The CDSCO has made clear there will be no further opportunities for extensions, meaning any units that remain non-compliant by the deadline must suspend operations until requirements are met.
The Central Drugs Standard Control Organisation (CDSCO) has issued an order requiring all pharmaceutical manufacturers to comply with global Good Manufacturing Practices (GMP) by January 1, 2026. The order follows international incidents involving toxic Indian cough syrups and targets 1,470 pharmaceutical units with annual turnover below Rs 250 crore that had already received additional time to meet new Schedule M GMP standards.
The CDSCO has made clear there will be no further opportunities for extensions, meaning any units that remain non-compliant by the deadline must suspend operations until requirements are met. This change is expected to have a significant impact on India’s pharmaceutical sector, which supplies over 20% of the world’s generic medicines.
The order explicitly states, “No further extensions will be granted.” Companies that have not met the standards by January 2026 face a halt in production, a move regulators believe is necessary to restore confidence in Indian pharmaceuticals both domestically and abroad. The affected units had until May 2025 to apply for additional time, but the latest directive now removes any ambiguity regarding future allowances.
Out of the total 5,308 drug manufacturing units in India, approximately 3,838 micro, small, and medium enterprises (MSMEs) have already complied with the revised norms. The remaining 1,470 firms, primarily smaller facilities, have now received a final ultimatum to upgrade their operations or shut down.
The push for stricter compliance comes after exported cough syrups from India were linked to child deaths in Gambia, Uzbekistan, and Cameroon, prompting criticism over regulatory oversight. Under the revised Schedule M, all manufacturers are required to implement strict quality control measures, ensure traceability of raw materials, and maintain comprehensive documentation in line with World Health Organisation (WHO) standards.
The new GMP rules have already been in force for larger pharmaceutical companies with turnover exceeding Rs 250 crore since June 28, 2024.
