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    PMO acts on pharma MSMEs ‘crisis call’

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    By Teena Thacker

    Copyright indiatimes

    PMO acts on pharma MSMEs 'crisis call'

    New Delhi: The Prime Minister’s Office (PMO) has directed the Ministry of Micro, Small and Medium Enterprises to take necessary steps after representatives from the pharmaceutical industry warned that stringent regulatory action over quality issues could cause serious disruptions, leading to shortages of critical medicines of mass use such antibiotics, anti-diabetics and oncology drugs.The industry representatives had warned of a sharp increase in the prices of medicines due to limited supplies from affected manufacturers and said this might make India more dependent on imported drugs.The Federation of Pharma Entrepreneurs (FOPE), which mostly represents small manufacturers, had communicated its concerns to the PMO, after which Shankar Lalwani, BJP MP from Indore, again raised the matter with the PMO.According to the FOPE, out of an estimated 6,000 micro, small and medium (MSME) pharmaceutical units, only 1,700 submitted their good manufacturing practices (GMP) upgradation plans as mandated by the government.”The rest now stand at the edge of a regulatory cliff, facing shutdowns, stop-production notices, and possible licence cancellations,” the FOPE said in its representation, a copy of which was seen by ET. “For an industry segment that supplies more than 40% of India’s domestic generic medicine demand, this is not just a compliance issue. It’s a question of livelihood, survival, and national health security.”Live EventsFor most MSME pharma manufacturers, especially those in tier-2 and tier-3 cities, the mandated upgradation spells crippling financial pressure, according to the FOPE.”The cost of redesigning layouts, installing clean rooms, qualifying equipment, upgrading utilities, and training personnel can run into crores of rupees, often beyond the capacity of small businesses. These units are likely to get closed due to non-compliance,” it said in the representation. “We are looking at potential job loss for over 500,000 skilled and semi-skilled workers.”The FOPE, therefore, urged the government to extend the deadline for compliance with the Revised Schedule-M (Drugs and Cosmetics Act) for two years.It has pointed to significant challenges faced by the industry, like the process for obtaining no objection certificate (NOC) for exports, which it said is complex and so time-consuming that often by the time the NOC is received, the export orders get cancelled.The industry body also pointed to the “double standards” of the regulatory body in the MSME sector where NSQ ( not of standard quality) issues and recalls are recorded. For MSME, any such declaration leads to rigorous investigation by the Drugs Controller General of India with regulatory action, it said.Add as a Reliable and Trusted News Source Add Now!
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    (You can now subscribe to our Economic Times WhatsApp channel)Read More News onPMOPharma MSMEsRegulatory ActionFOPECompliance IssuesExportDrugs Controller General of Indianoc(Catch all the Business News, Breaking News, Budget 2025 Events and Latest News Updates on The Economic Times.) Subscribe to The Economic Times Prime and read the ET ePaper online….moreless

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