Govt mulls extension for pharma new manufacturing practice norms to bail out small firms

pharmaceutical sector, a major global supplier of generic medicines.The revised Schedule M GMP had been earlier extended from the previous 1 January 2025 cutoff. The proposed extension for MSMEs, which have revenue of ₹250 crore or less, comes in the backdrop of less than a third of them submitting their upgrade plans, with the remaining units risking immediate closure and penalties.There are a total of 10,500 drug manufacturing units in India, of which 8,500 fall under the MSME category.

These units produce 70% of India's generic drugs and they face upgrade costs of ₹10-15 crore per facility. Of these 8,500 MSMEs, 2,000 have already complied with the revised schedule for the new quality standards.“Out of these 6,500 MSME drug firms, only 1,400 (21.53%) have submitted the necessary upgrade plans to the government,” said the first of the two government officials cited above, requesting anonymity.“The matter is under the deliberation of the central government, given that starting 1 January 2026, all the states and union territories will start doing the risk-based analysis of these plants, Himachal Pradesh and Uttarakhand governments have already started inspections,” said the second government official, who also did not want to be named.“The government has received various representations from the MSMEs.

Their main concern is regarding the structural changes required under the Revised Schedule M. While many have the intention to comply, they face physical constraints such as a lack of space for expansion or the inability to alter the existing layout of their plants to meet the new flow requirements,” said the official cited above.Lobby groups, including Laghu Udyog Bharati, which represents 2,000 MSME pharmaceutical units,