Industry Outlook Team | Saturday, 12 July 2025
An organization that promotes exports stated that a new law that centralizes the licensing procedure for medicine exports through a web portal might reduce shipments by over 45%, asking for time to transition to the new system.
In order to ship medications to a foreign nation, a certificate of pharmaceutical products (COPP) is required. It attests to the product's proper quality, safety, and effectiveness as well as its production conformity with good manufacturing procedures. All COPP applications must be submitted only through a single license portal, according to a statement released last week by the Central Drugs Standard Control Organization (CDSCO). According to experts at Pharmexcil, an organization that promotes Indian pharmaceutical and healthcare exports globally, this might seriously disrupt India's pharmaceutical exports.
“The circular was issued by CDSCO a week back. Earlier, this COPP was issued by the state authorities, which was a quick task process, and companies were able to manage to do their businesses. Now, CDSCO making it centralized on the online portal is making it difficult for companies to get the certification done. We are seeking some time from the CDSCO and the health ministry for this transition. We welcome this online process, but need some time to take it forward,” said Namit Joshi, chairman, Pharmexcil.
Also read: Biosimilars Set to Drive India's USD 1 Trillion Pharma Export Dream
Despite its support for digital innovations, Pharmexcil expressed concern about the sudden shift in the absence of a transition strategy. According to the report, this could endanger about 45% of India's total pharmaceutical exports, particularly those going to "Rest of World" (RoW) countries.
