Govt allows existing stock of 14 banned fixed-dose combination drugs to be sold after HC order

Delhi High Court accepted pharma companies’ argument that most banned drugs had been in use for over 30 years and said health ministry had not specified reasons behind ban issued in June.

A Delhi High Court order has forced the central government to modify a notification issued in June this year that banned the manufacture and sale of 14 fixed-dose combination (FDC) drugs over lack of “therapeutic justification”.

In the revised government notification issued last month, drugmakers have been allowed to exhaust their existing stock that was in the distribution network when the Union health ministry issued the 2 June gazette notification banning the FDC drugs. The June order was issued on the recommendations of an expert committee.

ThePrint has seen a copy of the modified notification.

FDC drugs are those 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 banned in the notification included many medicines used for treating cough, common infections, fever and body ache, and had combinations such as nimesulide and paracetamol dispersible tablets, chlorpheniramine and codeine syrup, and salbutamol and bromhexine, among others.

Following the 2 June government notification, a number of pharmaceutical companies, including Lupin, Glenmark, Cipla and Intas, filed petitions in the Delhi High Court the same month, seeking an order or direction to set aside the ban.

The HC, in its final order delivered in the matter in July, said the health ministry notification “only states that the FDC (drugs) may involve risk in human beings without specifying the reasons/extent and the nature”.

“In addition, the FDC (drugs) have been in the market since 1988,” it added.

The court further directed that the FDC drugs “which are already in the distribution channel shall not be withdrawn”.

A senior health ministry official told ThePrint last week: “We are now allowing pharma companies to sell their existing stock of the banned FDC drugs in the wake of the latest court order.”

“It may take months, in some cases even more than a year, before the banned FDC drugs go out of the market,” the official added.

A pharmaceutical expert who has been fighting 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, may continue to be used, was not scientific.

“The answer to this argument is that the absence of evidence of harm is not evidence of absence of harm,” the expert, who did not wish to be named, 

“The fact is we simply did not have a system of pharmacovigilance 30 years ago and could not show how the drugs do harm,” he added.