( MENAFN - KNN India) 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 signi.