Deadlines Loom for Drug Manufacturers: Global Standards Demand Compliance or Closure
The Indian government has set a firm deadline for all drug manufacturers to comply with global Good Manufacturing Practices (GMP) by January 1, 2026, following international concerns over toxic cough syrups linked to child deaths. This move comes after mounting international pressure following multiple incidents of contaminated cough syrups exported from India, which were linked to the deaths of children in Gambia, Uzbekistan, and Cameroon.
The Central Drugs Standard Control Organisation (CDSCO) has drawn a hard line, demanding that all drug manufacturers comply with global GMP standards or face closure. No further extensions will be granted.
The latest order targets 1,470 pharmaceutical manufacturing units with an annual turnover below Rs 250 crore that had been granted extra time to meet revised Schedule M GMP standards. These smaller facilities were earlier given until January 1, 2026, provided they applied for an extension before May 2025. The regulator has now made it clear that no more leeway will be allowed beyond that date.
Out of India's 5,308 drug manufacturing units, around 3,838 micro, small, and medium enterprises (MSMEs) have already complied with the upgraded norms. The remaining 1,470 companies, which had sought more time, now face a firm ultimatum - upgrade operations or shut down.
The revised GMP norms have already been in effect since June 28, 2024, for companies with turnover exceeding Rs 250 crore. Senior CDSCO officials said the industry had been given enough time and assistance to upgrade their facilities.
The decision effectively means that non-compliant units will have to suspend operations until they meet the upgraded GMP criteria, a significant push to tighten India's pharmaceutical manufacturing ecosystem, which supplies over 20% of the world's generic medicines.
This move highlights the government's commitment to global standards and domestic scrutiny, addressing concerns over lax enforcement and outdated manufacturing standards.
