Indian drug control weakest, need to bolster it: Pharma Secy

Terming Indian drug control as the "weakest in the world", a top government official today acknowledged that the industry is saddled with many issues and departments work at cross-purposes on key matters.
"In the entire world, I think our drug control system probably is the weakest today. It needs to be strengthened," Department of Pharmaceuticals (DoP) Secretary V K Subburaj said at an event here.
Batting for quality, he said the health ministry is already seized of the matter and working on improving specific parameters, increasing the number of inspectors as well as drug control staff.
Putting out a ballpark figure, the secretary noted that the domestic industry -- both pharma and medical devices put together -- has a potential to grow up to USD 300 billion by 2030, from the existing USD 32 billion, but would require a proactive approach to solve various issues.

"Very tall targets unless we take proactive steps... The problem solving in this sector takes a long time... Various sectors pull in different directions," Subburaj said.
He singled out drug industry associations for working in opposite directions, adding that "if we take one decision, it is appreciated by one but the other one criticises us".

There are various organisations such as IPA, OPPI and IDMA, among others, which represent various sections of the drug industry in the country.
Citing an example, Subburaj pointed to divergent views of various bodies, because of which the government took one year to come up with Uniform Code of Pharmaceutical Marketing Practice (UCPMP).

"To take example of uniform marketing code, we thought we could arrive at a common solution. But even after 7-8 meetings, we failed to come to a conclusion. It's only now that we have arrived at a code," he added.
According to the secretary, it may take years to implement the bulk drug policy.
"We created the bulk drug policy, but before we could get necessary approvals, to implement it takes years. It is not that overnight decisions are taken because various departments pull in different directions," Subburaj said.
On the pricing front, he said -- albeit in a lighter vein

-- that all departments have worked closely to "strangle" the drug industry.
"Pricing is one important issue which is bothering all the industry... I think all departments have worked very closely to see that the sector gets strangled," Subburaj said.
He also spoke of guidelines on the bulk drug policy, which are expected to come out shortly.
"The idea is that in another 10 years, we should see there is no dependence (on bulk drug imports). We are moving towards that, coordinating with departments and the industry so that there is a good ecosystem in place for this sector," Subburaj explained.

He wanted the drug industry to sharpen focus on various other streams apart from generic drugs to further boost profitability of the sector.
"Not only generics, but also focus on other sectors like phytochemicals, blood products, proteins, monoclonal antibodies and veterinary medicines," he said.