Karnataka HC Stays Action Against Pharma Firms Producing Nutraceuticals in Drug Facilities

The Federation of Pharma Enterprises (FoPE), representing small and medium-scale pharmaceutical companies, along with the Karnataka Drugs and Pharmaceutical Manufacturers Association and other stakeholders, challenged the provisions of Schedule M.

The newly introduced Schedule M of the Drugs and Cosmetics Act imposes a complete ban on producing non-drug items, including nutraceuticals, in the same premises as drug manufacturing.

They argued that creating separate facilities solely for manufacturing cosmetics or nutraceuticals is not financially viable.

The petitioners sought permission to produce nutraceuticals in areas allocated for manufacturing topical products such as creams and lotions.

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Examining the matter, the Court noted;

"The petitioner’s apprehension that pending consideration to examine the matter of manufacturing of nutraceuticals within the drug manufacturing facility, the respondents are likely to take precipitative action.”

Subsequently, the Court said;

“Till the next date of hearing, the respondents shall not take any precipitative action against the petitioner in so far as it relates to manufacturing of nutraceuticals within the drug manufacturing premises.”

According to a recent Economic Times report, the government had declared its intent to enforce regulations against pharmaceutical companies producing nutraceuticals, health supplements, and drugs in shared facilities.