TPW March-April 2023

& GYNAE OBS

Volume 14 n No. 2 n march-april 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. Worth Knowing About 31 Myth vs Reality 35 Survey 43 AMR 47 Gynaecology Update 52 Innovation 57 Health Tips 63 Concern 65 Fast Fact 65 Technology 69 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 Research Update 76 Remedy 78 Drug Safety 80 Red Alert 81 Obgyn Market Forecast 86 FDA Update 94 FDA Approvals 95 Facts on Fingertips 97 Gleanings from Local Press 99 Appointments And Promotions 100 Asia Pharma Expo in pictures 104 Post Events 106 Upcoming Event 107 Registration Rules 108 Course and Conferences 111 News New Arrivals 5, BAPI News 16, FIP News 19, DGDANews 20,News 23 Interview T A Chowdhury 29 Prof. Ferdousi Begum 33 Prof. Dr. Rowshan Ara Begum 37 Prof. Dr. Sameena Chowdhury 41 Prof. Dr Firoza Begum 45 Prof. Dr. Kohinoor Begum 49 Prof. Dr. Salma Rouf 55 Prof. Dr. Nazma Hoque 59 Prof. Dr. Begum Nasrin 61 Prof. Dr. Sehereen F. Siddiqua 67 Dr. Nargis Fatema 71 Prof. Dr. Shahanara Chowdhury 73 CONTENTS In Conversation Dr. Sonia Nasrin 93 Dr. Farzana Deeba 83 Dr. Ummey Nazmin Islam 89

NEW ARRIVALS Brand Name: Progel Generic Name: Progesterone Strength: 8% (22.5 gm) Dosage Form: Vaginal gel Indications: Maintenance of Pregnancy in case of Threatened/Recurrent abortion, Luteal phase support, during IVF, Luteal support in case of luteal insufficiency, Secondary Amenorrhea, Dysfunctional uterine bleeding. Acme Brand Name: Dipoetin Generic Name: Darbepoetin Alfa Dosage Form: Injection Strength: 40 mcg, 60 mcg Indications: Indicated for the treatment of anemia due to- - Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis - The effects of concomitant myelosup - pressive chemotherapy, and upon initia - tion, there is a minimum of two additional months of planned chemotherapy. Brand Name: Audicare Generic Name: Ofloxacin USP + Clotrimazole BP + Beclometasone Dipro - pionate BP + Lidocaine Hydrochloride USP Dosage Form: Ear Drop Strength: 0.3% + 1% + 0.025% + 2% w/v Indications: For the treatment of otitis externa & otitis media. Brand Name: Arodoxin Generic Name: Doxorubicin HCL USP Dosage Form: Injection Strength: 10 mg, 50 mg Indications: Breast cancer, Acute Lympho - blastic Leukemia, Acute Myeloblastic Leu - kemia, Hodgkin lymphoma, non-Hodgkin lymphoma, Metastatic Breast Cancer, Meta - static Wilms’ Tumor, Metastatic Neuro - blastoma, Metastatic Soft Tissue Sarcoma, Metastatic Bone Sarcomas, Metastatic Ovarian Carcinoma, Metastatic Transitional Cell Bladder Carcinoma, Metastatic Thy - roid Carcinoma, Metastatic Gastric Carcinoma, Meta - static Broncho - genic Carcinoma. Brand Name: Palbolib Generic Name: Palbociclib INN Dosage Form: Capsule Strength: 125 mg Indications: Hormone receptor positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer Aristopharma Brand Name: Aritax Generic Name: Paclitaxel USP Dosage Form: Injection Strength: 100 mg, 300 mg Indications: Breast cancer, lung cancer, ovarian cancer, AIDS-related Kaposi sarcoma. THE PHARMA WORLD 7

Beximco Brand Name: Levamdocal® Generic Name: Levamlodipine Dosage Form: Tablets Strength: Levamlodipine 1.25 Indications: Treatment of Hypertension Brand Name: Levamdocal® Generic Name: Levamlodipine Dosage Form: Tablets Strength: Levamlodipine 2.5 Indications: Treatment of Hypertension Brand Name: Levamdocal® Generic Name: Levamlodipine Dosage Form: Tablets Strength: Levamlodipine 5 Indications: Treatment of Hypertension Brand Name: D-Rise® Generic Name: Cholecalciferol Dosage Form: Oral Solution Strength: 2000IU/ml Indications: Vitamin D deficiency in children (0-12 Years) Brand Name: D-Rise® Generic Name: Cholecalciferol Dosage Form: Chewable tablet Strength: 1000 IU Indications: Vitamin D deficiency in children and young adolescents (1-18 Years) Brand Name: Terbex® Cream 10gm Generic Name: Terbinafine Hydrochloride Dosage Form: Cream Strength:  Terbinafine Hydrochloride BP 10 mg/gm Indications: Terbex® cream is indicated for the treatment of the following dermatological infections: interdigital tinea pedis (athlete’s foot), tinea cruris (jock itch) or tinea corporis (ring worm) due to susceptible organisms and planter tinea pedis (moccasin type) due to trichophyton sp. Brand Name: Lulexa® Cream (20 g)   Generic Name: Luliconazole Dosage Form: Cream Strength:  Luliconazole INN 10 mg/gm Indications: Lulexa® is used for topical treatment of Tinea Corporis Caused by the organisms Trichophyton rubrum and Epidermophyton floccossum, in patients of 2 years of age or older and for interdigital tinea pedis and tinea cruris in patients of 12 years of age and older. Brand Name: Bilexa® Bexicap® Generic Name: Fluticasone Furoate/ Vilanterol Dosage Form: Dry Powder Inhaler (DPI) Strength: Fluticasone Furoate 100 mcg /Vilanterol 25 mcg & Fluticasone Furoate 200 mcg /Vilanterol 25 mcg Indications: Asthma & COPD Brand Name: Xetril® Generic Name: Clonazepam Dosage Form: Tablet Strength: Clonazepam 1mg tablet Indications: Panic disorder, anxiety, restlessness, seizure, tension. THE PHARMA WORLD 9

Brand Name : Renofix Generic Name: Roxadustat INN Strength: 20 mg Dosage Form: Film-coated tablet Indications: Treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD) and cancer. Everest Biopharma 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. Eskayef Brand Name: Cistor Generic Name: Cisplatin Strength: 10 mg & 50 mg Dosage Form: Liquid Injection Indication: Ovarian cancer, bladder cancer & testicular cancer. Brand Name: Regotab Generic Name: Regorafenib Strength: 40 mg Dosage Form: Tablet Indication: Metastatic colorectal cancer, metastatic gastrointestinal stromal tumor, metastatic hepatocellular carcinoma. Brand Name: Aventy Generic Name: Avanafil Strength: 100 mg & 50 mg Dosage Form: Tablet Indication: Erectile Dysfunction. Brand Name: CoracaD-C Generic Name: Calcium Lactate Gluconate+Calcium Carbonate+ Vitamin D3 , Vitamin C Strength: 1000 mg+ 327 mg + D3 400 IU+ C 500 mg Dosage Form: Effervescent Tablet Indication: Stronger bones, healthy gum & teeth, immunity booster, hydrating supplement. Brand Name: Bilxen Syrup Generic Name: Bilastine Strength: 12.5 mg/5 ml Dosage Form: Syrup Indications: Allergic rhinitis, urticaria and allergic rhinoconjunctivitis. Brand Name: Florest Generic Name: Fluvoxamine Maleate BP Strength: 100 mg Dosage Form: Tablet Indications: Obsessivecompulsive disorder, depressive illness. Brand Name: Renofix Generic Name: Roxadustat INN Strength: 50 mg Dosage Form: Film-coated tablet Indications: Treatment of adult patients with symptomatic anemia associated with chronic kidney disease (CKD) and cancer. THE PHARMA WORLD 11

Brand Name: Lyroxen CR Generic Name: Pregabalin BP Strength: 165 mg Dosage Form: Tablet Indications: Indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. It is also indicated for adjunctive therapy for adult patients with Partial onset seizures. It can be used for the management of fibromyalgia and neuropathic pain with spinal cord Injury. Brand Name: Lyroxen CR Generic Name: Pregabalin BP Strength: 82.5 mg Dosage Form: Tablet Indications: Indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. It is also indicated for adjunctive therapy for adult patients with Partial onset seizures. It can be used for the management of fibromyalgia and neuropathic pain with spinal cord Injury. Goodman Brand Name: Tajenta Generic Name: Linagliptin INN Strength: 5 mg Dosage Form: Tablet Indications: Type 2 diabetes mellitus. 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: Tajenta-M Generic Name: Linagliptin INN + Metformin HCl BP Strength: 2.5mg + 500mg & 2.5mg + 850mg 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. Hamdard Brand Name: Hamdard Balm Generic Name: Marham Ajeeb Dosage From: 20g Ointment Composition: Each gram ointment contains- Cinnamomum camphora 200 mg, Menthol 200mg & Thymol 100mg. Indications: Headache, Pain, Backache, Sprain, Sciatica, Insect bites & Cuts. Brand Name: Amlasia Generic Name: Amalaki Rasayan Dosage From: 450ml Syrup Composition: Each 5 ml contains as extract- Phyllanthus emblica Juice) 3.03 ml, Piper longum 0.12 g & Honey 0.36 g. Indications: Hyperacidity, Dyspepsia, Flatulence, Heartburn, Anorexia, Anaemia, Heart disease & Jaundice. 12 THE PHARMA WORLD

