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GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 3567
TOBE ANSWERED ON13TH MARCH, 2026
SALE OFANTIDEPRESSANT DRUGS
3567.SHRITANGELLAUDAYSRINIVAS:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) the details of the data on the sale of antidepressant drugs maintained during the last five
years, year-wiseandState/UT-wise;
(b) the list of antidepressant drugs currently approvedandmarketedinthe country;
(c)the safeguards inplace to regulate prescription practices,includingoff-label use;
(d) whether any monitoring or audit mechanism exists to track prescription trends, misuse or
adolescent consumption andif so,the detailsthereof;
(e)the numberof adverse drug reactionsreportedinrelation toantidepressants 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 OFSTATE IN THE MINISTRYOFHEALTH 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 PricingAuthority (NPPA) Department of
Pharmaceuticals (DoP), the sales as reported under “anti-depressants and mood” category for
the last five yearsisasunder:
Year SalesValue(in₹inCr.)based onMaximum RetailPrice
2021 2,442.41
2022 2,820.74
2023 3,137.62
2024 3,478.35
2025 3,648.78
(Source-Pharmarack database December2025)Central Drugs Standard Control Organisation (CDSCO) has approved seven anti-
depressant 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
accordancewith 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 IndianPharmacopoeiaCommission(IPC)asNational CoordinationCentre (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
ICSRsisgivenbelow:
CalendarYear NumberofAdverseDrugsReactions
(ADR)ReportsofAntidepressantDrugs
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 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.
Isolated complaints regarding sale of drugs by e-pharmacies without proper
prescription etc. have beenreceived. As andwhen such complaintsare received, based onthe
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.
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