The Ministry of Health has banned the production, sale and dispersal of about 328 fixed dose combinations of drugs (FDCs).
This ban will bring an end to a long legal battle between the ministry and the drug manufacturers. The battle, which has been ongoing since 2016, called for these ‘unsafe’ drugs to be banned.
Around 6,000 drug brands are expected to be affected by this ban, among them popular brands such as Saridon (painkiller), Panderm (skin cream), Lupidiclox (antibiotic), Corex (cough syrup) and several others.
In March 2016, the government had banned up to 344 FDCs but this was met with heavy criticism and contested in various high courts, and even the Supreme Court, by the manufacturers.
In December 2017, the SC asked Drugs Technical Advisory
Board (DTAB) to intervene in the matter. The DTAB eventually said there
was no therapeutic evidence that the ingredients in about 328 of these
FDCs cause any harm to people.
The SC further added that the remaining FDCs, on the original list, could also not be banned as they have been manufactured in the country since before 1988.
The All India Drug Action Network sought the banning of the drugs which were not part of the DTAB report, as these itself accounted for about Rs 2,500 crore of the pharmaceutical market.
Since then, several drug manufacturers have claimed that such drugs have either been phased out or have gotten their combinations altered.
This ban will bring an end to a long legal battle between the ministry and the drug manufacturers. The battle, which has been ongoing since 2016, called for these ‘unsafe’ drugs to be banned.
Around 6,000 drug brands are expected to be affected by this ban, among them popular brands such as Saridon (painkiller), Panderm (skin cream), Lupidiclox (antibiotic), Corex (cough syrup) and several others.
In March 2016, the government had banned up to 344 FDCs but this was met with heavy criticism and contested in various high courts, and even the Supreme Court, by the manufacturers.
The SC further added that the remaining FDCs, on the original list, could also not be banned as they have been manufactured in the country since before 1988.
The All India Drug Action Network sought the banning of the drugs which were not part of the DTAB report, as these itself accounted for about Rs 2,500 crore of the pharmaceutical market.
Since then, several drug manufacturers have claimed that such drugs have either been phased out or have gotten their combinations altered.
