**Executive Summary**
This report outlines the regulatory measures implemented by the Ministry of Health and Family Welfare and CDSCO to ensure the quality and efficacy of medicines in India. It highlights mandatory testing requirements, risk-based inspections, and amendments to the Drugs Rules, 1945, regarding Good Manufacturing Practices (Schedule M) and authentication. Key deadlines for compliance with revised Schedule M are set for June 29, 2024 (large manufacturers), and January 1, 2026 (smaller manufacturers).
**Key Points / Main Content**
**Regulatory Standards and Licensing**
* **Uniform Standards:** All drugs manufactured in India, whether generic or branded and for domestic or international markets, must comply with the same quality standards under the Drugs & Cosmetics Act, 1940.
* **Mandatory Testing:** Licensees are required to test every batch of raw materials and final products, maintaining detailed records of these tests.
* **Bio-equivalence:** Results of bio-equivalence studies are mandatory for manufacturing licenses of oral dosage forms under Categories II and IV of the Bio-pharmaceutical Classification System.
**Quality Control and Enforcement**
* **Risk-Based Inspections:** Since December 2022, over 960 premises have been inspected, resulting in more than 860 actions, including license cancellations, suspensions, and stop-production orders.
* **Targeted Audits:** Intensive audits have been conducted for over 1,100 cough syrup manufacturers and 380 blood centers.
* **Contaminant Testing:** Amendments now mandate testing for Diethylene Glycol (DEG) and Ethylene Glycol (EG) in oral liquids at the finished product stage before market release.
* **Public Alerts:** Lists of drugs declared as "Not of Standard Quality," spurious, or adulterated are regularly uploaded to the CDSCO website under "Drug Alert."
**Packaging and Digital Integration**
* **Authentication (QR/Bar Codes):** Manufacturers of the top 300 drug brands must affix Bar Codes or QR codes on packaging. All Active Pharmaceutical Ingredients (APIs) must also bear QR codes to facilitate tracking.
* **SUGAM Labs:** An online portal integrated in September 2023 automates the workflow for testing medical products and tracking testing status.
**Revised Schedule M (Good Manufacturing Practices)**
* **Infrastructure Upgrades:** Revised requirements for premises, plant, and equipment for pharmaceutical products were notified in December 2023.
* **Compliance Deadlines:** Manufacturers with a turnover > Rs. 250 crores must comply by June 29, 2024; those with < Rs. 250 crores must comply by January 1, 2026.
**Impact Analysis**
**Drug Manufacturers**
**Impact**
Subject to stricter manufacturing standards (Schedule M), mandatory raw material/finished product testing, and new labeling requirements (QR codes).
**Action Required**
Upgrade facilities to meet revised Schedule M standards by the specified 2024/2026 deadlines and implement DEG/EG testing for oral liquids.
**State Drugs Controllers and Licensing Authorities**
**Impact**
Responsible for increased market surveillance, risk-based inspections, and enforcement of the Drugs & Cosmetics Act.
**Action Required**
Maintain heightened vigilance against substandard drugs, conduct audits of cough syrup manufacturers, and take prompt legal actions against non-compliant entities.
**Healthcare Facilities and State Health Departments**
**Impact**
Directed to ensure the rational use of specific medications, particularly for pediatric care.
**Action Required**
Adhere to the advisory issued on October 3, 2025, regarding the rational use of paediatric cough syrups.
**Central Drugs Standard Control Organization (CDSCO)**
**Impact**
Acts as the central coordinator for drug testing integration and regulatory advisory.
**Action Required**
Manage the SUGAM labs portal, publish drug sampling guidelines, and provide expert advice through Drugs Consultative Committee (DCC) meetings.
Key Entities Referenced
Drugs & Cosmetics Act, 1940: The primary legislation governing the manufacture, sale, and distribution of drugs in India, ensuring they meet prescribed quality standards.
Central Drugs Standard Control Organization (CDSCO): The national regulatory body responsible for drug approvals, risk-based inspections, and coordinating with state authorities to ensure medicine quality.
Revised Schedule M: An amendment to the Drugs Rules 1945 that prescribes updated Good Manufacturing Practices (GMP) and requirements for pharmaceutical premises and equipment.
New Drugs and Clinical Trials (NDCT) Rules, 2019: The regulatory framework used for evaluating the quality, safety, and efficacy of new drugs in consultation with expert committees.
Indian Pharmacopoeia Commission (IPC): The body responsible for setting official drug standards in India, which recently mandated testing for contaminants like Diethylene Glycol in oral liquids.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
Variations in Generic Medicines
Posted On: 20 MAR 2026 3:00PM by PIB Delhi
As per the information provided by Ministry of Health and Family Welfare there is no definition of
‘generic medicines’ under Drugs & Cosmetics Act, 1940 and Rules made there under and Central Drugs
Standard Control Organization (CDSCO) has not received any such reports regarding variations in quality,
therapeutic effectiveness and onset time of certain generic medicines.
The manufacture, sale and distribution of drugs are primarily regulated in the country under the
provisions of Drugs & Cosmetics Act & Rules 1945 made thereunder through a system of licensing and
inspection by State Licensing Authorities appointed by respective State Governments. Licensee is required
to comply with all the condition of license as prescribed under Drugs & Cosmetics Rules, 1945. As per
one of the conditions of license, licensee is required to test each batch or lot of the raw material used by
him for the manufacture of his product and also each batch of the final product and shall maintain records
or registers showing the particulars in respect of such tests.
Further, Drugs manufactured in the country, irrespective of whether generic medicines or branded
medicines or for domestic or international market are required to comply with the same standards as
prescribed in the Drugs and Cosmetics Act, 1940 and Rules made thereunder for their quality.
Ministry of Health and Family Welfare has informed that CDSCO approves new drugs in accordance with
the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019, based on a comprehensive
evaluation of their quality, safety, and efficacy in consultation with Subject Expert Committee (SEC)
experts.
Further, to ensure efficacy of drugs, the Drugs Rules 1945 amended vide G.S.R. 327(E) dated 3rd April,
2017, wherein requirement of bio-equivalence study results was placed to the concerned State/UTs Drugs
Authorities for grant of manufacturing license for oral dosage form of drugs falling under the Category II
and Category IV of the Bio-pharmaceutical Classification System.
Ministry of Health and Family Welfare has informed that no such feedback has been received.
Ministry of Health and Family Welfare has informed that CDSCO and Ministry of Health and Family
Welfare have taken following regulatory measures to ensure the production of quality medicines across 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). 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). Advisory has been issued on 03.10.2025 to all State/UT Health Departments and healthcare
facilities to ensure rational use of paediatric cough syrups. Further, the Drugs Controller (India)
directed all State/UT Drug Controllers on 07.10.2025 to ensure strict compliance with testing
requirements under the Drugs Rules, 1945, and on 27.10.2025 instructed them to maintain
heightened vigilance against spurious and substandard drugs and take prompt action under the
Drugs & Cosmetics Act, 1940.
(iv). 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.
(v). List of drugs of various companies, which are declared Not of Standard Quality/ Spurious/
Misbranded/ 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.
(vi). 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 application to facilitate tracking and tracing.
(vii). 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.
(viii). 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.
(ix). 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.
(x). The 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.
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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