Pharmaceutical Exports Face Regulatory Storm
The Pharmaceuticals Export Promotion Council of India urges a review of a CDSCO circular mandating online submission of COPP applications. This change could disrupt India's pharmaceutical exports to RoW markets. The Council calls for a delay and stakeholder consultations to balance quality standards with trade facilitation.
- Country:
- India
The Pharmaceuticals Export Promotion Council of India has raised concerns over the CDSCO's latest directive mandating exclusive online submission of Certificate of Pharmaceutical Product (COPP) applications via the ONDLS portal.
The council acknowledges the benefits of digital integration but warns that an abrupt shift could significantly disrupt India's pharmaceutical exports, notably to Rest of World (RoW) markets, which currently make up 45% of total exports.
Pharmexcil DG K Raja Bhanu highlighted the compounded regulatory challenges exporters face and urged the immediate postponement of the new policy while recommending stakeholder consultations to ensure a balanced approach between quality and trade facilitation.
(With inputs from agencies.)
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