India Pharma Outlook Team | Thursday, 21 August 2025
Manufacturers are being obliged to destroy stocks in order to comply with a new rule by the Central Drugs Standard Control Organization (CDSCO) that prohibits the export of pharmaceutical items with a shelf life of less than 60%. This regulation is causing enormous losses for the domestic industry.
The industry asked the regulator to update the rule or take another approach during a recent discussion with CDSCO. The Federation of Pharma Entrepreneurs (FOPE), a lobby group for the pharmaceutical industry, also wrote to the regulator this week, urging it to overturn the rule that was put in place the previous year.
FOPE president Harish Jain said that if importing countries are willing to accept such products, Indian exporters should not be impeded. In its letter, FOPE said that the requirement is causing a lot of loss by destroying stock.
According to industry insiders, authorities would need a minimum of 60% shelf life at the time of shipment in order for a consignment to be cleared, for instance, if a medication made in August 2025 had an expiration date of July 2027. Following allegations that an Indian company had shipped illegal medication combinations to African countries like Ghana and Nigeria, the CDSCO revised its export NOC checklist. Since then, any medications meant for export must have regulatory approval.
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The regulation should be restricted to narcotics, opioid combinations, and other habit-forming substances, not to every class of drugs, including vitamins. They claimed the regulation was a major hurdle as export consignments are made-to-order with importing country identifiers, and could not be turned around for the domestic market leading them to destroy it all. The step was meant to prevent a recurrence of such events.
