To mention the successful industries of Bangladesh, one cannot avoid the name of pharmaceutical industry. There are several sectors leading inside the country but pharmaceutical industry is the most technologically advanced sector of them. Adept approaches, acquaintance and state-of-the-art ideas from theprofessionals are the key reasons why this industry developed in the way it did. This industry has become ample pride for the nations. Due to dynamic measures from government this industry is forwarding swiftly which is why the industry is in list of booming sectors of Bangladesh.
The market size of Pharmaceutical Industry has already crossed $2billion last year. The success story of this industry is very amazing. It had to travel a longway to achieve the current prominent position in domestic and international markets. By now,country’s 97% of the demand of medicines is produced locally by national pharmaceutical companies. The pharmaceutical sector of Bangladesh is expanding rapidly and some companies have already certified by different international regulatory authorities. Regulatory agencies like UK-MHRA,Australia-TGA, EU, etc. has certified the companies for quality management and quality products manufacturing. Even more, few of the companies already achieved the US-FDA license.
|Type of Drug Manufacturer
||No. of Manufacturers
|Allopathic Drug Manufacturers
|Ayurvedic Drug Manufacturers
|Unani Drug Manufacturers
|Herbal Drug Manufacturers
|Homoeopathic Drug Manufacturers
Figure: Categorization of Drug manufacturing company
Pharmaceutical export is contributing to the GDP of the country and every year this contribution is positively growing In the meantime, Pharma sector has become the 2nd largest potential sector in Bangladesh to earn foreign currency. At present, about 30 pharmaceutical companies have started their export activities. Many smaller companies are on the verge of entering highly regulated overseas markets. Bearing in mind its successful past endeavors, the industry has the ability to establish itself in mass exportation.
Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO). According to this agreement, all signatory parties are bound to include 20 years product patent protection for pharmaceutical products in their domestic legislation. Formerly, the 48 LDCs are not obliged to perform legislation on product patent rights till 2016, which has been extended in late 2015 till 2033. Bangladesh is among these 48 countries. So until 2033, Bangladesh can export to any country if the drug is not under patent or has not implemented product patent protection. Bangladeshi pharmaceutical companies are provided with patent-free production rights domestically until 2033 (after new amendments in 2015) and limited exporting advantage.
Pharmaceutical Industry is rising at a very astounding rate and contributing to the national economy. The Current industry size with potential global standards & can emerge as major revenue generating sector of the country. Bangladesh is self-sufficient in meeting local pharmaceutical product demand. Bangladeshi pharmaceutical companies provide generic product and able to charge premium for its products. Top 10 companies hold approximately 70% market share.
It is highly complicated to enter into this industry because of huge investment requirement. Bangladesh export pharmaceutical products to 105 countries. Myanmar imports the highest quantity of medicines worth $15.360 million followed by Sri Lanka with $13.88 million, the Philippines with $7.43 million, Vietnam $5.17 million, Jordan $4.54 million, Afghanistan $4.45 million, $4.18 million and Slovenia $3.38 million.
Two organizations regulate drugs and pharmacies in Bangladesh.
The Directorate General of Drug Administration (DGDA) is the national drug regulatory authority which is under the Ministry of Health and Family Welfare. DGDA regulates all activities related to import and export of raw materials, packaging materials, production, sale, pricing, licensing, registration of all kinds of medicine including those of Ayurvedic, Unani, herbal and homeopathic systems.
The Pharmacy Council of Bangladesh (PCB) was established under the Pharmacy Ordinance Act in 1976 to control the pharmacy practice in Bangladesh. The Bangladesh Pharmaceutical Society is affiliated with the International Pharmaceutical Federation and Commonwealth Pharmaceutical Association. The National Drug Policy (2005) states that the World Health Organization’s current Good Manufacturing Practices (GMP) should be strictly followed and that manufacturing units will be regularly inspected by the DDA. Other key regulation features are restrictions on imported drugs (where these are produced by four or more local firms), a ban on local production of around 1,700 drugs that are considered non-essential or harmful and strict price controls on some 117 principal medicines.
The capability of the Bangladeshi drug industry to manufacture drugs for all kinds of needs is beyond doubt. While some manufacturers are already able to produce world class quality drugs, others would require considerable assistance to be able to reach that target. Bangladesh is a natural candidate to supplement or substitute other international manufacturers to the developing country markets of both finished drugs and APIs. In order to maximize growth, the pharmaceutical players need to set their vision in the global market.