THE PHARMA WORLD 13 Brand Name: Hamdard Basak Generic Name: Vasakarista Dosage From: 100ml Syrup Composition: Each 5ml contains as extractAdhatoda 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 6.78 mg & Myrica nagi 6.78mg. Indications: Dry irritable cough, Allergic & Smoker’s cough, Hoarseness of voice & Sore throat, Asthma and Respiratory tract infection. 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: Kulzam Generic Name: Aab-eHayat Dosage From: 15ml Drop Composition: Each 5ml contains- Camphor 1.61g, Thymol 0.81g, Menthol 0.40g, Eucalyptus oil 0.52ml, Pine oil 0.26ml, Caraway oil 0.26ml, Anisi oil 0.19ml and Tincture of ginger 0.19ml. Indications: Respiratory tract & lung infection, Pneumonia, Catarrh, Cough & Cold, Headache, Cuts, Insect’s bite and different type of pains & Rheumatism. Brand Name: Branula Generic Name: Brahmi Rasayan Dosage From: 225 ml Syrup Composition: Each 5 ml Branula syrup contains- Bacopa 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: Ispa Plus Generic Name: Isabgul Spicy Dosage From: 20 Sachets Composition: Each Sachet contains- Plantago ovata (husk) 3g, Cassia angustifolia 1g and other excipient Q.S. Indications: Constipation, Piles, IBS, Hyperlipidemia and Bowel regulation for bed ridden patient. Brand Name: Neement Generic Name: Marham Neem Dosage From: 20g Ointment Composition: Each gram ointment contains – Azadirachta indica 88.88mg, Delphinium denudatum 5.55mg, Pinus longifolia 22.22mg, Curcuma longa 44.44mg, Cedrus deodara 44.44mg, 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: Ameloss M Generic Name: Donepezil + Memantine Strength: 10mg+7mg, 10mg+14mg, 10mg+28mg Dosage Form: Capsule Indication: Alzheimer’s disease THE PHARMA WORLD 15 Incepta Brand Name: Prenovax 23 Generic Name: Pneumococcal Polysaccharide Vaccine 23 Strength: 0.5ml/ Dose Dosage Form: Pre-filled syringe Indication: Bacterial pneumonia. Brand Name: Fitaro Generic Name: Semaglutide Strength: 0.25mg, 0.5mg, 1mg, 1.7mg, 2mg, 2.4 mg Dosage Form: Injection Indication: Obesity Brand Name: Dupalaki Generic Name: Ciprofibrate Strength: 100 mg Dosage Form: Tablet Indication: Dyslipidemia Brand Name: Dewax Generic Name: Carbamide Peroxide 6.5% Strength: 10 ml Dosage Form: Ear drop Indication: Ear wax remover Brand Name: Safegut Chromic Generic Name: Chromic Catgut Strength: 0,1,2,2-0 Round Body Dosage Form: Indications: Episiotomy, cirmumcision, ceserian section. Brand Name: Tresoda Generic Name: Trastuzumab Strength: 420mg Dosage Form: IV infusion Indication: Breast cancer Brand Name: Respimax Pro Generic Name: Fluticasone + Umeclidinium +Vilanterol Strength: 100mcg+62.5 mcg+25 mcg, 200 mcg+62.5 mcg+25 mcg Dosage Form: Dry Powder Inhaler Indications: Uncontrolled asthma and COPD overlap Brand Name: Catium Trio convicap Generic Name: Indacaterol +Glycopyrronium + Mometasone Strength: 150mcg+50 mcg+80 mcg, 150 mcg+50 mcg+160 mcg National Drug Cong Ltd. Dosage Form: Dry Powder Inhaler Indication: Uncontrolled asthma. Brand Name: Benkinson Generic Name: Levodopa+ Benserazide Strength: 50mg+12.5mg, 100mg+25mg, 200mg+60mg, 100mg+25mg (CR), 200mg+50mg (IR) Dosage Form: Capsule, IR capsule, CR capsule Indication: Parkinson’s disease

16 THE PHARMA WORLD Sharif Brand Name: Vorifix Generic Name: Voriconazole USP Strength: 50 mg & 200 mg Dosage Form: Film-coated tablet Indications: Vulvovaginal candidiasis, tinea infections, invasive aspergillosis. One Pharma Brand Name: Broklin CR Generic Name: Pregabalin USP CR Strength: 82.5mg, 165mg & 330mg Dosage Form: Tablet Indications: Diabetic peripheral neuropathy, postherpetic neuralgia & fibromyalgia. Brand Name: Aponia Generic Name: Nabumetone USP Strength: 500mg, 750mg & 1000mg Dosage Form: Tablet Indications: Osteoarthritis & rheumatoid arthritis. Brand Name: Vorier Generic Name: Voriconazole USP Strength: 200mg Dosage Form: Tablet Indications: Tinea infection, vaginal candidiasis & candidiasis aspergillosis. Brand Name: Rosulux Generic Name: Rosuvastatin USP Strength: 5mg & 10mg Dosage Form: Tablet Indications: Homozygous familial hypercholesterolemia, mixed dyslipidemia, hypertriglyceridemia & prevention of cardiovascular disease. Brand Name: Onedex Cassava Shell Cap Generic Name: Dexlansoprazole Strength: 30mg & 60mg Dosage Form: Capsule (Dual Delayed Release) Indications: Erosive esophagitis, heartburn & GERD. Brand Name: Lansodex Generic Name: Dexlansoprazole Strength: 30 mg & 60 mg Dosage Form: Oral Capsule Indications: Erosive esophagitis, maintenance of healed erosive esophagitis, symptomatic non-erosive gastroesophageal reflux disease, heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD). Brand Name: Furabac Generic Name: Nitrofurantoin Strength: 100 mg SR Capsule Dosage Form: Capsule Indications: It is specially indicated for the treatment & prophylaxis of urinary tract infections. Popular Nipro JMI

THE PHARMA WORLD 17 Square Brand Name: G-Calbo DX Generic Name: Calcium (Algae Source)+Vitamin D3 Strength: 600mg+400IU Dosage Form: Tablet Indication: Calcium and Vitamin D3 is used for the treatment of osteoporosis, osteomalacia, rickets, Tetany, parathyroid disease. Brand Name: Orili Generic Name: Elagolix Strength: 150 mg Dosage Form: Tablet Indication: Management of moderate to severe endometriosis pain with or without moderate hepatic impairment. Brand Name: Prazolok Generic Name: Prazosin Strength: 5 mg Dosage Form: Extended Release Tablet Indication: Hypertension (primary and secondary hypertension) Brand Name: Femony Generic Name: Melissa leaf powder+Red Clover extract+Fenugreek seed extract+Lady’s mantle extract +Monk’s pepper powder Strength: 93.33mg+83.33mg +41.67mg+41.67mg+20 mg Dosage Form: Capsule Indication: For easing female cycle discomfort and supporting build estrogen Brand Name: Sorasiba Generic Name: Sorafenib Strength: 200 mg Dosage Form: Tablet Indication: Hepatocellular carcinoma (HCC), renal cell carcinoma (RCC) Brand Name: Imaceva Generic Name: Imatinib Strength: 100mg & 400mg Dosage Form: Tablet Indication: Acute lymphoblastic leukemia (AML), chronic myeloid leukaemia (CML), gastrointestinal stromal tumor (GIST).

18 THE PHARMA WORLD BAPI NEWS The Election of the Executive Committee of Bangladesh Aushad Shilpa Samity for 2023-2024 & 2024-2025 was held during 52 Annual General Meeting held on 16 March 2023 at the office of the Samity. Nazmul Hassan, MP, S M Shafiuzzaman & Muhammad Halimuzzaman has been re-elected President, Secretary General & Treasurer respectively of Bangladesh Aushad Shilpa Samity. Nazmul Hassan MP, Chairman, Nuvista Pharma Ltd., Abdul Muktadir, Chairman & Managing Director, Incepta Pharmaceuticals Ltd., Md. Harunur Rashid, Chairman & Managing Director, Globe Pharmaceuticals Ltd., S M Shafiuzzaman, Managing Director, Hudson Pharmaceuticals Ltd., & Muhammad Halimuzzaman, Deputy Managing Director & CEO, Healthcare Pharmaceuticals Ltd., have been elected President, Senior Vice President, Vice-President, Secretary General & Treasurer of Bangladesh Aushad Shilpa Samity respectively. n Salman F Rahman, MP, Vice Chairman of Beximco Group, Mizanur Rahman Sinha, Managing Director of The Acme Laboratories Ltd., Tapan Chowdhury, Managing Director of Square Pharmaceuticals Ltd., Dr. Momenul Haq, Managing Director, General Pharmaceuticals Ltd., Khandaker Tarique-ul-Islam, Managing Director, Medimet Pharmaceuticals Ltd. have been nominated as members of the Advisory Committee. n Election of the Executive Committee of Bangladesh Aushad Shilpa Samity for the term 2023-2024 & 2024-2025. Advisory Committee for the terms 2023-2024 & 2024-2025

THE PHARMA WORLD 19BAPI NEWS A meeting between BAPI and representative from E Y Indian Life Sciences Leader was held on 12 February, 2023 at BAPI Conference Room to discuss the present scenario of Bangladesh Pharma Industry, impact of LDC Graduation on pharma sector, to face the challenges of graduation and future opportunities of business for Pharma companies of Bangladesh. Ernst & Young India Life Sciences Leaders showed keen interest to assist Bangladesh pharmacompanies for overcoming the challenges of LDC Graduation and also to avail the opportunity for boosting up export of pharma products. The following officials were present in the meeting: 1. SM Shafiuzzaman-Secretary General, BAPI 2. Major General (Rtd.) Md. Mustafizur Rahman, CEO (BAPI & APiiPSL) 3. Dr.Md. Zakir Hossain-Member, Executive Committee, BAPI 4. Mojibul Islam, Member, Executive Committee, BAPI 5. K S M Mostafizur Rahman, Member, Executive Committee, BAPI 6. Ms Sharita Millat, Member, Executive Committee, BAPI After detailed discussion, the following decisions were initiated: l EY India Life Sciences Leaders would request Government of Telagana (Hyderabad) India to facilitate potential collaboration with BAPI for local production of API & biologics l The issue of potential collaboration with BAPI to be discussed later more elaborately. l BAPI to consider EY as knowledge partner.. n Bapi & EY Indian Life Sciences Leader Hold Meeting at Bapi Office Joint Meeting between BAPI & PQM + was held on 15 February, 2023 on present & future collaboration for promoting local production of API. A discussion meeting between BAPI & PQM + for encouraging development of local production of API and future prospect of API manufacturing in Bangladesh and assurance of the necessary support and collaboration from the PQM+ for implementing the objective. SM Shafiuzzaman, Secretary General, BAPI welcomed the representative from the Plot Owners at BAPI and emphasized that joint efforts from BAPI & PQM + has made a congenial atmosphere for developing the area for producing API locally which is no doubt encouraging for the plot owners. Major General (Rtd.) Md. Mustafizur Rahman then requested the participants for their valued opinion on National Policy strategy and future action plan concerning local production of API. Members opined that PQM + has initiated different program to develop a systematic plan for local production of API and for promoting the scheme PQM + organized a series of Training Program in liaison with BAPI and subsequently managed to develop Trainers. Members present in the meeting praised PQM + for their workmanship for building Trainers. CEO, BAPI underscored the need for cooperation, support and experience of PQM + to share with the plot owners by way of organizing Training Program, Seminar & Workshop regularly to achieve the definite goal in producing API locally and also to boost up export of huge volume of API’s from Bangladesh. n Meeting held between BAPI & PQM+

