Expert Panel to Evaluate Nutraceutical Production in Pharma Plants

New Delhi, May 28 (KNN) A five-member expert committee has been formed by India's drug regulator to examine whether manufacturing of nutraceuticals should be permitted within pharmaceutical manufacturing facilities.

The committee comprises officials from the regulatory authority, experts from the National Institute of Pharmaceutical Education and Research (NIPER), and an industry representative. They have three weeks to submit recommendations on the contentious issue.

Earlier, the drug regulator had stated that action would be taken against companies violating norms by manufacturing supplements and drugs at the same site.

However, this stance drew objections from pharmaceutical industry associations.

"It has been decided to constitute a committee to examine the request of the industry associations to consider permitting manufacturing nutraceuticals in drug manufacturing facilities," said a notice dated May 27th, reported ET.

The Federation of Pharma Entrepreneurs (Fope) had warned that cracking down on combined nutraceutical-drug production could impact exports and the domestic market, especially for small and medium enterprises.

Currently, under the revised Schedule M rules, a facility approved for drug manufacturing cannot produce other products.

Historically, exceptions had been granted to older plants, but that reprieve was discontinued.

The expert committee's report is expected to guide the regulator's next steps on managing nutraceutical-drug manufacturing overlaps, balancing quality concerns with industry viability.

(KNN Bureau)