Delay implementation of ONDLS-only COPP submission model: Pharmexcil requests CDSCO, Health Ministry

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-07-12 10:23 GMT | Update On 2025-07-12 10:23 GMT

New Delhi: The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has formally requested the Ministry of Health & Family Welfare and Central Drugs Standard Control Organisation (CDSCO) to defer the implementation of a recent directive mandating the exclusive online submission of Certificate of Pharmaceutical Product (COPP) applications via the ONDLS portal.

In a statement released Friday, Pharmexcil Director General K. Raja Bhanu emphasized the need for immediate stakeholder consultations.

“This request has been made keeping in mind that regulatory policies must strike a balance between maintaining stringent quality standards and being trade-facilitative,” Bhanu said.

Pharmexcil is seeking a review of this circular issued by the CDSCO.

While the Council supports digital integration and modernisation of regulatory frameworks, it foresees a major disruption to India's pharmaceutical exports, particularly to Rest of World (RoW) markets, if the mandate is abruptly enforced without a transitional roadmap for exporters, PTI reported.

Currently, Indian exports to RoW markets account for 45 per cent of total exports.

"Exporters are now burdened with a dual regulatory bottleneck - domestically through CDSCO's NOC/new drug classification delays, and internationally due to slower regulatory submissions and approvals abroad," Bhanu said.

Read also: Expert Panel Approves Post-Marketing Surveillance Study of Eculizumab (Soliris) by AstraZeneca in India

While the government rightly aspires to ensure responsible manufacturing, some of the regulatory developments are misperceived by industry players as commercial limitations, he said.

The inability to secure timely COPP approvals or No Objection Certificates (NOCs) has the potential to push overseas buyers toward alternate suppliers from competing nations, causing irreversible long-term damage to Indian exporters, he added.

Read also: Cipla Secures CDSCO Panel Nod to Manufacture Amantadine Oral Solution with Trial Waiver

Article Source : with inputs

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Delay implementation of ONDLS-only COPP submission model: Pharmexcil requests CDSCO, Health Ministry

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