BAPI NEWS 20 THE PHARMA WORLD Bangladesh Aushad Shilpa Samity & GPE Expo Pvt. Ltd., India jointly organized the 14th ASIA PHARMA EXPO-2023 a three day long international exhibition on COMPLETE pharma Manufacturing technologies during 02-04 March 2023 at Bashundhara International Convention City (BICC) at Dhaka, Bangladesh. Hon’ble Member of Parliament Mr. Nazmul Hassan MP, President of Bangladesh Aushad Shilpa Samity (Bangladesh Association of Pharmaceutical Industries-BAPI) & President of Bangladesh Cricket Board (BCB) inaugurated the Opening Ceremony as Chief Guest. Major General Mohammad Yousuf, Director General, Directorate General of Drug Administration, Bangladesh & Mr. Ravi UdayBhaskar, Director General of Pharmaceuticals Export Promotion Council of India (pharmexcil) were the Special Guests on the occasion. Abdul Muktadir, Senior Vice President, S M Shafiuzzaman, Secretary General, Muhammad Halimuzzaman, Treasurer of Bangladesh Aushad Shilpa Samity & Major General (Retd) Md. Mustafizur Rahman, CEO, BAPI & APIIPSL were also present on the occasion. Asia Pharma Expo-2023 More than 655 exhibiting companies from 27 countries like India, USA, UK, Germany, Italy, China, Taiwan, South Korea, Switzerland, Japan, Spain, Thailand, UAE, Ireland, Singapore, Denmark etc. participated in the event & displayed Processing, Packaging Machineries, Packaging Materials, Bulk Drugs Manufacturing Plants, API, Drug Intermediates, Excipients, Analytical & Biotech Lab Instruments, Lab Reagents, Glassware, Cleanroom Eqpts, Utility Products & Services and Technology based Magazines. n

THE PHARMA WORLD 21 NEWS FIP journal supports strengthening of clinical and social pharmacy practice research as a scientific discipline FIP’s Pharmacy Education journal (PEJ) is supporting a new set of statements that aim to improve the quality of publications on advancing paradigms of clinical and social pharmacy practice research. The Granada Statements, recently developed by a group of clinical pharmacy and social pharmacy journal editors, comprise 18 recommendations gathered into six topics: the appropriate use of terminology, impactful abstracts, the required peer reviews, journal scattering, more effective and wiser use of journal and article performance metrics, and authors’ selection of the most appropriate pharmacy practice journal to submit their work. n Ethical dilemmas in pharmacy practice are the focus of a new format of CPD from FIP A decision-making framework and its application to help pharmacists deal with different ethical dilemmas in pharmacy practice are presented in a new format of continuing professional development — “FIP CPD Bites” — from FIP. “FIP CPD Bites” provides learning support on different topics relevant to practice, science and education in pharmacy. FIP’s first series in this new format comprises seven videos developed by FIP experts on ethics. “As practising pharmacists, we are clinically, ethically and socially accountable for decisions we make regarding the all-important pharmaceutical care of our patients. We often experience ethical dilemmas, where two or more issues could be pulling in opposite directions, making it difficult to decide what direction to take that would be justifiable and in the best interests of the patient. To enable better understanding of our obligations, these CPD bites offer real-life examples in role-play, accompanied by clear, simply articulated analyses and recommended actions to help colleagues make professionally justifiable ethical decisions,” said Dr Betty Chaar, chair, FIP Working Group on Ethics. n FIP highlights profession’s actions on SF medicines to WHO Executive Board Pharmacists, as primary health care professionals with medicines expertise, are at the forefront of the fight against substandard and falsified (SF) medicines, FIP told the World Health Organization Executive Board in Geneva, Switzerland. The FIP statement drew attention to a collaboration with the WHO to create a university course on fake medicines that has been successfully piloted and called for further implementation beyond the pilot. Statements were also made in collaboration with World Health Professions Alliance members on strengthening the global architecture for health emergency preparedness, response and resilience  (supporting the development of a cohesive multidisciplinary and professionalised health emergency workforce and emphasising the need for decent working conditions for healthcare professionals) and reorienting health systems to primary health care as a resilient foundation for universal health coverage. n Insights on how digital health interventions can support pharmaceutical care delivery A new FIP report  “How can digital health interventions support national pharmaceutical care delivery”  discusses challenges and opportunities facing nations and professional organisations in implementing digital health interventions in pharmaceutical care services. FIP Technology Advisory Group members and digital health experts, global and regional pharmacy leaders, and researchers, highlights on: selected best practices and ongoing initiatives; barriers, challenges and recommendations in the implementation of digital health in pharmaceutical care services; education and training needs; and future areas of work and opportunities for growth. The report, which is accessible to FIP members only, is the work of the FIP Global Pharmaceutical Observatory. n

DGDA NEWS 22 THE PHARMA WORLD Dr. Md. Anwar Hossain Howlader, Secretary, Health Services Division, Ministry of Health and Family Welfare (MoHFW) inaugurated the Medical Devices Testing Laboratory at the Na - tional Control Laboratory (NCL) of the Directorate General of Drug Adminis - tration (DGDA) on 13 March, 2023. The Secretary observed that Medical devices are highly signifi - cant healthcare products for public health. In some emergency cases medical devices are essential for saving lives like pacemaker, cardiac stents, ventilator etc. During the Covid-19 emergency, its utmost sig - nificance was realized. The Medical Devices market is about 1 billion $ with local market growth of about 15% and exported to 14 Countries. About 92% of Medi - cal Devices are imported. Invasive (In-vivo) Medical Devices, In-vitro Di - agnostics, etc. are widely imported. DGDA is solely responsible for reg - istration and marketing authorization, licensing, regulatory inspection, labo - ratory testing, and research approval of medical devices in Bangladesh. The National Control Laboratory (NCL) has Inauguration of the Medical Devices Testing Laboratory at the National Control Laboratory (NCL) of the Directorate General of Drug Administration (DGDA) insufficient infrastructure to test the quality, safety, efficacy, and overall quality assurance of medical devices whether imported or locally manufactured. Locally manufactured medical devices are still less sophisticated like Needles, can - nulas, syringes, blood bags, infusion sets, latex condoms, etc. But for other sophisticated medical devices of class B, C, and D classed medical devices are import-based. The Secretary added that the inaugurated new Labora - tory for Testing Medical Devices is the first dedicated facility for testing medical devices. The inauguration of the labora - tory opened a new dimension in the area of better access to healthcare products for quality-assured medical devices. The Director General of the Directorate General of Drug

THE PHARMA WORLD 23 Administration (DGDA) chaired the program. The Director General mentioned that at present there are 11 (Eleven) manufacturers in Bangladesh, who are producing medical devices locally, but many other manufacturers are in pipeline. During the Covid-19 pandemic, local manufacturers contributed for ensuring access to essential medical devices. Domestic manufacturers are manufacturing First Aid bandages, Latex gloves (Examination & Surgical), Condoms, Burette sets, Butterfly needles, Sutures, Alcohol Pad, Scalpels, Scalp Vein Set, Oxygen Masks, Insulin Syringe, Disposable Syringe, Infusion Set, Vacuum blood collection tube, IV Cannula, Urine Collection Bag, Suction Catheter, feeding tube, Wound Drain Tube, Blood lancet, Umbilical Cord Clamp, 3 way stop cock with extension tube, Autoclave, Intrauterine Device (IUD) and Contraceptive Implants. With the support of USAID’s PQM+ program, DGDA currently inaugurated the medical device lab for testing PPE and Medical Oxygen. Special guests of this event included Mr. Md Enamul Haque, Additional Secretary, HSD, MoHFW; Ms. Liza Talukdar, Activity Manager of USAID, Dhaka, Dr. Omar Khyyum, Chief of Party, USP-PQM+ and Dr. Emily M. Kaine, Senior Vice President, GHMS USP. The secretary also visited the drug testing laboratory (DTL), which is globally accredited by ISO 17025:2017, and the highly prestigious WHO Prequalification. The DTL is performing quality assurance of all medical products supplied to the government and private sector. n Directorate General of Drug Administration (DGDA) organized a workshop to strengthen the regulatory capacity of DGDA officials and competent relevant senior technical officials from pharmaceutical manufacturers on March 05, 2023, in collaboration with United States Pharmacopeia (USP) Lockville, USA, and United States Pharmacopeia (USP) Hyderabad, India. Directorate General of Drug Administration (DGDA) and US Pharmacopeia, in collaboration with Bangladesh Association of Pharmaceutical Industries (BAPI), Pasteur Pharmatech Solutions brought the regulators and pharma industry professionals from Bangladesh to a common platform, through an interactive and insightful workshop intending to strengthen regulatory capacity. Major General Dr. Mohammad Yousuf, Director General of DGDA inaugurated the program and delivered the opening speech. During the opening remarks, Major General Mohammad Yousuf, DG,  DGDA said, “We want to take this opportunity to work more closely with the United States Pharmacopeia’s South Asia region and engage our regulatory staff and Bangladesh pharmaceutical industry in creating a quality culture in the manufacturing processes and constantly raising awareness about the importance of pharmaceutical primary reference standards to be used in producing quality medicine for domestic use and most importantly for regulated markets. “We are very happy to have the USP team from Rockville USA & Hyderabad India in DGDA Office and build stronger partnerships & collaboration for the pharmaceutical quality systems in Bangladesh” he added. DG, DGDA suggested USP to work with key stakeholders for scaling up engagement initiatives such as USP education initiatives & work with the industry to drive quality. Md. Salahuddin, Director, DGDA, presented the country profile and DGDA overview. In the presentation, he highlighted the availability of a  skilled workforce, and capabilitybuilding programs in the domain of pharmaceutical quality management as Bangladesh’s new API Park is ready to kick off start the manufacturing activities and expand the access to US and other regulated markets.  Among the delegates, Matruprasad P, Kishor M, Zeenat Khan, Joe Eaton, Partha Mukherjee, Zeenat Khan, R. Karthik Iyer, and. Farooque Khan discussed on different topics including USP Overview, USP as Solution Provider, USP Publications, USP Revision Process, Reference Standards Development, Compendial Hot Topics such as Nitrosamines & Dissolution, General Chapter Updates on Chromatography chapter, Pharmaceutical Analytical Impurities and regarding Getting Involved with USP through Education updates. n DGDA organizes workshop to strengthen regulatory capacity

