A few decades in the wilderness separated pain-killer analgin and diabetes drug pioglitazone when the Health ministry decided to ban the two last month. Analgin had been anathema in a long list of western nations for years 36 to be precise in the US. The only EU country to have banned pioglitazone,on the other hand,was France,three years back. It is also banned in Tunisia.
The stories of these two drugs are a telltale testament of Indias drug regulatory structure patchy at the best of times and prone to complete collapse when whatever system there is,is subverted. The decision to suspend marketing of pioglitazone was not routed via the Drug Technical Advisory Board,which,incidentally,will now take a call on the revocation of that decision.
On the other hand,the bans on analgin and anti-depressant deanxit are widely perceived to have been a fallout of strident and persistent criticism from the Parliamentary Standing Committee on Health. DTAB in its meeting in July last year had recommended focussed pharmacovigilance on analgin and other painkillers.
That in a way strikes at the core fallacy of drug regulation in India the almost complete lack of post marketing surveillance data and a mandatory format of stakeholders consultations that allows the Health ministry to rely on opinions of individual doctors to take decisions affecting an estimated 30 lakh patients. An expert committee is consulted only when the decision in flayed in almost all quarters.
It is also because we do not or cannot monitor drug effects once they have been licensed that the regulatory establishment recently decided that all drugs banned in countries with a robust regulatory system,namely,the US,the UK,Canada,Australia,Japan and the European Union would be automatically suspended in India till their safety has been established.
Nothing wrong with the decision per se,but as the pioglitazone misadventure has proved,subjective picking of countries and absence of a cogent policy on issues like whether a ban in one country is enough for a relook may not augur well for the future. How for one will safety be ascertained without a foolproof system for reporting adverse drug reactions?
The greatest pitfall in purely copycat regulation that the pioglitazone decision appears to have been,though,is this: What will the government do if it rescinds the decision now and then a couple of the model countries ban it in the next few years?
Abantika is an Assistant Editor based in Delhi
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