Last Updated on July 22, 2023 by The Health Master
Differing from the Delhi high court, the Gujarat high court refused to grant relief to a pharmaceuticals company which has challenged the central government’s prohibition of 14 fixed dose combinations (FDCs) last month by declaring them “harmful for human use”.
On June 2, on the recommendations of the expert committee and the drugs technical advisory board (DTAB), the Centre prohibited the manufacture, sale and distribution for human use of 14 FDCs including nimesulide + paracetamol dispersible tablets and chlorpheniramine maleate + codeine syrup.
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The prohibition on these drugs combinations was imposed on the ground that “there is no therapeutic justification for the ingredients contained in these FDCs and the FDCs may involve risk to human beings”.
The government imposed a prohibition on the FDCs under Section 26A of the Drugs and Cosmetics Act, 1940, in the larger public interest.
A pharma company, Comed Chemicals Ltd, moved the high court seeking its intervention in the order. It cited an order passed by the Delhi High Court before which a pharma company had challenged the June 2 notification.
The company got interim relief that its FDC product — chlorpheniramine maleate + codeine syrup — sold under three different brand names need not be withdrawn if it is already in the distribution channel, and no coercive actions should be taken against the company for stock already out for sale.
However, the Delhi High Court stayed further production of the drug till the next hearing.
Comed Chemicals also requested the Gujarat High Court to grant relief in line with the order passed by the Delhi High Court.
After a preliminary hearing, Justice V D Nanavati issued notice to the authorities seeking a reply by July 27.
However, the High Court refused the interim relief saying that once the drugs have been declared dangerous, the court cannot permit their use.
It said that the Delhi High Court’s order is an interim order, and it cannot be treated as a precedent.
In refusing to grant a stay, the High Court said, “The balance of convenience, in the opinion of this Court, is not in favour of the petitioner herein once the impugned notification has declared that the use of the product manufactured by the petitioner is harmful for human use and the same may result in health hazard, if such relief is granted.”
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