MoH&FW Invites Public
Comments on Draft Amendment to Rationalise Residual Shelf-Life Requirement for Imported
Drugs
Ø
Proposed
amendment aims to facilitate Ease of Doing Business while ensuring continued availability
of quality medicines with adequate shelf life
Ø
Draft
notification proposing amendments to Rule 31 of the Drugs Rules, 1945
1.
Draft
Notification Issued: The Union Ministry of Health and Family
Welfare has published a draft
notification proposing amendments to Rule 31 of the Drugs Rules, 1945.
2.
Objective: The amendment aims to:
o Rationalise the residual shelf-life
requirement for imported drugs.
o Promote Ease of Doing Business (EoDB)
in the pharmaceutical sector.
o Improve efficiency in the pharmaceutical
supply chain.
3.
Gazette
Notification: The
draft was issued through Gazette
Notification G.S.R. 505(E) dated 22 June 2026.
4.
Proposed
Change: The
existing requirement of more
than 60% residual shelf life at the time of import is proposed
to be replaced with a requirement of at
least 12 months of remaining shelf life.
5.
Exception: The existing rule of more than 60% residual shelf life
will continue to apply to:
o Biological products.
o Radiopharmaceuticals.
This
is due to their specialised nature and public health considerations.
6.
Purpose
of the Amendment: The
proposal seeks to ensure that imported medicines still have sufficient usable
shelf life for:
o Distribution.
o Storage.
o Consumption before expiry.
7.
Expected
Benefits:
o Improve pharmaceutical supply chain
efficiency.
o Reduce wastage of medicines.
o Optimise inventory management.
o Lower supply chain costs.
o Enhance availability of essential
medicines.
8.
No
Change in Safety Standards:
The Ministry clarified that the amendment only relates to residual shelf-life at the time of
import and does
not affect:
o Quality standards.
o Safety requirements.
o Efficacy standards.
These
continue to be governed by the Drugs
and Cosmetics Act, 1940 and the Drugs Rules, 1945.
9.
Public
Consultation: The
Ministry has invited objections
and suggestions from stakeholders before finalising the
amendment.
10. Submission of Comments: Stakeholders may submit their feedback to
the Under Secretary
(Drugs), Ministry of Health and Family Welfare, within the
prescribed consultation period.
·
Ministry: Ministry of Health and Family Welfare
·
Rule
Proposed for Amendment: Rule 31 of the Drugs Rules, 1945
·
Gazette
Notification: G.S.R. 505(E)
·
Notification
Date: 22 June 2026
·
Current
Requirement:
Imported drugs must have more
than 60% residual shelf life
·
Proposed
Requirement:
Imported drugs must have at
least 12 months of remaining shelf life
·
Exceptions: Biological products and
radiopharmaceuticals (continue under the 60% rule)
·
Parent
Legislation: Drugs and Cosmetics Act, 1940
·
Objectives: Ease of Doing Business, reduced medicine
wastage, improved inventory management, stronger medicine availability, and
more efficient pharmaceutical supply chains.
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.
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family
Welfare)
NOTIFICATION
New Delhi, the 22nd June, 2026
G.S.R.
505(E).— The following draft of certain rules further to amend the Drugs Rules,
1945, which the Central Government proposes to make, in exercise of the powers
conferred by sub-section (1) of section 12 and subsection (1) of section 33 of
the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the
Drugs Technical Advisory Board is hereby published for information of all
persons likely to be affected thereby, and notice is hereby given that the said
draft rules shall be taken into consideration on or after the expiry of a
period of thirty days from the date on which the copies of the Gazette of India
containing these draft rules are made available to the public.
Objections
and suggestions which may be received from any person within the period
specified above will be considered by the Central Government.
Objections
and suggestions, if any, may be addressed 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 emailed at drugsdiv-mohfw@gov.in.
DRAFT RULES
(i)These rules may be called the
Drugs (...... Amendment) Rules, 2026.
(ii)These rules shall come into force from the date as
specified by the Government at the time of final publication of the rules in
the Official Gazette.
In the Drugs Rules,
1945, in Rule 31, the second proviso shall be substituted as follows:-
“Provided further that the licensing
authority shall not allow the import of any drug having less than one year residual shelf-life period as on the date of
import. However, in the case of Biological drugs and Radiopharmaceuticals, 60%
of the labelled shelf-life may be allowed.”
[F.
No. X.11014/08/2026-DR]