Industry Analysis of Pharmaceutical Industry in Bangladesh

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Industry Analysis of Pharmaceutical Industry in Bangladesh

In Bangladesh the pharmaceutical sector is one of the most developed hi-tech sectors which is contributing in the country's economy. After the promulgation of Drug Control Ordinance - 1982, the development of this sector was accelerated. The professional knowledge, thoughts and innovative ideas of the pharmaceutical professionals working in this sector are the key factors for these developments. Due to recent development of this sector it is exporting medicines to global market including European market. This sector is also providing 97% of the total medicine requirement of the local market. Leading pharmaceutical companies are expanding their business with the aim to expand export market. Recently few new industries have been established with high tech equipments and professionals which will enhance the strength of this sector. Two organizations, one government (Directorate of Drug Administration) and one semi-government (Pharmacy Council of Bangladesh) control pharmacy practice in Bangladesh. The Bangladesh Pharmaceutical Society is affiliated with international organizations International Pharmaceutical Fede The Bangladesh pharmaceutical market in 2004 stood at approximately US $ 560 million, which is very small when compared to the population base of the country, which currently stands at about 140 million. To put this number on a proper perspective, the total global pharmaceutical sale in 2004 was $430 billion. This is expected to grow at 8.1% to about $530 billion in 2005. Of course the majority of the sale in 2004 was in brand products, the market segment where Bangladesh does demonstrate safety and efficacy through clinical trials, rather they would have to demonstrate that the drug products that they are filing are therapeutically equivalent to the Reference Listed Drug. One of the major barriers that pharmaceutical companies must overcome to enter the regulated market is to be fully compliant with current Good Manufacturing Practices (cGMPs). Although many of the firms are ISO certified, it is a fact that virtually none of the pharmaceutical manufacturing plants that are currently in operation in Bangladesh fully complies with cGMP regulations as described in the US Code of Federal Register (CFR). FDA inspections of manufacturing operations are meant to evaluate a firm's cGMPs, and to verify documents, data and manufacturing records submitted in the ANDA. This inspection is a critical part of the drug application approval process. The firms must demonstrate substantial compliance to the satisfaction of the FDA investigators if they are to avoid receiving FDA observations (483's) and approval of their ANDAs. Ration and Commonwealth Pharmaceutical Association. Cross sectional Analysis

Pharmaceutical industries are an important means of bringing drug information to health care professionals (1). Their primary goal is to convince clinicians to prescribe their products. These ads often cite external documents in support of their claims (2). Pharmaceutical companies worldwide are heavily involved in aggressive drug promotions through advertisements. But the scientific claims made for drugs are often inaccurate and not based on proper scientific evidences (2, 3, 4). As with many countries worldwide, drug promotion and marketing make up a very large part of the activities of pharmaceutical companies in Bangladesh. It is generally believed that overstatements and misinformation are common promotional activities of drug companies in Bangladesh (5). In a study, drug promotion through industry in promotional brochures showed 50 per cent of claims were based on debatable scientific evidence, while 12 per cent were fake (6). The MediMedia Index of Medical Specialities (MIMS) Bangladesh is an index of important information of available drugs in Bangladesh, mostly used by physicians as a practical reference for daily prescribing. It is a widely available...
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