GLEANINGS FROM LOCAL PRESS Local production of pharma raw materials gaining traction P harmaceutical companies are gradually enhancing their capacity to produce the raw materials needed to make medicines, which will go on to reduce Bangladesh’s overreliance on imports and augment the country’s competitive edge in the global market. In the last 12 years, the value of active pharmaceutical ingredients (APIs) made in the country grew four times to more than Tk 2,000 crore thanks to the entry of more firms in the segment in recent years. It was about Tk 500 crore in 2010. “The pharmaceuticals sector will not face severe challenges after the graduation of Bangladesh from the group of the least-developed countries in 2026 as we are building our capacity of making APIs,” said Abdul Muktadir, chairman and managing director of Incepta Pharmaceuticals. Currently, 15 firms, including Eskayef, Square, Beacon and Beximco, produce APIs, up from 10 a couple of years ago, said SM Shafiuzzaman, secretary-general of the Bangladesh Association of Pharmaceutical Industries, which represents 265 domestic drug-makers. Local companies meet 10 per cent to 15 per cent of the annual demand for APIs, according to Monjurul Alam, director for global business development at Beacon Pharmaceuticals. He believes if APIs are produced in sufficient quantities, pharmaceutical companies will be able to buy them immediately. “This will reduce the lead time.” A significant development in API production will provide a huge gain to the pharmaceuticals industry in a country where 97 per cent of the demand for medicines is met through local manufacturing. Although API production has not grown in keeping with the pharmaceutical sector, local companies produce high-quality raw materials, albeit on a limited scale, helping the drug industry add value to their products. And Shafiuzzaman thinks Bangladesh would not be able to manufacture 100 per cent of the required APIs due to patent issues. Currently, Bangladesh has to depend on imports to meet around 85 per cent of requirements for APIs. This costs the country about $1.3 billion annually. The country has made major progress in completing the construction of the API Industrial Park in Gazaria of Munshiganj. Syed Shahidul Islam, the immediate past project director of the park, said the physical development work of the initiative has been completed and 27 companies have been handed over plots for setting up factories. Acme Laboratories, UniMed UniHealth Pharmaceuticals, Healthcare Pharmaceuticals, and Ibn Sina Pharmaceutical Industry have already set up their plants. Of them, Healthcare Pharmaceuticals is about to begin trial production. “We are ready for commissioning,” said Md Halimuzzaman, chief executive officer of Healthcare Pharmaceuticals. A central waste treatment plant has been set up in the park at a cost of Tk 100 crore and this is about to be commissioned. And Muktadir believes that the rising API production would help the pharmaceuticals sector grow its share in the global generic drug market, valued about $400 billion. Local companies export products to 157 countries in Asia, Africa, North America, South America and Europe. Medicines exports rose more than 11 per cent year-on-year to $188 million in 2021-22, data from the Export Promotion Bureau showed. The pharmaceuticals exports have grown almost three folds in the last seven years. Pharma-makers also think that Bangladesh should focus on potential API markets across the world. The global market is estimated to reach $216 billion in 2027. “Diplomatic efforts should be initiated so that once API is available, Bangladesh can have a ready market,” said Muktadir. Beacon Pharmaceuticals’ Alam said there was no need to worry about the challenges Bangladesh would face in the post-LDC era. “This is because we have already introduced pharma products in the local market and these products should be considered as prior art.” Prior art is any evidence that one’s invention is already known. n Source: Daily Star
