sector of Bangladesh. In view of the success in the area of the exporting pharma products, the government has announced the pharma sector of the country as the “Thrust Sector”. The milestone episode in the history of the pharma industry of Bangladesh is the declaration from the Honourable Prime Minister Sheikh Hasina for the pharma sector as Product of the Year-2018 for the outstanding contribution to the economy of the country. The way the export market is flourishing, it is expected that the export volume of pharma products would definitely increase many fold within a short span of time. What plan does BAPI have to accelerate the growth of our pharma industries even further? Please tell us in brief. Renowned pharma companies have invested substantial amount of money for development of R& D for felicitating export of finished medicines globally. For encouraging further enhancement of the export destinations, I led pharma delegation to Ethiopia, Turkey, Brazil, China, Kenya & other countries of the world in order to promote and explore new pharma markets and attending a lot of pharma expo in the world and every year double digit growth in pharma sector in Bangladesh. On the other hand, the government has taken initiative for steady growth of export of pharma products from Bangladesh. For accomplishing the objective, the government has set up API Industrial Park at Gazaria, Munshiganj. Very soon the API Industrial Park will go for producing API’s, which will ultimately lead to increased volume of exports of medicines from Bangladesh. As an Industry leader, you have been leading BAPI very successfully for the last two decades. What is the secret of your success? As the President & Secretary General, I am contributing my service for the betterment of pharma member companies, with utmost sincerity and devotion to work. The key success of my tenure is to safeguard the interest of the member companies and successful lobbying with the Regulatory authorities i.e. Ministry of Health, Dgda, DG Health Services, Ministry of Commerce, Export Promotion Bureau, National Board of Revenue and Trade Bodies like the Federation of Bangladesh Chambers of Commerce & Industry, MCCl, Bangladesh Employers’ Federation etc. for solving the problems of the pharma industry. Hon’ble Prime Minister is also very soft towards pharma sector and she has given 10% cash incentive for formulation product and 20% cash incentive for API export. n THE PHARMA WORLD 19

DGDA NEWS 20 THE PHARMA WORLD A conference about the update of plasma-based medicines investments. Sinovac to invest Tk.5,000cr in plasma-based medicines investments in Bangladesh The Chinese company Sinovac Biotech, which produces a Covid-19 vaccine, is going to start producing Plasma-Derived Medical Products (PDMP) in Bangladesh with an investment of Tk 5,000 crore. The medicine is used for the treatment of various complicated diseases. The company has taken a license from the government and incor - porated the Sinovac Biotech (Bangladesh) Ltd, sources at the Bangladesh Investment Develop - ment Authority (BIDA) said. Blood plasma collection is set to begin by March or April next year, company sources said. The plasma will be used for fractionation – a process that separates blood plasma into its different components to be used to produce medicines such as immunoglobulins. It is expected that eight types of medicines for various dis - eases will be made from this. Important medi - cines from plasma include Immunoglobulin-VF (Preventing haemolytic disease of the newborn and for Rh-negative pregnant mothers), In - tramuscular Immunoglobulin (immunisation against hepatitis A, measles and poliomyelitis), albumin (to treat patients suffering from shock due to blood loss), Intravenous Immunoglobu - lin IVIg (for some primary immune deficiency disorders), Antithrombin concentrate ( to pre - vent blood clots during surgery or childbirth) and Factor IX concentrate (to treat patients with inherited bleeding condition haemophilia B). According to the proposal of Sinovac Biotech (Bangladesh) Ltd submitted to Bida, at least 20 plasma banks and cold storage rooms will be built across the country by the beginning of next year. The plan is to have the banks in 20 districts, all of which will follow European standards. The target is to produce 300 tonnes of PDMPs annually in the first phase. Gradually, they plan to increase the production up to 1,000 tonnes or more depending on demand. Production will start by 2025 and it will be made available in markets by 2026. WHO/MPP mRNA Technology Transfer Program Announced on 21 June 2021, WHO and the Medicines Patent Pool established a technology transfer Programmer for m RNA vaccines in South Africa, in order to build manufacturing capacity in LMICs to produce mRNA vaccines, in an effort to improve health security in Least Mid - dle Income Countries (LMICs) through local and/or regional production of mRNA COVID-19, as a primary target. The center for mRNA technology development

THE PHARMA WORLD 21 and transfer comprises Afrigen/Biovac/South African Medical Research Council, South Africa and will share technology and technical know-how with a network of technology recipients in LMICs. the programmer currently receives funding from European Commission, Belgium, France, Germany, as well as Canada, Norway the African Union, South Africa and the ELMA foundation. The mRNA technology transfer program has the following four main objectives. 1. Establish or enhance sustainable mRNA vaccine manufacturing capacity in regions with no or limited capacity. 2. Introduce new technologies in LMICs and promote regional research and development (R&D) 3. Strengthen regional bio manufacturing know-how and workforce development 4. Develop regulatory capabilities and workforce to support and accelerate regional approval and distribution of mRNA vaccines This meeting, hosted at the Westin in Cape town, in the first of a series of annual Face-2- Face meeting between the programmer partners and key international stakeholders. The proposed objectives are to: 1. Review the progress of the mRAN technology transfer program. 2. Share experience on vaccine development among the program partners. 3. Review business models, intellectual property issues and regulatory aspects relevant to mRNA vaccines. 4. Review the science of mRNA technology and discuss key applications relevant to LMICs. 5. Strengthen the mRNA R&D network and build communities among the partners by R&D interests. 6. Highlight the role of technology transfer and establishment of manufacturing and R&D on national and regional economic development. DGDA officials attended Regional Workshop on Ensuring Quality of Medicines from Contaminated Substances at Jakarta, Indonesia DGDA Participates in Regional Workshop on Ensuring Quality of Medicines from Contaminated Substances From 2 to 4 May 2023, the WHO Regional Office of South-East Asia (SEARO) organised a Regional workshop to support Member States in protecting public health from contaminated medicines, in Jakarta, Indonesia. The main objective was to support all Member States in the region in using a risk- based approach to ensure the quality of the medicinal products. Participants discussed with global experts from WHO, Australia Therapeutic Goods Administration (TGA) and the United-States Pharmacopoeia (USP) how to best address this issue at the national, regional and global level. Participating Regulatory authorities expressed concerns from the continuing occurrence of reports of contaminated products from multiple regions and countries around the world. The quality of medical products is non-negotiable, and it is unacceptable that lives are put at risk by such contaminations. The regulatory authorities confirmed their commitment to address this issue and ensure the quality, safety, and efficacy of all medical products (including traditional medicines) for the benefits of the population in the region and beyond. WHO called for regulators and governments to: l Ensure that all medical products in their respective markets are approved for sale by competent authorities and obtainable from authorized/licensed suppliers; l Detect and remove from circulation in their respective markets any substandard medical products; l Assign appropriate resources to improve and increase risk-based inspections of manufacturing sites within their jurisdiction in accordance with international norms and standards; l Increase market surveillance including risk-based targeted testing for medical products released in their respective markets including informal markets; and l Enact and enforce, where relevant and as appropriate, laws and other relevant legal measures to help combat the manufacture, distribution and/or use of substandard and falsified medicines.

DGDA NEWS In a landmark event that united reg - ulatory authorities from across the globe, the 1st Global Joint Summit of Human and Veterinary Medicines Regulatory Authorities to Preserve Antimicrobials was held on May 4th5th, 2023. The summit, focused on the theme of “Phasing out over-thecounter sales of antibiotics,” aimed to emphasize the critical role of regula - tion in combating antimicrobial re - sistance (AMR) worldwide. The summit brought together es - teemed heads of regulatory authori - ties for human and animal medicines, as well as their designates, from di - verse geographical regions. Their col - lective goal was to emphasize the importance of global regulation in ad - dressing the escalating AMR crisis. By engaging human and animal regula - tory authorities, the summit sought to optimize the use of existing legislation and enforcement measures, while also fostering the development of innova - tive, non-regulatory “Smart” solutions to tackle the pressing issue of overthe-counter sales of antibiotics. Key participants in the summit included the Directorate General of Drug Administration (DGDA) of Bang - ladesh, which played an active role in sharing their experiences in regu - lating over-the-counter medicines. The DGDA introduced several ground - breaking ideas, such as the incorpo - ration of a red label in the packaging of antibiotics. This visual cue serves as a reminder to healthcare profes - sionals and consumers alike about the responsible use of antibiotics. Additionally, the DGDA emphasized the importance of robust law enforce - ment to ensure strict compliance and accountability in the distribution and sale of antibiotics. The success of the 1st Global Joint Summit of Human and Veterinary Medicines Regulatory Authorities to Preserve Antimicrobials serves as a powerful testament to the impor - tance of global collaboration in tack - ling the AMR crisis. Let us embrace the lessons learned and continue our collective journey toward a healthier, antimicrobial-resilient future. 1st Global Joint Summit of Human and Veterinary Medicines Regulatory Authorities to Preserve Antimicrobials. Global Summit Urges Stricter Control on Over-the-Counter Sales of Antibiotics The success of the 1st Global Joint Summit of Human and Veterinary Medicines Regulatory Authorities to Preserve Antimicrobials serves as a powerful testament to the importance of global collaboration in tackling the AMR crisis. 22 THE PHARMA WORLD

