Delhi HC quashes ban on 344 fixed dose combination medicines

The drug companies had contended that the government has not properly implemented the powers under section 26A, under which the ban was ordered.

By: PTI | New Delhi | Published:December 1, 2016 12:17 pm
fixed dose combination, fdc, fdc ban, fdc case, medicine ban,  Corex cough syrup, Vicks Action 500 extra, Vicks Action 500, medicine ban, india news The court had from March 14 onwards stayed the operation of the Centre’s decision with regard to medicines of several pharma majors. (Source: File)

In a blow to the Centre, its decision to ban 344 fixed dose combination (FDC) medicines, including well known brands like Corex cough syrup, Vicks Action 500 extra and several anti-diabetes medication, was on Thursday set aside by the Delhi High Court which said the step was taken in a “haphazard manner”. Justice Rajiv Sahai Endlaw allowed 454 petitions moved by various pharma and healthcare majors, like Pfizer, Glenmark, Procter and Gamble and Cipla, challenging the government’s March 10 notification banning the FDCs, saying the decision was taken by the Centre without following procedure prescribed in the Drugs and Cosmetics Act.

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The court had from March 14 onwards stayed the operation of the Centre’s decision with regard to medicines of several pharma majors. The court on Thursday said that proceedings till issuance of the notification of March 10, 2016, “do not suggest there was any grave urgency”.

It also said that the power under section 26A (power to prohibit manufacture of drugs and cosmetics in public interest) of Drugs and Cosmetics Act cannot be exercised in public interest except when a drug poses a risk to consumers. During the hearing in the case, the drug companies had contended that the government has not properly implemented the powers under section 26A, under which the ban was ordered.

They had also argued that the ban order was passed without considering clinical data and had termed as “absurd” the government’s claim that it took the decision to ban FDCs on the ground that safer alternatives were available.

The government had banned over 300 FDC drugs on the ground that they involve “risk” to humans and safer alternatives were available. As per the March 10 notification, “On the basis of recommendations of an expert committee, the central government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of said drugs in the country.”

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  1. A
    Abhishek
    Dec 1, 2016 at 8:22 am
    Banning anything must be a last resort. Its haphazard use creates a poor business environment. lt;br/gt;WHile one cannot doubt that fixed dose combinations can be dubious. Many of such combinations are not allowed in most of the advanced countries. However, sufficient notice must be given and a clear standard operating procedure must be established to tackle such cases.
    Reply
  2. H
    Harsh
    Dec 1, 2016 at 12:25 pm
    Sufficient notice to whom? Most pharma companies are aware of the impact of their medicines on human body, and continue to peddle them in countries like ours, despite being banned in Developed countries. The judge has probably just gone on technical grounds of the section while not considering the overall impact on human poce.
    Reply
  3. R
    raj kishore
    Dec 1, 2016 at 1:59 pm
    IN INDIA THE COMBINATION OF DRUGS ARE ON ,WHERE IN US IS NOT LIKE INDIA COMBINATION THE DRUG PRICE IS REDUCED,THERE FORE,ANY INCOMBITABLE OF DRUGS ARE AVAILABLE IN INDIA.IF IT IS NECESSARY OF TWO OR THREE DRUGS ARE REQUIRED ,EVERY DRUG IS GIVEN SEPARATELY.NO INTEREACTION OF DRUGS IS THERE.THANKS.
    Reply
  4. V
    vs
    Dec 1, 2016 at 10:38 am
    Is the govt. running the country or the courts?
    Reply
  5. G
    Guptan Veemboor
    Dec 1, 2016 at 12:40 pm
    I fail to understand why it was banned at all? Doctors must be prescribing these medicines knowing about it.
    Reply
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