102 THE PHARMA WORLD Shaida Yesmin has recently joined Novatek Pharmaceuticals as Manager, HR and Admin. Prior to this, she served in RM Appearls Sourcing in HR and Admin department. She has completed her BBA from University of Derby of the UK and MBA from Prime University Bangladesh. She also has a Post-graduate Diploma in Human Resources Management from United International University Bangladesh. Md. Ruhul Amin Sikder has recently joined Novatek Pharmaceuticals as Assistant General Manager, Sales. Prior to this, he worked in One Pharma as Sales Manager. Starting his career in Beximco Pharmaceuticals in 1994, Ruhul Amin also served in Silva Pharmaceuticals, Globe Pharmaceuticals, and Orion Pharma in different capacities. Ruhul Amin has completed his B. Sc. from University of Dhaka. Md. Delwar Hossain has recently been promoted to Chief Marketing Officer in Biopharma. He has 20 years of experience in pharmaceutical marketing. He started his career in Beximco Pharmaceuticals. His performance in biopharma has been widely acclaimed. He did his B. Pharm, M. Pharm from Jahangirnagar University and MBA from University of Dhaka. Md. Afzal Hossain has recently been promoted to Chief Sales Officer in Biopharma. He worked in Beximco Pharmaceuticals & Imperial Chemical Industries (ICI) before joining Biopharma. Md Akramul Kabir has recently been promoted to Assistant General Manager in Marketing department of UniMed UniHelath Pharmaceuticals. Prior to this, he was designated as Marketing Manager. He obtained his B. Pharm from Northern University Bangladesh & M. Pharm from University of Development Alternative. Md. Shafiqul Islam has recently joined Novatek Pharmaceuticals as Assistant General Manager, Sales. Prior to this, he served in The Acme Laboratories as Assistant Sales Manager. He started his career in Square Pharmaceuticals and worked in different capacities. He obtained his Bachelor degree in Fisheries and M. Sc. in Zoology from University of Dhaka. Dr. Raiatun Tehrin has joined as Marketing Manager at SMC Enterprise. Prior to this, she had been working in Navana Pharmaceuticals, ACME Laboratories Ltd. and Ziska Pharmaceuticals Ltd. at Strategic Marketing Department. After completing MBBS, she also obtained MPH and EMBA. Md. Abdur Razzak has been promoted to Senior Assistant Manager in the Product Management Department (PMD) of Biopharma. He has completed B. Pharm from Southeast University, M. Pharm from University of Development Alternative and MBA (Marketing) from Jahangirnagar University.
THE PHARMA WORLD 103 Md. Abul Kalam Azad been promoted to Senior has APPOINTMENTS & PROMOTIONS Assistant Manager, PMD in Biopharma. He has completed B. Pharm and M. Pharm from University of Development Alternative (UODA). Md. Golam Mostafa Kamal has recently been appointed as Assistant Manager, Strategic Brand Management Department in Asiatic Laboratories. Prior to this, he worked in Naafco Pharma as Group Coordinator, PMD. He completed his B. Pharm from Stamford University Bangladesh and M. Pharm from University of Development Alternative. Mir Raqibul Hasan has recently been promoted to Senior Assistant Manager, PMD in Biopharma. He has completed B. Pharm (Hon’s) from East West University, M. Pharm from University of Development Alternative (UODA) & MBA (Marketing) from Jahangirnagar University. Mehedi Hasan Sabuj has recently joined Novatek Pharmaceuticals as Senior Brand Executive, Strategic Brand Management Department. Prior to this, he worked in Nipa Pharmaceuticals as Senior Product Executive, Product Management Department. He obtained his B. Pharm and M. Pharm from University of Development Alternative. Mohammad Abdullah Al Masood has recently been promoted to Senior Assistant Manager, PMD in Biopharma. He has completed B. Pharm (Hon’s) & M. Pharm from Southern University, PGD- MM from Bangladesh Institute of Management (BIM). Md. Shah Paran Saadhin has recently been promoted to Senior Assistant Manager, PMD in Biopharma. He has completed B. Pharm (Hon’s) from Southeast University and M. Pharm from University of Development Alternative (UODA).