Beximco Pharma gets FBCCI’s Business Excellence Award NEWS Nazmul Hassan MP, the managing director of Beximco Pharma, recieved FBCCI’s Business Excellence Award in the category of ‘Business Leadership’. The FBCCI celebrated its 50th anniversary by holding the Bangladesh Business Summit 2023 and the Best of Bangladesh Expo. At the celebration, Nazmul Hassan MP was honored with the award for his contributions to the growth of the pharma industry, particularly for establishing Bangladesh as a new hub for worldwide generic medications. n Healthcare category has been added for the first time in Bangladesh Innovation Conclave. And ACI is the first winner of this Innovation category. This is a proud moment for all of us. I am thankful to all the members of ACI who conceptualized, developed, manufactured, marketed, popularised & supported the brand, says a company press release. After the innovation of Chlorhexidine Gluconate 7.1% solution (Hexicord) WHO (World Health Organisation) changed their recommendations for neonatal cord care (just after birth) to use Chlorhexidine Gluconate 7.1% solution instead of Dry Cord. NTWC, Bangladesh  recommends Single use of Hexicord to Umbilical Cord. This reduces almost 23% newborn death, 68% of neonatal severe infection. n ACI wins Bangladesh Innovation Award under Healthcare category THE PHARMA WORLD 25

Beacon Pharmaceutical Limited (BPL), one of the leading oncology drug makers in Bangladesh, will provide all-out support to the Pharmacy Department of Khulna University (KU) to strengthen advanced research on cancer treatment. A Memorandum of Understanding (MoU) was signed between the BPL and the KU authorities through a programme held on the university campus, says a press release. According to the MoU, the BPL will provide the all-out required support to the Pharmacy Department of the university to ensure the advanced research on cancer treatment to make the efforts a success. Mohammad Anisur Rahman Khan, executive vice president, human resources and administration of the BPL, and Prof Amit Roy Chowdhury, a treasurer of the KU signed the MoU on behalf of the two sides. During the MoU signing ceremony, the KU has given a special honour to Mohammad Ebadul Karim, MP, also the managing director of the BPL for his outstanding contribution to the development in the country’s pharmaceutical sector and for exporting of life-saving anti-cancer drugs to the world market at affordable prices. Presided over by Mahmud Hossain, vice chancellor of the KU, Mosammat Hosne Ara, pro vice chancellor of the KU and Md Manjurul Alam, Director, of the global business of the BPL, among others, were present on the occasion. n 26 THE PHARMA WORLD Beacon to provide support to KU for advanced research in cancer treatment The first Annual Business Conference of DBL Pharmaceuticals was held at Hotel Sea Palace, Cox’s Bazar on 5th January 2023. DBL Pharma marked the conference to align their field forces with a crafted vision of serving humanity by providing high-quality and differentiated medicines. M. A. Quader, Group CEO & Deputy Managing Director, DBL Group, inaugurated the conference. During the speech, Mr. Quader talked about the success story of DBL group in different business. He also expressed his expectation and hope to achieve a good position of DBL Pharma in pharma industry. M. A. Rahim, Vice Chairman, DBL Group also attended in the conference and expressed his interest for pharma business and is committed to serve the nation with highly qualified medicine. Ahmed Kamrul Alam, Executive Director, Business Operations focused on the recent success story of DBL Pharma. He also presented the upcoming new projects and venture of DBL Pharma for the betterment of mankind. Md. Shahriar Hasan Khondoker & Md. Rajaul Karim, Manager, Marketing presented the strategies for the year 2023. Mahbubur Rahman, Head of Sales guided the Sales team to achieve the goal of 2023. DBL Pharmaceuticals is newly launched pharmaceutical venture of DBL Group. It is a family-owned company led by four brothers. It has built an advanced manufacturing facility in Bangladesh to comply all the regulatory guidelines of US FDA, UK MHRA and other regulatory standards of the world. n First Annual Business Conference of DBL Pharma held

THE PHARMA WORLD 27 UK delegation visits Beximco facilities A senior level UK delegation including several British MPs visited the Beximco Pharma Tongi facility on 18 March 2023. Rabbur Reza, COO of Beximco Pharma, accompanied and showed them around the facility. The visitors were highly impressed by the the facility’s manufacturing and quality control practices. Observation of International Women’s Day 2023 at Everest Pharmaceuticals Ltd On the occasion of International Women’s Day 2023, Everest Pharmaceuticals Ltd. had organised an awareness session on cervical cancer for the female employees of Everest and few other companies. This session was conducted by one of the most renowned Oncologists of Bangladesh, Prof. Dr. Aliya Shahnaz, Head of the Department of Radiotherapy in Dhaka Medical College Hospital, who had encouraged the participants to be aware and take necessary steps for the prevention of cervical cancer.

THE PHARMA WORLD 29NEWS ACI, one of the largest conglomerates in the country has achieved a new milestone, completing the first ever export of pharmaceutical products to ACI’s Subsidiary in America - ACI Healthcare USA, Inc. The products were shipped from U.S. Food and Drug Administration (USFDA) approved facility - ACI Healthcare Ltd, Sonargaon, Narayanganj, says a press release. With this achievement, ACI has strengthened its standing in the global market; a momentous occasion of pride for ACI as well as the pharmaceutical sector of Bangladesh, says the company press release. To commemorate this milestone, a programme was organised at the InterContinental, Dhaka recently. Prof. Dr. Abul Bashar Mohammed Khurshid Alam, DG, DGHS; Major General Mohammad Yousuf, DG, DGDA, M Anis Ud Dowla, Chairman, ACI Group, Dr. Arif Dowla, Group Managing Director, ACI Ltd.; M Mohibuz Zaman, MD and CEO, ACI Healthcare Ltd; and other dignitaries of society and higher officials of ACI were present in the programme. n ACI makes maiden export of pharmacy products to US with a delegation, led by Saudi Arabia’s Commerce Minister Majid bin Abdullah Al Qasabi, according to a press release. Salman said, “We have to follow various international procedures in case of drug export. As such, the people outside the country can put their trust in the medicines made by Bangladesh. People across the world say that the medicines of Bangladesh are of good quality.” Majid bin Abdullah Al Qasabi said trade and investment between Bangladesh and Saudi Arabia have not yet reached the desired level. “We will explore the trade relations between the two countries in the visit. Besides, we want to utilize our potential in information technology, communication and manpower export,” he added. Managing Director of the Beximco Pharmaceuticals Nazmul Hassan Papon also spoke on the occasion. n Beximco Pharma to start production in KSA in 2024: Salman Prime Minister’s Private Industry and Investment Adviser Salman F Rahman said Beximco Pharmaceuticals will start production of medicines in the Kingdom of Saudi Arabia (KSA) from the next year under a joint venture of Bangladesh and the KSA. “To this end, necessary manpower and technical support will be taken from Bangladesh,” he told reporters after visiting Beximco Pharmaceuticals Industry

INTERVIEW T A Chowdhury Professor of Obstetrics & Gynaecology BIRDEM & Ibrahim Medical College “To ensure a healthy outcome a woman Should take pregnancy only when she Is physically and mentally fit” As a pioneer Gynaecologist of the country, what, in your opinion, are the most common Gynaecological disorders prevalent among our women? Common gynaecological conditions found in Bangladeshi women have changed over the years. Many gynaecological conditions which used to occur as a consequence of lack of care during delivery such as urinary fistulae, rectal injuries, genital prolapses etc., have become less common now due to better obstetric care. Infection-related complications have also become less common due to the widespread use of antibiotics, though indiscriminate use of antibiotics has long-term adverse effects. On the other hand, more and more patients are now seeking treatment for chronic, non-communicating diseases such as cancer of the genital tract, other tumours, abnormal bleeding from the genital tract, and endometriosis, which are becoming more common. Of course, the number of patients coming for infertility treatment is also increasing as patients are becoming more aware about the effective treatment available for this condition. What is the main cause of preeclampsia? What are the early signs to look out for? How can we prevent preeclampsia in pregnancy? The cause of eclampsia is not known despite of the enormous amount of research going on, but still, this is a very common complication of pregnancy and labour. A significant number of maternal death still occur in this country as a complication of pre-eclampsia and eclampsia. Unfortunately, there are very few early symptoms of pre-eclampsia. Pre-eclampsia and eclampsia can only be detected in the early stage if the pregnant patient comes for regular antenatal check-ups and is detected to have high blood pressure and or protein in the urine. It is difficult to prevent pre-eclampsia except in those cases where risk factors are present; it can be controlled only by proper treatment once it is detected. So early detection and treatment so that the condition does not progress to eclampsia is the mainstay for its management. Can women with PCOS become pregnant without any medical assistance? What is the best fertility treatment for women with PCOS? Women with Polycystic Ovarian Syndrome can definitely become pregnant if they desire. Often pregnancy does not

occur easily as in normal patients because many of them also suffer from anovulation because of their hormonal imbalance. These patients can be made to ovulate regularly by treatment, but they have got the risk of developing ovarian hyperstimulation syndrome during ovarian stimulation. Pregnancies in these patients are more likely to be complicated than pregnancies in non-PCOs patients. There is nothing called the best treatment. They can be treated by usual methods, but many of them will also need to take the help of assisted reproductive techniques. Caesarean section rates continue to rise alarmingly not only in Bangladesh but globally as well.  What, in your opinion, is the number one reason for choosing C-sections over vaginal birth nowadays? Are there any long-term effects of C-sections on the mother? Caesarean Section rate is increasing all over the world, but the increase rate in Bangladesh is more than the average global rate. Many factors contribute to this increase. Sociocultural factors are important, as the patient and her relatives will not accept any damage to the mother or baby if it happens during vaginal delivery and will go on accusing the obstetrician of not performing a caesarean section in time. Trained midwives who are essential for safe vaginal delivery is not available in most delivery stations and as such the obstetricians generally are not confident to leave a patient in labour in the care of relatively inexperienced hospital staff. Sometimes the patient and her party demand that a caesarean section is done citing various reasons. The times during labour and delivery is very daunting for the mother. What can be done to take care of the mother pre- and post-pregnancy? Counselling during pregnancy is absolutely essential for convincing a pregnant woman and her relatives that the vaginal route is the natural route for delivery in uncomplicated deliveries and is associated with fewer complications. But to ensure a safe vaginal delivery the labor room facility should be ideal in regards to manpower and equipment and other facilities. Facilities for intensive care, if needed, should be available and respectful maternity care should be provided at every centre where delivery is conducted. A patient in labour should be allowed to have a companion on whom she has confidence should always be with the patient. Senior-level obstetricians should always be available on call at all times during the day and night. What steps do you suggest to improve overall women’s healthcare in Bangladesh and ensure safe motherhood for all? In order to ensure a healthy outcome a woman should take pregnancy only when she is physically and mentally fit. All pregnancies should be planned. Age of trying for pregnancy is also important to get the best outcome. Teen-age pregnancy or pregnancy at an advanced age, all may have serious consequences for the mother and baby. All pregnant patients must have at least 4 regular antenatal visits and must have delivery in a facility to ensure timely help if any complication occurs. n 32 THE PHARMA WORLD

