New Delhi : After a string of global scandals over toxic Indian cough syrups linked to child deaths abroad, the Central Drugs Standard Control Organisation (CDSCO) has drawn a hard line, all drug manufacturers must comply with global Good Manufacturing Practices (GMP) by January 1, 2026, or face closure. The CDSCO’s 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 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. Under the revised Schedule M, all drugmakers must ensure stricter quality control, traceability of raw materials, and better documentation to align with World Health Organisation (WHO) standards.
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