**Executive Summary**
This document outlines regulations and actions concerning the sale of spurious drugs, emphasizing that their manufacture, sale, or distribution is a punishable offense under the Drugs and Cosmetics Act, 1940 and associated rules. Key provisions include strict enforcement, sample testing, and public disclosure of drug alerts. The information was provided by the Minister of State for Chemicals and Fertilizers in the Lok Sabha.
**Key Points / Main Content**
* **Legal Framework:**
* Manufacture, sale, and distribution of spurious, adulterated, or not-of-standard-quality drugs are punishable offenses under the Drugs & Cosmetics Act, 1940, and the Drugs Rules, 1945.
* Licensing authorities are empowered to take action against such offenses.
* Section 18 prohibits the manufacture, sale, stocking, or distribution of drugs without proper authorization.
* The Drugs and Cosmetics Rules, 1945, govern licensing, labeling, inspection, and manufacturing standards to prevent counterfeit medicines.
* **Enforcement and Monitoring:**
* Central Drugs Standard Control Organization (CDSCO) and State Drugs Control Authorities draw samples for testing and analysis.
* Drug samples found to be substandard, spurious, or adulterated are reported to CDSCO.
* Reports are uploaded on the CDSCO website as monthly drug alerts.
* Manufacturers may be directed to recall drugs, and actions are taken based on investigation outcomes.
* **Definition of Spurious Drugs:**
* A drug is considered spurious if manufactured under the name of another drug, is an imitation intended to deceive, bears a false manufacturer's name, claims production by a non-existent manufacturer, or has been wholly or partly substituted.
* **Drug Banning Statistics:**
* 2021: NIL drugs banned.
* 2022: NIL drugs banned.
* 2023: 14 drugs for human use and 2 for animal use banned.
* 2024: 157 drugs for human use and 1 for animal use banned.
* 2025: 1 drug for human use and 36 for animal use banned.
* **Penalties and Consequences:**
* Punishment for manufacturing or selling spurious drugs is under Section 27 of the Act.
* If a spurious drug causes death or grievous hurt, offenders face imprisonment of not less than 10 years, extendable to life imprisonment, and a fine of at least ₹10 lakh or three times the value of confiscated drugs.
* In other cases, punishment includes imprisonment of not less than 7 years, extendable to life imprisonment, and a minimum fine of ₹3 lakh or three times the value of confiscated drugs.
* Drugs and related materials can be confiscated under Sections 31 and 34.
* Company officials responsible may be held liable.
* Offenses relating to spurious drugs are cognizable and non-bailable.
**Impact Analysis**
**Manufacturers**
* **Impact:** Manufacturers are subject to strict regulations regarding drug quality and authenticity. They may face recalls, confiscation of materials, and legal penalties, including imprisonment and substantial fines, if found to be producing or distributing spurious drugs.
* **Action Required:** Ensure adherence to the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, in all aspects of drug manufacturing, sale, and distribution. Implement robust quality control measures and be prepared for potential drug recalls and investigations.
**Consumers**
* **Impact:** Consumers benefit from increased safety and assurance of drug quality due to stringent enforcement against spurious drugs. Public alerts on banned drugs help them avoid potentially harmful medications.
* **Action Required:** Stay informed about monthly drug alerts published on the CDSCO website. Report any suspected spurious or substandard drugs to relevant authorities.
**Regulatory Authorities (CDSCO and State Drugs Control Authorities)**
* **Impact:** These authorities are responsible for the implementation and enforcement of the Drugs and Cosmetics Act. They are empowered to conduct tests, issue alerts, direct recalls, and take legal action against offenders.
* **Action Required:** Continue to draw samples, conduct tests and analysis, upload monthly drug alerts on the CDSCO website, and initiate investigations and actions as per the provisions of the Act and rules.
**Company Officials**
* **Impact:** Company officials can be held liable for offenses relating to spurious drugs, facing potential imprisonment and fines, alongside the company.
* **Action Required:** Ensure compliance with all regulations and establish internal controls to prevent the manufacture, sale, or distribution of spurious drugs. Cooperate fully with investigations.
Key Entities Referenced
Drugs & Cosmetics Act, 1940: The primary law governing the manufacture, sale, and distribution of drugs in India, under which actions against spurious drugs are taken.
Drugs Rules, 1945: Rules that support the Drugs & Cosmetics Act, 1940, by regulating licensing, labeling, inspection, and manufacturing standards.
Section 27 of the Act: Specifies the punishment for manufacturing or selling spurious drugs, including imprisonment and fines.
Section 17B: Defines what constitutes a spurious drug under the Drugs and Cosmetics Act.
Central Drugs Standard Control Organization (CDSCO): The national regulatory body responsible for the regulation of medical devices and drugs in India, involved in sample testing and drug alerts.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
Sale of Spurious Drugs
Posted On: 13 MAR 2026 3:52PM by PIB Delhi
As per the information provided by Department of Health and Family Welfare
manufacture/sales/distribution of Spurious/ Adulterated/Not of Standard Quality drugs etc. is a punishable
offence under the Drugs & Cosmetics Act, 1940 and the Drugs Rules, 1945 and concerned licensing
authorities are empowered to take action in such cases.
As per the information provided by Department of Health and Family Welfare, Central Drugs Standard
Control Organization (CDSCO) as well as State Drugs Control Authorities draw samples of drugs for test
and analysis from supply chain under the provisions of Drugs and Cosmetics Act, 1940 and Rules
thereunder. All the drug samples found not of standard quality/spurious/ adulterated by the Central Govt.
Laboratory and reports of Not of Standard Quality (NSQ)/spurious /adulterated forwarded by the State
Drugs Controllers to CDSCO are uploaded on the website of CDSCO as part of the monthly drug alerts to
make it available publicly.
In such cases, the manufacturers (as per the label claim) are directed to recall such drugs and based on
investigation outcomes, actions are taken by the concerned licensing authorities under the provisions of
Drugs & Cosmetics Act & rules made thereunder.
The 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
Further, under the Drugs and Cosmetics Act, 1940, the manufacture, sale, or distribution of spurious drugs
is strictly prohibited. According to Section 17B, a drug is considered spurious if it is manufactured under
the name of another drug, is an imitation intended to deceive, bears a false manufacturer’s name, claims to
be produced by a non-existent manufacturer, or has been wholly or partly substituted with anothersubstance. Section 18 prohibits the manufacture, sale, stocking, or distribution of such drugs without
proper authorization. The Drugs and Cosmetics Rules, 1945 support these provisions by regulating
licensing, labeling, inspection, and manufacturing standards to prevent the production of counterfeit
medicines.
Punishment for manufacturing or selling spurious drugs is provided under Section 27 of the Act. If the
spurious drug causes death or grievous hurt, the offender may face imprisonment of not less than 10 years,
which may extend to life imprisonment, along with a fine of at least ₹10 lakh or three times the value of
the drugs confiscated. In other cases, the punishment includes imprisonment of not less than 7 years,
which may extend to life imprisonment, along with a minimum fine of ₹3 lakh or three times the value of
the drugs. Additionally, under Sections 31 and 34, the drugs and related materials may be confiscated, and
company officials responsible for the offence may also be held liable. Offences relating to spurious drugs
are cognizable and non-bailable, ensuring strict enforcement against manufacturers of fake medicines.
This information was given by Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in a
written reply in the Lok Sabha today.
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PC/PM
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