THE PHARMA WORLD 33 How does emergency contraception work? Copper IUDs work by limiting sperm’s ability to fertilize eggs. They must be inserted within five days (120 hours) of unprotected sex, and they are considered the most effective form of emergency contraception. They can also be used as a long-term birth control method. The medications found in emergency contraception pills work to alter hormone levels and delay ovulation, which is the release of a mature egg from the ovary. This helps ensure sperm have no egg to fertilize. Ulipristal pills must be taken within five days of unprotected sex. Levonorgestrel pills are most effective when taken within three days of unprotected sex. Confused about emergency contraception? What is emergency contraception? Emergency contraception is a way to prevent pregnancy after unprotected sexual intercourse, according to the American College of Obstetricians and Gynaecologists (ACOG). It must be used before a pregnancy occurs. According to Mount Sinai obstetrician-gynaecologist Dr. Cynthia Abraham, “When used correctly, emergency contraception works well to prevent pregnancy after unprotected sex. It can be useful if birth control fails…But there’s a fairly short time in which to use it.”  Types of emergency contraception There are two main types of emergency contraception, according to the ACOG. These are IUDs (intrauterine devices) and emergency contraception pills. IUDs: Copper IUDs are currently the only type of IUD used in emergency contraception. They must be inserted into your uterus by a health care practitioner. The other type of IUD, the levonorgestrel (hormonal) IUD, is used for long-term contraception only. However, a recent study of over 600 patients published in the New England Journal of Medicine found that both levonorgestrel IUDs and copper IUDs were equally effective forms of emergency contraception. Emergency contraception pills: The emergency contraception pill, commonly known as “the morning-after pill,” is the second type of emergency contraception. Ulipristal acetate pills are considered the most effective of the two. However, they have been shown to be less effective for people who weigh 195 pounds or greater than for people under this weight. Emergency contraception side effects The side effects of copper IUDs include menstrual pain and bleeding, especially within the first few months of the IUD being inserted. Medication can be used to help treat these symptoms, which can last up to a year before they begin to ease. The side effects of emergency contraception pills are considered shortterm and mild. They include: l Spotting and bleeding for up to a month after use l A delayed or early next period l Abdominal pain l Nausea and vomiting l Headaches l Fatigue l Dizziness l Tender breasts WORTH KNOWING ABOUT

INTERVIEW Prof. Ferdousi Begum Professor & Head of Dept. Obstetrics & Gynaecology, Institute of Woman and Child Health Dhaka Professor Ibrahim Medical College, Dhaka President Obstetrical & Gynaecological Society of Bangladesh (OGSB) Immediate Past President South Asian Federation of Obstetrics & Gynaecology (SAFOG). President Gestosis Society, Bangladesh Chapter Member SEAR-TAG, Women’s and Children’s Health, WHO. Associate Editor International Journal of Gynaecology & Obstetrics “We emphasize on working comprehensively to reach the targets of SDGs and FP2030” OGSB has been working to promote reproductive health and ensure maternal & neonatal health since its inception. As the president of OGSB, please tell our readers about the activities, services and future projects of OGSB. Yes, OGSB is working continuously on reproductive, maternal and newborn health since 1972; we have started our journey serving women who were victims of the liberation war. Activities of OGSB include updating the members (specialists in Obstetrics and Gynaecology) by providing training, organizing conference; training all other categories of services providers working in reproductive health; teaching and training both undergraduate and postgraduate students, organizing seminar and workshops regularly. OGSB members are serving women, mothers, female adolescents, girl child and newborns all over the country from the especial care centres to the grassroot level. OGSB has conducted and publish many researches works. We work closely with the Government of Bangladesh to develop and implement all reproductive health policies and strategies. We also support and work closely. We play an important role of women’s health in international arena. Reducing maternal & newborn mortality and morbidity by implementing emergency obstetric care, safe mother hood, successful family planning services; introduction of midwife and community based skilled birth attendants; management of COVID-19 and its vaccination for pregnant & lactating women are only a few examples of activities of OGSB. At present OGSB is working with govt. of Bangladesh to reduce maternal and newborn mortality and to provide standard care including the PPH, Eclampsia, Labour Care guide, Robson TGCS (to optimize the caesarian section rate), maternal and perinatal death review, labour room protocol, near miss analysis, improvement of sexual and reproductive health, strategies to reach SDGs, post creation in Obstetrics and Gynaecology, mentoring and quality improvement, leadership and facility readiness, Improvement of essential Gynaecological practice, maternal mental health and many others. In future we will continue with these and will emphasize on working comprehensively to reach the targets of SDGs and FP2030, improvement of quality of care, development of superspecialists, leadership of health service providers, universal health care and many others. As an eminent Gynaecologist of the country, what in your opinion, are the most common Gynaecological disorders prevalent among our women? Gynaecological disorders vary according to different age groups. For adolescents: menstrual irregularities, pain during menstruation, teenage pregnancy and its complication, polycystic ovary syndrome, endometriosis, etc. For adult female: abnormal uterine bleeding (AUB), different kinds of tumors of THE PHARMA WORLD 35

36 THE PHARMA WORLD reproductive organs (fibroid in uterus, ovarian cyst / tumor), different forms of cancer of reproductive organs, hormonal problem, infertility, polycystic ovary syndrome, adenomyosis, endometriosis complications of early pregnancy, urinary tract infection, urinary incontinency including fistula, utero vaginal prolapse and many others. For  post-menopausal women:    post menopause  bleeding, osteoporosis and bone fracture, post-menopausal syndrome, gynaecological cancers, hormonal deficiency, mental problems are common. What is the correlation between PCOS and metabolic syndrome? Which patients are at the highest risk for developing metabolic syndrome? Is there any way to screen and prevent metabolic syndrome in Patients with PCOS Early? Polycystic ovary syndrome (PCOS) and Metabolic Syndrome are closely related. Metabolic Syndrome is a medical term for combination of diabetes, high blood pressure and obesity. It puts one at greater risk of getting coronary heart disease. Most of the patients of PCOS also have obesity, high blood sugar level and many of them have high blood pressure; and they are at one of the highest risk group for metabolic syndrome especially at older age. So, we must screen and take care of PCOS patient so that metabolic syndrome can be prevented. PCOS patient are to be screened frequently for body weight, blood pressure and blood sugar level. Prevention includes life style modifications (diet); (low carbohydrate, more vegetables, avoiding junk food), regular exercise and physical activity (at least 30 min/ day), low salt, timely medication and other required treatment. They also need psychological support, follow up and encouragement. We need to develop these habits from the early childhood by healthy environment at home and school, especially during play time and on the playground with safety and security so that both PCOS and Metabolic syndrome can be prevented. What are the first signs of cervical cancer? Can cervical cancer be cured? What are your suggestions to increase awareness and promote early screening of cervical cancer? Symptoms and signs of carcinoma cervix appear late and not very prominent. These include increased white discharge, post coital bleeding, blood mixed and fowl smelling vaginal discharge, irregular vaginal bleeding and lower abdominal pain. When we look at that cervix of the uterus of patient with special instrument (as uterine cervix is placed high up in the vagina), we can see ulcer, bleeding area, or growth in advanced cancer. In early stage of the cancer we only see reddish hue or some changes from normal change in blood vessel pattern and bleeding on touch with instrument and finger. Yes cancer of cervix can be totally cured if they are detected at early stage with different screening methods and can be given proper and full treatment and lifelong structured follow up. People of our country including girls and women are not aware of the cancer of cervix, vaccination, screening and adequate proper timely treatment. We now know that 98% of cancer of cervix is caused by Human Papilloma Virus (HPV). The high risk group for HPV infection through sexual intercourse are marriage in early age and early sexual intercourse, multiple sexual partners/polygamy, low social economic condition and multiparty. These group of women are higher risk of developing carcinoma cervix. So, people have to avoid these factors. Screening program for carcinoma cervix is to examine cervix of uterus; 3 yearly for women of 25-60 years of age by HPV DNA testing, pap smear, liquid cytology, visual inspection with Acetic acid (VIA). These test can detect cancer at precancerous stages and at earlier stage of cancer when treatment is simple, easy and totally curable. Carcinoma cervix is one of the few cancers which can be prevented by vaccine, which is available in Bangladesh. Soon HPV vaccination of girls aged 9-14 years will be started under Govt. immunization program. Caesarean section (CS) rates continue to rise alarmingly not only in Bangladesh but globally as well. What, in your opinion, is the number one reason for choosing C-sections over vaginal birth nowadays? Are there any long-term effects of C-sections on the mother? The last Bangladesh Demographic Health Survey (2016) shows that the CS rate of Bangladesh as a whole is 30 %. In many hospitals, where more complicated cases are admitted, CS rate is 60%. But in many private clinic CS rate is 80-100%. Causes of high CS varies. Number one cause of CS now is previous history of CS. Once CS is done, rate of CS in next pregnancy increases. So, the first-time mothers are to be taken proper care, so that CS is done only in appropriate indications: pregnant mothers, family and service providers. It is to be noted that caesarean section is an important operative technique to save lives of mother and newborns. However, many of the CS done may avoided, especially by properly trained/ skilled manpower and appropriate instruments and equipment, to counsel pregnant women and family, proper monitoring during labour. Bangladesh is a country of lowest health manpower and health budget (as set by WHO). Effect of CS are many. The most important is Placenta Accreta Syndrome (PAS), where the placenta is attached to / embedded in the scar of previous CS, which may involve the uterine wall and even spread to surrounding organs especially urinary bladder. And during CS of these patients, severe bleeding may occur, along with injury to various organs. Patients may even die if adequate blood transfusion and immediate surgery cannot be done. Other remote complications are; chronic pelvic pain resulting from infection and adhesion. The times during labour and delivery is very daunting for the mother. What can be done to take care of the mother pre and post pregnancy? Pre pregnancy care is a must. A mother along with her spouse should prop-

