Date: 2026-06-26Category: Press ReleaseState: Union GovernmentCountry: India
Union Ministry of Health and Family Welfare Invites Public Comments on Draft Amendment to Rationalise Residual Shelf-Life Requirement for Imported Drugs
**Executive Summary**
The Union Ministry of Health and Family Welfare has published a draft amendment to Rule 31 of the Drugs Rules, 1945, to rationalise residual shelf-life requirements for imported drugs. The proposal seeks to replace the current "60 per cent" residual shelf-life requirement with a fixed 12-month minimum to enhance Ease of Doing Business and reduce medicine wastage. Stakeholders are invited to submit objections or suggestions to the Under Secretary (Drugs) within the prescribed period following the June 22, 2026, notification.
**Key Points / Main Content**
**Proposed Regulatory Changes**
* Amends Rule 31 of the Drugs Rules, 1945, regarding the shelf-life of drugs at the time of import.
* Revises the minimum residual shelf-life requirement from "more than 60 per cent" to a flat minimum of 12 months.
* Retains the existing "more than 60 per cent" requirement for specialised categories, specifically biological products and radiopharmaceuticals.
**Objectives and Benefits**
* Aims to promote Ease of Doing Business within the pharmaceutical sector.
* Seeks to reduce avoidable wastage of medicines caused by restrictive shelf-life mandates.
* Intends to improve supply chain efficiency and the utilisation of pharmaceutical inventories.
* Ensures patients have access to quality medicines with sufficient time for distribution and consumption before expiry.
**Scope and Standards**
* The amendment applies exclusively to the residual shelf-life requirement at the point of entry into the country.
* Does not alter existing regulatory requirements for the quality, safety, or efficacy of medicines under the Drugs and Cosmetics Act, 1940.
**Impact Analysis**
**Pharmaceutical Importers and Businesses**
**Impact**
They will benefit from more flexible import requirements and reduced costs associated with inventory wastage and restrictive shelf-life barriers.
**Action Required**
Review the draft Gazette Notification G.S.R. 505 (E) and submit any objections or suggestions to the MoHFW via email or post.
**Patients and Healthcare Providers**
**Impact**
Availability of essential medicines is expected to strengthen due to optimized supply management, while ensuring a minimum 12-month usable life upon import.
**Action Required**
No immediate action required, though public health stakeholders may provide comments on the draft.
**Ministry of Health and Family Welfare (Regulatory Authorities)**
**Impact**
Responsible for overseeing the transition to the new requirement and ensuring compliance for non-exempted drugs.
**Action Required**
The Under Secretary (Drugs) must collect and process public feedback submitted to the Kartavya Bhawan office or via the provided official email address.
Key Entities Referenced
Rule 31 of the Drugs Rules, 1945: The specific regulatory provision being amended to revise the minimum residual shelf-life requirement for imported drugs from 60% to 12 months.
Drugs and Cosmetics Act, 1940: The primary legislation governing the import, manufacture, and distribution of drugs in India, under which the current rules are framed.
Ministry of Health and Family Welfare: The central ministry responsible for proposing this draft amendment and overseeing pharmaceutical safety and regulatory standards.
Ministry of Health and Family Welfare
Union Ministry of Health and Family Welfare
Invites Public Comments on Draft Amendment to
Rationalise Residual Shelf-Life Requirement for
Imported Drugs
Proposed amendment aims to facilitate Ease of Doing
Business while ensuring continued availability of quality
medicines with adequate shelf life
प्रव तथ: 26 JUN 2026 10:22AM by PIB Delhi
The Union Ministry of Health and Family Welfare has published a draft notification proposing
amendments to Rule 31 of the Drugs Rules, 1945, with the objective of rationalising the residual shelf-life
requirement for imported drugs and further promoting Ease of Doing Business in the pharmaceutical
sector.
The draft amendment, published for public consultation vide Gazette Notification G.S.R. 505 (E) dated
22nd June 2026, proposes to revise the existing requirement of a minimum residual shelf life of more than
60 per cent for imported drugs to a minimum residual shelf life of 12 months at the time of import.
However, in view of their specialised nature and public health considerations, the existing requirement of
a minimum residual shelf life of more than 60 per cent shall continue to apply to biological products and
radiopharmaceuticals.
The proposed amendment seeks to facilitate greater efficiency in the pharmaceutical supply chain while
maintaining the availability of quality medicines for patients. By ensuring that imported drugs have a
minimum remaining shelf life of twelve months upon entry into the country, the proposal provides
sufficient time for distribution and consumption before expiry, thereby ensuring that patients continue to
receive medicines with adequate usable shelf life.
The amendment is also expected to improve utilisation of pharmaceutical inventories across the supply
chain by reducing avoidable wastage of medicines arising from restrictive residual shelf-life requirements.
This, in turn, is expected to optimise supply management, reduce costs, and strengthen the availability of
essential medicines in the country.
The Ministry has clarified that the proposed amendment pertains solely to the residual shelf-life
requirement applicable at the time of import of drugs. The proposal does not alter any other regulatory
requirements relating to the quality, safety or efficacy of medicines under the Drugs and Cosmetics Act,
1940 and the Drugs Rules, 1945.The Ministry has invited objections and suggestions from all stakeholders on the draft notification.
Comments may be submitted to the Under Secretary (Drugs), Ministry of Health and Family Welfare,
Government of India, U-6, Work Hall–C Wing, First Floor, Kartavya Bhawan-1, New Delhi –
110001, or through email at drugsdiv-mohfw[at]gov[dot]in, within the prescribed period.
The draft Gazette Notification may be accessed at: https://egazette.gov.in/WriteReadData/2026/273833.pd
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HFW/ Amendment to Rule 31 of Drugs and Cosmetics Rules , 1945 /26 June 2026/1
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