[MoH&FW
Notification S.O. 4996(E) dated 3 September 2026]
1.
Draft
Notification Issued
o The Ministry of Health and Family Welfare
has issued a draft
notification S.O. 4996(E) dated 3 September 2026 concerning
specified antimicrobial drugs and their formulations for animal use.
2.
Reason
for Proposed Prohibition
o The Central Government is satisfied that
use of the specified antimicrobials or groups of antimicrobials in animals may involve risks to humans.
o Safer alternatives for animal use are stated to be
available.
3.
Proposed
Regulatory Action
o The draft proposes to prohibit the import, manufacture, sale
and distribution of the specified antimicrobial medicinal
products for animal use.
4.
Legal
Basis
o The proposal has been issued under Section 26A of the Drugs and Cosmetics
Act, 1940.
o It follows consultation with the Drugs Technical Advisory Board (DTAB).
5.
Antimicrobials
Covered
o The draft notification presently lists the
following under Antibiotics:
§ Carboxypenicillins
§ Phosphonic acid derivatives
6.
Public
Consultation
o The draft will be considered after expiry of 30 days
from the date on which copies of the Gazette containing the notification are
made available to the public.
o Objections and suggestions received during
the specified period will be considered by the Central Government.
7.
Submission
of Objections/Suggestions
o Comments may be addressed to the Under Secretary (Drugs), Ministry of
Health and Family Welfare, U-6, Work Hall-C Wing, First Floor,
Kartavya Bhawan-1, New Delhi–110001.
o Email: drugsdiv-mohfw@gov.in
·
If
finalized, the specified carboxypenicillins
and phosphonic acid derivatives, including their formulations
covered by the notification, would face prohibition on import, manufacture, sale and
distribution for animal use.
·
The
stated policy objective is to address potential human-health risks associated with their
use in animals where safer alternatives are available.
·
At
present, this is a draft notification and the prohibition is not yet final.
S.O.
4996(E).— Whereas, the Central Government is satisfied that the use of drug
formulations containing any antimicrobials or group of antimicrobials and their
formulations as listed below in animals are likely to involve risk to Humans.
And,
whereas, safer alternatives to the said drugs for animal use are available;
And,
whereas, the Central Government is satisfied that it is necessary and expedient
in the public interest to prohibit the Import, manufacture, sale, and
distribution of any antimicrobial medicinal products as listed below for animal
use;
Now,
therefore in exercise of the powers conferred by section 26A of the Drugs and
Cosmetics Act, 1940 (23 of 1940), the draft notification is hereby published
after consultation with the Drugs Technical Advisory Board for information of
all persons likely to be affected thereby, and notice is hereby given that the
said draft notification 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 notification 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.-
Following
antimicrobials and groups of antimicrobials and their formulations for animal
use: -
1.
Antibiotics
(i) Carboxypenicillins
(ii)
Phosphonic acid derivatives
[F.
No. X.11035/125/2024-DR]