Putting an end to a long-drawn legal battle, the Union Health Ministry has banned the manufacture, sale and distribution of 328 fixed-dose combinations (FDCs) of drugs with immediate effect and restricted another six, stated several media reports.
Putting an end to a long-drawn legal battle, the Union Health Ministry has banned the manufacture, sale and distribution of 328 fixed-dose combinations (FDCs) of drugs with immediate effect and restricted another six, stated several media reports.
Among the banned drugs are that are widely popular include painkiller Saridon, skin cream Panderm, combination diabetes drug Gluconorm PG and antibiotic Lupidiclox. The Health Ministry has been trying to ban them for the past two years to get these ‘irrational’ and ‘unsafe’ drugs banned.
Last December, the SC had asked for the matter to examined by the Drugs Technical Advisory Board (DTAB). The DTAP report had said there was no therapeutic justification for ingredients in 328 of the FDCs and recommended banning them. It also suggested restricted manufacture and sale subject to certain conditions of six FDCs. On 15 drugs, the SC had ruled that government couldn’t use the DTAB report to prohibit them, but it could still look into the safety of those 15 drugs with a fresh investigation.
The All India Drug Action Network, a civil society group which one of the petitioners welcomed the decision saying: “ “The banned FDCs account for about Rs 2,500 crore and represent only the tip of the iceberg. In our estimate, the market for unsafe, problematic FDCs in India is at least one-fourth of the total pharma market which is valued at Rs 1.3 trillion,” it said in a statement.
During the Delhi High Court hearing in the case, the drug companies had contended that the
The government, in 2016, had banned over 300 FDC drugs on the ground that they involve "risk" to humans and safer alternatives were available. The decision was overturned by the court.
As per the March 10 notification, "On the basis of recommendations of an expert committee, the central government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of said drugs in the country."
Defending its stand, the Centre had argued that the FDC medicines are "new drugs" and thus, require licence from Drugs Controller General of India (DCGI) for sale and manufacture.
The government had also said there were no valid licences for making any of the banned FDCs and added it was difficult to implement any action at state level.
However, it had also said that the lack of approval for these FDCs were a secondary issue and the primary focus was that they "lacked safety and efficacy" and thus, "ban was the only answer".
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