THE PHARMA WORLD 23NEWS New FIP tool encourages countries to assess readiness for pharmacist vaccination During World Immunization Week 2023, FIP has offered a new tool from its Regulators Advisory Group to help countries self-assess the readiness of their regulations to enable pharmacist-delivered vaccination services. “This new resource from FIP is based on the experiences of professional regulators in countries where pharmacy-led vaccination has been successfully introduced and regulated. With it, we aim to support regulators, policy-makers and national organisations in developing strategies or enabling regulatory frameworks in countries where the pharmacy workforce has a limited role in vaccination strategies so that it can contribute further to the global imperative of improving immunisation coverage,” said Brett Simmonds, chair of FIP’s Regulators Advisory Group. Sore throat highlighted by FIP as a condition that allows pharmacists to make a big impact A new resource from the International Pharmaceutical Federation (FIP) to aid community pharmacists in supporting people to manage sore throat is published recently. Intended as a “quick reference guide for pharmacists”, it covers causes, triage, and pharmacological and non-pharmacological treatments, and it provides links to further resources. “Sore throat is a common condition that is usually self-limiting. Pharmacists can support its management through a range of products and services, thereby avoiding unnecessary visits to general practitioners,” said Rúben Viegas, FIP practice development and transformation projects coordinator, and author of the guide. This guide is intended as an add-on to FIP’s 2021 publication “Empowering self-care: A handbook for pharmacists”. “Self-care is a fundamental pillar of universal health coverage due to the important role it plays in the sustainability of health systems. This quick reference guide highlights sore throat as a condition for which pharmacists are ideally placed to support informed self-care, delivering substantial impact, and empowering patients to make better health choices and lead healthier lives,” Mr Viegas explained. FIP announces its 2023 World Pharmacists Day campaign theme “Pharmacists strengthening health systems” will be the theme of World Pharmacists Day on 25 September, FIP announced. At a time when health systems around the world are recovering from the COVID-19 crisis, FIP’s 2023 World Pharmacists Day campaign presents opportunities to increase awareness of pharmacists as an intelligent solution. The campaign is led by FIP every year, with the theme chosen by the FIP Council, and provides an opportunity to promote the pharmacy profession. “Beyond doubt, pharmacy is essential to a strong healthcare system and COVID-19 has proven this. But there is a wide range of further needs that pharmacies can provide to make health systems stronger. Our message is: Let pharmacies do more. I encourage colleagues across the globe to prepare to join me in this year’s campaign to celebrate our profession’s achievements in supporting our societies, but also to make its value and further potential in improving health more known,” said FIP president Dominique Jordan. FIP highlights role of pharmacists in vaccination and public health at World Congress Leveraging pharmacies to expand vaccination pathways and deliver immunisation for all was the topic presented at the World Congress on Public Health. “Pharmacists significantly contributed to bringing the [COVID] pandemic under control through a variety of roles, including vaccination services. But vaccination coverage rates for other respiratory diseases like influenza or pneumococcal pneumonia remain suboptimal. It is vital to protect and further expand the advancements in terms of pharmacists’ scope of practice, to achieve equitable vaccination coverage and community protection, leaving no-one behind,” said FIP’s lead for practice development and transformation, Mr Sousa Pinto.

24 THE PHARMA WORLD T he Director-General’s Global Leaders Awards, which were established in 2019, will go to Jean-Jacques Muyembe-Tamfum and Peter Piot. Both recipients are distinguished scientists and public health leaders who were closely involved in the discovery of Ebola virus disease before advancing to leadership positions in global health. The award honours their lifetime achievements in public health. Professor Muyembe-Tamfum from the Democratic Republic of the Congo (DRC) is being recognized for his innovation, leadership and ground-breaking contributions to the management and treatment of diseases such as Ebola virus disease. He has played a critical role in improving health outcomes in the Democratic Republic of the Congo, the African region, and the global community. Professor Muyembe-Tamfum is the Director General of the DRC’s National Institute of Biomedical Research in Kinshasa, full Professor of Microbiology at the University of Kinshasa Medical School and the inaugural president of the Congolese Academy of Science. Professor Piot from Belgium is being recognized for his extraordinary leadership in the response to the HIV/AIDS epidemic and other significant global health challenges. He has played a vital role in launching major global health initiatives such as UNAIDS, the Global Fund, and others that have improved health outcomes around the world. Under his leadership, UNAIDS became the chief advocate for worldwide action against AIDS, also spearheading UN reform by bringing together 10 different UN organizations. Professor Piot also played a part in the earlier discovery of the Ebola virus, and the containment of the first known outbreak, participating in field epidemiological investigations. “These outstanding individuals embody lifelong dedication, relentless advocacy, a commitment to equity, and selfless service of humanity and people’s health,” said WHO Director-General, Dr Tedros Adhanom Ghebreyesus. “In a time of multiple emergencies, health crises, and conflict, we recognize that leadership in public health and science are more important than ever to advance global health. Our awardees today personify that passion.” WHO NEWS WHO announces Global Health Leaders Awards Jean-Jacques Muyembe-Tamfum and Peter Piot awarded for lifelong commitment to health In a time of multiple emergencies, health crises, and conflict, we recognize that leadership in public health and science are more important than ever to advance global health. Our awardees today personify that passion

NEWS It is a matter of great honour and pride that the state-of-the-art manufacturing facilities, the Oral Solid Dosage Unit (SDU) of The ACME Laboratories Ltd. has received the esteemed USFDA approval recently, says the company press release.  This prestigious accreditation will enable ACME to export products to the US market. Our commitment to the Quality, Safety, and Efficacy of global healthcare continues to show our dedication to imbue a positive impact on people’s lives and to serve the nation. ACME Laboratories Ltd. receives prestigious USFDA approval Incepta wins national environment award Incepta Pharmaceuticals Limited has won a “National Environment Award-2022” in an environmental protection and pollution control category for institutions.  Abdul Muktadir, chairman and managing director, received an award and a certificate from Information and Broadcasting Minister Hasan Mahmud at Bangabandhu International Conference Centre in Dhaka, said a press release. The Ministry of Environment, Forest and Climate Change organised the programme marking World Environment Day and National Tree Plantation Campaign and Tree Fair-2023. Environment, Forest and Climate Change Minister Md Shahab Uddin chaired the programme where Deputy Minister Habibun Nahar and Saber Hossain Chowdhury, chairman of the standing committee on the ministry, were present.  THE PHARMA WORLD 25

NEWS Central Asia’s premier healthcare exhibition, the 27th Tashkent International Healthcare Exhibition – TIHE 2023 was held for three long days on April 13 to April 15 at UzExpo Centre, Uzbekistan. A total of 250 companies from 13 different countries of Central Asia, including Bangladesh, participated in this event. Mr. Md. Jahangir Alam, Ambassador of Bangladesh in Uzbekistan, was the guest of honor. Mr. Jahangir and the senior officials of other countries had performed the opening ceremony by cutting the ribbon, and this was followed by a visit to the stalls. Everest Pharmaceuticals is a proud manufacturer of many life-saving drugs for hepatitis and oncology. It was a proud moment not only for Everest PharmaEverest Pharmaceuticals participates in the 27th Tashkent International Healthcare Exhibition – TIHE 2023 ceuticals Ltd but also for Bangladesh as a whole to be able to represent our promising pharmaceutical products in the 27th Tashkent International Healthcare Exhibition – TIHE 2023. THE PHARMA WORLD 27 UniHealth has launched it’s latest eye treatment lens TECNIS enhance IOL at an event jointly organized by Johnson and Johnson Vision and UniHealth Vision in the capital Dhaka recently, said a press release. The new lens will be effective in restoring the sight of cataract patients. Among others, Dr. Md. Abdur Rakib Tushar, renowned Ophthalmologist of Harun Eye Foundation Hospital; Dr. M Nazrul Islam, phaco surgeon and glaucoma specialist of Bangladesh Eye Hospital and Institute; and Dr. Vineet Ratra, Senior Consultant of Shankar Netralaya, Chennai, India presented on the topic. M. Mosaddek Hossain, Chairman and Managing Director of UniMed UniHealth Pharmaceuticals was also present on the occassion. UniHealth launches latest eye treatment lens TECNIS

