Critically discus the December, 2017 Supreme Court directives to government to weed out large numbers of irrational, unscientific and hazardous fixed dose combination drugs.
Acknowledging the Fact that unscientific and irrational FDC s are threatening public health and lack of threrapeutic justification .So The Centre decided to withdraw irrational and harmful from the drug market .
In 2016 DCGI banned 344 FDCs which consists of 6000 different brands .
In the same year Delhi High court stayed on centre’s ban under the pressure of 454 petitions filed by many indian domestic and foreign drugs makers challenging the validity of ban .After that in December 2016 the Delhi High court quashed the centre’s order of ban on 344 FDCs.
This Delhi High court ruling were challenged by centre in Supreme court by an appeal in 2017 .centre stood at strong that it should be banned because already foreign countries banned combination of drugs .
Drug companies filed petitions saying government didn’t sought the advice of the DTAB (drugs technical advisory board of india ).
Under the section of 26A it is mandatory on companies to obtain marketing approval from DCGI through clinical trials .
Majority of companies obtained Lincensed through the State Lincensed Authorities without conducting clinical trials before entering into the market.
DCGI decided to ban these fixed dose of combination of drugs because it is harmful to use in long run.
And many complex combinations were banned in many countries .which are posing the severe threats to patients .Supreme court ordered for a committee for the scientific opinion on this issue.
Then kokate expert committee constituted for scientific opinion submitted its report after few weeks stating that Hundreds of FDCs are irrational and unscientific to use in therapeutic .15th December 2017 Supreme court order cleared the dispute between the corporate companies and the government by banning the combination of drugs ruling favouring towards public interest .