The Karnataka High Court has granted temporary relief to pharmaceutical companies, allowing them to continue manufacturing nutraceuticals in drug-licensed units. This decision came after the Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) along with the Federation of Pharma Enterprises (FoPE), and the Council of Softgel Manufacturers Association Interest challenged the provisions of Schedule M, which prohibits the production of non-drug products, including nutraceuticals, in facilities licensed for drug manufacturing. The court's order prevents the government from taking any action against these firms until the next hearing, thus providing some breathing space for the companies. This relief is significant for the nutraceutical industry, which often uses the same manufacturing infrastructure as pharmaceutical products, and this legal battle centres on whether such production practices should be allowed within drug-licensed units. The court's intervention offers a temporary pause in enforcement of the rule, giving companies time to address their concerns before the matter is further examined. The direction from the Karnataka High Court is to refrain from taking any action against companies manufacturing nutraceuticals in units licensed for drug production until its next hearing, in a significant relief for the pharmaceutical industry. The newly notified Schedule M proposes a blanket ban on manufacturing of any other article or product apart from drugs in the same facility. "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," the court said. The industry had approached the court challenging some provisions in the Schedule M, arguing that setting up new plant exclusively for cosmetic manufacturing is financially not viable. They pleaded that drug facilities be permitted to manufacture nutraceuticals in the area dedicated for making topical products such as external preparations such as creams and lotions, as per a media report. The Court direction was based on the 37th meeting of the Drugs Consultative Committee (DCC) which recommended that the allied product manufacturing activity will not adversely affect the quality of medicines manufactured by them. The Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO) vide office memorandum dated 27.5.2024 constituted a committee to examine the matter of manufacturing of nutraceuticals within the drug manufacturing facility, as per the Karnataka HC order. 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. 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, stated the HC order. The court's ruling came in response to the government's previous directive, which stated that it would take action against pharmaceutical companies violating the norms by producing nutraceuticals, health supplements, and drugs in the same facility. The court's temporary stay prevents the government from acting against these units until the next hearing. This decision grants the petitioners some breathing space while the legal matter regarding the regulation of manufacturing practices in drug-licensed units is reviewed. pharmabiz
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