Parliament Question: Regulation of Drug Quality and Safety

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 5711 TOBE ANSWERED ON27TH MARCH, 2026 REGULATION OFDRUG QUALITYAND SAFETY 5711.SHRIBHASKAR MURLIDHAR BHAGARE: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) whether the Government is aware of the circulation of fake, spurious and substandard medicinesandvaccines invariouspartsof the country,if so,the detailsthereof; (b) whether there is any proposal to strengthen public drug testing laboratories under State authoritiesandenable citizenstovoluntarilysubmit medicinesamples for verification; (c) whether the Government proposes to introduce consumer-friendly verification mechanisms such as QR-code based tracking and other authentication systems for medicines, if so, the detailsthereof; (d) the number of drug samples tested by the Central Drugs Standard Control Organization and State Food and Drug Administrations during the last three years, year-wise and State- wise alongwith the numberfound Not of Standard Qualityor spurious; and (e) whether any random sampling drives have been conducted and against manufacturers or distributors found involved in the sale of fake or substandard medicines and if so, the details thereof? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT. ANUPRIYAPATEL) (a)to(e): Complaints regarding Manufacture/ sales/distribution of not of standard quality/ spurious/adulterated drugs/vaccine, as and when received, action is initiated by the licensing authorityasperthe provisions of Drugs& Cosmetics Act, 1940 andrulesthereunder. To strengthen the drug testing infrastructure and enhance laboratory capacity across the country, Ministry of Health and Family Welfare has implemented a Centrally Sponsored Scheme 'Strengthening of States’ Drug Regulatory System (SSDRS). The scheme envisages upgrading existing State laboratories, setting up of new drug testing laboratories and upgradation of existing State drug control offices in the country. Under the SSDRS Scheme,funds totallingRs. 756 Crore has beenreleased toStates/UTs aspart of the Central Share and 19 New Drug Testing Labs have been constructed and 28 existing labs have been up-graded in variousStates/UTs. Further, Section 26of the Drugs and Cosmetics Act, 1940, specifically empowers individualcitizens andconsumer associations tohave medicinestested. 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 facilitatetracking andtracing. Central Drugs Standard Control Organization (CDSCO) has made the said requirements regarding QR Codes available to the general public by publishing the notification in this regard on its website (https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications) and has also advised industry stakeholdersfor public awareness campaignsinthisregard. Under the Drug and Cosmetics Act 1940, drugs inspector randomly draws drug samples from the supply chain for quality checks. List of drugs of various companies, which are declared Not of Standard Quality/ Spurious/ Misbranded/ Adulterated by the Central Drugs Testing Laboratories are regularly uploaded on the website of Central Drugs Standard Control Organization (CDSCO) under the heading of Drug Alert (www.cdsco.gov.in). In case of drug samples failing in quality check, regulatory, actions are taken by the concerned licensing authoritiesunder the provisions of Drugs & Cosmetics Act & Rulesthereunder. As per information received from States/UTs Drugs Controllers, the number of drug samples tested by variousStates/U.Ts inlast three yearsandtheir status isasunder: FinancialYear No.ofdrugs No.ofdrugssamples No.ofdrugssamples samplestested declaredNotof declaredSpurious/ StandardQuality Adulterated 2022-23 96,713 3,053 424 2023-24 1,06,150 2,988 282 2024-25 1,16,323 3,104 245 *******