Govt Bans Import of Medicines With Less Than One Year Shelf Life
The Indian government has banned the import of medicines with less than one year of remaining shelf life to ensure drug quality and safety.
In a significant move to ensure the quality and efficacy of pharmaceuticals entering the country, the Central Government has barred the import of medicines that have less than one year of remaining shelf life. This new regulation aims to prevent the entry of drugs that are nearing their expiry date, ensuring that patients receive medication with adequate stability and potency.
New Rules Under Drugs Amendment
The decision was formalized through a notification issued by the Ministry of Health and Family Welfare. These changes have been introduced under the Drugs (Thirteenth Amendment) Rules, 2026, which specifically amends Rule 31 of the Drugs Rules, 1945. The mandate officially came into effect on October 28, 2026, following its publication in the Official Gazette.
According to the ministry's notification, the licensing authority is now strictly prohibited from allowing the import of any drug that does not possess at least one year of residual shelf life as of the date it is imported into India.
Special Exemptions for Critical Drugs
While the one-year rule applies to general medications, the government has recognized that certain specialized medicines have naturally shorter lifespans. Consequently, a separate provision has been carved out for specific categories of drugs:
- Biological Drugs: These complex medicines are granted a different threshold.
- Radiopharmaceuticals: Due to the nature of radioactive decay, these drugs cannot adhere to a one-year minimum.
For these two categories, the government has stipulated that 60 per cent of the labelled shelf-life may be allowed for import, providing the necessary flexibility for life-saving treatments that expire quickly.
The Road to Implementation
This policy change was not an overnight decision. The Ministry of Health and Family Welfare finalized the amendment after an extensive consultation process. The government had first released the draft amendment on June 22, 2026, opening the floor for stakeholders to provide feedback.
The process involved:
- Consultations with the Drugs Technical Advisory Board.
- A 30-day window for the public and industry stakeholders to submit objections and suggestions.
- A comprehensive review of the feedback received before the final notification was issued.
"Objections and suggestions received from the public on the said draft rules have been considered by the Central Government," the notification stated.