**Executive Summary**
This document, released on February 6, 2026, by the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, provides information on the number of drugs banned by the Central Government under the Drugs & Cosmetics Act from 2021 to 2025. It also addresses the handling of complaints related to banned drugs and outlines requirements for manufacturing and marketing drugs.
**Key Points / Main Content**
* **Banned Drugs Statistics:**
* 2021: No drugs banned.
* 2022: No drugs banned.
* 2023: 14 drugs banned for human use and 2 for animal use.
* 2024: 157 drugs banned for human use and 1 for animal use.
* 2025: 1 drug banned for human use and 36 for animal use.
* **Enforcement & Penalties:**
* Manufacturing, selling, and distributing banned drugs is a punishable offense under the Drugs & Cosmetics Act, 1940.
* State Licensing Authorities (SLAs) are empowered to take action against offenders.
* **Complaint Handling:**
* Complaints regarding the selling of banned drugs are addressed by the Central Drugs Standard Control Organisation (CDSCO) and taken up with the State Drugs Controller.
* **Drug Regulation:**
* The manufacture, sale, and distribution of drugs are regulated under the Drugs and Cosmetics Act, 1940, and its rules.
* **New Drug Permissions:**
* Changes in the composition of active ingredients require new drug permission from CDSCO before obtaining a manufacturing license from SLA, reviewed under New Drugs and Clinical Trial Rules, 2019.
* **Brand Name Undertaking:**
* Applicants intending to market a drug under a brand name must furnish an undertaking in Form 51, ensuring the name does not cause confusion or deception and is not already in existence.
* **Manufacturing/Marketing Complaints**
* Complaints regarding manufacturing/marketing with changes in composition without CDSCO approval are addressed by the State Drugs Controller under the Drugs Act and Rules.
**Impact Analysis**
**Stakeholder: Drug Manufacturers**
* **Impact:** Manufacturers must adhere to regulations regarding drug composition and obtain necessary permissions from CDSCO and SLA.
* **Action Required:** Manufacturers intending to market a drug under a specific brand name must furnish an undertaking in Form 51.
**Stakeholder: State Licensing Authorities (SLAs)**
* **Impact:** SLAs are empowered to take action against the manufacture, sale, and distribution of banned drugs.
* **Action Required:** SLAs need to take action against offenses under Drugs & Cosmetics Act, 1940.
**Stakeholder: Central Drugs Standard Control Organisation (CDSCO)**
* **Impact:** CDSCO is responsible for handling complaints related to the selling of banned drugs and granting permissions for new drugs.
* **Action Required:** CDSCO must review applications based on New Drugs and Clinical Trial Rules, 2019.
**Stakeholder: State Drugs Controller**
* **Impact:** State Drug Controllers are responsible for necessary actions in case of CDSCO complaints.
* **Action Required:** State Drug Controllers need to act under the provision of Drugs Act and Rules.
Key Entities Referenced
Drugs & Cosmetics Act, 1940: Indian law regulating the import, manufacture, distribution, and sale of drugs and cosmetics.
Central Drugs Standard Control Organisation (CDSCO): National regulatory body for pharmaceuticals and medical devices in India.
Department of Health & Family Welfare: Indian government department responsible for public health and family welfare.
New Drugs and Clinical Trial Rules, 2019: Indian regulations governing the approval and conduct of clinical trials for new drugs.
Department of Pharmaceuticals: Department under the Ministry of Chemicals and Fertilizers responsible for pharmaceuticals.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
Sale of Banned Medicines
Posted On: 06 FEB 2026 1:41PM by PIB Delhi
As per the information provided by Department of Health & Family Welfare, number of drugs banned by
Central Government under the provisions of Drugs & Cosmetics Act, year wise is as follows:
Year No. of Drugs Banned
2021 NIL
2022 NIL
2023 14 for human use and 02 drugs for animal use
2024 157 for human use and 01 drug for animal use
2025 01 human use and 36 drugs for animal use
However, several writ petitions were filed in various High Courts across the country challenging the ban
of the Fixed Dose Combinations (FDCs) and the Court granted interim protection for the drugs already in
the distribution network.
Manufacture, sale and distribution of Banned Drug in the country is a punishable offence as per Drugs &
Cosmetics Act, 1940 and State Licensing Authorities (SLAs) appointed by respective State Governments
are empowered to take action against such offences.
As and when any such complaints/issues are received in Central Drugs Standard Control Organisation
(CDSCO) on selling of banned drugs, the matter is taken up with State Drugs Controller for necessary
action.
Department of Health & Family Welfare has informed that manufacture, sale and distribution of drugs are
regulated under the provisions of Drugs and Cosmetics Act, 1940 and Rules thereunder.
Any change in composition in respect of active ingredients of medicines require New drug permission
from CDSCO before obtaining the manufacturing licence from SLA. Such applications are reviewed
based on the provisions under New Drugs and Clinical Trial Rules, 2019.
Further, Drugs and Cosmetics Rules, 1945 was amended vide GSR no. 828(E) dated 06.11.2019,
providing that in case an applicant intends to market the drug under a brand name or trade name, the
applicant shall furnish an undertaking in Form 51 to the licensing authority to the effect that to the best ofhis knowledge based on search in trademarks registry, central data base for brand name or trade name of
drugs maintained by CDSCO, literature and reference books on details of drug formulations in India, and
internet, such or similar brand name or trade name is not already in existence with respect to any drug in
the country and the proposed brand name or trade name shall not lead to any confusion or deception in the
market.
As and when any such complaints/issues regarding manufacturing/ marketing of any medicine with
change in composition of active ingredients without CDSCO approval are taken up the matter with the
concerned State Drugs Controller for necessary action under provision of Drugs Act and Rules.
This information was given by the Union Minister for Chemicals and Fertilizers, Shri Jagat Prakash
Nadda in a written reply in the Lok Sabha today.
***
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