|
Pharmexcil flags export disruption risk from CoPP mandate; seeks urgent policy review
|
|
Our Bureau, Mumbai
July 15 , 2025
|
|
|
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has expressed concern over the recent circular issued by the Central Drugs Standard Control Organization (CDSCO), which mandates exclusive online submission of Certificate of Pharmaceutical Product (CoPP) applications via the Online National Drugs licensing system (ONDLS) portal.
ONDLS portal is developed by Centre for Development of Advanced Computing (CDAC) in coordination with the CDSCO, Directorate General of Health Services (DGHS), ministry of health and family welfare, Government of India and State/UT Drugs Regulatory Authorities.
While the Council supports digital integration and modernization 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. Currently, Indian exports to RoW markets account for 45% 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”, said K. Raja Bhanu, Director General (DG) of Pharmexcil. The council has formally requested the Ministry of Health & Family Welfare and CDSCO to delay the implementation of the ONDLS-only CoPP submission model and engage in immediate stakeholder consultations. A proposal for a phased rollout with existing processes running in parallel has been put forth, that will allow time for exporters to align without compromising ongoing business.
“This request has been made keeping in mind that regulatory policies must strike a balance between maintaining stringent quality standards and being trade-facilitative,” the Pharmexcil DG said.
“Quality and commerce may not always align in the short term, but this balance is the only sustainable path forward- which will be transformative for Brand India. While the government rightly aspires to ensure responsible manufacturing, some of the regulatory developments are misperceived by industry players as commercial limitations. 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 concluded.
Additional challenges identified by Pharmexcil are that several drugs that have been on Indian pharmacy shelves for years are being newly classified as ‘new drugs’ based solely on dosage forms (e.g., coated tablets), triggering delays in CoPP issuance and drastically increasing export turnaround time.
Pharmexcil has also highlighted that “Brand India” is being undermined by premature regulatory alerts—especially those triggered by interim data published on CDSCO’s portal regarding domestic samples, many of which are unrelated to export batches. Global regulators interpret these incomplete data sets as red flags, leading to alerts across RoW markets.
|
|
|
|
|
|
|
|
TOPICS
|
Shanghai-based Hualian Pharmaceutical Machinery Company Limited, a family-run enterprise with roots going back to 1986, ...
|
|
|
|
|