The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has raised concerns over the recent circular by the Central Drugs Standard Control Organization (CDSCO), which mandates the exclusive online submission of Certificate of Pharmaceutical Product (CoPP) applications through the Online National Drugs Licensing System (ONDLS) portal.

The ONDLS portal, developed by the Centre for Development of Advanced Computing (CDAC) in collaboration with CDSCO, the Directorate General of Health Services (DGHS), the Ministry of Health and Family Welfare, and state regulatory authorities, is intended to streamline pharmaceutical regulatory processes.

While Pharmexcil supports the digital modernization of regulatory systems, it has cautioned that abrupt implementation could disrupt India’s pharmaceutical exports—particularly to Rest of World (RoW) markets, which constitute 45% of total exports. The Council has urged the Ministry of Health and CDSCO to adopt a phased transition, allowing both digital and current systems to run in parallel to ensure business continuity.

“Exporters are already facing delays in receiving NOCs and drug classifications from CDSCO. Imposing another bottleneck without adequate transition could push global buyers toward other markets,” said K. Raja Bhanu, Director General of Pharmexcil.

He emphasized that while regulatory compliance is crucial, policies must balance quality enforcement with trade facilitation to protect India’s global pharmaceutical reputation. Premature alerts and interim data published on CDSCO’s portal are also raising red flags for global regulators, impacting Brand India in key export markets.

Pharmexcil has flagged additional issues, such as delays in CoPP issuance caused by reclassification of existing drugs as ‘new drugs’ based solely on dosage forms like coated tablets—further stalling exports.

The Council has formally requested stakeholder consultations and a transitional roadmap to safeguard India’s pharmaceutical trade position.