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The Pondicherry Drug Manufacturers Association (PDMA), a collective of over 60 micro, small, and medium enterprise (MSME) pharmaceutical manufacturers in the Union Territory, has appealed to Dr. Aravind Virmani, a member of NITI Aayog, seeking urgent relief measures to comply with the revised Schedule M norms.
In a formal letter, the industry representatives highlighted significant challenges in meeting the December 31, 2025, deadline for infrastructure upgrades. They argue that without government support, the industry faces the risk of widespread disruption and potential closures.
The appeal, signed by PDMA secretary E. Srinivasan and treasurer D. Subramaniam, states that the mandated upgrades require substantial capital investment that is difficult for many MSME units to mobilize within the prescribed time-frame. These units are vital contract manufacturers for both national and international pharmaceutical companies, contributing significantly to domestic and export supply chains. The letter also points out that the dual pressure of upgrading facilities and maintaining current production commitments is causing considerable operational strain.
According to Srinivasan, almost all manufacturing units in the Union Territory have begun the upgradation process, but it is proving impossible to complete the work in the remaining four months. "We need a minimum of two more years," he told Pharmabiz. He stressed that the appeal is intended to safeguard employment and ensure the sector's long-term sustainability. Without the requested supportive measures, Pondicherry's pharmaceutical MSME sector, a significant contributor to the national economy, could face severe setbacks.
To address these challenges, the PDMA has asked the government for two key interventions. The first is an extension of the compliance deadline, which would allow units a longer timeframe to phase their upgrades without compromising existing market obligations. The second is a targeted financial assistance program, specifically a special subsidy scheme of up to Rs. 10 crore, to ease the financial burden on these small-scale manufacturers.
P Ramesh Kumar, president of the PDMA, said the revised Schedule M, introduced by the Drugs Controller General of India (DCGI), aims to elevate India's drug manufacturing standards to global benchmarks, such as WHO-GMP (Good Manufacturing Practices). While the industry fully supports the vision behind these new standards, the changes pose a considerable challenge for smaller manufacturers.
Despite the challenges, PDMA is taking proactive steps to prepare its workforce. The association is conducting workshops for all industry employees to develop skills related to technological upgradation. Both Central and state drug control authorities are fully supporting these skill development initiatives for the technical staff in the industry.
The government has previously offered some support, including a conditional deadline extension for MSMEs and schemes like the Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS). However, the PDMA's appeal highlights that these measures may be insufficient to address the specific financial and logistical hurdles faced by many small-scale manufacturers in the region, raising concerns that a significant percentage of India's approximately 8,500 pharma MSMEs could face closure if they fail to comply.
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