India’s drug regulator had said earlier that action will be taken against those flouting norms by manufacturing supplements and drugs in the same facility. However, following objections raised by various pharma lobbies, the drug regulator has formed a committee that will give its recommendations within three weeks on the issue.
The committee comprises senior officials from the regulatory authority, experts from the National Institute of Pharmaceutical Education and Research (NIPER) and an industry expert.
“It has been decided to constitute a committee to examine the request of the industry associations to consider permitting manufacturing nutraceuticals in drug manufacturing facility,” said the notice dated May 27.
“The committee shall submit the report within the time period of three weeks,” the notice said.
ET had earlier reported that the government may “reconsider” its decision to act against pharmaceutical companies manufacturing nutraceuticals, health supplements and drugs in the same facility following objections raised by industry bodies.Federation of Pharma Entrepreneurs (Fope), a pharma lobby that works with micro, small and medium enterprises (MSMEs), had said any clampdown in this regard will affect not only exports but also the domestic market.Under the revised Schedule M of Drugs and Cosmetics Act 1940, a manufacturing facility approved for drugs cannot be used for manufacturing other products.
Executives of Fope had also met the health secretary and the Drug Controller General of India (DCGI) seeking an exception to select units as was given earlier.
An exception was earlier provided to the units established prior to December 2001, he said. “Subsequently, this concession was extended to all manufacturing establishments by the DCGI under his letter dated March 1, 2007, based on the decision of the Drugs Consultative Committee in its 37th meeting,” an industry expert said.
