HC sets aside Centre’s ban on 344 FDCs, terms it haphazard

The Centre’s ban of 344 fixed dose combination (FDC) drugs, including well-known brands like Corex cough syrup and Vicks Action 500 extra, was dealt a blow by the Delhi High Court when it today set aside the decision, saying it was taken in a “haphazard manner” without consulting statutory bodies as mandated under the law.
Justice Rajiv Sahai Endlaw said that section 26A of Drugs and Cosmetics Act which provides the power to stop manufacture of drugs and cosmetics in public interest, does not vest the central government with “carte blanche” to regulate, restrict or prohibit the manufacture, sale or distribution of a drug.
The court said the “power of regulation, restriction or prohibition under section 26A cannot be exercised in public interest, for any reason other than the drug posing a risk to consumers thereof or having no therapeutic value or no therapeutic justification” and added that these aspects have to be considered by DTAB and DCC which was not done.
It said that the March 10, 2016 decision banning the 344 FDCs was issued based on the recommendations of the Kokate Committee and without consulting the Drugs Technical Advisory Board (DTAB), Drugs Consultative Committee (DCC) or Central Drugs Laboratory which were bodies set up under the Drugs and Cosmetics Act.
The judge said that from the facts in the 454 petitions moved by pharma majors, like Pfizer, Glenmark, Procter and Gamble and Cipla, it has emerged “there was a total exclusion of DTAB, DCC and Central Drugs Laboratory and which in my view cannot be permitted”.
The court said, “If the law requires the government to exercise its power after taking advice from and in consultation with the statutory bodies created thereunder i.e.
the DTAB and DCC, the exercise of power without such advice and consultation cannot be upheld even if exercised bona fide and in consultation with and on advice of other experts who may be as competent as the DTAB and DCC.
“The maxim, what is prescribed to be done in a particular way must be done in that way and no other way, would apply,” it said.
“Thus, the exercise of power by the central government in issuing the impugned notification is held to be not in consonance with the provisions of the Drugs Act. The petitions have to succeed on this ground,” the court said while allowing the 454 pleas. (More