New GMP Regulations Threaten Pharma MSME Survival

ENA Sectors 2024-11-01 17:17:12 New Delhi, Nov 1 (KNN) A significant portion of India's pharmaceutical manufacturing sector faces an existential crisis as stringent good manufacturing practices (GMP) regulations are set to take effect at year-end. Industry experts estimate that approximately 40 per cent of small and medium-sized pharmaceutical units could cease operations when these new standards become mandatory for companies with annual revenue below Rs 250 crore, reported FE. The scale of potential disruption is substantial, with more than 8,000 of India's 10,500 pharmaceutical manufacturing units classified as medium, small and micro enterprises (MSMEs). According to a senior pharmaceutical association executive speaking anonymously, some facilities have already suspended operations, anticipating that compliance with the new standards would render their businesses financially unviable. While industry associations have petitioned for an extension to the implementation deadline, government authorities have yet to announce their decision. Viranchi Shah, National President, Indian Drugs Manufacturers Association (IDMA), confirmed that presentations have been made to the Central Drugs Standard Control Organisation (CDSCO), which is currently reviewing the timeline. The government's revision of GMP rules earlier this year aimed to align Indian pharmaceutical manufacturing with global standards and incorporate modern technological advancements. However, the required upgrades present significant technical and financial challenges for smaller manufacturers. Jatish Sheth, Secretary General, Confederation of Indian Pharmaceutical Industry (CIPI), has requested a one to two-year extension for implementing these changes, citing the need for substantial infrastructure and system modifications. Industry experts highlight two primary challenges: the considerable investment required for upgrading manufacturing and testing facilities, and the extensive documentation needed to ensure manufacturing traceability. The sector also faces staffing difficulties, with a high attrition rate of 25-30 per cent compounding the shortage of skilled personnel. In response to these challenges, industry associations and government bodies are collaborating to support MSMEs through training programs. The CDSCO and IDMA are jointly conducting educational sessions across major pharmaceutical manufacturing hubs, including Hyderabad, Indore, Baddi, and Daman, to assist manufacturers in achieving compliance. While the government has introduced financial support through the revamped pharmaceuticals technology upgradation assistance scheme (RPTUAS), offering up to Rs 2 crore per manufacturer, disbursement of funds has reportedly been slower than anticipated. Sources indicate that the government's hesitation to extend the deadline stems from concerns about benefiting manufacturers unwilling to upgrade their facilities, though considerations are being made for companies demonstrating commitment but lacking immediate resources for compliance. (KNN Bureau) 39779 https://knnindia.co.in/news/newsdetails/sectors/new-gmp-regulations-threaten-pharma-msme-survival 2024-11-01 17:17:12 knnindia.co.in New GMP Regulations Threaten Pharma MSME Survival