Health experts highlighted on World Thalassemia Day that over 10 per cent of Bangladesh’s population are carriers of genetic disorders caused by thalassemia or haemoglobin E. According to the South East Asia Regional Office of the World Health Organization (WHO), approximately 9,000 children are born with thalassemia each year in Bangladesh, while 60,000 to 70,000 patients in the country are living with beta-thalassemia or haemoglobin E disease. At a seminar held at Bangabandhu Sheikh Mujib Medical University (BSMMU) in observance of World Thalassemia Day, speakers stressed the significance of individuals undergoing blood tests before marriage as a priority, citing these projections. They also stressed the need to create awareness among patients, their relatives, healthcare providers at all levels, and the public about the disease. BSMMU emphasised the importance of premarital blood tests to prevent thalassemia, as it can save future generations from being affected by the condition. During his speech, BSMMU ViceChancellor Prof Dr Md Sharfuddin Ahmed emphasised the importance of a screening programme for the diagnosis of thalassemia. He also stressed the need for the latest medical services, such as gene therapy and stem cell therapy, to be made available to ensure quality care for patients without the need for medical services outside the country. The event was attended by Advocate Monzil Morsed, BSMMU ProVC Prof Dr Md Moniruzzaman Khan, Treasurer Prof Dr Mohammad Atiqur Rahman, Dean of the Faculty of Medicine Prof Dr Masuda Begum, and others. The speakers at the event added that necessary initiatives should be taken at both government and private levels to achieve the goal of bringing down the number of thalassemia-affected births to zero in Bangladesh by 2028 through premarital thalassemia screening. Over 10pc people in Bangladesh thalassemia carriers 28 THE PHARMA WORLD A discussion forum and a Fatty Liver awareness workshop on the health rights of Sylhet’s marginal population were organized. This awareness program was sponsored by Jalalabad Liver Trust and hosted by Trinamool Women Entrepreneurs Society Grassroots. Prof. Dr. Mamun Al Mahatab Swapnil was the Chief speaker under the chairmanship of Bilkis Noor and the direction of Dr. Nafisa Shabnam, editor of Sylhet Mahanagar Grassroots. Dr. Arman Ahmed Shiplu, Deputy Director of Jalalabad Ragib Rabeya Medical College Hospital, addressed the issue as the special guest. The purpose was explained by Himanshu Mitra, Executive Officer of Trinamool Women Entrepreneurs Society, Grassroots. Salma Sultana Sumi, Shamsunnahar Soma, Fatty Liver awareness workshop held at Sylhet Lucky Chowdhury, Razia Khatun, and Boombox leader Golam Rabbani has also given speech among others. Pharmasia  Limited, one of the esteemed sister concerns of  SONYRANGS GROUP is setting its global footprint in Afghanistan & Bhutan market. Pharmasia received first global registration of 07 products from Bhutan Food and Drug Authority. Commercial order has also received from Afghanistan and Bhutan business partners. Those shipments will be executed very shortly. Pharmasia has a dedicated team to prepare the registration documents in regards to the global registration requirement. At present, more than 30 products are under-registration in Yemen, Hong Kong, Cambodia & Myanmar. Pharmasia is continuously working to explore its global footprint to more countries to contribute to national foreign currency. Pharmasia setting its footprint in Global Market

THE PHARMA WORLD 29 AMR n By James Gallagher The AI helped narrow down thousands of potential chemicals to a handful that could be tested in the laboratory. The result was a potent, experimental antibiotic called abaucin, which will need further tests before being used. The researchers in Canada and the US say AI has the power to massively accelerate the discovery of new drugs. It is the latest example of how the tools of artificial intelligence can be a revolutionary force in science and medicine. • AI breakthrough could spark medical revolution Stopping the superbugs Antibiotics kill bacteria. However, there has been a lack of new drugs for decades and bacteria are becoming harder to treat, as they evolve resistance to the ones we have. More than a million people a year  are estimated to die from infections that resist treatment with antibiotics. The researchers focused on one of the most problematic species of bacteria - Acinetobacter baumannii, which can infect wounds and cause pneumonia. You may not have heard of it, but it is one of the three superbugs the World Health Organization has identified as a “critical” threat. It is often able to shrug off multiple antibiotics and is a problem in hospitals and care homes, where it can survive on surfaces and medical equipment. Artificial intelligence To find a new antibiotic, the researchers first had to train the AI. They took thousands of drugs where the precise chemical structure was known, and manually tested them on Acinetobacter baumannii to see which could slow it down or kill it. This information was fed into the AI so it could learn the chemical features of drugs that could attack the problematic bacterium. The AI was then unleashed on a list of 6,680 compounds whose effectiveness was unknown. The results - published in Nature Chemical Biology - showed it took the AI an hour and a half to produce a shortlist. The researchers tested 240 in the laboratory, and found nine potential antibiotics. One of them was the incredibly potent antibiotic abaucin. Laboratory experiments showed it could treat infected wounds in mice and was able to kill A. baumannii samples from patients. The next step is to perfect the drug in the laboratory and then perform clinical trials. He expects the first AI antibiotics could take until 2030 until they are available to be prescribed. Curiously, this experimental antibiotic had no effect on other species of bacteria, and works only on A. baumannii. Many antibiotics kill bacteria indiscriminately. The researchers believe the precision of abaucin will make it harder for drug-resistance to emerge, and could lead to fewer side-effects. In principle, the AI could screen tens of millions of potential compounds - something that would be impractical to do manually. Source: BBC New superbug-killing antibiotic discovered using AI Scientists have used artificial intelligence (AI) to discover a new antibiotic that can kill a deadly species of superbug.

30 THE PHARMA WORLD Officials from the US Food and Drug Administration (FDA) and prominent European regulators said that supply chain oversight, inadequate compendial methods to test for unsafe ingredients, aging facilities and poor quality management are some of their top global compliance concerns. Multinational companies were also criticized for “not operating in a global environment” and not sharing information across their networks. These assertions were made by regulators during recent panel discussion at the International Society for Pharmaceutical Engineering’s (ISPE) Europe Annual Conference in Amsterdam. In response to a question on the regulators’ top concerns, Friedman, deputy director of FDA’s Office of Manufacturing Quality (OMQ) at the Center for Drug Evaluation and Research (CDER), said that raw material quality and safety, inadequate monographs to test for unsafe drug ingredients, and aging facilities are major problem areas. He pointed to recent poisonings related to diethylene glycol (DEG) and ethylene glycol (EG) contamination in pharmaceutical ingredients as a major source of concern. “Vulnerable test methods” are another problem, he said. “There is a risk that substitutions can occur, like what happened with heparin, and we need to be thinking of what is the next risk on the horizon? What is the next material that can be vulnerable to such tragic poisoning and adulteration … This is an area that really needs special attention.” There is also a need to update and modernize certain pharmacopeial monographs. He noted that “some compendia do not have good monographs for glycerin, propylene glycol and other at-risk excipients, so that is an area that needs improvement.” Another issue of concern: insufficient quality systems at aging facilities. He said that such facilities are “unreliable with low capability and are not appropriate for new product demand.” “The question is, will senior management keep an aging facility operating at the edge of failure or will they invest in more reliable facilities,” said Friedman. “Are you designed for quality are not? Design is one of the biggest parts of the quality system.” Regulators were also asked to address what role multinational companies can play to support   global harmonization efforts for inspections. Rosa, who directs the Division of Drug Quality I in FDA’s OMQ, said multinational companies are not always the best models of global harmonization because these companies “are not operating in a global environment.” Rosa said “one of the things that we are seeing, and it is a little bit unfortunate, is that many global companies have multiple facilities around the world are not operating in a global environment. We are still seeing a lot of silos. Companies are implementing corrections at their own facilities and not necessarily sharing this information across their networks.” He added that such firms need to strengthen their internal audit programs and share the results of audits across the network to learn from their quality mistakes. “What is happening over the past four or five years is that the regulators are serving as a quality control unit for these companies. And it is challenging for us.” The panel was asked to describe how firms can ensure sustainable GMP compliance and what skills industry needs to achieve this level of compliance. Friedman said that one way to achieve such GLOBAL NEWS Regulators discuss concerns, sustainable GMP compliance at ISPE Europe “We are seeing, and it is a little bit unfortunate, is that many global companies have multiple facilities around the world are not operating in a global environment.”

