SLPMA talks about barriers to gain entry into US markets
By Ishara Gamage
The biggest problem encountered by local pharmaceutical companies, when attempting to enter the US market is that they need to obtain US Food and Drug Administration (FDA) approval, the Sri Lanka Pharmaceutical Manufacturers' Association (SLPMA) said.
Joining, the recently concluded Phase II session of the AmCham Sri Lanka TRADESHIFTS 2020 initiative, SLPMA, representatives, Dr. Janaka Wickramasinghe and Viraj Manathunga said that none of the local companies currently have FDA approval.
TRADESHIFTS 2020 is a three to four phased project designed to study, identify and attract opportunities for Sri Lanka arising out of the current and imminent global supply chain shifts in the region.
“The audits to get the FDA approval are tough making it one of the most challenging approvals to obtain,” the SLPMA said.
According to them, many companies avoid getting FDA approval since it does not bring any added advantage. Therefore, many companies opt for the EU GMP certificate instead.
With only EU GMP approval, companies can export to the rest of the world but not to Canada and the US.
The Pharmaceutical industry here is not in a mature state; however, it is a highly regulated industry. When a pharmaceutical manufacturing factory is started the first goal should be to supply the domestic market.
In order to cater the domestic market the stability of the product is important as the company must be able to satisfy the certifying authority that the product/drug is safe for use and has a shelf life.
There is six months accelerated data that is approved by the local regulators, but when it comes to exports real time shelf life data is required.
It takes 3-4 years for a pharmaceutical company to be able to export its products. Until such time these companies will have to be satisfied with selling their products to the domestic market.
Out of the 14 pharmaceutical manufacturing companies currently in operation, only 3 are exporting (to countries such as Myanmar and Cambodia). The total revenue of exporting pharmaceuticals is approximately USD 7 million per annum.
Having FDA approval is beneficial. When considering the total market share of pharmaceutical imports to the US, India accounts for around 75% of imports of pharmaceutical products. India has a heavily invested pharmaceutical industry with 500+ operational plants.