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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