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GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 1122
TO BE ANSWERED ON24THJULY, 2026
USEOFDIABETES DRUG OZEMPIC
1122.SMT. KANIMOZHI KARUNANIDHI:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether the Government is aware of the growing use of certain GLP-1 class drugs, such
as Ozempic, which are approved for the treatment of diabetes, being increasingly used off-
label or without proper medical oversight, andthe concerns raised regarding potential misuse
for non-diabeticpurposes, if so, the details thereof; and
(b) whether the Government proposes to strengthen monitoring, prescription guidelines,
public awareness and vigilance mechanisms to prevent harm arising from inappropriate use
of such medicationsandif so, the details thereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT. ANUPRIYAPATEL)
(a): Drugs such as Ozempic, are required to comply with safety, quality and efficacy
requirements under the New Drugs and Clinical Trials Rules, 2019 prior to approval for
manufacture/import or marketing. Such approvals are granted by the Central Drugs Standard
Control Organisation (CDSCO) based on evaluation of clinical data and other scientific
evidencegenerated underthe provisions of said rules.
CDSCO has approved GLP-1 receptor agonist drugs in India strictly for the
indications of Type 2 Diabetes Mellitus (T2DM) in adults andchronic weight management in
adultswith specified medical conditions.
In viewof the potentialmisuse bynon-diabetesindividuals, the prescription anduse of
such drugs have been restricted exclusively to endocrinologists and internal medicine/
specialists. Initiation andcontinuation of therapy are required to be undertaken onlyunder the
strict supervision and monitoring of the treating specialist physician. This regulatory
safeguard is intended to prevent inappropriate use and to ensure that these drugs are
administered strictly under qualified medical supervision, thereby mitigating risks associated
with misuse andunsafe consumption.In addition, CDSCO has issued an Advisory dated 10.03.2026 to all concerned
stakeholders, emphasizing strict compliance with the provisions of the Drugs and Cosmetics
Act, 1940 and Rules made thereunder, and directing that manufacture, sale, and distribution
strictly conform toapprovedindications andconditionsof permission.
(b): CDSCO hasissued anadvisory dated27.03.2026 directing State/UTDrugs Controllers
to ensure strict adherence to the conditions of approval and the warnings specified on the
approved product labels for GLP-1 based weight loss drugs. It further emphasizes that the
manufacture/import, distribution, wholesale and retail sale and dispensing of such drugs shall
take place only through authorized channels and strictly in accordance with the approved
indicationsandlabelling.
The advisory also directs the State/UT Drugs Controllers to initiate appropriate
regulatory action in cases involving diversion of products, leakage into unauthorized supply
channels, promotional practices influencing the supply chain,or any non-compliance with the
conditions of approval. In addition, they have been advised to undertake active monitoring of
print, electronic, digital, social media and outdoor advertising platforms to detect non-
compliantadvertisements or surrogate promotionalactivitiesrelating tothese drugs.
Wherever violations are detected, appropriate action initiated under the provisions of
the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, the Drugs and
Cosmetics Act, 1940 and the Rules made thereunder against the manufacturers, importers,
marketersor anyotherentities.
Following steps has been taken by National Coordination Centre-Pharmacovigilance
Programme of India (NCC-PvPI), Indian Pharmacopoeia Commission (IPC), to strengthen
monitoring, public awareness to prevent harm arising from inappropriate use of GLP-
1receptoragonists
(i). NCC-PvPI organized a meeting with representatives from Marketing Authorisation
Holders (MAHs) and Adverse Drug Reaction Monitoring Centers (AMCs) on
20thMay, 2026 and 22ndMarch, 2026, respectively, to sensitize the stakeholders
about the safety of Semaglutide (Ozempic) and otherGLP-1 receptor agonists and
reporting of suspected Adverse Drug Reactions(ADRs) tothe PvPI.
(ii). All AMCs under PvPI across the country have been sensitized through emails and
posters to closely monitor and report ADRs associated with semaglutide and
otherGLP-1 receptoragonists.
(iii). Awareness posters have also been posted on IPC social media handles to encourage
healthcare professionalsandthe public toreport ADRs associated with GLP-1receptor
agonists including Semaglutide.
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