Centre proposes minimum 12-month shelf life rule for imported drugs

The Centre has proposed a significant change to India's pharmaceutical import regulations by mandating that imported drugs must have a minimum remaining shelf life of 12 months—or at least 60% of their total shelf life—when they enter the country.

The proposal, issued by the Ministry of Health and Family Welfare through a draft notification, seeks to amend the Drugs Rules, 1945. If implemented, the new rule will apply to medicines imported into India for sale and distribution, with the objective of ensuring that patients receive products with sufficient usable life.

What the proposed rule says

Under the draft amendment, imported drugs would be required to meet either of the following conditions at the time of import:

• A minimum remaining shelf life of 12 months, or

• At least 60% of the total shelf life remaining.

The government has invited comments and objections from stakeholders before finalising the proposal, in line with the standard rule-making process.

Why the change is being proposed

Officials believe the proposed requirement will improve the quality of medicines available in the Indian market while reducing the circulation of products nearing expiry.

The move is also expected to minimise wastage throughout the supply chain by ensuring adequate time for transportation, warehousing, distribution and dispensing before medicines reach patients.

Industry experts say the rule could strengthen quality assurance standards and bring greater consistency to the import of pharmaceutical products.

Impact on pharmaceutical imports

If notified, the regulation is likely to affect pharmaceutical companies importing finished drug formulations into India. Importers may need to adjust procurement schedules and logistics to ensure compliance with the new shelf-life requirement.

Manufacturers exporting medicines to India could also be required to modify inventory management and shipment timelines to meet the proposed standards.

However, experts note that medicines with shorter approved shelf lives may require specific regulatory consideration depending on their nature and intended use.

Public consultation underway

The draft notification has been placed in the public domain for stakeholder feedback. After reviewing comments from industry bodies, healthcare professionals and other interested parties, the government may revise or finalise the proposal before formally notifying the amended rules.

The proposed amendment is part of the Centre's broader efforts to strengthen India's pharmaceutical regulatory framework and ensure that medicines reaching consumers meet stringent quality and safety standards.