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