Scrutiny Over Pharma Companies Producing Drugs and Supplements Together

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The government has decided to take action against pharma units that are flouting norms by manufacturing nutraceuticals, health supplements and drugs in the same facility, said people with knowledge of the development.

Under the revised Schedule M of the Drugs and Cosmetics Act 1940, a manufacturing facility approved for drugs cannot be used for manufacturing other products. The Drugs Controller General of India (DCGI) has now directed the state authorities to act against units that have licenses to manufacture drugs and food products and are flouting this norm, the people cited earlier.

According to the Federation of Pharma Entrepreneurs (FOPE), any clampdown in this regard will pose a significant challenge to the industry, affecting exports and the domestic market. As per a recent notice by the DCGI, an enforcement and surveillance drive carried out by the Food Safety and Standards Authority of India (FSSAI) found that many units in Himachal Pradesh have dual licenses under the FSS Act 2006 and Drugs and Cosmetics Act 1940 for manufacturing nutraceuticals, health supplements and drugs in the same factory.

The DCGI has asked the state's controlling authorities to accord top authority to the matter. The regulator has also asked them to conduct inspections with the FSSAI so that "manufacturing of spurious and without license drugs in guise of nutraceuticals are dealt with promptly."

Harish K Jain, president of FOPE, said enforcing the rule would pose a challenge for the pharma industry and have implications for both exports and the domestic market, as it would take a long time for the industry to align with this rule.

"If the company has to choose whether their facility can only make drugs or dietary supplements, one of the two businesses will come to a standstill," said Jain.

This will result in significant losses to the company; exports will stop, giving them liability from international distributors and customers, depriving the country of foreign exchange, and tarnishing the credibility of India's supply chain, which goes against the 'Make in India' philosophy, and affecting the consumer.