**Executive Summary**
This document is a response to a parliamentary question regarding substandard quality of medicines in India. It details the actions taken by the Central Drugs Standard Control Organization (CDSCO) and the Ministry of Health and Family Welfare to ensure the import and manufacture of safe, efficacious, and quality medicines. Key actions include risk-based inspections of drug manufacturing premises, amendments to the Drugs Rules, and establishment of regulatory guidelines.
**Key Points / Main Content**
* **Inspections and Enforcement:**
* CDSCO and State Drugs Controllers (SDCs) conducted risk-based inspections of over 960 drug manufacturing premises since December 2022.
* Over 860 actions were taken, including show cause notices, stop production orders, suspension/cancellation of licenses/product licenses, and warning letters.
* Lists of drugs declared Not of Standard Quality/Spurious/Misbranded/Adulterated are available on the CDSCO website.
* **Amendments to Drugs Rules:**
* Effective August 1, 2023, manufacturers of top 300 drug formulation brands must affix Bar Codes or Quick Response Codes on packaging.
* Every Active Pharmaceutical Ingredient (API) manufactured or imported must bear a Quick Response Code on its label for tracking and tracing.
* Revised Schedule M related to Good Manufacturing Practices has been introduced, effective June 29, 2024, for manufacturers with turnover > Rs. 250 crores and conditional extension till December 31, 2025, for manufacturers having turnover of less than Rs. 250 Cr subject to their upgradation plan.
* **Regulatory Guidelines and Systems:**
* Regulatory guidelines for sampling of drugs, cosmetics, and medical devices were published in February 2024.
* An online portal (SUGAM labs) is in place since September 2023 to integrate drug testing labs and automate the testing workflow.
* Mandatory undertaking (Form 51) is required from applicants intending to market a drug under a specific brand name, ensuring no existing similar brand name and no potential confusion.
* **Coordination and Training:**
* Central regulator coordinates with State Drug Control Organisations through Drugs Consultative Committee (DCC) meetings.
* Training programs on Good Manufacturing Practices are provided to officials of CDSCO and State Drug Regulatory Authorities.
**Impact Analysis**
**Pharmaceutical Manufacturers**
* **Impact:** Compliance with revised regulations, including affixing barcodes/QR codes, adherence to revised Schedule M (Good Manufacturing Practices), and providing undertakings for brand names.
* **Action Required:** Implement necessary changes in manufacturing processes, packaging, and quality control to comply with the updated Drugs Rules and guidelines.
**State Drug Controllers (SDCs) / State Licensing Authorities**
* **Impact:** Increased responsibility in conducting risk-based inspections, enforcing regulations, and taking actions against non-compliant manufacturers.
* **Action Required:** Conduct inspections, issue notices, and enforce penalties as per the Drugs and Cosmetics Act, and participate in DCC meetings.
**CDSCO Officials**
* **Impact:** Increased focus on conducting risk-based inspections, implementing and enforcing regulations, coordinating with State Drug Controllers, and providing training.
* **Action Required:** Conduct inspections, participate in training programs, and coordinate with State Drug Controllers through DCC meetings.
**Consumers**
* **Impact:** Increased assurance of the safety, efficacy, and quality of medicines due to stricter regulatory oversight and improved tracking mechanisms.
* **Action Required:** No direct action required; benefit from improved medicine quality.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: Governs the import, manufacture, distribution, and sale of drugs and cosmetics in India.
Drugs Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940, providing detailed regulations for the manufacture, sale, distribution, and testing of drugs and cosmetics.
Central Drugs Standard Control Organization (CDSCO): National regulatory body for pharmaceuticals and medical devices under the Ministry of Health and Family Welfare, responsible for regulating drug manufacturing and quality control.
Ministry of Health and Family Welfare: The central ministry responsible for health policy and programs in India, including drug regulation and quality control.
Drugs Consultative Committee (DCC): Committee that facilitates coordination between Central and State Drug Control Organizations for uniformity in administering the Drugs and Cosmetics Act.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 1003
TOBE ANSWERED ON05TH DECEMBER, 2025
SUBSTANDARDQUALITYOFMEDICINES
1003.SHRIABHISHEK BANERJEE:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) the number of pharmaceutical manufacturing units inspected by Central Drugs Standard
Control Organization (CDSCO) in 2023–24 and 2024–25 that were found to be non-
compliantwith quality normsandthe numberof unitsorderedtoshut, State-wise;
(b) the quantity (in number of batches) of medicines rejected for substandard quality in those
inspectionsandthe value of such batches; and
(c) the steps taken/proposed to be taken by the Government to strengthen quality control,
including augmentation of labs, digital traceability, and stricter oversight of Active
Pharmaceutical Ingredient (API) sourcing, particularly in view of scholar criticisms about
India’sdependenceonimportedAPIsandquality lapses?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a)to(c): In order to assess the regulatory compliance of drug manufacturing premises
in the country, the Central Drugs Standard Control Organization (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 as per the provisions of
the Drugs Rules1945.
Further, 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 Central Drugs Standard Control Organization
(CDSCO) under the heading of Drug Alert (www.cdsco.gov.in) and actions initiated as per
provisions of the Drugs andCosmetics Act, 1940 andrulesthereunder.
CDSCO and Ministry of Health and Family Welfare have taken following regulatory
measures to ensure the import and manufacture of safe, efficacious and quality medicines
across the country:(i) On 17.11.2022, the Drugs Rules, 1945 were amended vide G.S.R. 823(E) which has
come into force from 1st of August, 2023 providing that the manufacturers of top
300 brands of drug formulation products, as specified in Schedule H2, shall print or
affix Bar Code or Quick Response Code on itsprimary packaging labelor, in case of
inadequate space in primary packagelabel, on the secondary package label thatstore
data or informationlegible with software application tofacilitateauthentication.
(ii) On 18.01.2022, the Drugs Rules, 1945 were amended vide G.S.R. 20 (E) providing
thateveryActive PharmaceuticalIngredient (bulkdrug) manufacturedor importedin
India shall bear Quick Response Code on its label at each level of packaging that
store data or information readable with software applicationto facilitate trackingand
tracing. The stored data or information shall include the minimum particulars
including unique product identification code, Batch Number, Manufacturing date,
ExpiryDate etc.
(iii) 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. However, for manufacturers having
turnover of less than Rs. 250 Cr, conditional extension up to 31.12.2025 is currently
operational for those who submitted their upgradation plan for the extended
complianceperiod.
(iv) InFebruary2024,CDSCO publishedregulatoryguidelinesfor the sampling ofdrugs,
cosmetics, and medical devices by Central and State Drugs Inspectors. These
guidelines provide a structured approach to ensure the quality and efficacy of
productsavailableinthe marketthrough uniform drug sampling methodology.
(v) 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
qualityspecificationandtracingthe testing status inthe laboratories.
(vi) The Drugs Rules, 1945 have been amended making it mandatory that, in case the
applicant intends to market the drug under a brand name or trade name the applicant
shall furnish anundertaking inForm51to the licensing authority thatsuch 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 deceptioninthe market.
(vii) 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.
(viii) Central government isproviding 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 inFinancialYear 2024-25, 20551persons have beentrained.
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