Experts say that out of around 10,000 pharmaceutical units in the country, 2,000 are compliant with Good Manufacturing Practices (GMP) and 3,000 are being upgraded. The remaining around 5,000 units are yet to have their facilities upgraded as per the newly notified Schedule M and may face closure if the government does not extend the deadline for implementation of Schedule M.
The industry is seeking a two-year extension to build infrastructure, hire and train additional staff. However, “the government has not issued an extension notice yet, which means the industry will have to comply with the regulations or take some action,” a senior government official said.
The official said the government may soon begin audits and risk-based inspections of drug manufacturing units to ensure compliance with the new standards.
The industry now needs to comply with the newly notified Schedule M standards for pharmaceutical manufacturing practices and requirements for facilities, plants and equipment, with provisions for annual product quality reviews, quality risk management, and pharmaceutical quality systems. there is. Industry leaders had previously met. The health minister asked for an extension, citing issues such as delays in procuring machinery and updating infrastructure. The industry said more time is needed to ensure the survival of micro, small and medium enterprises (MSMEs). “The Minister of Health is looking into this matter and has also asked the Department of Pharmaceuticals (DoP) for more details on this matter.” has not been decided yet,” another official said.
Former Defense Secretary Arunish Chawla had earlier told ET that good management was in place by the government.
“We have liberalized the scheme especially to help MSMEs to upgrade their quality standards to the revised Schedule M. This is progressing well.Recently, we have further liberalized We have ensured that the entire quality system, including utilities, laboratories, and factories, is functioning reliably.”The stability room, quality evaluation system, and core production system, that is, the entire top-quality production chain, are included in this plan. ” he said. “The industry has welcomed this scheme with open arms, with many registering for upgrades under the scheme, some of which have already submitted gap analyses. has already passed the technical committee and they are being assisted in achieving global quality standards, namely the revised Schedule M and WHO GMP standards. ”
Industry executives said infrastructure development will take time until December 2026 as companies face financing issues, equipment procurement and infrastructure development.
In a letter to the health minister, the pharmaceutical lobby said: “Staff training and machine validation processes are necessary to ensure machine operation and proper business operations.” “Therefore, a proper training program must be followed, which requires additional time.”