THE PHARMA WORLD 31 compliance is for firms to auto - mate their manufacturing process - es, including the pharmaceutical labs. Friedman said that when he goes into pharmaceutical labs, he still sees staff use manual pipet - ting, which he called “ridiculous.” He said that “everyone should be doing automated pipetting” as well as automate their sam - ple preparations.” He added that “there are some labs that are fully automated and use digitized pho - tos of the microbiology lab so that way you don’t question whether someone fudged the results for your petri dish.” Panelists were asked to address how regulators can support a “safe space” for industry to develop new and novel technologies without the fear of regulatory delays. Korakianiti, who heads EMA’s Quality and Safety of Medicines department, said the EU’s recently established Quality Innovations Group (QIG) is such a space in the EU and is designed to help trans - late new ideas into reality. “It is very important to learn to - gether, to have a space where we can hear the successes of what you’re trying to do as well as the failures and find a solution,” she said. To ease the process of convert - ing these innovations into ap - plications, it is also important for industry to meet early with regu - lators on these technologies, as - serted James Pound, the deputy director of standards and compli - ance at MHRA. Pound added that a “sandbox - ing approach,” which is used in the UK to test new regulatory ap - proaches in the financial sector, could also be leveraged in the pharmaceutical space. Ibarra Lorente, head of the pharmaceutical inspections and enforcement for AEMPS, said that industry should also engage with academia on bringing new tech - nologies to market. Source: ISPE

Prof. Dr. Mohammod Shahidullah (PRL) Department of Neonatology Bangabandhu Sheikh Mujib Medical College & University, Dhaka Chairman, Board of Management Bangladesh Shishu Hospital & Institute President, Bangladesh College of Physicians & Surgeons “Paediatricians must have a mindset with excellent human qualities and treat a child with respect” INTERVIEW As an eminent Paediatrician of the country, would you please give us, in brief, an overall scenario of Paediatric Diseases and their treatment in Bangladesh? We all know that children constitute a significant portion of the country’s total population. These children are also our future. We need to remember that child health is very crucial and if children have good health from birth throughout childhood, they will not only be physically fit, but also intellectually capable. They will also have successful academic carreer and professional excellence in future. And finally, when a child becomes an adult, having a nice and healthy childhood trajectory is more likely to maintain good health. Therefore, child health is so crucial. However, when it comes to the issue of child health, we still see that children are suffering from many diseases. Across the globe, and particularly in resource-limited countries such as Bangladesh, the common child health problems are pneumonia, malnutrition, diarrhoea, drowning etc. It is note worthy that two third of under five children death is contributed by newborn death. Overall, neonatal death, particularly from prematurity is a significant problem in Bangladesh’s underfive population. So, if we summarize, the main child health problem in Bangladesh are pneumonia, malnutrition, diarrhoea, drowning and preterm /low birth weight & its complications. However, deaths from pneumonia, malnutrition, diarrhoea, preterm and low birth weight have decreased partly in last 2 decades but the number remains fairly high in comparison to the developed countries. Prematurity is one of the major killers of children under 5. What can be done to combat this and improve the survival and well-being of premature babies? Prematurity, low birth weight and its complications, neonatal infection, perinatal asphyxia or birth asphyxia, birth defect and birth injuries are the five main causes of mortality among newborns. Among these five causes, complications related to prematurity and low birth weight is a significant contributor of under-5 mortality.  So, we have to focus on prematurity and low birth babies. Now in order to reduce neonatal mortality due to preterm birth, we must address few issues. First and foremost, we should take early measures to avoid preterm births. Child and adolescent pregnancy should be avoided since these are significant causes of birth of a premature baby. So, if we can prevent that through promotion of conception after 18 years, or even better, between 20 and 30 years, we will be able to combat mortality due to preterm birth significantly. THE PHARMA WORLD 33

34 THE PHARMA WORLD Secondly, when a woman becomes pregnant, whether at the right age or early age, she should receive four prenatal appointments and quality antenatal care. Therefore, it’s not only the number of visits, but also the quality of antenatal care. Not only should the mother’s weight and blood pressure be taken into consideration, but also events like maternal diabetes, hypertension, urine infection, albumin in the urine are also important. All of these need to be addressed during antenatal care. We also need to consider that mother’s mental health is important. The likelihood of a baby being born prematurely will be minimized if we can provide quality antenatal care. It is an important preventative measure. However, even after all these measures other factors can also lead to premature births. Now once the baby is born the first thing is to ensure essential newborn care. This means keeping the baby warm and that is known as thermal care. This can be achieved by skin to skin care with the mother. When the baby is born, whether by vaginal birth or caesarean section, he or she should be placed on the mother’s chest right after birth. This is known as zero separation. Preterm and low birth weight babies require immediate kangaroo mother care (iKMC), which is recommended by WHO. Kangaroo Mother Care, which involves skin-to-skin contact and exclusive breastfeeding, significantly improves a premature or low birth weight baby’s chance of survival. Another important issue is to prevent neonatal infection. We must take care to of a newborn in a hygienic way. Last but not the least, certain extremely preterm newborns who are also very low birth weight may require treatment in Special Care Newborn Units (SCANU) and Neonatal Intensive Care Unit (NICU). So, across the country, in every district hospital, we need to have a functional SCANU. Another important intervention is: If a mother is going to give birth to a premature baby, between 24 and 34 weeks of pregnancy, we should provide antenatal corticosteroids to those mothers. Maternal administration of antenatal corticosteroids before anticipated preterm birth is one of the most important interventions to improve neonatal outcome. They are effective in reducing neonatal respiratory morbidity and other complications of prematurity. What are the common causes of neonatal sepsis in Bangladesh? What can be done to prevent it? One of the most common causes of neonatal sepsis is any maternal infection during  pregnancy. For example, if the mother has a persistent infection such as UTI or chorioamnionitis, the baby may be delivered with congenital infection or pneumonia. If the mother’s membrane ruptures for more than 18 hours, the infant is more likely to get sepsis. Another issue is ensuring safe and clean delivery. Lacking in this regard will increase the risk of infection to the newborn. Moreover, if we do not apply Chlorhexidine to the umbilical cord soon after birth, if we do not promptly transfer the infant to the mother, and if we do not use clean cloths when wrapping the baby, these may lead to neonatal infection. And, most importantly, if we do not provide breast milk soon after birth and do not continue exclusive breastfeeding, the infant may get infections. Breastmilk not only provides nutrition but also protects against infection. Therefore babies should start breastfeeding within 1 hour of birth. Knowing all these facts- when a mother becomes pregnant, she must be screened for infections. If mother has a urinary tract infection, chorioamnionitis and prolonged rupture of membrane, she should be treated accordingly. What diseases our children confront in summer usually and what preventive measures parents should take? Despite being a spring season illness, chickenpox occasionally appears around the start of summer. In summer many viral illnesses, fever, cold cough, headaches, and sore throats are prevalent. Because of dryness in summer chance of drinking polluted water is common & this can cause diarrhoea, typhoid etc. Nowadays Dengue is common in late summer and during the months of monsoon. Last few years children suffering from Dengue have multiple Co-morbidities leading to hospital admission & even unwanted death. How do you propose to address child malnutrition and where do we stand in this regard? I believe it is important to address child malnutrition even before a mother becomes pregnant. Therefore, if a woman is short, skinny and thin, if her weight is low, there is a chance of birth of a small baby. And that baby may possibly suffer from malnutrition in childhood. The adolescent girl and even women of reproductive age should, therefore, be provided with sufficient nutrition prior to conception. Throughout the prenatal period, if we can provide quality care to a mother then the fetus in the womb will have optimum growth and is likely to be born with a good birth weight. In that case childhood malnutrition is less likely to occur. Moreover, healthy neonatal period, infection prevention, and ensuring proper nutrition during childhood can prevent malnutrition. Besides six months of exclusive breastfeeding, proper complementary feeding including rice, protein, Oil and vegetable should be started from six months of age. What if the infant gets diarrhoea? Breastfeeding should be continued instead of giving antibiotics. Also nursing and supplemental feeding for infant above six months of age should continue. Where do we stand as regards paediatric/neonatal care? What is your suggestion for improving the total scenario in the child healthcare system? In Bangladesh, we currently have infrastructure to provide child health and newborn care. However space and bed allocation for newborn and Paediatric patients fall short of demand. Moreover there is a quality is-

