Parliament Question: Measures to prevent counterfeit drugs and ensure drug quality

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE RAJYASABHA UNSTARREDQUESTION NO. 3622 TOBE ANSWERED ON24TH MARCH, 2026 MEASURES TOPREVENTCOUNTERFEIT DRUGS AND ENSUREDRUG QUALITY 3622.SMT.JEBI MATHER HISHAM: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a)whether Government hasassessed the scale andspread of counterfeitmedicinesinviewof reportsindicatinga significant rise intheircirculation,the details thereof,State/UT-wise; (b) whether the volume and financial size of the counterfeit medicine market in the country hasbeenestimated; (c) the steps taken to ensure the genuineness andquality of medicinesdistributed through Jan Aushadhi outletsamidconcernsof counterfeit circulation; (d) the State/UT-wise details of quality tests conducted by CDSCO during the last five years; and (e) whether Government has examined the factors contributing to the influx of adulterated medicinesandthe corrective measures undertaken? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT.ANUPRIYAPATEL) (a)to(e): The terminology “Counterfeit Medicines” is not defined under the Drugs and Cosmetics Act, 1940 and Rules made thereunder. However, the Drugs and Cosmetics Act defines spurious, adulterated and misbranded drugs which includes counterfeit drugs. Presently, there is no specific study conducted to assess the current volume and estimated market size of counterfeit medicines. However, a nation-wide survey (2014-16) was conducted to assess the extent of Not of Standard Quality (NSQ)/Spurious drugs. Out of a total 47,012 drug samples drawn from both Governments and private sources, the estimated percentage of NSQ and spurious drugs from Retail outlets was 3% and 0.023% respectively, while thatfrom Government sources was 10.02% and0.059% respectively.Central Drugs Standard Control Organization (CDSCO) and Ministry of Health and Family Welfare have taken following regulatory measures toensure the production of quality medicinesacross the countryincluding those distributed through Jan Aushadhi outlets: - (i) In order to assess the regulatory compliance of drug manufacturing premises in the country, the CDSCO alongwith State Drugs Controllers(SDCs) have conductedRisk- 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 bythe StateLicensingAuthorities. (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) 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 havingturnover of less thanRs. 250Cr from 01.01.2026. (iv) 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 toensure the qualityandefficacy of products available inthe 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 quality specification andtracingthe testing status inthe laboratories. (vi) The Drugs Rules, 1945 have been amended in year 2023 to mandate that manufacturers of the top300 drug formulationbrandslisted inSchedule H2shall 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 tofacilitatetrackingandtracing. (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 CosmeticsAct.(viii) Central government is providing regular residential, regional training and workshops to officials of CDSCO andState Drug RegulatoryAuthoritieson Good Manufacturing Practices. In the Financial Year 2023-24 CDSCO has trained 22854 persons while in FinancialYear2024-25,20551personshavebeentrained. As per information received from States/UTs Drugs Controllers, the number of drug samples tested by variousStates/U.Ts andtheirstatus isasunder: FinancialYear No.ofdrugs No.ofdrugssamples No.ofdrugssamples samplestested declaredNotof declaredSpurious/ StandardQuality Adulterated 2020-21 84,874 2,652 263 2021-22 88,844 2,545 379 2022-23 96,713 3,053 424 2023-24 1,06,150 2,988 282 2024-25 1,16,323 3,104 245 On the isolated complaints regarding sale of not of standard quality and spurious/adulterated drugs, as and when received, action is initiated by the licensing authority asperthe provisions of Drugs & Cosmetics Act, 1940 andrulesthereunder. **********