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A new rule by the CDSCO barring exports of pharmaceutical products with less than 60% shelf life is leading to significant losses
(Representational pic/Reuters)
A new rule by the Central Drugs Standard Control Organisation (CDSCO) barring exports of pharmaceutical products with less than 60% shelf life is leading to significant losses for the domestic industry, with manufacturers being forced to destroy stocks to comply, The Economic Times reported.
In a recent meeting with CDSCO, the industry urged the regulator to revise the rule or consider an alternative solution. Pharma lobby group Federation of Pharma Entrepreneurs (FOPE) also wrote to the regulator this week, calling for a repeal of the regulation introduced last year.
FOPE president Harish Jain argued that if importing countries were willing to accept such products, Indian exporters should not face restrictions. In its letter, FOPE noted that the requirement was causing substantial losses due to destruction of stock.
Industry executives explained that, for example, if a drug manufactured in August 2025 had an expiry in July 2027, regulators would require a minimum of 60% shelf life at the time of export for the consignment to be cleared.
The CDSCO updated its export NOC checklist after reports surfaced that an Indian company had exported unlicensed drug combinations to African nations such as Ghana and Nigeria. Regulatory approval has since become mandatory for all medicines intended for export.
Industry experts told ET that the rule should apply only to narcotics, opioid combinations, and other habit-forming drugs, not to all categories of medicines, including vitamins. They said the regulation posed a major challenge, as export consignments are custom-made with importing country details and cannot be diverted to the domestic market, forcing companies to destroy them.
A government official told ET that the step was aimed at preventing recurrence of such incidents. The official added that India, known globally as the “world’s pharmacy,” could not risk reputational challenges related to the quality of exported drugs.
Aparna Deb is a Subeditor and writes for the business vertical of News18.com. She has a nose for news that matters. She is inquisitive and curious about things. Among other things, financial markets, economy, a…Read More
Aparna Deb is a Subeditor and writes for the business vertical of News18.com. She has a nose for news that matters. She is inquisitive and curious about things. Among other things, financial markets, economy, a… Read More
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