Lok Sabha Question No. 3567 (UNSTARRED), answered on 2026-03-13
Subject: Sale of Antidepressant Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Shri Tangella Uday Srinivas

## GOVERNMENTOFINDIA MINISTRYOF HEALTH AND FAMILY WELFARE DEPARTMENTOFHEALTH AND FAMILY WELFARE

LOK SABHA UNSTARRED QUESTION NO. 3567 TO BE ANSWERED ON 13 TH MARCH, 2026

## SALE OF ANTIDEPRESSANT DRUGS

## 3567. SHRI TANGELLA UDAY SRINIVAS:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) the details of the data on the sale of antidepressant drugs maintained during the last five years, year-wise and State/UT-wise;
- (b) the list of antidepressant drugs currently approved and marketed in the country;
- (c) the safeguards in place to regulate prescription practices, including off-label use;
- (d) whether any monitoring or audit mechanism exists to track prescription trends, misuse or adolescent consumption and if so, the details thereof;
- (e) the number of adverse drug reactions reported in relation to antidepressants during the last five years, year-wise; and
- (f) the current status of rules regulating sale of prescription drugs, including Schedule H, H1 and psychotropic medicines, through e-pharmacy platforms along with enforcement actions taken?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SMT. ANUPRIYAPATEL)

(a) to (e): 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. As per market data available with National Pharmaceutical Pricing Authority (NPPA) Department of Pharmaceuticals (DoP), the sales as reported under 'anti-depressants and mood' category for the last five years is as under:

|   Year | Sales Value (in ₹in Cr.) based on Maximum Retail Price   |
|--------|----------------------------------------------------------|
|   2021 | 2,442.41                                                 |
|   2022 | 2,820.74                                                 |
|   2023 | 3,137.62                                                 |
|   2024 | 3,478.35                                                 |
|   2025 | 3,648.78                                                 |

(Source- Pharmarack database December 2025)

Central Drugs Standard Control Organisation (CDSCO) has approved seven antidepressant drug products for use in country. Drugs, including anti-depressants, are approved along with their indication(s), dosage form, route of administration, and strength in accordance with the regulatory framework.

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 and Rules made thereunder and for raising awareness in the public regarding adverse effects of misuse of drugs.

The Indian Pharmacopoeia Commission (IPC) as National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) collates and analyses, Individual Case Safety Reports (ICSRs) related to adverse drug reactions. The year-wise distribution of ICSRs is given below:

|   Calendar Year |   Numberof Adverse Drugs Reactions (ADR) Reports of Antidepressant Drugs |
|-----------------|--------------------------------------------------------------------------|
|            2021 |                                                                      666 |
|            2022 |                                                                     1271 |
|            2023 |                                                                     1836 |
|            2024 |                                                                     2063 |
|            2025 |                                                                     1798 |

- (f) 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 relating to regulation of sale and distribution 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, monitoring of epharmacy, etc.

Isolated complaints regarding sale of drugs by e-pharmacies without proper prescription etc. have been received. As and when such complaints are received, based on the merit, the matter is referred to the concerned State Licensing Authority for taking action as per the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945, as the State Licensing Authorities are empowered to take action in case of any violation of the conditions of sale licenses.

*******