CDSCO extends COPP application deadline for pharma units to August 15

Pharma firms get time till August 15 to file COPP applications online via ONDLS as CDSCO addresses onboarding challenges and industry pleas

In an effort to assist pharmaceutical manufacturing units in onboarding the quality certification process, the Central Drugs Standard Control Organisation (CDSCO) has extended the deadline for submitting online applications for a WHO GMP COPP certificate by another month.

 

A Certificate of Pharmaceutical Product (COPP) is issued to confirm that a pharmaceutical product is authorised for sale in its country of origin and manufactured in compliance with Good Manufacturing Practices (GMP).

  

To digitise the process, the apex regulatory body had mandated last month that all manufacturing units submit WHO COPP applications online starting from 15 July 2025. This deadline has now been extended to 15 August.

 

The extension follows reports that several pharma units have encountered difficulties in uploading documents on the government’s Online National Drugs Licensing System (ONDLS) portal.

 

In a circular dated 15 July, Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi said it had come to the organisation’s attention that a number of manufacturers were still in the process of registering and uploading documents on the ONDLS platform.

  

Commenting on the matter, Bhavin Mukund Mehta, vice-chairman of pharma export promotion body Pharmexcil and whole time director, Kilitch Drugs, said many manufacturers—especially small and mid-sized exporters—are still aligning with digital onboarding requirements.

 

The regulatory body had also received multiple representations from industry associations highlighting these onboarding challenges and seeking more time to complete the process.

  

ONDLS is a single-window platform for processing applications such as the issuance of manufacturing and sales licences, GMP certificates, market standing certificates, and post-approval changes—all online.

 

 “The extension will help provide much-needed breathing space to ensure a smooth transition,” Mehta added.

 

Calling digitisation of regulatory processes a step in the right direction for India’s pharmaceutical ecosystem, Mehta emphasised that implementation must support ease of compliance while maintaining global standards.

  

The decision also comes at a time when small and medium-sized pharmaceutical manufacturing units—with annual turnover of less than Rs 250 crore—have been requesting a similar extension to submit gap analysis plans required to avail an extension for implementing revised Schedule M guidelines.

 

The CDSCO had earlier instructed all eligible units to submit online applications via ONDLS to seek an extension for compliance with the updated Schedule M norms.