**Executive Summary**
This document is the answer provided by the Minister of State in the Ministry of Health and Family Welfare to Unstarred Question No. 2114 regarding the sale of anti-depressants, to be answered on December 12th, 2025. It addresses queries about data maintenance, drug approvals, off-label prescriptions, regulatory measures, and the status of draft rules for e-pharmacies. The response covers the regulatory framework under the Drugs & Cosmetics Act, CDSCO approvals, and initiatives to regulate online sales.
**Key Points / Main Content**
* **Drug Regulation:**
* Sale of drugs is regulated by State Governments under the Drugs & Cosmetics Act, 1940, through licensing and inspection.
* State Licensing Authorities (SLAs) can take action against violations of the Act.
* Data related to the sale of anti-depressant drugs in the State/UTs is not maintained centrally.
* **Drug Approvals:**
* The Central Drugs Standard Control Organisation (CDSCO) has approved seven anti-depressant drug products for use in the country during the last three years.
* Drugs, including anti-depressants, are approved with specific indications, dosage form, route of administration, and strength.
* **Regulatory Compliance and Awareness:**
* Notices/Advisories/Letters have been issued to State Drugs Controllers and other stakeholders for compliance with the Drugs and Cosmetics Act.
* Efforts are being made to raise public awareness about the adverse effects of drug misuse.
* **E-pharmacy Regulation:**
* Draft rules for regulating online medicine sales were notified on 28.8.2018, inviting public comments.
* The draft rules include provisions for registration, periodic inspection, distribution procedures, prohibition of advertising, complaint redressal, and monitoring of e-pharmacies.
**Impact Analysis**
**State Governments**
*Impact:*
* Responsible for regulating drug sales through licensing and inspection according to the Drugs & Cosmetics Act, 1940.
* State Licensing Authorities (SLAs) are empowered to take action against violations.
*Action Required:*
* Ensure strict enforcement of the Drugs & Cosmetics Act and Rules.
* Take action against violations related to the sale of anti-depressant drugs.
**Central Drugs Standard Control Organisation (CDSCO)**
*Impact:*
* Involved in the approval of anti-depressant drug products for use in the country.
*Action Required:*
* Continue to approve drugs according to the regulatory framework, including indications, dosage forms, routes of administration, and strengths.
**State Drugs Controllers and Other Stakeholders**
*Impact:*
* Responsible for compliance with the Drugs and Cosmetics Act.
*Action Required:*
* Ensure strict adherence to the requirements of the Drugs and Cosmetics Act and Rules.
* Implement measures to prevent drug misuse and ensure proper prescription practices.
**E-pharmacies**
*Impact:*
* Subject to new regulations currently under development.
*Action Required:*
* Await the finalization and implementation of the draft rules for e-pharmacies.
* Prepare for registration, inspection, and compliance with the new regulations regarding distribution, advertising, and complaint redressal.
**Public**
*Impact:*
* The public is to be made aware of the adverse effects of drug misuse.
*Action Required:*
* Stay informed about the potential risks of drug misuse.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The primary law governing the regulation of drugs and cosmetics in India.
Central Drugs Standard Control Organisation (CDSCO): The national regulatory body in India responsible for approving drugs.
Drugs Rules, 1945: Rules made under the Drugs and Cosmetics Act, 1940 for regulating the sale and distribution of drugs including e-pharmacy.
Ministry of Health and Family Welfare: The government ministry responsible for health policy in India, including drug regulation.
State Licensing Authorities (SLAs): State-level bodies responsible for licensing and inspecting drug sales.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2114
TOBE ANSWERED ON12TH DECEMBER, 2025
SALE OFANTI-DEPRESSANTS
2114.SHRISRIBHARATMATHUKUMILLI:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether the Government maintains data on the number of anti-depressant drugs sold in
the country during the last five years and if so, the details thereof, year-wise and State/UT-
wise;
(b) the details of anti-depressant drugs currently approved, available and marketed in the
country;
(c) whether the Government is aware that anti-depressants are being prescribed for off-label
uses inthe countryandif so, the details thereof;
(d) whether the Government has put in place safeguards and regulatory measures to prevent
misuse or inappropriate prescription of anti-depressants for off-label indicationsand if so, the
detailsthereof; and
(e) the current status of the draft rules on the regulation of sale and distribution of drugs
through e-pharmacyplatforms, first notifiedin2018?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a)to(d): Sale of drugs in the country is regulated under the provisions of Drugs &
Cosmetics Act, 1940 and the Rules made thereunder, by the State Governments through a
system of licensing and inspection. State Licensing Authorities (SLAs) are legally
empowered to take action against violation of provisions of the said Act and Rules. Data
relatedtothe sale of anti-depressant drugs inthe State/UTs isnot maintainedcentrally.
During the last three years, Central Drugs Standard Control Organisation (CDSCO)
has approved seven anti-depressant drug products for use in country. Drugs, including anti-
depressants, are approvedalongwith their indication(s), dosage form, route of administration,
andstrength inaccordance with the regulatoryframework.
Various notices/Advisories/Letters have been issued to all State Drugs Controllers,
other stakeholders for strict compliance of the requirements of Drugs and Cosmetics Act andRules made thereunder and for raising awareness in the public regarding adverse effects of
misuse of drugs.
(e) In order to comprehensively regulate online sale of medicines, the Government of
India has published draft rules vide its notification dated 28.8.2018, inviting comments from
public and stakeholders on amendments to the Drugs Rules, 1945 for incorporating
provisions relatingtoregulation of sale anddistribution of drugs through e-pharmacy.
The draft rules contain provisions for registration of e-pharmacy, periodic inspection
of e-pharmacy, procedure for distribution or sale of drugs through e-pharmacy, prohibition of
advertisement of drugs through e-pharmacy, complaint redressal mechanism,monitoringof e-
pharmacy, etc.
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