How and why Delhi High Court revoked ban on 344 popular drugs

Combination drugs or fixed dose combination (FDC) drugs are those with two or more active pharmaceutical ingredients combined in a fixed dose to form a single drug.

Written by Abantika Ghosh | Published:December 2, 2016 6:35 am
fixed dose combination, fdc, fdc ban, fdc case, medicine ban,  corex cough syrup, vicks action 500 extra, vicks action 500, medicine ban, india news Pharma companies argued that Centre banned drugs without following procedure prescribed in the Drugs and Cosmetics Act

On Thursday, the Delhi High Court set aside the Centre’s decision to ban 344 fixed dose combination (FDC) medicines, many of them popular drugs that have been household names for years, saying the government had acted in a “haphazard manner”. Aneesha Mathur and Abantika Ghosh explain

What are combination drugs and why were they banned?

Combination drugs or fixed dose combination (FDC) drugs are those with two or more active pharmaceutical ingredients combined in a fixed dose to form a single drug. For instance, a combination of nimesulide and paracetamol that is prescribed as an anti-pyretic (used to prevent or reduce fever). Cough syrups Phensedyl and Corex, the widely advertised Vicks Action 500, antibiotic combination Zimnic AZ are some of the popular FDCs, which involve commonly used medications such as paracetamol, aceclofenac and nimesulide. In a gazette notification issued on March 10, the Health Ministry banned 344 such combination drugs. The ban was prompted by a view long held by health experts that these drugs have dangerous side-effects and that many of these combinations do not have any advantage over the individual drugs. Eventually, the government acted on the opinion of the Kokate Committee — set up to examine these drugs — which recommended the ban.

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So why did the court set aside the ban?

Justice Rajiv Sahai Endlaw allowed 454 petitions moved by various pharma and healthcare majors such as Pfizer, Glenmark, Procter and Gamble and Cipla, who challenged the government’s ban on FDCs, saying the decision was taken by the Centre without following procedure prescribed in the Drugs and Cosmetics Act. The bench noted that the government had not consulted the Drugs Technical Advisory Board or the Drugs Consultative Committee but had acted on the advice of a ‘technical committee’, which, they said, violated the provisions of the Drugs and Cosmetics Act.

Further, it said, that under Section 26A of the Drugs Act, a drug can be banned only after the licence holder of that drug is given a three-month notice. The court also said that the “manner in which the proceedings till the issuance of the Notification have gone, does not suggest any such grave urgency (to ban the drugs)” since most of these FDCs had been available for long. On March 14, the court had stayed the Centre’s ban and now, it has struck it down.

What was the argument made by the pharma companies?

In its argument, Pfizer said that its Corex syrup had been granted approval by the Drug Controller in 1995, which implied that there was “therapeutic justification” for the ingredients, and said that a non-statutory committee could not have withdrawn the approval without even conducting tests. The pharma companies also argued that the ban order was passed without considering clinical data and termed as “absurd” the government’s claim that it took the decision to ban FDCs on the ground that safer alternatives were available.

What was the government’s defence?

The government said that the lack of approval for FDCs were a secondary issue and the primary focus was that they “lacked safety and efficacy” and thus, “ban was the only answer”. It also argued that these FDC medicines are “new drugs” and require licences from the Drugs Controller General of India (DCGI), not the state drugs licensing authorities. Further, the government argued that the technical committees did not have any role to play as Section 26A of the Act allowed the government to to take action “to its own satisfaction.” The court dismissed both the arguments.

Has the demand for a ban on FDCs been raised in the past?

Independent studies across the world have pointed out that many of these combinations do not have any advantage over the individual drugs. A study in the Indian Journal of Pharmacology in 2010 found that the “nimesulide and paracetamol combination offers no advantage over nimesulide alone or paracetamol alone, either in terms of degree of analgesia or onset of action.” There was also a parliamentary Standing Committee report that called for a “clear, transparent policy” for approving FDCs.

What happens now?

The quashing of the notification does not imply that the drugs will now be available in the market. The Centre may challenge the judgment in the Supreme Court or take the steps prescribed under the Drugs Act. Also, the Supreme Court is in the process of hearing a plea filed by the Central government to transfer all cases challenging the March 10 notification before itself — pharma companies had challenged the ban before the Delhi, Chennai and Bangalore high courts.

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  1. A
    Anjali
    Mar 5, 2017 at 9:05 am
    Well everything said and done…two appeals have been filed by an Intervener against the order of the single judge of Delhi High Court which did away with the ban. The two appeals have been filed against Pfizer- Corex and Abbott- Phensedyl cough syrups. Last hearing was 13 Feb 2017. The silence of the central government has been shocking to asy the least. Appeals are LPA 104/2017 104/2017 LPA 105/2017
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    Dhanasekaran Balasubramanian
    Dec 2, 2016 at 4:42 pm
    simply some of the western countries like united state, canada, britain, etc are banning some drugs is not a criteria to ban particular drugs in india. in western countries mostly big hospitals are being run by big companies they in order to gain more profit could have influenced their govt agencies to ban cheaper drugs.
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  3. D
    Deepak Ashok
    Dec 4, 2016 at 1:10 pm
    Most of the banned FDCs were of no use and contained anticold medicines and irrationally combined antibiotics which could be dangerous if taken without prescription (but are usually sold by Retailers over the counter). Also cough syrups like Corex contain Codiene to which many young adults get addicted and continue to buy it illegally. (Many such drugs were sold over the counter previously). I think SC decision is not right and irrational FDCs should be banned.
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  4. N
    Nanban
    Dec 2, 2016 at 7:31 pm
    seriously ?? if something is dangerous, it does not matter how it is banned ! For once when the goverment is proactive, we bring in red tape to stop it.
    Reply
  5. K
    Krish P
    Dec 4, 2016 at 1:58 pm
    This is another judicial verdict which goes against common sense just like urgent bail given to Salman Khan.lt;br/gt;Judiciary has given cause for concern by giving such verdicts in favour of rich and mighty. The simple question that needs answering here is -has any person been harmed or suffered medically due to these drugs being banned for more than 6 months now? I think the answer is a clear No. Therefore this court decision only serves to help the big pharma companies and is not for public good.
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    dr lakshmipathy
    Dec 2, 2016 at 3:31 pm
    technically not correct but the fact is FDC's are harmful
    Reply
  7. பார்த்தா
    Dec 2, 2016 at 4:13 pm
    Nimesulide was never permitted to be used in United States, Canada, Britain, Australia etc. In few countries where it was permitted such as Finland, Spain, Turkey, it has been banned due to severe side effects including deaths and liver failure needing liver transplantlt;br/gt;It is not appropriate to permit usage of Nimesulide in any combination..lt;br/gt;Corex cough syrup ( containg codeine phosphate) was misused by people as an addictive drug...it should be compulsorily banned.
    Reply
  8. S
    Shri Soni
    Dec 5, 2016 at 11:24 am
    Unfortunately,the law is slowly replaced by perception or viewpoint of corporate enies...
    Reply
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