The pharmaceutical exporters are facing some issues in the Online National Drug Licensing System (ONDLS) being implemented for the issue of Certificates of Pharmaceutical Products (COPP) under the World Health Organisation’s Good Manufacturing Practices (GMP) scheme.

“We have received feedback from a few companies highlighting issues faced during the process,” Raja Bhanu, Director General, Pharmaceuticals Export Promotion Council (Pharmexcil), said.

In a communication, the Council sought inputs from its member-exporters to understand the extent and nature of these challenges across the industry.

To ensure a smooth transition to the ONDLS, Pharmexcil would represent the concerns of the industry to the Central Drugs Standard Control Organisation (CDSCO). It has asked exporters to inform it of challenges encountered while applying through ONDLS, technical glitches or system-related problems, and any difficulties in compliance with the new WHO GMP requirements.

Further, instances of delays in application processing or COPP issues and their impact on export schedules or commitments should also be informed, the DG said.

The ONDLS portal is developed by the Centre for Development of Advanced Computing (CDAC) in coordination with the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, and State/UT Drugs Regulatory Authorities.

Published on April 21, 2026