Stricter shelf life rule a bitter pill to swallow for pharma companies

A new rule by the drug regulator barring exports of any product with less than 60% shelf life is causing huge losses to the domestic pharmaceutical industry with manufacturers being forced to destroy stocks to comply.

According to the Federation of Pharmaceutical And Allied Products Merchant Exporters (FPME), the norm applies only to products manufactured under export NOC (No Objection Certificate) issued by CDSCO. This includes unapproved drugs, new drugs, certain unapproved FDCs, NDPS banned in India but allowed for export, among others.

In a recent meeting with the Central Drugs Standard Control Organisation (CDSCO), the industry urged for a revision in the rule or an alternative solution.


Pharma lobby group Federation of Pharma Entrepreneurs (FOPE) has also written to the regulator this week urging the latter to repeal the rule introduced last year.

"Our view is that if the importing country allows it, why should we have an objection," said Harish Jain, president, FOPE.

"This is causing substantial losses due to destruction of stock," FOPE said in its letter, a copy of which was seen by ET.

"If the manufacturing date is August 2025 and the expiry is July 2027, the drug regulatory authority wants at the time of exports the consignment should have 60% minimum shelf life remaining. Otherwise, they will not allow export," said a senior industry executive.

The CDSCO has updated the export NOC checklist, making regulatory approval mandatory for all medicines destined for exports after reports that an Indian company had been exporting unlicensed combinations of drugs to African nations like Ghana and Nigeria.

"We have requested the regulatory authority to make this rule mandatory for narcotic drugs, opioid drug combinations, and other habit forming drugs but not for every medicine, even vitamins," said a second industry executive. "This has become a huge challenge for the industry. The companies have to destroy stocks because the export consignments are custom-made with importing country details and cannot be used in India."

A government official said the step was taken to make sure that such incidents do not occur. "India is a world pharmacy and we cannot afford to face reputational challenges, particularly concerning the quality of drugs which are being exported to other countries," he said.