104 THE PHARMA WORLD Mr. Sazzad Hasan has been recently appointed as Sr. Brand Executive at Asiatic Laboratories in Strategic Brand Management Department. Prior to this, he worked in Roche, Orion Pharma & GK-UNHCR project in different capacities. He completed his Bachelor of Pharmacy from Gono Bishwabidyalay & Masters of Pharmacy from North South University. Kazi Sadia Rahman has recently joined Novatek Pharmaceuticals as Brand Executive, Strategic Brand Management Department. Prior to this, she served in Navana Pharmaceuticals as Product Executive, Product Management Department. She obtained her B. Pharm and M. Pharm from Daffodil International University. Sultan Mahmud Shakib has recently joined Novatek Pharmaceuticals as Brand Executive, Strategic Brand Management Department. Prior to his, he served in ZAS Corporation as Executive, Product Management Department. He obtained his B. Pharm and M. Pharm from University of Development Alternative. Tamanna Sultana has recently joined as Product Executive in the Product Management Department of Biopharma. She has completed B. Pharm and M. Pharm from State University of Bangladesh. Sunjida Reza Maliha has joined as Brand Executive at Everest Pharmaceuticals. She completed her B.Pharm (Professional) from Jahangirnagar University and currently pursuing her M.Pharm from Jahangirnagar University. Nusrat Jahan has recently joined as Product Executive in the Product Management Department of Biopharma. She has completed B. Pharm and M. Pharm from North South University. Baishakhi Abedin has recently joined as Brand Executive at Everest Pharmaceuticals. She completed her B.Pharm (Professional) from North South University and currently pursuing her M.Pharm from North South University. Arnab Paul has joined as Brand Executive at Everest Pharmaceuticals. He completed his B.Pharm from North South University.
APPOINTMENTS & PROMOTIONS THE PHARMA WORLD 105 Ahamadunnabi Sourov has recently joined as Brand Executive at Everest Pharmaceuticals. He completed his B.Pharm (Professional) and M.Pharm in Pharmaceutical Sciences from Jahangirnagar University. Md. Irfath Islam has recently joined as Brand Executive at Everest Pharmaceuticals. He completed his B.Pharm degree from Brac University. Rafia Raunaq Rumu has recently joined as Brand Executive at Everest Pharmaceuticals. She completed her B.Pharm (Professional) from Jahangirnagar University and currently pursuing her M.Pharm from Jahangirnagar University. Ishrat Jahan Anty has recently joined as Brand Executive at Everest Pharmaceuticals. She completed her B.Pharm from North South University. Farida Easmin has recently joined as Brand Executive at Everest Pharmaceuticals. She completed her B.Pharm (Professional) from Jahangirnagar University. Monisha Saha has recently joined as Brand Executive at Everest Pharmaceutical. She completed her B.Pharm and M.Pharm from University of Asia Pacific. Zarif Bin Islam has recently joined as Brand Executive at Everest Pharmaceuticals. He completed his B.Pharm from North South University, and currently pursuing MBA from Brac University. Alisha Benta Mahmood has recently joined as Brand Executive at Everest Pharmaceuticals. She completed her B.Pharm from East West University and M.Pharm from University of Asia Pacific.
106 THE PHARMA WORLD ASIA PHARMA EXPO 2023 IN PICTURES
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POST EVENT 108 THE PHARMA WORLD T he 14th ASIA PHARMA EXPO 2023 (APE 2023) & ASIA LAB EXPO 2023, international exhibitions on COMPLETE pharma manufacturing technologies concluded at ICCB, Dhaka, Bangladesh. The 3-days Exhibition was held from March 2 to 4, 2023 at Dhaka. The Exhibition celebrated 21 highly successful years in Bangladesh and helping to develop the pharmaceutical industry of Bangladesh and making significant contribution to Bangladesh economy. BAPI President, Nazmul Hassan, MP inaugurated the exposition as the Chief Guest. Director General of Drug Administration (DGDA) Major General Mohammad Yousuf was the Special Guest. Mr Ravi Uday Bhaskar, Director General, PHARMEXCIL was the Guest of Honour alongside the high officials from various pharma companies. Mr Nazmul Hassan, the President of the Bangladesh Association of Pharmaceutical Industries (BAPI) and CEO of Beximco Pharmaceuticals