issue regarding the prevalence of many Fixed Dose
Combinations (hereinafter referred to “FDCs”) that were
flooding the Indian market and had not been tested ... Licensing Authorities have issued manufacturing
licenses for a very large number of FDCs without prior
clearance from the Central Drugs Standard Control
Organization (CDSCO). Such
sale in the territory of India of drugs based on the said FDCs (At one stage of
the hearing the learned ASG appearing ... informed that the
challenge in all these petitions is to 100 odd FDCs only and there is no
challenge to the other
States/Union
Territories requesting them to call upon the manufacturers of various
FDCs in their respective States/Union Territories to prove the safety
and efficacy ... FDCs for which licences were issued prior to
01.10.2012 without the approval of DCGI. This was followed by
another letter dated 05.07.2013 setting a time
notification no.S.O.4467(E), whereby the Fixed Drug
Combinations (FDCs) of the following formulations had been
proscribed;
a) Metformin 1000 mg + Pioglitazone ... Central Government under Section 26A of the Act,
whereby the FDCs of the following formulations have been
proscribed.
a) Metformin 500 mg + Pioglitazone
Schools of Education (SoEs), Teaching Learning Centres (TLCs), Faculty Development Centres (FDCs), Centres for Excellence in Science and Mathematics (CESMEs), Centres for Academic Leadership
cosmetic."
4. By the Notifications dated 10.03.2016, the respondents banned 344
FDCs. By a separate Notification being SO No. 1855 (E) dated ... other points raised in the writ petitions,
the case of 344 FDCs that have been banned, plus another 5
FDCs that have been banned, which
4471(E) dated
07.09.2018, whereby the manufacture and sale Fixed Drug
Combinations (FDCs) of the formulations "Glimepiride 1mg/ 2mg/
3mg + Pioglitazone 15mg/ 15mg/ 15mg ... Central Government has proscribed the manufacture, sale
and distribution of the aforesaid FDCs on account of inclusion of the
formulation Metformin in the said FDCs
January, 2016 with respect to applications of FDCs received by the O/O DCG (T)
for proving safety and efficacy categorized under category ... adverse effect.
Chandler S. Gautam,
Lekha Saha, Fixed dose
drug combination
(FDCs); rational or
irrational; a view point
Br J Clin
Pharmacol
Committee of comprising of ten experts for
examining the efficacy of the FDCs which were manufactured and
sold in the market by various manufacturers ... issued 344 notifications
prohibiting proscribing the manufacture, sale and distribution of 344
FDCs with immediate effect. One of the said notifications - being
further submitted
that the firms were also involved in manufacturing many other FDCs which are not approved by
DCGI. The Appellant consistently maintained that ... emphasized that the country had permitted a large number of absurd FDCs (Fixed Drug
Combination) due to failure to understand pharmacological logic and failure
