Domestic pharmaceutical industry has not approached the government for early intervention to resolve regulatory issues faced by them in the US, Parliament was informed today.
“There is no representation from the industry to the government for early intervention and dialogue with the US health regulator,” Minister of State for Commerce and Industry Nirmala Sitharaman said in a written reply to the Rajya Sabha today.
Despite the regulatory action by the US Food and Drug Administration (USFDA), Indian pharmaceutical exports to the US have increased from USD 3.4 billion in 2013-14 to USD 3.8 billion in 2014-15, she added.
On steps being taken by the government to grow domestic pharma industry, Sitharaman said, “India and the US are collaborating in information sharing about good manufacturing practices, inspections, capacity building of inspectors and industry.” In recent times various Indian drug firms — Sun Pharmaceuticals, Wockhardt, Dr Reddy’s Laboratories, Cadila Healthcare — have come under the USFDA scanner for various reasons including manufacturing norms violations at their respective facilities.
The USFDA has refused entry of 12,012 Indian products, including drugs, into the American market between January 2011 and March 2016 for various reasons.
The reasons given for the refusal include misbranding, adulteration, packaging, labelling, pesticides, unapproved products and the like.