The upcoming enforcement of stricter Good Manufacturing Practices (GMP) regulations by 2024-year end presents a significant hurdle for India’s small and medium-sized pharmaceutical manufacturers. As the deadline approaches, industry experts warn that roughly 40% of these MSMEs may face closure if they cannot comply with the new standards, which are set to align India’s manufacturing with global practices.

Of the 10,500 pharmaceutical manufacturing units across India, more than 8,000 fall into the MSME category, making them particularly vulnerable to the high costs of compliance. Both the Indian Drugs Manufacturers Association (IDMA) and the Confederation of Indian Pharmaceutical Industry (CIPI) have called for a one- to two-year extension on the GMP deadline, citing the significant financial and technical burdens that come with upgrading facilities and documentation systems. The government has not yet responded to these appeals, and financial support through the revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS) has been slow, leaving many MSMEs scrambling to gather the funds needed for compliance.

The compliance challenges are steep: manufacturers must invest heavily in facility upgrades and meet rigorous documentation standards for product traceability. Adding to these hurdles are workforce shortages, with high attrition rates making it difficult to retain qualified staff. To support MSMEs, the Central Drugs Standard Control Organisation (CDSCO) and IDMA have initiated training programs in major pharmaceutical hubs like Hyderabad, Indore, Baddi, and Daman to help companies better understand and implement the new requirements.

While the government has yet to make a decision on extending the deadline, it may offer flexibility for manufacturers that show genuine commitment but lack immediate resources. Industry leaders are hopeful that with additional time or resources, more MSMEs can adapt to these requirements and continue contributing to India’s pharmaceutical sector, ensuring that they are better positioned to compete in the global market.
 
Source – Chemical Industry Digest