India Pharma Outlook Team | Friday, 18 July 2025
The Central Drugs Standard Control Organisation (CDSCO) further prolonged the deadline for pharma firms to file online applications for the WHO Good Manufacturing Practices (GMP) Certificate of Pharmaceutical Product (COPP) to August 15, 2025. The decision comes following technical issues caused during companies' registration on the government's online licensing portal.
Earlier, the CDSCO had also made it compulsory for all the manufacturers to apply for the COPP online through the Online National Drugs Licensing System (ONDLS) from July 15. However, some of the pharma units, especially small and medium-sized exporters, experienced issues during document uploading and registration.
In a July 15 circular, Drug Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi had said that the organization had received several representations from industry bodies asking for extra time for digital onboarding.
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"A few manufacturers are yet to upload their documents. The extension is to give them sufficient time to comply," the circular added.
Bhavin Mukund Mehta, whole-time director at Kilitch Drugs and vice-chairman of Pharmexcil, also welcomed the move. "The extension will provide much-needed space for maneuver for a smooth transition," he said. He also stated that digitisation is a welcome step, but should ensure ease of compliance.
The extension also responds to a request by small pharma units to extend due dates for filing gap analysis plans under new Schedule M guidelines, which regulate compliance with GMP in India.
