New Delhi: A Delhi High Court order has compelled the central government to revise a notification issued in June of this year which prohibited the production and sale of 14 fixed-dose combination (FDC) drugs due to lack of “therapeutic justification.”
In the modified government notification issued last month, drug manufacturers have been given permission to deplete their existing stock that was already in the distribution network at the time the Union health ministry issued the ban on the FDC drugs in the June gazette notification. The original ban was implemented based on the recommendations of an expert committee.
ThePrint has obtained a copy of the revised notification.
FDC drugs are medications that contain a combination of two or more active pharmaceutical ingredients (APIs) in a single form, usually manufactured in a fixed ratio (the molecules in a particular ratio).
The drugs that were banned in the notification included numerous medicines used for treating cough, common infections, fever, and body ache. These drugs contained combinations such as nimesulide and paracetamol dispersible tablets, chlorpheniramine and codeine syrup, and salbutamol and bromhexine, among others.
After the government issued the ban on FDC drugs in the June notification, several pharmaceutical companies, including Lupin, Glenmark, Cipla, and Intas, filed petitions in the Delhi High Court that same month, seeking to overturn the ban.
In its final order delivered in July, the High Court stated that the health ministry notification “merely states that the FDC drugs may involve risk in human beings without specifying the reasons/extent and the nature.”
“Additionally, the FDC drugs have been on the market since 1988,” it added.
The court also directed that the FDC drugs “which are already in the distribution channel shall not be withdrawn.”
A senior health ministry official informed ThePrint last week: “We are now allowing pharmaceutical companies to sell their existing stock of the banned FDC drugs in light of the recent court order.”
“It may take months, and in some cases even more than a year, before the banned FDC drugs are phased out of the market,” the official added.
A pharmaceutical expert who has been advocating against the “irrational use” of FDC drugs pointed out that the argument that these drugs have been in use for nearly 30 years and, therefore, should continue to be used, was not scientifically valid.
“The response to this argument is that the absence of evidence of harm is not evidence of the absence of harm,” stated the expert, who preferred to remain anonymous, in an interview with ThePrint.
“The fact is that we simply did not have a pharmacovigilance system 30 years ago and could not demonstrate how these drugs cause harm,” the expert added.
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344 drug combinations were initially banned in 2016
The 14 banned FDC drugs were part of 344 drug combinations that were initially banned in 2016 by the central government after an expert panel, established by the Supreme Court, declared them “irrational” and found that they were marketed to patients without scientific data proving their efficacy and safety.
The 2016 ban followed a case filed in the Supreme Court by the All India Drug Action Network (AIDAN), an independent network of multiple NGOs working to enhance access and promote the rational use of essential medicines.
AIDAN stated that all pharmaceutical companies in India are required to obtain marketing approval from the Central Drugs Standard Control Organisation (CDSCO) — which necessitates providing a therapeutic justification for a drug — before obtaining a manufacturing license from state drug administrations.
For FDC drugs, however, the companies had obtained a manufacturing license from state authorities without acquiring a marketing license from the CDSCO, according to AIDAN.
The government’s 2016 ban notification was challenged in the Delhi High Court by some pharmaceutical companies regarding 15 drugs. The companies argued that these drugs were launched prior to 1988 when the rule mandating marketing approval by the CDSCO for every drug came into effect.
The court then directed the health ministry to establish a committee to examine the case of these 15 drugs.
Fourteen out of the 15 drugs on the list were banned in the June notification based on the committee’s recommendations.
(Edited by Nida Fatima Siddiqui)
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