THE PHARMA WORLD 37 erly plan the pregnancy so that there is less complication and to ensure safe pregnancy, healthy mother and baby. Before getting pregnant a woman should go to pre pregnancies/pre conception care center to screen for detection and necessary correction of anaemia, Diabetes Mellitus, Hypotension, Obesity, thyroid disorder, mental health, VAW, hemoglobinopathy and many others. Postnatal care is an important component of maternal and newborn health care. If extends from immediately after birth of the baby to 42 days after childbirth. Most of the maternal and newborn deaths occur during the first week after delivery which occur mainly due to mismanagement during delivery). In addition, proper care (counseling) to ensure healthy newborn and healthy mother including nutrition, water intake, vaccination, supplementation (maternal); promotion and protection of breastfeeding and Infant and Young Child Feeding (IYCF), early detection and treatment of danger signs/complications of mother and newborn, proper birth spacing (2-5 years); weight reduction, use of appropriate contraceptives (almost all contraceptives can be used during postpartum period), planning of family, follow up of chronic conditions (diabetes, high blood pressure, thyroid problem, heart disease, etc). What steps do you suggest to improve overall women’s healthcare in Bangladesh and ensure safe motherhood for all? Ensuring safe motherhood and taking care of women’s health is the responsibility of everybody. The women and mothers have to be empowered (with good nutrition, education, wealth and decision making capacity) with full support from partner and family; so that they can understand the importance of the situation, take their own decision and meet the related expenditure. Adequate health care facility (pre pregnancy care, ante natal care, intrapartum care (care during delivery), postnatal care, newborn care, family planning services, prevention and care of violence against women (sexual, ciber and domestic violence), female education and employment, opportunity for safe work, male involvement, taking care of adolescent and elderly (menopausal and geriatric), provision for sports and relaxation, mental health care for all ages, adequate geriatric meaningful targeted research and proper interpretation and implementation is important. Manpower involved in Healthcare to take care of women and mothers including specialist obstetrician and gynae oncologist; infertility, fetomaternal medicine, gynae oncology, urogynaecology), nurses, midwives, support services, health education, mental health specialists are to be trained/produced and deployed with proper follow up and support. Govt. and politician with their goodwill and commitment has a definite role to play through policy making and implementing them. Media also has a definite role to play with regular publication of maternal, newborn health situation, laps & gaps, publication of positive case reports and situation/ initiatives; can change the present situation to an ideal one. Teachers can raise consciousness among female and male students and parents about importance of safe maternal and newborn health for building a healthy and prosperous nation. n M MYTH VS R REALITY VS MYTH: If you have HPV, you will get cervical cancer. REALITY: While human papillomavirus (HPV) is present in nearly every case of cervical cancer, it does not mean a woman will develop cervical cancer. In fact, most women will be exposed to the HPV infection at some point in their lives, but only a small percentage of women develop cervical cancer. Many times, HPV will clear up on its own or will be detected in pre-cancerous stages when treatment is highly effective. MYTH: Debilitating period pain is always a sign of endometriosis. REALITY: Painful periods don’t always point to endometriosis; sometimes they’re a separate condition known as dysmenorrhea. Pelvic pain can also be caused by scar tissue, previous infections or a history of appendicitis. Irritable or inflammatory bowel syndromes can also cause pelvic pain. MYTH: A high insulin level means PCOS REALITY: High insulin is both a symptom of PCOS and an underlying physiological driver. Testing for insulin resistance can be helpful to rule out other conditions that are commonly misdiagnosed as PCOS. MYTH: Mammograms are the only breast health check you need. REALITY: Sometimes Mammograms may miss some breast cancers. And if something is found on a mammogram, a woman will likely need other tests (more mammograms or a breast ultrasound) to find out if it is cancer. MYTH: Pap tests detect all gynaecologic cancers and STDs. REALITY: Cervical cancer is the only gynaecologic cancer that can be detected by the Pap test. The Pap test effectively detects pre-cancerous changes to the cervical cells and detects cervical cancer earlier when it’s highly treatable.

THE PHARMA WORLD 39 INTERVIEW Prof. Dr. Rowshan Ara Begum Former Head of the Dept Obs & Gynae, Holy Family Red Crescent Medical College & Hospital Past President Obstetrical and Gynaecological Society of Bangladesh - OGSB Councillor Bangladesh College of Physicians and Surgeons (BCPS); Bangladesh Medical & Dental Council (BMDC) Vice President South Asia Federation of Obstetrics and Gynaecology (SAFOG); Bangladesh Menopause Society (BMS); Fertility and Sterility Society of Bangladesh (FSSB) Focal Person Mentorship Program- Labour Room Protocol, United Nations Population Fund (UNFPA) Member National Advisory Committee The National Technical Advisory Committee on Covid-19 (NTAC) “To improve women’s health we should ensure respectful maternal care and optimise and utilise antenatal and postnatal care services” As an eminent Gynaecologist of the country, what in your opinion, are the most common Gynaecological disorders prevalent among our women? Gynaecological problems affect the female reproductive system. Every woman suffers from some Gynaecological disorder at some point in her life. 1. Dysmenorrhea or painful menstruation 2. Leucorrhea 3. Vaginitis—Trichomoniases, Candidiasis, Bacterial Vaginosis. 4. Amenorrhea 5. PCOS 6. Endometriosis 7. Fibroids 8. Pelvic inflammatory disease 9. Menopaused syndrome 10.Pain during sex (Dyspareunia). 11.Abnormal uterine bleeding What is the main cause of preeclampsia? What are the early signs to look out for? How can we prevent preeclampsia in pregnancy? Pre-eclampsia is a multisystem disorder characterized by the new onset of hypertension BP-140 mm Hg systolic or >90 mm Hg diastolic on two occasions at least 4 hours apart, after 20 weeks of gestation or, at the time or after delivery in a woman with a previously normal BP, and significant end-organ dysfunction with or without proteinuria. Preeclampsia is a hypertensive disorder in pregnancy related to 2% to 8% of pregnancy-related complications worldwide. The exact causes are not known, however, it is thought to occur when there is a problem with the placenta & risks factors are any one of the following: a) History of PE b) Multifetal gestation c) by renal disease d) Autoimmune disease e) Type 1 or Type 2 diabetes and chronic hypertension Moderate Risk factora) First Pregnancy b) Maternal age >35 or older c) BM > 30 d) Family History of PE Early signs a) BP Systolic > 140, > 160 b) Diastolic > 90 or > 110,

c) Significant proteinuria – Greater than or equal to 300 mg/24 hours urine collection d) Dipsticks reading of 1+, No organ dysfunction. Preventive a) BP measurement at all opportunity b) Every ANC & PNC. c) Control weight gain, pregnancy for obese & over wt. d) Calcium supplementation. e) Risk Screening of low dose Aspirin. Danger signs i.e headache, blurred vision, oliguria, epigastric pain etc. should be known to every healthcare provider. Disorders like polycystic ovary syndrome (PCOS) and anovulation due to hormonal imbalances are the leading cause of infertility in women. How are they treated? Is there any way to prevent such disorders? PCO treatment follows some guidelines – I. Life -Style Changes → Exercise therapy → Calorie restricted diet II. Medical Management Though menstrual irregularities are common so most guidelines follow recommend combined pills (OCP) to regularise the cycle, it decreases LH secretion, increases sex hormone binding globulin, and decreases testosterone. 6-month hormone therapy gives satisfactory results against hirsutism & Acne. Metformin acts by impeding- hepatic glucose production & increasing peripheral insulin sensitivity. III. Prevention There is no proven way to prevent PCOS but lifestyle & hormone remedies – a) Stay at a healthy weightb) Weight loss can lower insulin & androgen levels, ct also restore ovulation, c) Limit Carbohydrates in diets. d) Be active – exercise helps, can lower Blood sugar level. Obstetric Fistula is one of the most severe and tragic injuries that can occur during childbirth. How can it be prevented and treated? What can be done nationally to rehabilitate women suffering from obstetric Fistula? Obstetric fistula  is a medical condition in which a hole develops in the birth canal as a result of obstructed labour and is considered among the most debilitating maternal morbidities. For the prevention of obstetric fistula, we need – a) Prevention of early childbirth or delaying the age of the first Pregnancy. b) Good & quality ANC c) Encourage Institutional delivery d) Good & quality intra-preterm care with Portogram. e) Prevent Obstructed Labor. f) Prolong Catheterization after Prolong obstructed Labor. g) For Rehabilitationh) Early recognize the fistula patient from grass root Level & provide them to Fistular Care Centres. i) Develop more centres & more trained skilled surgeons for providing treatment of fistula. Caesarean section rates continue to rise alarmingly not only in Bangladesh but globally as well.  What, in your opinion, is the number one reason for choosing C-sections over vaginal birth nowadays? Are there any long-term effects of C-sections on the mother? Worldwide rates of Caesarean sections are growing, and Bangladesh is no exception. There are multiple reasons behind it. However, the important reasons are: a) Fear of pain b) Elderly primigravida c) Obesity, Assisted reproductive technique, d) Not Practicing Operative vaginal delivery – Forceps & vacuum e) Not practicing External cephalic version. f) Cases of primary C/S is increasing, so C/S is repeated for following childbirth as well. g) Shortage of midwives in the country In the private sector – it is gradually rising due to clinic practice & not maintaining Labor Room practice, no midwives, & no guideline. In the public sector– a) Most of the cases are referred from other centers & are complicated, b) Midwife crisis everywhere, lack of manpower, lack of patient counseling, not using operative vaginal delivery,  inconclusive or  non-reassuring CTG interpretation c) 54% are done of Dystonia & FHR reasons, so both should be re-assessed by a trained person. Complications and long-term effect a) Primary C/S leading to second or third C/S. b) Increased risk of mortality and morbidity c) The patient may develop central placenta previa in following pregnancy, which is life-threatening. What steps do you suggest to improve overall women’s healthcare in Bangladesh and ensure safe motherhood? To improve women’s health we should take care of our – 1. Adolescent health 2. Women’s reproductive health 3. Maternal health l Ensure safe delivery l Ensure respectful maternal care l Optimise and utilise antenatal and postnatal care service  l Improve intrapartum care by following Labour Room protocol. l Increase the number of skilled health care providers, especially Midwives for maternal health. l Encourage Institutional delivery l Build up awareness 4. Health of Menopausal women – Appreciate them and work to raise awareness about their Menopausal health. n THE PHARMA WORLD 41

