India’s federal government banned the manufacture, sale and distribution of 156 fixed dose combination (FDC) drugs for a variety of conditions last week. This is the government’s second big assault on FDCs – the first ban was announced in 2016 and included 344 combinations – and the list may be expanded in future.
FDCs are cocktails of two or more active pharmaceutical ingredients formulated as a single product and contain a variety of drugs such as painkillers, antibiotics and cough syrups. Running to thousands of products, they comprise a large portion of India’s pharmaceutical market and are often characterised by lax regulation and questionable and unproven therapeutic value. However, they are highly lucrative as they escape price control mechanisms applied to federally approved drugs.
While medical experts state that there is a place for FDC’s backed by clinical trials, many remain unapproved by the government but have received approval from state governments. Health groups have criticised FDCs as ‘irrational’ drugs. A government expert committee and the Drug Technical Advisory Board recently evaluated 324 FDC’s and found many posed health risks and proposed banning them.
Efforts to reign in FDCs have had a chequered history with every ban challenged in court and orders overturned as companies find ways to escape the assault on one of their most profitable products.
‘These bans of FDCs have become routine and it is only a matter of time before new FDCs enter the market,’ says T Prashant Reddy, co-author of The Truth Pill – the Myth of Drug Regulation in India. ‘And this cycle will continue until even the new drugs are banned. The government is not tackling the core problem which is the manner in which these new FDCs are entering the market as the Drugs Controller General of India claims that state drug regulators are approving these FDCs despite lacking the power to do so.’ It may be time to tackle these approvals, he adds.
Several pharmaceutical companies launched an immediate challenge to the ban in the Delhi High Court. They are seeking to quash the government order while also receiving interim relief to exhaust all existing stocks and that no action be taken against stockists and retailers until this is achieved. The hearings will continue next week.
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