Ltd (BPL) inaugurated the 3-day exhibition on March 2, 2023 at Dhaka. In his inaugural ceremony speech, Mr Nazmul Hassan informed; “The price of medicine hasn’t gone up that much when compared to our production expenses. Besides, you cannot just hike up the prices of medicine as we have to take into consideration people’s purchasing power. So we all have to work together to provide quality medicines at low prices in such difficult times’. Despite the tough times, the pharma industry grew by 12-15% last year. We are trying to ensure that there is no shortage in the supply of medicines,” the BAPI president added. Major General Mohammad Yousuf, DG of the Directorate General of Drug Administration, Ministry of Health and Family Welfare, attending the event as the Special Guest, said, “Providing drugs at low cost is a big challenge for us now. Despite the increase in material prices, the price of medicines has not gone up that much.” Echoing the same, BAPI Vice President Mr A. Mukadir said, “We need to increase our exports to save foreign exchange. Also if API raw materials are produced locally, we will be able to save more and we are going towards that direction.” Mr Marcel Menhorn (Area Sales Manager), Bausch+Ströbel SE+Co. KG, Germany; Mr. Oliver Patat (Regional Sales Director) TEREOS, France; Mr PH Vachhrajani (Sr Vice President) CADMACH MACHINERY CO. PVT. LTD., India; Mr Luca Cevenini (Area Manager) MARCHESINI Group S.p.A., Italy – some of the international exhibitors - shared their views during the Opening Ceremony, and recognized the importance and promising future growth of the Bangladesh pharma manufacturing industry. Aasif Ahsan Khan, founder of PodTech Lifecare & G7 Universal, a UAE-based entity, said the Expo was a successful one and lauded BAPI’s proactive role in helping the pharmaceutical industry grow faster. Isa Khan, Associate Director of Saka International who had the largest pavilion in the Expo, informed that among their 27 partners, two companies from Italy and UAE exhibited in 2023 for the first time in the ASIA PHARMA EXPO Exhibition. Ingo H Kusel, Area Sales Manager of German company LB BOHLE, shared his experience while exhibiting at the ASIA PHARMA EXPO 2023 that the good sign was that all the people were experiencing the technologies in person, not in digital means. One of the co-organisers, Paresh Jhurmarvala, GPE EXPO PVT LTD, said that all the foreign exhibitors expressed their satisfaction with a huge response from the visitors. “Over 12,000 people have visited the expo. It ushers in new hope as the whole world is now recovering from the Covid-19 crisis. Bangladesh’s pharma sector is getting recognised worldwide and more companies want to participate in the Expo.” ASIA PHARMA EXPO 2023 ASIA LAB EXPO 2023 l More than 658 exhibiting companies from 32 countries, including – USA, Germany, France, Singapore, The Netherlands, China, Japan, Taiwan, Thailand, India, UAE, Vietnam, South Korea. l 12,000+ trade visitors
THE PHARMA WORLD 109UPCOMING EVENTS N.B. Dates/Venues of forthcoming events are subject to change/cancellation etc. with or without notice. So, intending participants are advised to check all details relating to VISA and other relevant matters before departure. EVENT VENUE DATE Morocco Medical Expo 2023 Rabat Morocco May 04–06, 2023 EgyMedica 2023 Cairo, Egypt May 18 – 20, 2023 Hospitalar 2023 São Paulo, Brazil May 23 – 26, 2023 Central Asia Pharma Healthcare Expo Tashkent, Uzbekistan Jun 07–09, 2023 Medlab Asia 2023 Bangkok, Thailand Jun 12–14, 2023 PharmaTech Asia 2023 Bangkok, Thailand Jun 14–17, 2023 China (Shanghai) International Medical Devices Exhibition Shanghai, China Jun 28–30, 2023 in-Pharma Japan 2023 Koto, Japan July 05–07, 2023 Medicall Chennai 2023 Chennai, India July 28–30, 2023 Vietnam Medi-Pharm Expo 2023 Ho Chi Minh, Vietnam Aug 03–05, 2023 PhilMedical Expo 2023 Philippines, Manila Aug 23–25, 2023 INAPHARM 2023 Jakarta, Indonesia Aug 23–25, 2023 Medical Fair Thailand 2023 Bangkok, Thailand Sep 13–15, 2023 Pharmed & Healthcare Vietnam HoChi Minh, Vietnam Sep 13–16, 2023 Pharma Pro & Pack Expo 2023 Hyderabad, India Sep 14–16, 2023 ARABLAB 2023 Dubai, UAE Sep 19–21, 2023 Medicall Delhi 2023 New Delhi, India Oct 07–09, 2023 Indonesian Hospital Expo 2023 Jakarta, Indonesia Oct 18–21, 2023 PharmSci 360 Florida, USA Oct 22–25, 2023 CPhI Barcelona 2023 Barcelona, Spain Oct 24–26, 2023 Africa Health 2023 Johannesburg, S. Africa Oct 24–26, 2023 India Med Expo 2023 Hyderabad, India Oct 27–29, 2023 Medica Connected Healthcare Forum Düsseldorf, Germany Nov 13–16, 2023 CPhI & P-MEC India 2023 Noida, India Nov 28–30, 2023 Vietnam Medipharm Expo 2023 Hanoi, Vietnam Dec 07–09, 2023