INTERVIEW THE PHARMA WORLD 43 “To reduce the mother’s concern, counselling during antenatal care about benefits of normal delivery can play a significant role” ternal deaths are because of preeclampsia and eclampsia. Eclampsia is also a major reason for serious maternal morbidities. On the other hand, the incidence of neonatal mortality and morbidities including preterm birth, stillbirth etc. is also quite high in women suffering from preeclampsia and eclampsia. Eclampsia is a preventable disease. If it is detected early in preeclampsia phase, during antenatal care, both the mother and baby could be saved from the adverse effects of eclampsia. The early sign symptoms are oedema, hypertension and proteinuria which usually occur in the second half of pregnancy. If not treated promptly, eclamptic seizures can occur in pregnant women. Younger age of pregnancy, primigravida, obesity, history of preeclampsia in family, lack of education and inadequate antenatal care are the risk factors of preeclampsia. Maternal risk factors combined with uterine artery doppler study, mean arterial pressure, maternal serum pregnancy-associated plasma protein A (PAPP-A)  and placental growth factors can identify most of the cases of the early onset of preeclampsia. So regular antenatal cause is the key to prevent eclampsia. What is the correlation between PCOS and metabolic syndrome?  Which patients are at the highest risk for developing metabolic syndrome? Is there any way to screen and prevent metabolic syndrome in Patients with PCOS Early? Polycystic ovarian syndrome (PCOS) is one of the most common endocrine and metabolic disorders affecting 1 in 10 women and girls of reproductive life. PCOS is a syndrome characterised by anovulation, hyperandrogenism, polycystic ovaries and obesity. PCOS is sometimes associated with co-morbidities like metabolic syndrome and related to obesity. This syndrome is characterised by increased waist circumference, high triglycerides, elevated blood pressure, high blood sugar and low HDL. If any 3 of these 5 risk factors are present, then it is metabolic syndrome. Metabolic syndrome is a life-threatening condition associated with a 5-fold higher risk of type-2 diabetes and a 2-fold higher risk of stroke and heart disease. So, it is essential to control blood pressure, lose weight, and lower cholesterol level to avoid complications. So, it is very important to modify the lifestyle, adopt healthy eating habits, have regular exercise, and stop smoking and alcohol. Obstetric Fistula is one of the most serious and tragic injuries that can occur during childbirth. How can it be prevented and treated? What can be done Prof. Dr. Sameena Chowdhury Obstetrician & Gynaecologist President, Endometriosis Adenomyosis Society of Bangladesh (EASB) Past President, OGSB As an eminent Gynaecologist of the country, what in your opinion, are the most common Gynaecological disorders prevalent among our women? The common gynaecological problem, we gynaecologists face in the hospital includes vaginal discharge, menstrual disorder, pelvic inflammatory disease, uterine fibroid, ovarian tumour, endometriosis, polycystic ovarian disease, cancer cervix, urogenital prolapse and also menopausal problems. Most of these diseases occur during the reproductive age but as life expectancy is increasing, problems beyond the reproductive age are also rising. Urogynaecological and postmenopausal problems are now becoming a common suffering of our women. What is the main cause of preeclampsia? What are the early signs to look out for? How can we prevent preeclampsia in pregnancy? Eclampsia is a major cause of maternal mortality in Bangladesh. About 24% of all maternal deaths are associated with eclampsia (BMMS 2016). It is estimated that about 1000 to 1200 ma-

44 THE PHARMA WORLD nationally to rehabilitate women suffering from obstetric Fistula? WHO estimated that each year 50000 to 100000 women and girls worldwide are suffering from of obstetric fistula (OF). Most of these occur due to prolonged and obstructed labour. OF is an abnormal opening that develops between the genital tract, urinary tract, and rectum. It is a serious and debilitating complication where women suffer from constant urinary incontinence, social isolation, and shame and are associated with other health problems. Obstetric fistula is a preventable condition; it can largely be avoided by: l Delaying the age of first pregnancy by preventing early age of marriage l Each pregnancy needs antenatal care and timely access to quality obstetric care. l Harmful traditional practices during delivery cases should be stopped. For prevention, it is necessary to raise public awareness and ensure access to antenatal care throughout pregnancy and childbirth. On 23 May International Day to end obstetric fistula is observed for creating awareness. If there is obstructed labour, immediate emergency obstetric care is necessary, followed by keeping an indwelling urinary catheter for 21 days. This helps reduce the development and size of the fistula and makes it easier to repair the fistula surgically. To prevent OF, appropriate and timely caesarean section is needed. The surgical closure  of an obstetric fistula is the most effective way to treat this condition. The medical college hospitals offer such surgeries. There is a National Fistula Centre at Dhaka Medical College, which also serves as a training center for fistula repair surgery. OGSB Hospital and IRCH at Mirpur-13 has established a Fistula Centre to serve quality care to these vulnerable women. Repairing the fistula is not enough; sufferers must also be rehabilitated. They should be encouraged to have some form of income-generating skills in order to sustain their livelihoods. Some unfortunate women are victims of inoperable fistulas. They should be cared for and dealt with on a national level in order to provide them with disability pensions. Caesarean section rates continue to rise alarmingly not only in Bangladesh but globally as well.  What, in your opinion, is the number one reason for choosing C-sections over vaginal birth nowadays? Are there any long-term effects of C-sections on the mother? Data from WHO shows that c-section rates have increased about 14% worldwide since 1990. Data from Bangladesh maternal mortalities survey 2016 shows that 33% of childbirth is done by caesarean section. Around 1 million of caesarean section yearly, of which 750,000 are done in the private sector. This is a very alarming situation in Bangladesh. C-section is more prevalent in urban area and among relatively educated women. Both adolescent pregnancy and higher maternal age is one of the common significant factors associated with increasing C-section rate. History of previous C-section is the most important cause of high Csection rate so it is very important to reduce the primary C-section. If we consider the maternal perspective of caesarean delivery, we may see that they are afraid of labour pain, believe C-section is safe, and have had a negative experience with previous childbirth. The provider may also think that it is a safe procedure and can be done within a short time. To reduce the mother’s concern, counselling during antenatal care about benefits of normal delivery can play a significant role. We also need respectful maternity care. Pain relief is also an important issue during delivery. C-section is not free of complications. Complications may occur during operation, post-surgery and can be long-term. Late complications may be in the form of endometriosis in the surgical scar and abdominal wall, or incisional hernia. As late sequelae, there are high possibilities of placenta previa, placenta accreta, uterine rupture in later pregnancies. What steps do you suggest to improve overall women’s healthcare in Bangladesh and ensure safe motherhood for all? Safe motherhood means ensuring all women have access to healthcare services before pregnancy, during pregnancy and post-partum period including emergency obstetric care and newborn care. The pillars of safe motherhood include the followings: l Family planning is an important component l Antenatal care to ensure maternal health and nutrition, early identification of any complications of mother and treat it accordingly. Ensure immunisation. l Delivery care of mother and new born including immediate new-born care l Emergency obstetric and newborn care to prevent any life-threatening conditions. l Ensure postnatal care of the mother and the newborn, breastfeeding, skin-to-skin contact and the mother’s mental well-being. Because many mothers suffer from postnatal depression. l Post-abortion care is an important area that needs urgent treatment so facilities should be ready to give services. l STD/HIV/AIDS should be identified and treated during pregnancy at the antenatal check-up. All these pillars are based on the foundation of equity and education for women. Ensure primary health care - the community clinic services should provide quality antenatal care, counseling and proper referral to higher centres. Strengthening of  Family Welfare Centre (FWC) and Mother & Child Welfare Centre (MCWC) at all the secondary and tertiary hospitals. Access to information for all women about maternity care and newborn care. There should be skilled persons and the introduction of midwives at all the facilities to promote safe delivery services ensuring labour room management protocol. Promotion of institutional delivery is essential to ensure safe delivery and post-delivery care. Optimisation of caesarean section must be ensured. The use of “Robson Classification” will be of help in this issue. Pregnancy tracking of women by using artificial intelligence is a time demanding issue. n

THE PHARMA WORLD 45 SURVEY L arge numbers of people are affected by infertility in their lifetime, according to a new WHO report around 17.5% of the adult population – roughly 1 in 6 worldwide - experience infertility, showing the urgent need to increase access to affordable, high-quality fertility care for those in need. The new estimates show limited variation in the prevalence of infertility between regions. The rates are comparable for high-, middle- and low-income countries, indicating that this is a major health challenge globally. Lifetime prevalence was 17.8% in high-income countries and 16.5% in low- and middle-income countries. “The report reveals an important truth - infertility does not discriminate,” said Dr Tedros Adhanom Ghebreyesus, Director-General at WHO. “The sheer proportion of people affected show the need to widen access to fertility care and ensure this issue is no longer sidelined in health research and policy, so that safe, effective, and affordable ways to attain parenthood are available for those who seek it.” Infertility is a disease of the male or female reproductive system, defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. It can cause significant distress, stigma, and financial hardship, affecting people’s mental and psychosocial well-being. Despite the magnitude of the issue, solutions for the prevention, diagnosis and treatment of infertility – including assisted reproductive technology such as in vitro fertilization (IVF) - remain underfunded and inaccessible to many due to high costs, social stigma and limited availability. At present, in most countries, fertility treatments are largely funded out of pocket – often resulting in devastating financial costs. People in the poorest countries spend a greater proportion of their income on fertility care compared to people in wealthier countries. High costs frequently prevent people from accessing infertility treatments or alternatively, can catapult them into poverty as a consequence of seeking care.   “Millions of people face catastrophic healthcare costs after seeking treatment for infertility, making this a major equity issue and all too often, a medical poverty trap for those affected,” said Dr Pascale Allotey, Director of Sexual and Reproductive Health and Research at WHO, including the United Nations’ Special Programme of Research, Development and Research Training in Human Reproduction (HRP). “Better policies and public financing can significantly improve access to treatment and protect poorer households from falling into poverty as a result.” While the new report shows convincing evidence of the high global prevalence of infertility, it highlights a persistent lack of data in many countries and some regions. It calls for greater availability of national data on infertility disaggregated by age and by cause to help with quantifying infertility, as well as knowing who needs fertility care and how risks can be reduced. n “Infertility does not discriminate” 1 in 6 people globally affected by infertility: WHO

