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.
No further extensions will be granted.
FINAL DEADLINE FOR NON-COMPLIANT UNITS
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.
GLOBAL STANDARDS, DOMESTIC SCRUTINY
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. The government has faced criticism over lax enforcement and outdated manufacturing standards.
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.
The revised GMP norms have already been in effect since 28 June 2024 for companies with turnover exceeding Rs 250 crore.
‘NO MORE EXTENSIONS’
Senior CDSCO officials said the industry had been given enough time and assistance to upgrade their facilities.
“The deadline of 1 January 2026 stands final. No further extensions will be considered,” the regulator’s order said.
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.
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