Home HEALTH Pharma companies producing drugs, supplements in same unit under lens

Pharma companies producing drugs, supplements in same unit under lens

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The government has decided to take action against pharma units which 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 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 take action against units that have licences to manufacture both drugs and food products and are flouting this norm, the people cited earlier told ET.

According to the Federation of Pharma Entrepreneurs (FOPE), any clampdown in this regard will pose a significant challenge to the industry, affecting not only exports but also 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 licences under FSS Act 2006 and Drugs and Cosmetics Act 1940 for manufacturing nutraceuticals, health supplements and drugs in same factory.

The DCGI has asked the state drugs controlling authorities to accord top authority to the matter. The regulator has also asked them to carry out inspections with the FSSAI so that “manufacturing of spurious and without licence drugs in guise of nutraceuticals are dealt promptly”.

Harish K Jain, president of FOPE, said enforcement of the rule will pose a challenge for the pharma industry and will have implications for both exports and the domestic market, as it will 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 company; exports will stop, giving them liability from international distributors and customers, deprive country of foreign exchange, tarnish credibility of India’s supply chain, which goes against the ‘Make in India’ philosophy, and affect the consumer…”

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