110 THE PHARMA WORLD WISH TO EXPORT TO BAHRAIN? Any medicine must be licensed before marketing in Bahrain as per law no. (18) of 1997, medicine Importation and distribution must be done through authorized pharmacy only (Local agent), this agent can be the applicant on behalf of the pharmaceutical company as long as the agreement is prone to NHRA and acknowledged. The local agent must inform NHRA with any agreements made with new pharmaceutical companies for review and approval before starting the licensing process. Pharmaceutical companies (MAH) should note that they are responsible for the medicines quality, efficacy and safety throughout its life cycle. LICENSING PROCEDURE 1. Before Submission Before submission of medicine licensing application the manufacturer license must be valid. The applicant must prepare the file according to requirements laid out in this guideline and assure all the requested documents are available. Please note that for each application the most up to date version of forms should be downloaded directly from NHRA website. 2. Application fees As per resolution 17 of 2016, application fees and service fees is chargeable for each new medicine application submitted to NHRA. The applicant must refer to the latest fee structure from NHRA website. 3. Data requirement The data requirement for each application will differ, depending on the drug submission type. However all required data should be in accordance with ICH Common Technical Document (CTD) in eCTD format. The Common Technical Document is organized into five modules. Module 1 is region specific. Modules 2, 3, 4, and 5 are intended to be common for all regions and must be submitted in soft copy according to ICH guideline. In case of generic products, the comparative bioavailability/bioequivalence study report should be present under module 5. This should be in accordance with GCC bioequivalence guideline or approved by European Medicine agency (EMA), United stated Food and Drug Administration(USFDA), World Health Organization (WHO) & Ministry of Health, Labour & Welfare Japan (MHLW). The applicant must refer to GCC approved bioavailability/ bioequivalence center list on NHRA website MODULE 1 REQUIREMENTS 1. Cover letter: Original company paper signed and dated. 2. Comprehensive CTD table of contents. 3. Forms: Completed forms must be included in this section. The latest version of the below forms must be filled, signed and stamped with date by the MAH Company. i. Application Form. ii. Check list. iii. Pricing form. 4. Product Information i. Summary of product characteristics (SmPC): the template for this document is part of the application form however in Module 1 a declaration from the MAH that the SmPC submitted is correct and similar to the one approved in COO is included in this section (If there is any differences the company shall declare it). ii. Label text (immediate and secondary packaging). iii. Package leaflet (bilingual English/Arabic). iv. Artwork (outer pack, inner pack and package leaflet). v. One finished product sample. 5. Contact details: for the Marketing Authorization Holder responsible person for communication with the NHRA on quality issues. 6. Patency Information: Proof that the innovator patency is expired form Bahrain patency office and GCC patency office is required. 7. Certificates i. Certificate of Pharmaceutical Product (CPP) according to WHO format; legalized and issued from the COO (batch releaser country). ii. GMP certificates or proof of inspection by a recognized health authority for all finished product manufacturer(s) including bulk manufacturer, primary packager, and secondary packager. iii. Certificate of suitability for the active substance, if available. iv. Certificate of suitability for TSE. v. Certificate of analysis for the drug substance from the API supplier. vi. Certificate of analysis for the finished product.
