Parliament Question: Ban on Fixed Dose Combinations

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 2289 TOBE ANSWERED ON01ST AUGUST,2025 BAN ONFIXED DOSECOMBINATIONS

2289.DR.THIRUMAAVALAVAN THOLKAPPIYAN:

Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:

(a) whether the Government has banned any medicine, irrational fixed dose combinations in the countryduring the last three years, if so, the detailsthereof,year-wise; and

(b) whether the Government has any data of the medicine and its treatment category along with the namesof the companies producingit andif so, the detailsthereof? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT.ANUPRIYAPATEL)

(a)& (b) : There are provisions under the Drugs and Cosmetics Act, 1940, under which Central Government may regulate, restrict or prohibit manufacture, etc 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 ingredientscontained inFDCs.

Whenever, any such concerns on any drug including FDCs are reported, the matter is examined in consultation with expert committee/ Drugs Technical Advisory Board (DTAB) and appropriate action is taken for prohibition of such drugs under the provisions of Section 26Aof the Drugs andCosmetics Act, 1940.

The Central Government has prohibited number of drugs including FDCs for manufacture, sale or distribution. Through notification issued on 07.09.2018, the Central Government prohibited328 FDCsfor manufacture, sale or distribution. The Government also restricted 06FDCsfor manufacture,sale or distribution with certainconditions. Subsequently, Central Government vide notifications S.O. 180 (E) to S.O.259 (E), dated 11.01.2019, prohibited 80 FDCs for manufacture, sale or distribution. Further, Central Government vide

notification S.O. 2394 (E) to S.O. 2407 (E) dated 02.06.2023 prohibited 14 FDCs for manufacture, sale or distribution. Recently, Central Government vide notification S.O. 3285

(E) to S.O. 3440 (E) dated 02.08.2024 prohibited 156 FDCs for manufacture, sale or distribution.The Central Government also prohibited the manufacture for sale, sale and distribution for humanuse of drug fixed dose combination of S(+)Etodolac +Paracetamol vide S.O.3284(E) dated12.08.2024.

List of bannedFDCsisavailable on the website of CDSCO i.e.www.cdsco.gov.in ********