A significant portion of India’s pharmaceutical manufacturing sector faces a severe crisis as stricter Good Manufacturing Practices (GMP) regulations are set to take effect by year-end. Industry experts warn that about 40% of small and medium-sized pharmaceutical units may shut down when these rules become mandatory for companies with annual revenue below Rs. 250 crore.
Thousands of MSMEs at Risk
Out of India’s 10,500 pharmaceutical manufacturing units, more than 8,000 are classified as medium, small, and micro enterprises (MSMEs). A senior pharmaceutical association executive noted that some facilities have already stopped operations. They anticipate that complying with the new standards would be financially unfeasible.
Plea for Extension
Industry associations have asked for an extension to the deadline, but the government has not yet announced a decision. Viranchi Shah, National President of the Indian Drugs Manufacturers Association (IDMA), confirmed that the Central Drugs Standard Control Organisation (CDSCO) is reviewing the timeline after presentations from stakeholders.
Upgrades Pose Financial Challenges
The government revised GMP regulations earlier this year to align Indian manufacturing with global standards and integrate modern technology. However, smaller manufacturers face significant financial and technical challenges. Jatish Sheth, Secretary General of the Confederation of Indian Pharmaceutical Industry (CIPI), requested a one- to two-year extension. He emphasized the need for substantial infrastructure and system upgrades.
Key Hurdles for Compliance
Industry experts point out two main challenges: the high investment needed for upgrading manufacturing and testing facilities and the extensive documentation required for traceability. The sector also struggles with staffing shortages, compounded by a high attrition rate of 25-30%.
Training and Support Initiatives
Industry associations and government bodies are collaborating to help MSMEs comply with the new regulations. The CDSCO and IDMA are conducting educational sessions in major pharmaceutical hubs like Hyderabad, Indore, Baddi, and Daman.
Financial Support Delays
The government launched the revamped pharmaceuticals technology upgradation assistance scheme (RPTUAS), which offers up to rupees two crore per manufacturer. However, the disbursement of funds has been slower than expected.
Government’s Stance on Extensions
As reported by knnindia.co.in, experts suggest the government hesitates to extend the deadline due to concerns over supporting manufacturers unwilling to upgrade. However, it is considering companies that show commitment but lack immediate resources to comply.
