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Pharma MSMEs warn of nationwide protest against difficult regulatory environment
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Peethaambaran Kunnathoor, Chennai
September 22 , 2025
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In a move highlighting a ‘silent crisis’ threatening their survival, a Joint Forum of Pharmaceutical MSMEs Associations of India has sent a representation to Union health minister J P Nadda.
The Joint Forum represents over a dozen industry associations including CIPI, FOPE and LUB.
The letter reveals that a 2-day nationwide ‘Stop Production on paid-salary basis’ was suggested by their members to protest the difficult regulatory environment. However, the forum, considering itself responsible industry associations, has sought an urgent meeting with the health minister to avoid any such sensational activity and find a peaceful resolution for their grievances.
The forum's representation details that despite the government's supportive initiatives, regulatory and enforcement actions by the CDSCO appear to be aimed at closing down Indian pharma MSMEs at the behest of large corporates and multinational companies. The associations have requested urgent intervention, hand-holding, and a ten-year roadmap to ensure the continued existence of MSMEs in the Indian pharmaceutical industry, which is a significant contributor to global medicine supply.
A major point of contention is the revised Schedule M, which mandates new GMP requirements for MSMEs effective from January 1, 2026. The letter states that these requirements were notified without considering the objections and suggestions of the MSME industry and are feared to force nearly 4,000 to 5,000 manufacturing units to shut down due to the high costs of compliance. The forum has urged for the implementation date to be extended to a minimum of April 1, 2027, for units with a turnover of less than Rs. 50 crore, to allow them sufficient time for compliance.
The representation also raises concerns about the retrospective implementation of the bio-equivalence (BE) study notification (GSR 327 E) after a nine-year delay. The forum points out that the cost of these studies, at approximately Rs. 25 lakh to Rs. 50 lakh per product, is beyond the reach of MSMEs and could lead to drug shortages. The associations warned that this circular could act as a ‘death warrant’ for the industry.
Further regulatory issues highlighted in the letter include the retrospective application of NDCT Rules 2019 to previously approved drugs and the mandatory export NOC for non-narcotic drugs, which has hampered exports. The forum alleges that these stringent measures have made it difficult for MSMEs to compete globally, causing them to lose export business to countries like China, Bangladesh, and Sri Lanka.
The letter also addresses the issue of NSQ (Not of Standard Quality) drug data publications. The associations claim that the monthly publication of NSQ data, which affects only 2.64 percent of drugs, creates public and international concern without providing a fair chance to the companies before the data is released. They have requested a fair and transparent system that also publishes a ‘Standard Quality Drug List’ on a monthly basis to counter this negative perception.
In their plea, the Joint Forum of Pharmaceutical MSMEs Associations of India, representing over a dozen associations including CIPI, FOPE, and LUB, has called for an immediate appointment with the health minister. The associations believe that a direct meeting with the head of their family will lead to a final resolution, enabling them to work peacefully and continue their crucial role as the ‘Pharmacy of the World’.
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