THE PHARMA WORLD 35 sue as well as issue of equity. So, what exactly do I mean? We have a community clinic near to every door step in rural areas. Then there’s the Union Health Centre, Sub-district or Upazilla Health Complex, District hospital, Medical Colleges, and finally the large Institutes. So our infrastructure isn’t all that bad. And child health care is available in all of those facilities with some limitation. Now we need to have enough beds for the infants and children. Very importantly we are lacking in essential human resources, such as paediatricians and nurses to care for children and newborns. Finally I want to emphasize on quality of care. Equity is another important issue. It is observed that most of the facilities and resource allocation are more concentrated in metropolitan areas such as Dhaka, Chittagong etc. But babies are born across the country that is both urban and rural areas. Therefore child health care and newborn care should be provided across the country maintaining quality of care. What extra qualities do you think paediatricians should possess to provide effective paediatric care? What is your advice to future paediatricians? Not  just for paediatricians, it is true for every doctor that before becoming a doctor, you must  first become a good human being. So, every doctor, including paediatricians, should keep in mind- “Well, my patient is my first priority.” For that, they must have good human qualities and mindset to treat a child with respect. So, first and foremost, establish yourself as a good human being, then act as a doctor. Besides this a competent doctor must have both expertise and skills, not simply knowledge. A competent doctor is one who takes proper history of a patient. Conducts examination of the patient thoroughly and ask for bare minimum of investigations. Finally, my advice to all aspiring paediatricians and junior doctors is to first strive to be a better human being before attempting to become a competent physician. n

THE PHARMA WORLD 37 INTERVIEW Prof. Md. Abid Hossain Mollah Neonatal & Child Health Specialist Former Head of Paediatrics, Dhaka Medical College & Hospital “Holistic childcare, quality education, are the keys for sustainable development of our country and the care should be planned with empathy, not with sympathy” As an eminent Paediatrician of the country, would you please give us, in brief, an overall scenario of paediatric diseases and their treatment in Bangladesh? In Bangladesh, the incidence of child mortality has markedly dropped in recent years. Despite that, I’ll give you an overview of the diseases, still influencing child health, and their morbidity and mortality. Infections are still the, major reasons of suffering for our children despite a tremendous success of our national immunization program. The rate of vaccine-preventable diseases like tuberculosis, diphtheria, whooping cough, measles, tetanus etc., has dropped significantly compared to the prevaccine era. Pneumonia and meningitis rates have also come down due to vaccination. However, pneumonia still poses a big threat to our children, especially those under 5 years of age. Sufferings of children from diarrhoea, due to cholera, rota virus are also another health challenge in our country and we have no effective vaccines to prevent it. Bangladesh is a densely populated country, so food & water contamination is very common here which causes diarrhoea. Rotavirus is most common among under-5 Bangladeshi children. Other common respiratory illness affecting under 2 children is acute viral (RSV) bronchiolitis, a different illness from pneumonia, poses a significant impact on childhood morbidity. Childhood asthma, is again on rise. The major contributor of high infant mortality rate (IMR) is from high neonatal deaths. Among these, pre-term birth and associated complications is a major threat for survival of newborn babies. Perinatal asphyxia, which is the failure to establish breathing at birth, is another major killer of newborns followed by high infections of the newborns (sepsis). In addition to the above, non-communicable diseases are going up among our children and contributing significantly to childhood morbidity. These are obesity, with associated complications like obstructive sleep apnea, type 2 diabetes, adenoid enlargement, fatty liver, hypercholesterolemia, connective tissue diseases, hypertension etc. Another largely overlooked cause of deaths of our children are accidents & emergencies and drowning, which is the second leading cause of death for children under the age of five in our country. With the advent of diagnostic facilities, many genetic disorders are identified, and found prevalent among children of our country. Marriage between first-degree relatives, having

children at an older age, etc. can lead to chromosomal anomalies, genetic disorders like thalassemia and primary immune deficiency disorders, cystic fibrosis etc. and these are emerging. But due to limitation of proper investigation facilities, we failed to understand their actual magnitude in the country. There are also conditions specific to children’s development, i.e., autism spectrum disorder, attention deficit hyperactive disorder, speech delay etc. which are becoming more prevalent in our society. A major worry for children’s suffering is still from dengue and malaria. Prematurity is one of the major killers of children under 5. What can be done to combat this and improve the survival and wellbeing of premature babies? About 30% of delivered babies are preterm in our country. To prevent their unusual deaths, 1st thing is to ensure proper and regular antenatal care. Why is antenatal care so important? Firstly, during antenatal checkups, maternal diseases causing preterm delivery e. g. maternal diabetes, anemia, hypertension can be identified & treated early with appropriate drugs. Secondly, to monitor the baby’s in utero growth and to identify the problems, if any. Thirdly, to advise for proper nutrition, proper rest and finally, to counsel the family members on the significance providing psychological support to the pregnant mother by the family members. When a mother overcomes all these stressful situations, she naturally can give birth to a healthy baby. The fourth thing is to guarantee specialized and unique management and care for the pre-term infant. So, to achieve that, the health centers need to be equipped with enough human resources, specifically qualified nurses, skilled birth attendants. Trained nurses are more important to provide essential care required for these special babies round the clock. Another critical care issue, essential for these preterm and LBW babies are to monitor the newborns’ eye sight, hearing, and brain development as soon as possible in order to detect and treat these problems. These require widespread mass awareness and countrywide screening services. Water-borne diseases like jaundice, typhoid and dysentery some of the common summer illnesses in children. How to prevent and treat them? The diseases you just named here are highly prevalent in children, particularly among the school-going children. Why? Contaminated foods and drinks are sold everywhere on the streets, having no quality control. The street food vendors sell chotpoti, fuchka, jhalmuri right outside the gates of these schools. Children are very attracted to these spicy foods. These foods are unhygienic, left open in the streets, and is a prime reservoir of typhoid, jaundice and dysentery pathogens. The vendors do not maintain proper hygiene themselves either. The children are eating and drinking these may be due to their lack of awareness. Parents should pay emphasis on their children’s health by counselling their children about the dangers of these foods, not only on their academic performance. Secondly, strict laws should be implemented to guarantee food safety and hygiene of these items. The sellers should also be made aware of the risks of selling stale, dated items and the importance of using fresh, good-quality ingredients to make their food. They should also be taught about personal hygiene, such as washing their hands with soap, wearing clean clothes, and keeping their surroundings clean. Thirdly, parents and teachers should counsel students about the dangers of eating open foods, where flies and dirt from the street settle. So, building up awareness among the children is most important to prevent these food and water borne diseases. Could you please enlighten us on the prevalence and pattern of congenital anomalies in newborns of our country? Congenital anomalies can occur anywhere in a newborn’s body, from head to toe. Birth defects  mostly occur in the first three months of pregnancy, when the organs of the baby are developing. Any insult during the first trimester, e.g., due to any infection, physical injury, food or medicines, or nutrient deprivation might result in congenital anomalies. So, women should never take any medicine without a prescription during pregnancy, which can harm the foetus. She should also avoid contact with any person with contagious diseases. Congenital heart defects are the most common type of birth defect.  If a comprehensive newborn examination is done right after birth, many anomalies can be detected early and be treated timely. What is the difference between beta thalassemia major and minor? Should parents be concerned about beta thalassemia minor in their children? How is beta thalassemia treated? When a child is categorised as beta thalassemia major, it means he or she has been suffering from the disease i.e. the child has  low levels of haemoglobin with low levels of oxygen in his body since his early infancy and growth failure. For his survival, he needs frequent blood transfusions. In addition, because of the hemolytic process in thalassemia and repeated transfusion there is a huge accumulation of iron in different organs and tissues of the body starting from brain, heart, liver, kidney, adrenal and so on with their progressive dysfunction. So, along with blood transfusion, they need medicines to expel extra iron from their body, medicines for their growth & development and to manage specific organ dysfunction, and bone marrow transplant, the ultimate cure for thalassemia major. 38 THE PHARMA WORLD

