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Dispute between government regulation, high court rulings, and medical associations

Earlier this year the Indian government placed a ban on the prescribing of 344 fixed combination drugs. Deemed “irrational” or “unsafe”, these combinations were ruled to be potentially harmful. Some of these were simple over the counter products; others were available only by prescription.

The High Court of Delhi has overturned this ruling, on  the grounds that the government did not seek the advice of statutory bodies under the Drugs and Cosmetics Act before its ruling in March.

Many of these combinations may not be harmful in any way, but the necessity of them is under debate. Some, such as the fixed combination of paracetamol, codeine and caffeine, are available in many other countries and are a standard over the counter drug combination. Others are simply varying combinations of painkillers and anti-inflammatories.  

This is simply a supply and demand situation. Many combinations banned were commonly marketed by international medical brands. Medications such as cough syrups, Phensedyl, Corex and the widely advertised Vicks Action 500 were banned. It is little wonder then that 454 petitions were made by large companies such as Pfizer and Procter and Gamble to reverse the ban.

Certain procedures were ignored during the ban, such as the usual three months’ notice given to the license holder of the drug, or the expected consultations with expert panels. It is these missteps that the Court has used to overturn  the ban. In defence of the government’s position, however, numerous banned combinations have no real clinical benefit over using each medical compound alone rather than in combination.

Since the reversal of the ban, the Indian Medical Association (IMA) has suggested compiling its own list of combination medicines that could potentially be unsafe, or simply too inefficient to warrant prescribing over singular medications. The Association has a membership count of over 2 Lakh (200,000) doctors. This list would apply to the medications prescribed by all members of the organisation so it is well within reason that this suggestion would have the political sway to be made official law. A recommendation by the IMA would have the legitimacy of being the medical opinion of a professional body in the field.

Issues like this, in which bureaucracy sees medications banned, legalised, and then potentially banned again in the following months, perfectly illustrate one of the major issues of decisions made without consultation of relevant experts. In the coming months we may see a revised list published by the IMA, whether there are differences between this and the current list are yet to be established.

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