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.

In its 82-page verdict, the court said no power has been
vested with the government under the Drugs Act to choose not to consult DTAB, DCC and Central Drugs Laboratory.
"Even otherwise it defies logic as to why would the central government, when has available to it the machinery (DTAB and DCC) provided under the Drugs Act itself to discharge the functions of a technical nature under section 26A, would, instead of using the said machinery choose to follow another course of action," it said.

The court also noted that while in these proceedings the Centre contended that before issuing the notification under section 26A it was not required to consult the DTAB, it has itself been in the past seeking the advice of DTAB.
"Such inconsistent stand is not understandable," it said.
"To say the least, the central government, though acting in public interest, seems to have gone about it in a haphazard manner. It claims the FDCs, for manufacture of which licences were issued by state licensing authorities between September, 1988 and 1st October, 2012 without the same having approval of the Drugs Controller, were wrongly granted such licences.

"However, instead of taking action for cancellation of said licences, the manufactures were asked to apply for licences to the Drugs Controller, while continuing to manufacture the drugs for which according to the central government licence was wrongly given," it said.
The court had on March 14 stayed the operation of the Centre's decision with regard to medicines of several pharma majors.
The government had banned the 344 FDC drugs on the ground that they involve "risk" to humans and safer alternatives were available.
It had also said that the banned FDCs had no "therapeutic justification".
Some of the well-known medicines on which the ban on sale has been lifted include Pfizer's Corex cough syrup, Glaxo's Piriton expectorant and Crocin Cold, P&G's Vicks Action 500 extra, Reckitt's D'Cold, Piramal's Saridon, Glenmark's Ascoril and Alex cough syrups, Abbott's Phensedyl cough syrup and Alembic's Glycodin cough syrup.