THE PHARMA WORLD 39 On the other hand, when a child is categorised as beta thalassemia minor, it means, he or she is only the carrier of the gene, inherited from the parents, but neither will suffer from the disease nor will develop any complications and also will require any treatment in this clinical status. They will grow up like other normal child and as a rule parents should not be disheartened on thalassemia carrier. Where do we stand as regards paediatric/neonatal care? What is your suggestion for improving the total scenario in the child healthcare system? The paediatric population includes children from birth up-to 18-years of age and in Bangladesh, it is about 47% of total population. To provide optimum care to this huge group of population, we need skilled manpower including trained doctors, trained nurses and other healthcare staff along with medicines & other logistics. But the basic defect in optimum child care process through skilled doctors is “the non-recognition of Pediatrics as a major subject/discipline” in our MBBS curriculum like medicine, surgery and gynae & obstetrics. Therefore, the MBBS students & doctors (the predominant health care provider) are greatly influenced by the dominance of the major subjects. The emotions, thought process etc of the students are nurtured within the major domains. As a result, the students get very little exposure to child health, getting little chance to develop child “management skills”, essential for offering optimum treatment as well as addressing the health issues of considering the huge childhood population in the country. The pediatric assessment in final MBBS examination is still not conducted as a separate subject as Pediatrics but within the subject medicine throughout many decades. So, to develop skilled manpower to provide optimum child care, it is essential to declare and execute “Pediatrics as a major subject” and to re-structure and re-design our MBBS curriculum as Pediatric friendly, so that the MBBS students and future doctors will get better exposure and better training who can handle the paediatric problems confidently. I’m giving more emphasis on the MBBS curriculum because not all MBBS graduates will pursue paediatrics as their post-graduate specialty. So, in order to care for such a large children population, we must develop skills during the MBBS level. Secondly, we must broaden the area of research, particularly studies aimed at specific illnesses or abnormalities in children. Our paediatricians should be more active in research so that we can use our own data as a reference. Because we are still heavily reliant on foreign statistics, which does not accurately represent our children. Thirdly, we need to prepare guidelines for the management of common diseases affecting the children, which is to be followed uniformly, everywhere throughout the country. Antimicrobial resistance (AMR) is a serious issue due to practice of taking antibiotics even for minor ailments. Therefore, it is essential that specific guidelines are consistently followed across the nation if we want to protect ourselves against AMR and to avoid jeopardizing the child healthcare system. Lastly, the capacity for diagnostic facilities throughout the country should be enhanced, where we have major limitations. Because, without proper diagnosis, we will not be able to treat properly. What extra qualities do you think paediatricians should possess to provide effective paediatric care? What is your advice to future paediatricians? I would say a paediatrician should act empathically. You need to consider the child who came to you as your own. You should assess, treat, and provide care for the child just the way you expect for your own child. Otherwise, you’ll not be able to ensure rational assessment and rational use of the drugs. I always tell my students, “You all will become parents one day. But I’ll feel very sad if any of you fail to recognize the need of your own child, fail to treat your own child.” Our country will only move forward if we can ensure proper care for the children, and the care should be given with empathy, not with sympathy. n

THE PHARMA WORLD 41 INTERVIEW Prof. Dr. Md. Abdul Mannan New-born & Child Specialist Professor, Department of Neonatology BSMMU, Dhaka “There is no alternative to regular follow-up care and early intervention” Jaundice, primarily caused by a high level of bilirubin, affects a considerable number of infants in Bangladesh. Additionally, low birth weight, often associated with malnutrition and poor maternal health, increases the vulnerability of newborns to various infections and illnesses. Neonatal mortality contributes more than 65% of under-5 mortality in our country. The picture is improving, nevertheless. One of the most significant achievements highlighted in the 2022 Bangladesh Demographic and Health Survey (BDHS) is the decline in childhood mortality rates. The under-5 mortality rate decreased from 43 to 31 per 1000 live births, and neonatal mortality declined from 27/1000 to 20/1000 live births between 2017 and 2022, reflecting a commendable 12% drop. We are getting closer to the SDG target, which is to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births. Newborn screening (NBS) for congenital hypothyroidism (CH) has been a successful public health initiative over the last few decades by promoting early detection of this very preventable illness. Previous pilot and phase 1 programs conducted in Bangladesh from 1999 to 2011, revealed a higher incidence of CH compared to global data. As a result, a second phase of newborn screening program was initiated in Bangladesh to specifically detect cases of CH. Despite all these, we still do not have countrywide screening programme. Addressing neonatal diseases in Bangladesh requires a comprehensive approach, including improved healthcare infrastructure, increased access to birth attendants, better antenatal care, and enhanced awareness among caregivers about neonatal health and hygiene practices. Prematurity is one of the major killers of children under 5. What can be done to combat this and improve the survival and well-being of premature babies? Prematurity is indeed a significant cause of child mortality worldwide, and efforts to combat this issue are crucial for improving the survival and well-being of premature babies. First of all we need Prenatal care and education. Ensuring access to quality prenatal care is vital. Regular check-ups during pregnancy can help to identify risk factors and enable early interventions to prevent premature birth. Educating expectant mothers about healthy lifestyles, proper nutrition, and the importance of seeking medical care can also contribute to reducing premature births. Establishing well-equipped NICUs staffed with trained healthcare professionals can significantly enhance the survival rates of premature babies. These units provide specialized care, monitoring, and interventions such as respiratory support, temperature regulation, and nutritional support. Kangaroo mother care (KMC), where the premature baby is placed on the mother’s chest right after birth, without deAs an eminent neonatologist of the country, would you please give us, in brief, an overall scenario of neonatal diseases prevalent in Bangladesh? What are your thoughts on recent developments in neonatal health in our country? Neonatal diseases continue to pose significant challenges in Bangladesh, affecting the health and well-being of newborns across the country. Common neonatal diseases include perinatal asphyxia, neonatal sepsis, jaundice, prematurity and congenital anomalies. Asphyxia, caused by a lack of oxygen during delivery, contributes to a significant number of neonatal deaths. Respiratory distress syndrome also poses a threat to newborns. One prevalent condition is neonatal sepsis, which is a severe bloodstream infection. It remains a leading cause of mortality among newborns due to inadequate healthcare facilities and limited access to quality medical services in rural areas.

THE PHARMA WORLD 43 lay, has numerous benefits. KMC is an approach of providing early, continuous, and sustained skin-to-skin contact between mother and baby, exclusive breastmilk feeding, and follow-up care for high-risk neonates. It has been shown to lower mortality and morbidity in preterm and low birthweight neonates by protecting against infection, regulating temperature, breathing, and brain activity, and enhancing mother-baby bonding. Implementing strict infection prevention and control measures in hospitals and NICUs, including hand hygiene, sterile procedures, and proper sanitation, can minimize the risk of infections. Prematurity also increases the likelihood of vision impairments. According to WHO guidelines, newborns weighing less than 1.5 kg, having a gestational age of 30 weeks or less, having hypotension, or receiving oxygen supplementation, should be evaluated for retinopathy of prematurity (ROP). The first ROP screening should take place by 25-30 days of life. This is possible with a coordinated effort of all health care personnel involved in childcare. All eligible babies should be screened before discharge. Preterm babies may also face longterm developmental challenges. We must create an atmosphere that promotes their neurological and sensory development. There is no alternative to regular follow-up care and early intervention. Early intervention services, including physical therapy, occupational therapy, and speech therapy, can address any developmental delays or disabilities at the earliest stage. Raising public awareness about the causes, risks, and consequences of prematurity is crucial for garnering support from family and society, as only a healthy mother can give birth to a healthy child. Advocacy efforts can help prioritize prematurity prevention and support for premature babies within healthcare systems and communities. What causes neonatal jaundice and what are the risk factors? Is there a way to prevent it? Neonatal jaundice is a condition characterized by the yellowing of a newborn’s skin and eyes due to elevated levels of bilirubin in the blood. The increased bilirubin load is due to  increased red blood cells (RBC) mass and a decreased RBC lifespan. It occurs when the liver is unable to efficiently process and eliminate bilirubin, which is a byproduct of the breakdown of RBCs. The main cause of neonatal jaundice is physiological immaturity, as the baby’s liver is not yet fully developed. Another concern is blood type incompatibility between the mother and baby. If the mother is Rh-negative and the baby is Rh-positive, the mother’s immune system may produce antibodies against the Rh factor present in the baby’s blood. These antibodies can cross the placenta and attack the baby’s red blood cells, causing them to breakdown and increase bilirubin levels. Similarly, ABO incompatibility arises when a mother’s blood type is O, and her baby’s blood type is A or B. This can happen in the first 24 hours after birth. Certain infections i.e., sepsis can also lead to the development of Jaundice. Risk factors for neonatal jaundice include prematurity, a family history of jaundice, blood type incompatibility, bruising during birth, and certain medical conditions such as glucose-6-phosphate dehydrogenase deficiency. Prevention of neonatal jaundice is challenging, but steps can be taken to manage the condition. Close monitoring of bilirubin levels, especially in high-risk infants, is important. Phototherapy, which involves exposing the baby’s skin to special lights, is a common treatment to reduce bilirubin levels. In severe cases, exchange transfusion may be necessary to replace the baby’s blood with fresh blood. Prompt medical attention and early detection are crucial for effective management of neonatal jaundice. Sepsis is one of the common causes of neonatal mortality. How can we prevent neonatal sepsis? What is the role of the mother and family members in this regard? Neonatal sepsis continues to remain a leading cause of morbidity and mortality among infants, especially in middle and lower-income countries. Newborns with early-onset neonatal sepsis may get an infection from their birthing parent before or during delivery. Premature babies are most vulnerable to sepsis. These infections occur due to prolonged labour (more than 18 hours) and if there’s an infection in the placenta and amniotic fluid (a condition known as chorioamnionitis). Then, there is late-onset neonatal sepsis where newborns get an infection after delivery due to an aseptic environment and through unclean medical equipment such as catheters, IVs and tubes. Most newborn deaths from infection could be prevented by ensuring that all babies receive essential newborn care (ENC), including appropriate cord care, early initiation and exclusive breastfeeding, maintenance of warmth, and prompt treatment with antibiotics. Hygienic practices such as clean delivery and using sterile equipment are also known to reduce newborn infections. The use of 7.1% chlorhexidine on the umbilical cord stump has been shown to lower neonatal mortality. Breastfeeding should begin within an hour of delivery to decrease infant fatalities, in part because it prevents neonatal infection by providing antibodies to help the baby fight illness. Exclusive breastfeeding also lowers a baby’s risk of illness from unsanitary food replacements. There is a big part of mother and family members in preventing neonatal sepsis. Adequate prenatal care is vital. Regular antenatal visits allow healthcare professionals to monitor the mother’s health, identify any potential infections, and provide appropriate treatment or preventive measures. Then, maintaining good hygiene is a must. Family members should practice proper handwashing before handling the baby. Creating a clean and safe environment for the newborn is crucial in preventing infections. Family members should ensure that the baby’s clothes, bedding, and other items are regularly washed and kept in a hygienic condition. n