INTERVIEW THE PHARMA WORLD 47 “Good prenatal care can prevent complications during pregnancy and delivery” Disorders like polycystic ovary syndrome (PCOS) and anovulation due to hormonal imbalances are one of the leading causes of infertility in women. How are they treated? Infertility can be caused by both male and female factors. In women, PCOS is one of the most common causes of infertility. In PCOS, there is anovulation due to high levels of androgens and luteinizing hormone (LH). Insulin resistance is also present in women with PCOS. So, women suffering from PCOS are usually obese and this obesity can interfere with ovulation. The first step of treatment of PCOS is weight reduction through lifestyle changes such as dietary regulation and physical exercise. If the dietary regulation and exercise do not help, we can add some adjuvant therapies like metformin and myoinositol. However, there is no internationally recognised dose for these medications in treating PCOS. And even when dietary changes, weight loss, and these medications have failed, we go for laparoscopic ovarian drilling. After that, if a woman wants to get pregnant, we start ovulation induction therapy. What is your advice to patients who are having trouble conceiving? What are ways to improve reproductive health and increase fertility? As I’ve said before, fertility depends on both male and female factors. We have to remember that age is a very important factor. Women are born with a limited number of eggs. After the age of 32, the reserve of egg starts to decline. As women reach the age of 35, the decline accelerates. And for men, though we previously used to say that men can have a baby even at the age of 70, nowadays we know that after the age of 40, genetic problems can arise in the sperm, which contribute to infertility. Additionally, there are lifestyle factors. For example, people nowadays use mobile phones and laptops, which is especially true for the male partners. Exposure to radiation emitted by these devices can harm fertility in the male and also cause genetic/chromosomal problems. If we talk about environmental factors, there are certain things that should be avoided, such as avoiding producing crops using too much fertilizer. Pollutants such as industrial releases, carbon dioxide and carbon monoxide emissions from motor vehicles, smoking etc. can cause infertility. In addition, illicit use of drugs has also become a concerning issue in our society. This causes infertility as well. Obesity is another very important factor for both partners. Couples who are trying to conceive should keep their body weight in a healthy range. BMI for both male and female partProf. Dr Firoza Begum Professor High Risk Pregnancy and Infertility Specialist Ex-Chairman Dept. of Fetormaternal Medicine BSMMU

ners should be below 25 (kg/m2). We should advise them on dietary regulations. It is also crucial to first determine if any partner in the couple has any medical conditions and treat them accordingly. We should see if the semen quality is normal in the male partner. In the female, on the other hand, we should see whether there are any ovulatory problems, whether the tubal functions are normal or not, to exclude any defect in the uterus or not. If everything is ok, the couple can conceive with no problem. We advise the women to take some supplements like prenatal vitamins, folic acid, minerals and other micro-nutrients before they try to conceive. It is very important to improve the health of the oocyte and finally the embryo for successful implantation. Is an IVF pregnancy considered high-risk? What are the risks and success rate of the procedure? In our country, most of the women come for IVF after the age of 35 and the male spouse is often older than 40. Moreover, they opt for IVF because they could not conceive naturally due to some problems, whether in the male partner or the female partner. So, yes, if we consider the age and associated complications, it is a highrisk pregnancy. The risks of IVF could be a risk of miscarriage, failure to conceive, or failure of the procedure etc. In patients with PCOS, Ovarian hyperstimulation syndrome (OHSS), is a possible complication of IVF. In many cases, it can be a life-threatening condition. Previously there were many cases of OHSS, but nowadays due to a change in our treatment protocol, we can minimise the complications. First-time IVF success rates often fall between  30%-40%. Chances of successful pregnancy increase to 70- 80% after 3 cycles. The success rate actually depends on the age of the woman, e.g. how much egg we can collect after stimulation. It also depends on the semen parameter and whether there is any associated problem or not. If there is no problem, and the age is below 35, the success rate is 40%-50% after a single attempt. Equal access to fertility care remains a challenge for low and middle-income population. What can be done to increase the affordability and equitability of assisted reproduction technologies (ART) in our country? In low and middle-income countries, infertility is a common issue due to a part of the population remaining malnourished and nutrition deprived. The low-income group includes rickshaw pullers, truck drivers, day labourers etc. The prevalence of sexually transmitted diseases usually is higher in such population. It is possible to get treatment. However, the spouse/ wives do not know that their partners are carrying the disease. Remained undiagnosed and untreated, the transmitted disease can affect the female partner and cause tubal block, chronic pelvic pain and even infertility. So, to increase the affordability and equitability of ART in these groups, firstly, what we need the most is health education. It is very important. Secondly, there should be a health insurance system. Infertility is a problem that can happen to anyone, whether the patient is from middleincome, low-income, or high -income background. So, the socio-economic background does not matter. So, facilities for an insurance policy should be made available in our country, so that the patient can afford the treatment. Otherwise, they cannot afford. As I have said before, it takes 3-4 chances of IVF to reach a success rate of 70%- 80%, not in one trial. So, definitely it should be covered by insurance. The times during labour and delivery is very daunting for the mother. What can be done to take care of the mother pre- and post-pregnancy to ensure safe motherhood? Pre-pregnancy, again, I should say, the patient should first go to the doctor to understand whether she is fit for pregnancy or not. This is very Important. And, if a mother is healthy, we can expect a healthy baby. So, prepregnancy counselling is very important to exclude any medical disorder, to maintain good health of the patient, we can give some prenatal vitamins to the woman, and also, we can talk to the husband to exclude any of his health problems. After that, the couple can proceed for pregnancy. During pregnancy, the mother should visit the doctor for scheduled follow-ups, do some investigation according to the doctor’s advice. Regular follow-up is very important to check if she develops any complications during the antenatal period and treat any complication that arise promptly. For example, hypertension, as pre-eclampsia is a major cause of maternal mortality in our country. Many women develop diabetes during pregnancy. So, it is essential for the mother to get regular check-up. In the postnatal period, for delivery, they should go for institutional delivery. There are many government hospitals, there are facilities available at the District and Upazilla level as well. Doctors and Healthcare providers are available. They can go and get treatment, especially the delivery services from hospitals. Go to doctor for regular visit to exclude any post-pregnancy complications. So, all pregnant women should have their delivery at healthcare institutions, not at home. Because if any problems or complications arise at home, we cannot solve it timely. In severe cases, it may even lead to maternal death. In the post-pregnancy period, the patient should visit the doctor after 3 days and 7 days of delivery. They should check the health of the baby as well whether the baby has sepsis, jaundice or any other problems and provide treatment accordingly. They should follow up again at 6-weeks to check the health of the mother whether she has developed any hypertension, or any other problem, and solve it accordingly. We must remember that good care of the mother during the prenatal period can prevent complications during delivery. n 48 THE PHARMA WORLD

THE PHARMA WORLD 49 AMR Antibiotic-resistant genes are abundant in agricultural soil Despite being a severe threat to human health, the occurrence of antibiotic resistance genes or ARGs in soil and their interactions with ecological factors, such as climate and land use, are poorly understood globally. An OHT-affiliated researcher and collaborators analyzed 1,088 metagenomic soil samples globally and generated a map of the 558 ARGs identified from these samples. The abundance of ARGs in agricultural habitats was higher than that in non-agricultural habitats. Clinical pathogens and gut microorganisms, which mediated the control of climatic and anthropogenic factors for ARGs, carried most of the soil ARGs. Health systems strengthening is needed to address AMR Researchers conducted medicine interviews, ethnographic fieldwork, and key informant interviews with participants in villages in rural Chikwawa, Malawi, to understand the care and medicine use practices among households dependent on subsistence farming. The most frequently used drugs were cotrimoxazole and amoxicillin, both available in the Access list of the WHO’s AWaRe category. Participants recognized that keeping, sharing, and buying medicines informally was not ideal for their personal or public health. Still, they reported using antibiotics and other medicines in these ways because of precarious conditions, barriers to formal healthcare, and the inevitability of future illness. Awareness campaigns inadequately address AMR when dealing with extreme scarcity, and health systems strengthening interventions are urgently needed. Researchers investigated trends in antimicrobial dispensing Researchers conducted a systematic review of 35 studies investigating antimicrobial dispensing practices with and without a prescription in diverse countries, including India, Canada, and Syria. Analysis revealed that penicillin was the most dispensed/studied antimicrobial class, followed by macrolides and cephalosporins. The most common intervention performed by community pharmacists while dispensing antimicrobials was asking questions, particularly about drug allergies and patient symptoms. None of the included studies reported assessing antimicrobial dispensing quality. The researchers call for an increased focus on training pharmacists in LMICs to counsel patients and raise awareness about proper antibiotic use. AMR emergence is modeled against antibiotic consumption, GDP In a pre-print article, One Health Trust researchers and collaborators modeled the frequency of reported AMR emergence as a function of factors like human antibiotic consumption and per capita GDP using thousands of reports of novel bacterial resistance recorded between 2006 and 2017 in 59 countries. Human antibiotic consumption was positively associated with AMR emergence rates (odds ratio [OR] = 1.04 per defined daily dose; 89% CI 1.0-1.5). Data suggested a slight positive association between livestock antibiotic consumption and AMR emergence, but only among countries with a higher GDP (log-dollars per human capita), however, GDP itself was highly correlated with AMR emergence (OR 31; 89CI = 7.2-97). Diarrheagenic E. coli associated with antibiotic resistance in children and calves In a cross-sectional study examining the associated characteristics of E. coli pathotypes in Ethiopia, researchers investigated possible zoonotic transmission and antibiotic resistance patterns of diarrheagenic E. coli (DEC) in 144 acute diarrheic children and 50 diarrheic calves. Researchers identified six strains of E. coli that were consistent between diarrheic children and calves, suggesting a potential zoonotic transmission among subjects. In addition, more than half of the E. coli isolates sampled were resistant to three categories of antibiotics (amoxicillin, gentamycin, and ampicillin). Source: CDDEP