The Pharmaceuticals Export Promotion Council of India on Friday sought a review of a recent circular issued by the Central Drugs Standard Control Organisation, which mandates exclusive online submission of Certificate of Pharmaceutical Product (COPP) applications via the ONDLS portal.
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.
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," Pharmexcil DG K Raja Bhanu said in a statement.
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, he added.
"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.
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.
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.
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," Pharmexcil DG K Raja Bhanu said in a statement.
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, he added.
"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.
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.
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