Drug imports: Centre sets one-year shelf-life requirement

The Centre has amended the remaining shelf-life requirement for imported drugs, setting a one-year threshold at the date of import while providing a separate percentage-based allowance for biological drugs and radiopharmaceuticals. The Ministry of Health and Family Welfare’s notification G.S.R. 951(E), dated 16 October 2026, replaces the second proviso to Rule 31 of the Drugs Rules, 1945.

The amendment appears in the Gazette of India issue dated 28 October 2026. Called the Drugs (Thirteenth Amendment) Rules, 2026, it takes effect on publication in the Official Gazette, rather than from a separately specified future date.

Residual shelf life means the usable period remaining before a medicine expires. The amendment concerns how much of that period must remain when a drug enters India, not the total shelf life assigned to the product.

The notification directs the licensing authority not to allow imports of drugs with less than one year remaining. For biological drugs and radiopharmaceuticals, it provides that 60 per cent of the shelf life stated on the label may be allowed.

A fixed period replaces the general percentage rule

The amended provision makes the date of import the point at which the remaining shelf life is assessed. It distinguishes the general condition, expressed as a fixed period of time, from the provision for biological drugs and radiopharmaceuticals, expressed as a share of labelled shelf life.

The earlier framework required imported medicines to have more than 60 per cent of their shelf life remaining on entry, according to DD News’s report of 26 June 2026 on the draft amendment. The report described the proposed replacement as a minimum of 12 months.

A percentage-based condition varies with a product’s labelled shelf life, whereas the new general condition specifies one year remaining. The final notification does not describe this change as a waiver of import licensing or registration.

For biological products and radiopharmaceuticals, DD News reported that the ministry had proposed retaining the percentage-based requirement because of their specialised nature and public health considerations. Those categories are therefore treated separately from other drugs in the final provision.

The October notification uses permissive wording for the 60 per cent allowance, rather than repeating the prohibition used for drugs with less than one year remaining. It does not provide a separate explanation of how licensing authorities should exercise that allowance.

Consultation preceded the final amendment

The final notification records that the draft was published through G.S.R. 505(E), dated 22 June 2026. Copies of that Gazette were made available to the public on 25 June 2026.

People likely to be affected were invited to submit objections and suggestions within 30 days of the copies becoming available. The October notification states that the Central Government considered the responses received before finalising the rules.

The ministry also records consultation with the Drugs Technical Advisory Board. It exercised powers under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, the statutory provisions cited in the notification as the authority for making the amendment.

The final text does not reproduce the consultation responses or identify which suggestions were accepted or rejected. It records completion of the consultation process and substitutes the new provision in Rule 31.

The June reports concerned a proposal open to public comment. The October notification is the final rule-making document and contains the commencement clause governing when the amendment takes effect.

Supply-chain objectives and continuing regulatory controls

The ministry presented the draft as a way to improve pharmaceutical supply-chain efficiency and reduce avoidable wastage, according to DD News. The broadcaster reported that the ministry considered one year of remaining shelf life sufficient to provide time for distribution and consumption before expiry.

DD News also reported the ministry’s expectation that the change would improve inventory management, reduce supply-chain costs and strengthen the availability of essential medicines. These were the stated objectives of the proposal, not measured results established by the October notification.

On regulatory scope, the ministry said the proposal concerned only remaining shelf life at import and would not alter existing provisions governing medicine quality, safety or efficacy, according to DD News. The final amendment is confined to replacing the specified proviso in Rule 31.

The Central Drugs Standard Control Organisation’s Imports & Registration guidance describes the wider framework separately. It says both bulk drugs, also called active pharmaceutical ingredients, and finished formulations are regulated under the Drugs and Cosmetics Act and its rules.

CDSCO’s guidance states that registration requirements apply to both the drug and its manufacturing site. It identifies the Drugs Controller General (India) at CDSCO as the licensing authority and describes applications for registration certificates and import licences through the online SUGAM system.

According to that guidance, applications may be made by a foreign manufacturer’s local authorised agent holding a manufacturing or sale licence, or by foreign manufacturers holding a wholesale licence in India. The shelf-life amendment does not replace those application arrangements.

The October notification contains no separate transition schedule or instructions for consignments already in transit. Its commencement clause specifies publication in the Official Gazette, and the substituted shelf-life condition is framed by reference to the date of import.