THE PHARMA WORLD 45 INTERVIEW As an eminent Paediatric rheumatologist of the country, would you please tell us about the common rheumatic diseases that affect children, and how do they differ from rheumatic diseases that affect adults? Children can develop a variety of musculoskeletal, arthritic, and connective tissue illnesses, which are referred to as paediatric rheumatic diseases. These conditions can harm a child’s gastrointestinal system, muscles, joints, skin, and eyes. Each of these autoimmune and inflammatory illnesses has its own unique symptoms, despite the fact that they all have some common ones like pain, heat, and swelling. Children of any age and from any ethnic background can develop rheumatic illnesses. Juvenile idiopathic arthritis (JIA), rheumatic fever, systemic lupus erythematosus (SLE), Henoch-Schonlein Purpura (HSP), and juvenile dermatomyositis are among children’s most frequently observed rheumatic health conditions. There are significant differences regardless of the fact that many rheumatic disease symptoms in children and adults are similar. These include variation in presentation and complications, differential diagnoses to consider, medication side effects, impact on growth, rehabilitation challenges, and psychosocial issues. Rheumatoid symptoms usually involve discomfort and pain. Children may not understand their condition, which can cause them to be scared and perplexed by the ongoing pain. The clinical characteristics and complications of the various subtypes of JIA are quite different from those found in adult rheumatoid arthritis. The HSP course in adults differs from that in children as adults tend to have less gastrointestinal involvement, joint symptoms, and fever, but more long-term renal complications. Therefore, they may require more aggressive medical therapy. Because of the increased occurrence of renal disease in adult patients, complete recovery of HSP is only 89% in adults compared with more than 95% in children. The 1997 ACR criteria for the classification of SLE, established on adult populations, are applied to children. Although childhood and adult SLE are similar in many aspects, important differences do exist in the epidemiology, disease manifestations, treatment approaches, and complications. In younger children, the female: male ratio is only 5:1, while in post adolescence, the female: male ratio approaches that is seen in adults (approximately 10:1). Certain clinical findings, such as Sjogren’s symptoms or isolated discoid lupus, which are not uncommon in adults, are seen only rarely in pediatric patients. Children with SLE tend to have a more severe disease course and require high-dose corticosteroid treatment more often than adults. Children with SLE are also more likely to experience major hematologic involvement and renal impairment. Cognitive dysfunction associated Prof. Dr. Md. Jahangir Alam Director Bangladesh Shishu Hospital and Institute, Dhaka Rheumatic heart disease has the most devastating effects on children and young adults

with neuropsychiatric lupus is more complex to diagnose and determine in children than in adults. Complications seen in JDM are different from those seen in adults with dermatomyositis. Calcinosis is a major cause of morbidity in JDM, seen most often in children who did not respond to treatment or were treated late secondary to delay in diagnosis. Mortality, which is very rare nowadays, is usually secondary to respiratory insufficiency and pneumonia, or to gastrointestinal vasculitis with ulceration and bleeding. Interstitial lung disease seen in some adults with dermatomyositis is extremely rare in JDM. In the adult population, dermatomyositis is more frequently associated with malignancy than JDM. What is rheumatic fever, and how does it affect children? What symptoms should parents look out for in their children? Is it curable? Rheumatic fever (RF) used to be a fairly common disease among children in developed countries until about the middle of the 20th century. It was a major cause of death in children until 1960 and a common cause of chronic structural heart disease in developed countries. In developing countries, it still remains a major cause of death and heart disease. Rheumatic fever is an illness caused by a particular type of bacterium called group A betahemolytic streptococcus (GAS). It is the same bacteria that can cause a  sore throat. It can affect the heart, as well as joints, skin, and nervous system. Symptoms of rheumatic fever appear between one and five weeks after a sore throat, with an average of three weeks. In recurrent cases, this incubation period is shorter, in keeping with a faster immune response. The diagnosis is based on major and minor criteria. In acute disease the arthritis and toxicity are obvious but it can be more insidious with mild carditis. This probably accounts for only about half of those with typical rheumatic heart disease giving a history of rheumatic fever. Diagnosis is based on Jones Criteria that were devised in 1944, revised in 1992, and updated in 2015. The update included the role of echocardiography to detect subclinical valvular lesions. They can be used to identify patients with a high likelihood of having RF. Jones Criteria A method of identifying patients with a high likelihood of having RF: l Evidence of recent streptococcal infection (e.g., history of scarlet fever, positive throat swab, or rising or increased anti-streptolysin O titer (ASOT) >200 U/mL or DNase B titer). l Plus, two major criteria; or l One major and two minor criteria. Definitions of these criteria are set out below. Major criteria 1. Polyarthritis: l The most obvious presenting feature is a flitting or migratory arthritis affecting large joints like the knees, ankles, wrists and elbows. l The joints are hot and red with decreased range of movement. Typically, one joint is exquisitely painful and inflamed while another is improving. l Usually one or two joints are affected at any time with each being only involved for between a few hours and a few days. Aspirin has been the traditional treatment but nowadays other non-steroidal anti-inflammatory drugs (NSAIDs) might be considered in view of Reye’s syndrome. If it fails to respond, consider an alternative diagnosis. 2. Carditis (occurs in 40% of patients): l There is pancarditis affecting the pericardium, myocardium, and endocardium. l Endocarditis leads to valvular heart disease which, along with myocarditis, is fatal in about 1%. l Examination of the pulse will show tachycardia beyond that expected for the temperature. A murmur of aortic regurgitation is common in older children or young adults. Auscultation of the heart may reveal a pericardial rub. It is present in 40-60% without chorea and 20-30% with chorea. Carditis has characteristic findings on Doppler echocardiography. The mitral valve is the most common to be involved at 65-70%, with the aortic valve second at 25%. Aortic valve disease, unlike most other manifestations of this disease, is more common in males. The tricuspid valve is affected in barely 10% and involvement of the pulmonary valve is very rare. Nearly all acquired mitral valve disease is rheumatic in origin. Certain characteristic murmurs have acquired eponymous names: Carey Coombs’ murmur is a soft, short diastolic filling murmur due to vegetation on the mitral valve. Austin Flint’s murmur is from aortic regurgitation as the vibration of the anterior leaflet of the mitral valve is buffeted simultaneously by the blood jets from the left atrium and the aorta. 3. Chorea (also known as Sydenham’s chorea and ‘St Vitus’ Dance’): l Occurs in 10-30% of patients. l It usually presents in children between 7-12 years, with a female preponderance. l There are both psychological and physical features. It causes rapid and purposeless movements, particularly of the face and upper extremities. l Pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection (PANDAS) and Tourette’s syndrome are other varieties of movement and neurological disorders described. l It may stop when the patient sleeps. 4. Subcutaneous nodules: l Occur in 10% of patients. l They are infrequent and appear over the extensor surfaces of the elbows, knees, ankles, knuckles, scalp, and spinous processes of the lumbar and thoracic vertebrae. l They are firm, painless lumps from a few millimeters to 2 cm in size. l They are normally in crops of THE PHARMA WORLD 47

