**Executive Summary**
This document pertains to Unstarred Question No. †2502 in Lok Sabha, scheduled for February 13, 2026, concerning the use of GLP-1 medications in India. It outlines the government's response regarding the approval, regulation, and monitoring of these drugs for obesity/weight management in the country. The response is provided by the Minister of State in the Ministry of Health and Family Welfare.
**Key Points / Main Content**
* **Drug Approvals:**
* The Central Drugs Standard Control Organization (CDSCO) has approved three drugs for obesity/weight management: Orlistat, Tirzepatide, and Semaglutide.
* **Prescription Requirements:**
* These drugs must be sold in retail on the prescription of an endocrinologist or Internal Medicine specialist, as per CDSCO approval conditions.
* All drugs should be used/consumed according to their recommendations.
* **Regulatory Control:**
* The sale and distribution of drugs are regulated through a system of licensing and inspection by State Licensing Authorities (SLAs) appointed by State Governments.
* SLAs are empowered to take action against violations of the Drugs and Cosmetics Act, 1940 & Rules 1945.
* **Adverse Event Monitoring:**
* The Indian Pharmacopoeia Commission (IPC), as the National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (PvPI), collates and analyzes Individual Case Safety Reports (ICSRs) related to adverse drug reactions.
**Impact Analysis**
**Healthcare Professionals (Endocrinologists, Internal Medicine Specialists)**
* **Impact:** Required to prescribe the specified drugs in accordance with CDSCO approval conditions.
* **Action Required:** Stay informed about the conditions of approval and recommendations for use for each drug.
**State Licensing Authorities (SLAs)**
* **Impact:** Responsible for licensing, inspection, and enforcement of regulations concerning the sale and distribution of the drugs.
* **Action Required:** Ensure compliance with the Drugs and Cosmetics Act, 1940 & Rules 1945, and take appropriate action in case of violations.
**Patients/Consumers**
* **Impact:** Need a prescription from a qualified specialist to obtain the specified drugs.
* **Action Required:** Use/consume the drugs in accordance with recommendations for use.
**Indian Pharmacopoeia Commission (IPC)**
* **Impact:** Responsible for monitoring and analyzing adverse drug reactions.
* **Action Required:** Continue to collate and analyze Individual Case Safety Reports (ICSRs) related to adverse drug reactions.
Key Entities Referenced
Drugs and Cosmetics Act, 1940 & Rules 1945: Act and rules governing the regulation of drugs in India, violations of which can be acted upon by State Licensing Authorities (SLAs).
Central Drugs Standard Control Organization (CDSCO): National regulatory body responsible for approving drugs in India, mentioned in the context of approving certain weight loss drugs.
Ministry of Health and Family Welfare: The government ministry responsible for answering the parliamentary question about GLP-1 medications.
State Licensing Authorities (SLAs): Authorities appointed by state governments to exercise regulatory control over the sale and distribution of drugs.
GLP-1 receptor agonists: Class of weight loss drugs that the government is assessing and regulating in India.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARRED QUESTION NO. †2502
TO BE ANSWERED ON13THFEBRUARY, 2026
USEOFGLP-1MEDICATIONS
†2502.SHRIOMPRAKASH BHUPALSINHALIAS PAVANRAJENIMBALKAR:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a)whether the Government hastaken cognizanceof the increasing use andmarketexpansion
of weight loss drugs, specifically GLP-1 receptoragonists in the country and if so, the details
thereof;
(b) whether these drugs are approved for use in the country for obesity management along
with the regulatory framework governing their prescription, sale and monitoring in this
regardandif so, the detailsthereof;
(c) whether the Government has conducted any assessment of the health risks, side effects
and long-term safety concerns associated with the non-therapeutic or aesthetic use of these
drugs andif so, the detailsthereof; and
(d) whether anyguidelines have been issued bythe Government toprevent misuse, excessive
prescription or self-medication of these drugs, particularly through online platformsand if so,
the detailsthereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a)to(d): Central Drugs Standard Control Organization (CDSCO) has approved the
following three drugs for obesity/weight management inthe country
(i) Orlistat
(ii)Tirzepatide
(iii)Semaglutide
These drugs are required to be sold in retail on the prescription of endocrinologist or
Internal Medicine/ specialists only as per the conditions of approval issued by CDSCO. All
drugs should be used/consumed inaccordance with recommendationsfor use.
Regulatory control over the sale and distribution of drugs is exercised through a
system of licensing and inspection by State Licensing Authorities (SLAs) appointed by State
Government.SLAs are empoweredtotake actionincase of violation of regulatoryprovisions
of Drugs andCosmetics Act, 1940& Rules1945.The IndianPharmacopoeiaCommission(IPC)asNational CoordinationCentre (NCC)
for Pharmacovigilance Programme of India (PvPI) collates and analyses, Individual Case
SafetyReports (ICSRs) related toadverse drug reactions.
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