**Summary:**
This document summarizes the Indian government's policy regarding the ban of Fixed Dose Combinations (FDCs) of drugs. Under the Drugs and Cosmetics Act of 1940, the Central Government is empowered to regulate, restrict, or prohibit the manufacture, sale, and distribution of drugs, including FDCs, if their use poses a risk to human beings or animals or lacks therapeutic justification. The Drugs Technical Advisory Board (DTAB) is consulted when concerns arise regarding drugs, including FDCs.
Over the past several years, the Central Government has prohibited a number of FDCs. Specifically, on September 7, 2018, 328 FDCs were prohibited, while 6 FDCs were restricted with certain conditions. Further prohibitions were issued on January 11, 2019 (80 FDCs), June 2, 2023 (14 FDCs), and August 2, 2024 (156 FDCs). The fixed-dose combination of Etodolac Paracetamol was also prohibited on August 12, 2024.
Detailed lists of the banned FDCs are available on the website of the Central Drugs Standard Control Organisation (CDSCO) at www.cdsco.gov.in.
Key Entities Referenced
Ministry of Health and Family Welfare: The ministry responsible for health policy in India.
Fixed Dose Combinations (FDCs): A combination of two or more active pharmaceutical ingredients in a single dosage form.
Drugs and Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Drugs Technical Advisory Board (DTAB): An expert committee that advises the Central Government on technical matters related to drugs and cosmetics.
Section 26A of the Drugs and Cosmetics Act, 1940: A section of the Drugs and Cosmetics Act that empowers the Central Government to prohibit the manufacture, sale, and distribution of drugs.
Central Drugs Standard Control Organisation (CDSCO): The national regulatory authority for pharmaceuticals and medical devices in India.
Etodolac Paracetamol: A fixed-dose combination drug that was prohibited for manufacture, sale and distribution for human use.
Anupriya Patel: The Minister of State in the Ministry of Health and Family Welfare at the time of this document.
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
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