Parliament Question: Ban on Fixed Dose Combinations (FDCs)

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 930 TO BE ANSWERED ON24THJULY, 2026 BAN ONFIXED DOSECOMBINATIONS(FDCs) 930: THIRU THANGATAMILSELVAN: DR. GANAPATHYRAJKUMAR P: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) whether the Government has recently issued notifications under Section 26Aof the Drugs and Cosmetics Act, 1940, prohibiting sixteen more Fixed Dose Combinations (FDCs), includingdermatological preparations, painkillers, antispasmodics andantibiotics; (b) if so, the details thereof, along with the specific reasons, expert evaluations and the objectivebehindbanning these sixteen FDCs; (c) the total number of FDCs banned by the Union Government during the last three years, year-wise; (d) the exactdate onwhich these prohibitionnotificationscame intoforce across the country; (e) the supervisory and regulatory mechanisms established by the Central and State drug regulatory authorities to enforce the ban and monitor the manufacture, distribution and retail sale of these 16FDCs; and (f) whether the Government proposes to review more existing FDCs in the near future, if so, the detailsandtimeframe thereof? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT. ANUPRIYAPATEL) (a)to(f): There are provisions under the Drugs and Cosmetics Act, 1940, under which Central Government may regulate, restrict or prohibit manufacture, of any drug including Fixed Dose Combination (FDCs) drugs in public interest if the use of drugs is likely to involve any risk to human beings or animals or there is no therapeutic justification for the ingredientscontainedin FDCs. The Central Government has prohibited manufacture, sale or distribution of 16 FDCs vide gazette notification dated 11.06.2026 vide S.O No. 3068(E) to 3083(E) with immediate effect inpublic interest undersection 26Aof Drugs andCosmetics Act 1940inthe country.The detailsthereof,alongwith thespecific reasonsare availableonthewebsite ofCDSCO i.e. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_fi le_division.jsp?num_id=MTQzOTc= The detailsof the FDCsprohibited during the last three yearsare asunder. (i) 14FDCsvide gazettenotification SOno. 2394(E)to2407(E)dated02.06.2023, (ii)156FDCsvide gazettenotification S.ONo. 3285(E)to3440(E)dated02.08.2024, (iii)The fixeddose combination of S(+)Etodolac+Paracetamol vide gazettenotification S.O.3284(E)dated12.08.2024. The prohibitions become effective across the country from the date of publication of the respective notifications inthe OfficialGazette. Manufacture, sale and distribution of prohibited/banned drugs is a punishable offence under Section 18 of the Drugs and Cosmetics Act, 1940 and the State Licensing Authorities are empowered to take action in this regard. As and when any such complaints/issues is received, the matter is taken up with the concerned State Licensing Authority for necessary actionincludingthe cancellationof the manufacturinglicenses. The meetings of Drugs Consultative Committee (DCC), a statutory committee under the said Act, comprising of all States /UTs Drugs Controllers as members, are held and various issues related manufacturing, sale and distribution of drugs are discussed/deliberated and decisions are taken for effective & uniform implementation of the various provisions of said Act & Rules. *******