Drugmakers seek time to transition to regulatory requirement for RoW exports

Namit Joshi, Pharmexcil Chairman

Drugmakers are seeking at least six more months to comply with a regulatory requirement of uploading a compliances-linked certificate onto a central website, which will allow them to export to the Rest-of-the-World (RoW) regions, said a top official with the Pharmaceuticals Export Promotion Council of India (Pharmexcil).

Concerned with the steep task ahead, Namit Joshi, Pharmexcil Chairman, told businessline there was a “humungous” amount of data that would have to be uploaded on the ONDLS (Online National Drugs licensing system) portal, and that would not just take time for companies (including 1000s of MSMEs), but the online services need to be ready to handle the load as well.

The regulatory Central Drugs Standard Control Organisation (CDSCO) deadline for online submission of the Certificate of Pharmaceutical Product (COPP) applications through the ONDLS portal was July 15, which has now extended by a month.

The industry is not against the centralisation, Joshi said, but transitioning to the system would require at least six months. “It will take some time because loading a humongous amount of data into the system is not feasible immediately,” he said. The RoW regions account for 45 percent of India’s $ 30-billion-odd pharmaceutical exports, he said.

The COPP certificate facilitates exports by reflecting the Good Manufacturing Practises-linked compliances like quality, reliability and sustainability, explained Joshi. This is an important responsibility of the country and regulators approving the pharma exports, he added.

The centralised certification system is already in place for regulated markets like the US and the Europe, said Joshi. But for exports to RoW, the certificate is given by State authorities. This has its benefits in terms of physically addressing queries raised by the regulator, he said, adding that it would not be possible on a centralised online system.

Turnaround time

The online service provider and regulatory authority also need to be time-bound in terms of seeking and clearing queries because any delay would allow competitors like China to further rush in, following which it would be difficult for Indian companies, Joshi explained.

A digital system also “depends on the efficiency of the people who are managing the portal. Now if they tend to delay further, [the] consignment gets completely delayed,” he observed. The industry’s suggestion is that “query turnaround time should also be limited”.

Once the data is uploaded, queries should be raised in a couple of days, and once the justification is given, the COPP should be issued in 24 or 48 hours, he said.

Published on July 18, 2025