CDSCO eases rules, pharma firms can now get 1-year NoC online via Sugam portal
Under the revised policy, exporters will no longer need to apply for a fresh NoC for every order.
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The Central Drugs Standard Control Organization (CDSCO) has overhauled its No Objection Certificate (NoC) system for exporting unapproved drugs, making the process more efficient and reducing the regulatory burden on exporters. The new system, now available on the Sugam portal, replaces the previous buyer-specific and quantity-specific NoCs with country-specific blanket NoCs.
Blanket NoCs to replace repeated applications
Under the revised policy, exporters will no longer need to apply for a fresh NoC for every order. Instead, CDSCO will issue blanket NoCs based on a company’s export record from the past year. For example, if a firm has exported 10 crore tablets in the past year, it will receive an NoC for the same quantity, applicable for an entire country rather than a single customer.
CDSCO NoC is required for export of unapproved drugs and new drugs. CDSCO has streamlined the process and also initiated issue of one year NoC in the spirit of ease of doing business subject to conditions. The revised process is live on SUGAM portal. pic.twitter.com/2bzXKWcjQf
— CDSCO_INDIA_INFO (@CDSCO_INDIA_INF) March 8, 2025
Faster approvals, reduced paperwork
Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi stated that this move will significantly cut down the number of NoCs issued annually. Currently, CDSCO processes 15,000 NoCs per year, but with this reform, the figure is expected to drop to 5,000 or even lower.
Enhanced regulatory oversight amid scrutiny
In addition to these regulatory changes, CDSCO has intensified risk-based inspections, conducting 905 inspections as of February 2025. The overhaul also comes amid increased scrutiny of pharmaceutical exports, particularly following the case of Mumbai-based Aveo Pharmaceuticals, which faced allegations of supplying drugs to West African nations like Ghana and Nigeria without proper clearances.
With these reforms, CDSCO aims to streamline exports, enhance regulatory oversight, and support Indian pharmaceutical companies in global markets.
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