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The Drugs Technical Advisory Board (DTAB) has recommended to the drug regulator to provide certain exemptions related to plant and equipment requirements under the revised Schedule M standards to the manufacturers of specific categories like disinfectants and medical gases, as those mandates are not relevant for such categories of drugs.
The decision was taken in the 93rd DTAB meeting held on February 16, 2026, following requests from the stakeholders to consider continuing certain exemptions provided under the previous Schedule M norms.
The Board was apprised that under pre-revised Schedule M certain exemptions to regulatory requirements were provided in the note under the Part related to “Requirement of Plants and Equipment” for certain product categories. Now, in the wake of the revised Schedule M notified on December 28, 2023, the stakeholders have requested to further consider this exemption under the revised Schedule M, it observed.
The Board, considering the request, opined that certain requirements of the revised standards "may not be relevant to certain categories of drugs namely Medical gases, empty gelatin capsules and disinfectant fluid."
"Accordingly, the Board recommended to continue the exemptions provided under Schedule M prior to the amendment of the categories of drugs," it added.
Recent reports suggested that companies including Fast Moving Consumer Goods (FMCG) major Wipro has approached the drug regulator with a request to exempt their plants from the provisions, considering they are not relevant in the particular context.
The revised Schedule M standards, on par with the international manufacturing quality standards, were initially notified in December, 2023, mandating compliance of the revised standards by pharma units above Rs. 250 crore turnover in six months and units below Rs. 250 crore turnover in 12 months from the date of notification.
The timeframe for micro, small and medium units under Rs. 250 crore was later extended till the end of December, 2025. The drug regulator is proceeding with action against non compliance of the revised schedule among the pharma units across the country, following the end of the deadline, even though the MSME units are seeking extension of the deadline for another three to five years so that they can comply with the revised schedule without shutting down their operations.
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