Lok Sabha Question No. 898 (UNSTARRED), answered on 2024-07-26
Subject: Substandard and Spurious Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Shri Vishnu Datt Sharma

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

## LOK SABHA UNSTARRED QUESTION NO. 898 TO BE ANSWERED ON 26 TH JULY, 2024

## SUBSTANDARD AND SPURIOUS DRUGS

## 898. SHRI VISHNU DATT SHARMA:

Will the Minister of HEALTHANDFAMILYWELFARE be pleased to state:

- (a) whether over 2,900 drugs have been found to be substandard and 422 spurious in tests conducted during the year 2022-23;
- (b) if so, whether the Government is planning to conduct nation-wide exercise to weed out spurious, adulterated and sub-standard drugs from the supply chain system, if so, the details thereof;
- (c) whether the Government has planned any comprehensive measures to counter this menace; and
- (d) if so, the details thereof and if not, the reasons therefor?

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

- (a): As per information received from various States/U.Ts Drugs Controllers, during year 2022-23, 3053 drugs have been found substandard and 424 drugs have been declared as spurious/adulterated.
- (b): In order to ensure the quality of drugs and to assess the regulatory compliance of drug manufacturing premises in the country, the CDSCO along with State Drugs Controllers (SDCs) have conducted risk-based inspections of more than 400 premises. The firms have been identified based on risk criteria like number of drugs declared as Not of Standard Quality, complaints, criticality of the products etc. Based on findings of inspections, more than 300 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses etc., have been taken by the State Licensing Authorities as per the provisions of the Drugs Rules 1945.
- (c) & (d): Central Drugs Standard Control Organization (CDSCO) and Ministry of Health and Family Welfare have taken following regulatory measures to ensure the quality of medicines in the country:
- (i). The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable.
- (ii). States/ UTs have set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal.
- (iii). The number of sanctioned posts in CDSCO has been significantly increased in last 10 years.
- (iv). To ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of some drugs.
- (v). The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government.
- (vi). The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.
- (vii). Further, Central Government has amended the Drugs Rules 1945 vide G.S.R. 922 (E) dated 28.12.2023 to revise the schedule M to the said rules related to Good Manufacturing Practices and requirements of premises, plant and equipment for pharmaceutical products.
- (viii). Central regulator coordinates activities of State Drug Control Organisations and provides expert advice through the Drugs Consultative Committee (DCC) meetings held with State Drugs Controllers for uniformity in administration of the Drugs and Cosmetics Act.

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