The history of pharmaceutical export from Bangladesh dates back to late 80s. At that point in time, only one or two pharmaceutical companies of Bangladesh took proactive efforts to initiate export of pharmaceuticals from Bangladesh. Despite the fact that there was no support or incentive from the Govt., these companies with their own initiative started exporting finished formulations to some of the neighboring less-regulated overseas markets like Myanmar, Sri Lanka and Nepal.
After being successful in these less-regulated markets, in early 90s few major companies in Bangladesh also took initiative to explore some of the more-regulated markets like Russia , Ukraine, Georgia and Singapore. Success in registering and marketing these products in these countries was a major breakthrough for Bangladesh pharmaceuticals industries. This was a clear testimony not only to the product quality, but also to capabilities to meet stringent regulatory requirements. Today, Bangladesh pharmaceutical industry has successfully started exporting its quality products to about 30 countries across four continents.
Today, Bangladesh is exporting a wide range of pharmaceutical products covering all major therapeutic classes and dosage forms. Beside regular brands, it is also exporting high-tech specialized products like inhalers, suppositories, nasal sprays, injectables and infusions. Apart from overseas retail customers, the country is supplying to world-renowned hospitals and institutions like Raffles Hospital of Singapore, Jinnah Hospital of Pakistan, MEDs of Kenya , SPC of Sri Lanka and KK Women & Children Hospital of Singapore. The product quality, packaging and presentation of the products have been highly appreciated in all the countries.
Export Opportunities from 2005
In 2002, India exported pharmaceutical products worth Tk. 6,750 crore. On the other hand , in 2002 China exported pharmaceutical products worth Tk. 13,200 crore. However, following the TRIPS compliance as part of the WTO Agreements, both India and China as well as other countries except the 49 LDCs , will not be able to export patented drugs from their countries from January 2005. Among the 49 LDCs , Bangladesh is the only country which has a very strong manufacturing base in pharmaceuticals. So, for Bangladesh the situation is going to be reversed as year 2005 will provide enormous export opportunities for Bangladesh pharmaceutical sector.
It can now manufacture and export patented drugs to atleast 48 LDCs. But, these opportunities can only be availed provided all the aforesaid problems are addressed on an immediate basis.
APIs: Huge Opportunities
In API, there are huge opportunities in the overseas markets. It can be mentioned here that 76% APIs (Active Pharmaceutical Ingredients) for US drug industry are imported. For API, there is no stringent registration requirement and the operational as well as promotional costs are also nominal. The only decisive factor in this regard is the cost competitiveness. This cost competitiveness can easily be availed by offering 'Cash Incentives' for export of APIs, as offered by other countries.
In the light of the export opportunities as revealed by WTO / TRIPS, Bangladesh firms have to invest in APIs or bulk drugs. In bulk drugs, the domestic market is too small to attract any company to invest. In this connection, the Commerce Ministry of Bangladesh is going to establish a 'API Park' with all necessary infrastructure and facilities like effluent treatment plants (ETP), icinerators etc. But without 'Cash Incentive ' for the export of APIs, it would be very difficult for us to compete in the overseas markets .
Formulations
In formulation, there are 3 types of overseas markets according to regulatory requirements. Firstly, there are highly regulated markets like USA, UK etc. that require various certifications from USFDA, UKMCA etc. and need huge investment in facilities and documentation.
Then there are the moderately regulated markets like Russia , Singapore etc. which usually require bioavailability, bioequivalence, clinical trials etc. Third category is the less regulated markets like Myanmar, Sri Lanka , Nepal, Kenya, Yemen etc. In this regard, some of the major companies have already made millions of dollars of investment in their manufacturing and R&D facilities, and are going for certification in the highly regulated markets. Square has already started operating their new state-of-the-art facility.
Beximco has also commenced manufacturing in their world class MDI plant and is going for certification in the regulated markets. Novartis has also started manufacturing in its new facility for exporting to Europe. Beximco has already made a US $ 50 million investment on a new plant conforming to USFDA standards. A few major companies have also invested in R & D.
Issues of Concern
Most of the countries like India, China and Singapore have already upgraded their registration requirement of imported drugs. On the other hand , registration requirement for imported products in Bangladesh is extremely relaxed. If proper attention is not given, there is a possibility that Bangladesh pharmaceutical market will be flooded with spurious and substandard products from neighboring countries.
Investment in R & D and bulk drug facilities is the immediate priority. And in case of new product registration, all patented products should get the top priority.
Actions to be taken
Although pharmaceutical export from Bangladesh is still at its infancy state, it is growing at a faster pace. More than that, the products have been highly appreciated in all the countries and pharmaceutical export from Bangladesh has huge potential to grow. But, in order to encourage and boost pharmaceutical export from Bangladesh, certain specific and objective oriented actions have to be taken right at this moment.
The country has to address the problems that have been faced by the pharmaceutical industry in its export activities. Problems relating to image , information, transfer of operational expenses and samples, scarcity of cargospace, duty drawback etc. have to be solved on an immediate basis. To encourage and boost pharmaceutical export from Bangladesh , govt. should immediately offer 'Cash Incentives' both for export of APIs and finished formulations.
In the light of the export opportunities as revealed by WTO/TRIPS, it has to invest both in bulk drugs and R & D facilities. With regards to bulk drugs, the domestic market is too small to attract any company to invest. Therefore, cash incentives are mandatory for export promotion. With regards to R & D, the country should be allowed to import all the equipment duty-free and tax-free. The registration requirement for imported products should be made stringent so that the market is not flooded with spurious and substandard drugs from neighboring countries. In case of new product registration, all patented products should be given priority.
In order to take full advantage of post WTO opportunities, our National Drug Policy / Drug Ordinance must be updated in line with WTO. TRIPS guidelines. Apart from that, there should be a separate cell dedicated for pharmaceutical export. And the govt. should set export target for pharmaceuticals.
- (The author is Secretary General, Bangladesh Association of Pharmaceutical Industries. Courtesy: BAPI website)