**Executive Summary**
This document is the response to Lok Sabha Unstarred Question No. 1179, concerning the sale of banned medicines, to be answered on February 6th, 2026. It details the number of drugs banned by the Central Government, actions taken against offenders, and regulations around drug manufacturing and sales. The Department of Health & Family Welfare provided the information regarding drugs banned by the Central Government.
**Key Points / Main Content**
* **Drug Banning Statistics (2021-2025):**
* 2021: NIL
* 2022: NIL
* 2023: 14 for human use, 2 for animal use
* 2024: 157 for human use, 1 for animal use
* 2025: 1 for human use, 36 for animal use
* **Legal Framework and Enforcement:**
* 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.
* Complaints about the sale of banned drugs received by the Central Drugs Standard Control Organisation (CDSCO) are forwarded to the State Drugs Controller for action.
* **Regulation of Drug Manufacturing:**
* Changes in the composition of active ingredients of medicines require new drug permission from CDSCO before obtaining a manufacturing license from SLA.
* Applications for new drugs are reviewed under the New Drugs and Clinical Trial Rules, 2019.
* **Drug Naming Conventions:**
* Drugs and Cosmetics Rules, 1945, amended in 2019, require applicants marketing drugs under a brand name or trade name to confirm the name is not already in use.
* The applicant must confirm the name will not lead to confusion or deception in the market.
* **Monitoring of Unapproved Drug Modifications:**
* Complaints regarding manufacturing or marketing medicines with changes in active ingredients without CDSCO approval are addressed with the State Drugs Controller for necessary action under the Drugs Act and Rules.
* **Court Injunctions:**
* 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.
**Impact Analysis**
**Stakeholder: Drug Manufacturers and Vendors**
* **Impact:** Subject to strict regulations regarding drug manufacturing, composition, and naming conventions. Liable to legal action for violations related to banned drugs.
* **Action Required:** Ensure compliance with Drugs & Cosmetics Act, 1940, and related rules. Obtain necessary approvals from CDSCO for changes in drug composition and be aware of the Court Injunctions.
**Stakeholder: State Licensing Authorities (SLAs)**
* **Impact:** Responsible for enforcing regulations against the manufacture, sale, and distribution of banned drugs.
* **Action Required:** Take action against offenders under the Drugs & Cosmetics Act, 1940.
**Stakeholder: Central Drugs Standard Control Organisation (CDSCO)**
* **Impact:** Responsible for reviewing applications for new drugs and ensuring compliance with regulations.
* **Action Required:** Address complaints regarding the sale of banned drugs and manufacturing of drugs with unapproved modifications.
**Stakeholder: Consumers/Public**
* **Impact:** Protection from potentially harmful or ineffective drugs, access to legally manufactured and marketed medicines.
* **Action Required:** Remain vigilant, report any suspicious medicines or practices to the authorities.
Key Entities Referenced
Drugs & Cosmetics Act, 1940: The primary legislation governing the regulation of drugs and cosmetics in India, referenced in the context of banning and controlling the sale of medicines.
Ministry of Chemicals and Fertilizers: The ministry to which the question about the sale of banned medicines is addressed and which provides the response.
Department of Pharmaceuticals: Department under the Ministry of Chemicals and Fertilizers, involved in answering the question about the sale of banned medicines.
Central Drugs Standard Control Organisation (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India, responsible for handling complaints related to banned drugs and ensuring necessary action.
Drugs and Cosmetics Rules, 1945: The rules framed under the Drugs and Cosmetics Act, 1940, governing various aspects of drug regulation, including brand name registration and preventing confusion in the market.
GOVERNMENT OF INDIA
MINISTRY OF CHEMICALS AND FERTILIZERS
DEPARTMENT OF PHARMACEUTICALS
LOK SABHA
UNSTARRED QUESTION No. 1179
TO BE ANSWERED ON THE 6th FEBRUARY, 2026
Sale of Banned Medicines
†1179. Dr. Anand Kumar:
Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:
(a) the number of medicines banned by the Government during the last five years, year-wise
and category-wise;
(b) whether the Government is aware of the fact that such medicines despite being banned,
continue to be sold and purchased in the market;
(c) if so, the details thereof along with the corrective steps being taken by the Government in
this regard;
(d) the action taken by the Government against such drug manufacturing companies and
vendors during the last five years;
(e) whether new medicines under different name have been manufactured by the drug
manufacturing companies by making minor changes in the composition of the medicines and
sold in the market; and
(f) if so, the details thereof along with the action taken by the Government in this regard?
ANSWER
THE MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS
(SHRI JAGAT PRAKASH NADDA)
(a) to (d): 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.
(e) to (f): 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 of his 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.
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