India’s pharmaceutical sector is warning of a looming export disruption after the Central Drugs Standard Control Organization (CDSCO) mandated that all Certificate of Pharmaceutical Product (COPP) applications be submitted solely through its online portal, as reported by CNBC. Industry representatives say the abrupt shift to digital-only submissions could hinder export operations, especially without a transitional phase to ease the change.
Pharmexcil, the Pharmaceuticals Export Promotion Council of India, has raised serious concerns over the abrupt shift to mandatory online COPP submissions. The council warns that this change could threaten nearly 45% of India’s pharmaceutical exports, particularly to Rest of World (RoW) markets that rely on timely regulatory approvals to sustain supply chains.
Although Pharmexcil supports the move toward regulatory digitalization, it has cautioned that implementing the policy without a transitional phase could immediately and negatively affect pharmaceutical exporters and companies.
The COPP serves as formal confirmation to importing countries that the drug is approved for sale in India and manufactured in compliance with WHO-recommended Good Manufacturing Practices (GMP).
Countries classified under the RoW category, particularly across Africa, Latin America, and various regions of Asia, typically mandate a valid COPP issued by India’s CDSCO as part of the drug import approval process.
Under the revised directive, the CDSCO now requires all COPP applications to be filed solely via the Online National Drug Licensing System (ONDLS) portal. This move eliminates the previously accepted manual and semi-digital submission methods that numerous exporters and state licensing bodies have traditionally depended on.
Delays in securing COPP can disrupt export schedules and strain relationships with international clients. Exporters fear that extended regulatory timelines could drive global buyers to seek alternative suppliers in other markets.
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