Lok Sabha Question No. 5625 (UNSTARRED), answered on 2026-03-27
Subject: Sale of Sub-Standard Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Shri Abdul Rashid Sheikh

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

## LOK SABHA UNSTARRED QUESTION NO. 5625 TO BE ANSWERED ON 27 TH MARCH, 2026

## SALE OFSUB-STANDARD MEDICINES

## 5625. SHRI ABDUL RASHID SHEIKH:

## Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

the measures being taken to stop manufacturing & sale of sub-standard medicines in the country?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

## (SMT. ANUPRIYAPATEL)

The manufacturing, sale and distribution of drugs in the country are regulated under the provisions of Drugs & Cosmetics Act, 1940 and rules thereunder. The regulatory control over the manufacture, sale and distribution of drugs in the country is exercised through a system of licensing and inspection by the State Licensing Authorities (SLAs). Compliance with the conditions of licence granted under the said Act and Rules is mandatory for manufacture, sale and distribution of drugs in the country. SLAs are legally empowered to take action against violation of provisions of the said Act and Rules.

Central Drugs Standard Control Organisation (CDSCO) and Ministry of Health and Family Welfare have taken following measures in recent years to stop manufacturing & sale of sub-standard medicines in the country:

- (i). In order 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 960 premises since December, 2022 and based on findings, more than 860 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses, warning letters have been taken by the State Licensing Authorities.
- (ii). Further, more than 1100 cough syrup manufacturers and 380 blood centres have been subjected to intense audit in coordination with State authorities. Increased market surveillance sampling of syrup formulations by Central and State drugs regulators has also been done.
- (iii). List of drugs of various companies, which are declared Not of Standard Quality/ Spurious/ Adulterated by the Central Drugs Testing Laboratories is uploaded and available on the website of CDSCO under the heading of Drug Alert (www.cdsco.gov.in) and actions initiated as per provisions of the Drugs and Cosmetics Act, 1940 and rules thereunder.
- (iv). The 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. Revised Schedule M has become effective for the drug manufacturers with turnover > Rs. 250 crores from 29.06.2024 and for manufacturers having turnover of less than Rs. 250 Cr from 01.01.2026.
- (v). In February 2024, CDSCO published regulatory guidelines for the sampling of drugs, cosmetics, and medical devices by Central and State Drugs Inspectors. These guidelines provide a structured approach to ensure the quality and efficacy of products available in the market through uniform drug sampling methodology.
- (vi). An online portal, SUGAM labs is in place since September 2023 for integrating the drug testing labs of the CDSCO. It automates the entire workflow for testing of Medical Products (Drugs, Vaccine, Cosmetics & Medical devices) to meet the quality specification and tracing the testing status in the laboratories.
- (vii). The Drugs Rules, 1945 have been amended in year 2023 to mandate that manufacturers of the top 300 drug formulation brands listed in Schedule H2 shall print or affix a Bar Code or QR Code on the primary packaging label, or on the secondary label where space is insufficient, to store data readable through software applications for authentication. Similarly, the Rules have also been amended to require that every Active Pharmaceutical Ingredient (bulk drug), whether manufactured or imported, shall bear a QR Code on each level of packaging containing data readable through software applications to facilitate tracking and tracing.
- (viii). In addition to the existing requirements of testing the raw materials, the Indian Pharmacopoeia Commission, Ghaziabad has issued an amendment to Indian Pharmacopoeia (IP) 2022, to also mandate the testing for DEG and Ethylene Glycol (EG) in oral liquids at finished product stage before market release.
- (ix). Central government is providing regular residential, regional training and workshops to officials of CDSCO and State Drug Regulatory Authorities on Good Manufacturing Practices. In the Financial Year 2023-24 CDSCO has trained 22854 persons while in Financial Year 2024-25, 20551 persons have been trained.

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