Mumbai | As part of efforts to strength pharma regulations, the government plans to step up vigilance on sale of spurious drugs by increasing the number of drug inspectors, a senior official said.
“Despite increased vigilance on counterfeit drugs, nearly 2 per cent of these drugs is sold in the market. Efforts are on to strengthen regulation and increase drug inspectors.
“Nearly 10,000 pharmaceutical manufacturing facilities across the country are monitored and inspected by national and state regulators,” said Sudhansh Pant, Joint Secretary at Department of Pharmaceuticals in Ministry of Chemicals and Fertilisers here.
There are six lakh pharmacies in the country, and in many cases one inspector takes care of 500-1,000 of these, he said, addressing the annual convention of the Indo-American Chamber of Commerce (IACC).
“We have both national as well as state regulations and with the expansion of industry size, we have also undertaken larger number of inspection. However, there is no linkage between the USFDA inspection and inspection done by our own regulators.”
Commenting on inspection of facilities of drug makers in India by the US Food and Drug Administration (USFDA), Pant said the growth of pharma industry has made government proud.
In the last four years, our pharma exports grew to USD 4.6 billion, whereas 26 warning letters were received by the industry from the USFDA. These warnings are insignificant, but we believe quality of drugs cannot be compromised, he said.
“The Modi Government has taken up this issue with the US Government and industry is talking with the American health regulator. We hope scenario will improve in the near future,” the official added.
Pant said investment in the sector has grown substantially in the last 4-5 years. However, lesser investment in green field units is cause of concern.
An improvement in ease of doing business has also started yielding results and government’s intention is to facilitate faster growth of the key industry, he said.
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