(Wahidur Rahaman): As among all the 50 LDC countries Bangladesh is the only country having a quality pharmaceutical manufacturing base with marketing potential, and exporting to at least 80 destinations of the world.
So can we form AAPU a banner at least within the 50 LDCs of Asia Pacific, Africa, and Pharmaceutical Union amongst the MOH/FDA authorities to avoid re-registration of Companies and products within the member countries under this umbrella?
The pharmaceutical export market can be categorized into three types-
1. Stringently regulated markets: USA, EU, UK, Australia, GCC which require USFDA, UKMHRA, TGA, cGMP, and GCC certifications and only a few from the top ten companies can hardly afford these certifications,
2, Mildly regulated export markets: Like Singapore, Sri Lanka, Vietnam, Philippines also need ACTD formats along with Bioequivalence clinical test study reports of pharma products these are critical procedures with time and money-consuming factors & many of the mid-level companies cannot afford.
3. Less Regulated Export Markets: of 50 LDCs of Asia Pacific & Africa the only target markets remain in our hands to explore under the Umbrella of AAPU.
So that the products which are registered by DGDRA Bangladesh may be treated as registered within these countries. If required Free Sales Certificates/Certificate of pharmaceutical products, Valid GMP Certificate, Product Approved Annexure, DML can be asked directly from our DRA Bangladesh by the importing countries MOH/FDA for the import of pharmaceutical products from Bangladesh under the joint Pharmaceutical inspection cooperation scheme (PIC/S) as existing among the 43 developed countries of the world eg. Australia, EU, Canada, USA, Singapore, etc.
This will not only save time and money but enable medium-ranking companies in getting access to the international marketing domain & the current pharmaceutical turnover will grow many fold higher within the shortest possible time before the implementation of WTO/TRIPS by the year 2016.
We also need to apply for the extension of TRIPS at least till the inauguration of our API at Ghazaria Munshiganj. Otherwise, it will be rather difficult to address the challenges of globalization to retain even our own local market share of approx 1.294 billion USD in 2012 with 14% growth over 2011 in Bangladesh. There are more than 600 generics in 25000 brand names,& 117 generics in the essential drug list of DGDRA Bangladesh. This enables us to fetch 97% of local market demand with only 3% import of specialized products like vaccines, anti-cancer, hormones & insulin, etc.
The establishment of WHO accredited Bioequivalence clinical test laboratory is the burning need of the time.
The export statistics report of our DGDRA Bangladesh on 47 pharmaceutical exporting companies from 2010 to 2012 was as follows.
- 2010- BDT= 3,274,323,537.91
- 2011-BDT=4,212,241,260.00(+29% over 2010)
- 2012-BDT=5,396,212,817.50(+28% over 2011)
This reveals average Pharmaceutical export growth of 29% which is even higher than the 14% annual growth in 2012 at the local market. Bangladesh annual market size in2010 was USD 932million, 2011 USD 1135 million & in 2012 USD 1294million,
As such considering the burning need of the time a specialized trade mission under the joint protocol of our Foreign Ministry/DGDRA/BAPI to the 50 LDCs may accomplish this strategic innovative vision for a major breakthrough in the pharmaceutical export of the nation considering the SWOT analysis to address the challenges of WTO TRIPS before 2016. This will also contribute substantially to the national economy as a whole too! (Source: The News Today)