48 THE PHARMA WORLD three or four, appearing 2-3 weeks after the onset of fever. l The histology resembles Aschoff bodies found in the heart and they are indicative of severe carditis. 5. Erythema marginatum (also known as erythema annulare): l It occurs in about 5-15% of patients. l The rash comprises pale-red macules or papules between 1 cm and 3 cm in diameter on the trunk and proximal limbs but never on the face. l The rash occurs early in the disease and remains long past the resolution of other symptoms. l It is exacerbated by heat and fades when the patient. Minor criteria 1. Fever l This is present in 90% of cases. It is usually over 39°C, stays high for a week, and is lower for the following two weeks. l In pure chorea the patient may be apyrexial. 2. ESR or serum CRP are raised (greater than 60 mm/h or 3.0 mg/dl respectively). 3. Arthralgia (but not if arthritis is one of the major criteria). 4. Prolonged PR interval (but not if carditis is the major criterion). 5. Those working in countries where there is a higher risk of rheumatic fever should note that there are slightly different Jones criteria for those whose patients are at a medium or high risk of rheumatic fever. Would you please tell us about the role of antibiotics in preventing rheumatic fever, and how important is early treatment of strep throat in preventing the condition? Rheumatic fever is an immune-mediated disease following a GAS infection. While the infection is treatable, its consequences might not always be. All rheumatic fever patients should be advised to undergo bed rest and closely observed for manifestations of carditis. They can be allowed to ambulate when the signs of acute inflammation have subsided. However, patients with carditis often require bed rest for longer periods. The main aims of management are to: l Eradicate the streptococcal infection if the infection is still present (usually pharyngitis). l Suppress inflammation arising from the autoimmune response. l Provide supportive treatment, particularly for cardiac complications such as congestive cardiac failure. Once the diagnosis of acute RF has been established and regardless of the throat culture results, the patient should receive 10 days of orally administered penicillin or amoxicillin or a single intramuscular injection of benzathine penicillin to ensure eradication of GAS from the upper respiratory tract. If penicillin allergic, 10 days of erythromycin, 5 days of azithromycin, or 10 days of clindamycin is indicated. After this initial course of antibiotic therapy, long-term antibiotic prophylaxis for secondary prevention should be instituted. Prevention of both initial and recurrent episodes of acute rheumatic fever depends on controlling GAS infections of the upper respiratory tract. Prevention of initial attacks (primary prevention) depends on the identification and eradication of GAS-causing acute pharyngitis. Primary Prevention Appropriate antibiotic therapy instituted before the 9th day of symptoms of acute GAS pharyngitis is highly effective in preventing first attacks of acute RF. However, approximately 30% of patients with acute RF do not recall a preceding episode of pharyngitis and did not seek therapy. Secondary Prevention Secondary prevention is directed at preventing acute GAS pharyngitis in patients at substantial risk of recurrent acute RF. Secondary prevention requires continuous antibiotic prophylaxis, which should begin as soon as the diagnosis of acute RF has been made and immediately after a full course of antibiotic therapy has been completed. Because patients who have had carditis with their initial epiChemoprophylaxis for Recurrences of Acute Rheumatic Feber (Secondary Prophylaxis) Drug Dose Route Penicillin G benzathine 600,000 IU for children wighing ≤60 lb and 1.2 million IU for children >60 lb, every 4 wk* Intramuscular or Penicillin V 250mg, twice daily Oral or Sulfadiazine or sulfisoxazole 0.5g, once daily for patients weighing ≤60 lb Oral 1.0g once daily for patients weighing >60 lb For people who are allergic to Penicillin and Sulfonamide Drugs Macrolide or azalide Variable Oral Duration of Prophylaxis for people who have had Acute Rheumatic Fever: AHA Category Duration Rheumatic fever without carditis 5 year or until 21 year of age, whichever is longer Rheumatic fever with carditis but without residual heart disease (no valvular disease*) 10 year or until 21 year of age, wichever is longer Rheumatic fever with carditis and residual heart disease (persistent valvular disease*) 10 year or until 40 year or age, whichever is longer; sometimes lifelong prophylaxis

THE PHARMA WORLD 49 sode of acute RF are at higher risk for having carditis with recurrences and for sustaining additional cardiac damage. Therefore, they should receive long-term antibiotic prophylaxis well into adulthood and perhaps for life. What causes rheumatic heart disease? What are the available treatment options? How effective are they? Is there a link between rheumatic fever and rheumatic heart disease? Rheumatic heart disease (RHD) is a potentially fatal heart condition caused by rheumatic fever, an autoimmune inflammatory response to GAS infection. The inflammation and scarring caused by rheumatic fever lead to rheumatic heart disease, which damages the heart muscle and valves. Rheumatic involvement of the cardiac valves is the most important sequela of acute rheumatic fever and also the 2nd most common major manifestation after arthritis. A single episode of acute rheumatic carditis often results in complete healing of the valvular lesions, while repeated episodes, especially involving previously affected valves, result in chronic rheumatic heart disease (RHD), which is the rationale for secondary prophylaxis. The current version of the Jones Criteria concentrated on the idea of subclinical carditis (SCC) detected by echocardiography because access to echocardiography is frequently available. In the absence of auscultatory findings and when there is no physiologic mitral or aortic insufficiency, SCC is defined as echocardiographic evidence of mitral or aortic valvulitis. For all cases of confirmed or suspected acute RF, echocardiography with Doppler should be carried out. The use of echocardiography can be used to rule out cardiac findings consistent with acute RF in patients with cardiac murmurs thought to be suggestive of rheumatic carditis, and echocardiography should be performed in moderate- to high-risk patient populations if acute RF is thought to be likely. Additionally, even in patients with diagnosed or suspected acute RF, serial echocardiography should be taken into consideration. What are some risk factors for developing rheumatic diseases in children? Are there any lifestyle changes that parents can help make to prevent rheumatic diseases in their children? Rheumatic heart disease is a preventable but serious public health problem in low- and middle-income countries, as well as in high-income marginalized communities, including indigenous populations. Rheumatic heart disease, which was common in Europe after WWII, now primarily affects low- and middle-income countries, particularly in Sub-Saharan Africa, the Middle East, South-East Asia, and the Western Pacific. RHD kills over 300,000 people each year and affects 40 million people, the majority of whom are children and adolescents in low- and middle-income countries, particularly where poverty is widespread and access to health care is limited. Overcrowding, poor hygiene, and the scarcity of medical services are all significant issues. Skin infection is a more common source of streptococci in tropical nations than pharyngitis. Those at the extremes of age (young or old), as well as those who are immunocompromised, have comorbidities such as diabetes, or have simultaneously chickenpox or influenza, and are dependent on drugs or alcohol, are particularly vulnerable. These are some well-known socioeconomic and environmental factors that contribute to the burden of rheumatic fever and rheumatic heart disease. The economic cost to countries with a persistently high incidence of rheumatic heart disease is significant because the disease has the most devastating effects on children and young adults. n

Mohammad Ziauddin General Manager, Marketing The ACME Laboratories Ltd. “If we can tackle the challenges together, Pharma Industry of Bangladesh will create enormous employment opportunities along with the positive impact in the healthcare eco system” FACE TO FACE Would you please introduce The ACME Laboratories Ltd., a leading pharma company of Bangladesh to our readers? The ACME Laboratories Ltd. is one of the top-tier pharmaceutical companies in Bangladesh. ACME is currently manufacturing more than 800 products in different dosage forms covering broader therapeutic categories & has an established footprint both locally and globally. For the seven decades, ACME continues its endeavors to fulfill its commitment- ‘For Health, Vigour and Happiness’. In its worldclass facilities, ACME manufactures high-quality medicines to serve humanity. These facilities comply with all the prestigious and recognized international accreditations like US FDA, UK MHRA, TGA & WHO. Since its inception, ACME Laboratories has demonstrated strong leadership position in the pharmaceutical industry and earned a series of accolades, the latest being FDA approval. What is the secret of your success? The secret of ACME’s success has always been its ‘people’. From the top management to blue-collar employees, ACME is occupied with highly qualified, trained & efficient personnel who can deliver the needs as per the company policy recommendations. Nevertheless, ACME has a robust number of Pharmacists, Microbiologists, Chemists, Engineers, Biotechnologists, Chartered Accountants & Business graduates in several divisions to outperform the tasks required to accomplish the current & future milestones. There is the culture in ACME for continual development through learning and stimulating innovative thoughts across the divisions. What, in your opinion, is the key to establish branding of a product? Establishing a brand depends on several key factors and the most vital one is ‘Built Quality’. When the customers (Doctors) have confidence on a particular brand because of its therapeutic benefits, they become loyal to that brand since the main goal of that product is healing the patients. Apart from that, story telling of brand’s USP (Unique Selling Propositions) to the customers in a unique way can help take the mind share of that brand. Thinking of sustainable brand development being steadfast with ethics is inevitable for the establishment of a product. 50 THE PHARMA WORLD