Centre Proposes 12-Month Shelf-Life Norm For Imported Drugs

In a move aimed at streamlining pharmaceutical imports while ensuring the continued availability of medicines, the Union Health Ministry has proposed relaxing the residual shelf-life requirement for imported drugs from the current threshold of more than 60 per cent of total shelf life to a minimum of 12 months at the time of import.

The proposal, issued through a draft notification under Rule 31 of the Drugs Rules, 1945, has been placed in the public domain for stakeholder consultation. The Ministry said the amendment is intended to improve supply-chain efficiency, reduce wastage of medicines and support ease of doing business in the pharmaceutical sector without compromising patient safety.

Under the existing rules, imported medicines must retain more than 60 per cent of their total shelf life when they enter the country. The draft amendment proposes replacing this percentage-based requirement with a uniform minimum residual shelf life of one year.

However, the existing norm will continue to apply to biological products and radiopharmaceuticals because of their specialised nature and public health significance. These products often have unique storage, handling and stability requirements that necessitate stricter regulatory oversight.

A senior official from the Union Health Ministry said the proposed change seeks to strike a balance between regulatory safeguards and practical challenges faced by manufacturers, importers and distributors. “The objective is to ensure that medicines entering the country have sufficient usable shelf life for distribution and patient use, while avoiding unnecessary constraints that can lead to wastage and supply disruptions,” the official said.

He added that the present percentage-based system can create difficulties for products with longer overall shelf lives. In some cases, medicines that remain perfectly usable for several years may not qualify for import because they fail to meet the residual shelf-life criterion despite having substantial time remaining before expiry.

The official said that adopting a fixed 12-month requirement would provide greater flexibility in inventory management while maintaining adequate protection for consumers.

According to the draft notification, the proposed amendment is expected to improve the utilisation of pharmaceutical inventories by reducing avoidable losses arising from restrictive shelf-life norms. This could help optimise stock management across the supply chain, lower operational costs and improve the availability of medicines in the domestic market.

Industry experts have often argued that rigid residual shelf-life requirements can complicate procurement planning, particularly for specialised medicines that are manufactured in limited quantities or sourced from overseas facilities. The proposed revision is expected to facilitate smoother movement of such products while ensuring that patients continue to receive medicines with adequate remaining shelf life.

The official, however, clarified that the amendment is limited to the shelf-life requirement applicable at the time of import and does not alter any other regulatory provisions governing medicines.

“All existing standards relating to the quality, safety and efficacy of drugs under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, will remain unchanged,” the official said.

Public health experts note that residual shelf-life regulations are intended to ensure that medicines remain effective and safe throughout the period they are available to patients. They also help prevent the circulation of products nearing expiry. At the same time, regulators across several countries have increasingly sought to balance these safeguards with practical considerations related to supply-chain management and medicine availability.

The proposed amendment comes at a time when India is seeking to strengthen pharmaceutical supply chains and improve access to essential medicines while reducing inefficiencies in procurement and inventory management.

The Ministry has invited comments and objections from stakeholders, including pharmaceutical companies, importers, healthcare providers and patient groups, before finalising the amendment.

Stakeholders can submit their views to the Ministry within the prescribed consultation period. The feedback received will be examined before a final decision is taken on the proposed changes.

Officials said the consultation process is intended to ensure that the revised framework addresses both public health priorities and operational requirements of the pharmaceutical sector while maintaining regulatory standards.