REGISTRATION RULES vii. Price Certificate showing, ex-factory price, whole sale and public retail price in the country of origin (legalized by the Ministry of Foreign Affairs & Embassy and issued within the last six months from the submission date). viii. Manufacturer registration certificate in Bahrain (batch releaser). 8. Laboratory Analysis It is mandatory to analyze the product samples for new registration applications prior to issuance of license. Documents to be submitted are as follows: i. Samples of the product. ii. Certificate of analysis for the sample submitted. iii. Reference standard for the active ingredients and related substances along with their certificate of analysis. iv. Product composition certificate. v. Complete method of analysis. vi. Product Specification. vii. Material safety data. Submission & Validation In order to submit new medicine licensing application the applicant must request an appointment by duly filing an appointment request form and sending to the PPR department by email. Appointments are assigned on a first-come basis. On the appointment day NHRA staff will check the file to make sure all the requested documents are available only valid applications will be accepted as per the checklist. Assessment & Queries Each application is assessed in accordance with NHRA standard operating procedures and where queries arise, a request for further information will be sent to the applicant. The applicant is requested to respond to such requests in a timely manner and in accordance with any decided timeline. Approval After completion of assessment and pricing of medicine a decision to approve or disapprove a product for licensing is done by the licensing committee. Upon approval from the committee the applicant has to pay the required fees prior to collection of the license. Medicine license is valid for 5 years. n THE PHARMA WORLD 111
COURSES & CONFERENCES THE PHARMA WORLD 113 N.B. Dates/Venues of forthcoming events are subject to change/cancellation etc. with or without notice. So, intending participants are advised to check all details relating to VISA and other relevant matters before departure. TITLE VENUE SCHEDULE Royal College of Obstetricians and Gynaecologists (RCOG) World Congress 2023 London, UK May 03–05, 2023 14th European Congress on Menopause and Andropause (EMAS) 2023 Florence, Italy May 03–05, 2023 3rd Global Experts Meeting on Frontiers in Nursing Education and Practice 2023 Barcelona, Spain May 10–12, 2023 Int’l Conference on Women`s Health and Breast Cancer 2023 Tokyo, Japan May 15–16, 2023 Int’l Conference on Fetal Medicine and Perinatology 2023 Roma, Italy May 18–19, 2023 International Conference on Gynaecology and Obstetrics 2023 Tokyo, Japan May 22–23, 2023 International Conference on Nursing care and patient safety 2023 Tokyo, Japan May 25–26, 2023 International Congress on Midwifery and Maternal health 2023 Paris, France Jun 08–09, 2023 International Conf. Expo on Toxicology & Applied Pharmacology 2023 Roma, Italy Jun 12–13, 2023 8th Int’l Conference on Pharmacy and Pharmaceutical Science 2023 Tokyo, Japan Jun 15–18, 2023 The 9th International Conference on Gynaecology and Obstetrics 2023 Amsterdam, Netherlands Jun 19–20, 2023 Global Congress on Gynaecology, Women Health & Breast Cancer 2023 Valencia, Spain Jun 21–22, 2023 7th International Conf. on Gynaecology and Obstetrics Pathology 2023 Amsterdam, Netherlands Jun 22–23, 2023 World Congress on Gynaecology and Women Health 2023 Valencia, Spain June 22–24, 2023 The 6th International Conference on Medicine and Surgery West Drayton, UK June 28–30, 2023 15th World Congress on Womens Health, Reproduction and Fertility 2023 Vancouver, Canada July 10–11, 2023 Society for the Study of Reproduction 56th Annual Meeting (SSR 2023) Ottawa, Canada July 11–14, 2023 9th International Congress of Gynaecology and Obstetrics (ICGO) 2023 Lisbon, Portugal July 17–19, 2023 “2nd International Conf. on Traditional and Alternative Medicine” 2023 Osaka, Japan July 26–27, 2023 Asia Pacific Congress in Maternal Fetal Medicine 2023 Ho Chi Minh City, Vietnam Aug 17–18, 2023 14th World Conference on Women Health Science and Care 2023 Bangkok, Thailand Sept 14–15, 2023 “10th Edition of Global Conference on Pharmaceutics and Drug Delivery Systems” (PDDS 2023), Valencia, Spain Sept 14–16, 2023