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Pills and shills

Drug regulation is a mess. Everyone who propped up this irresponsible system is to blame

Written by The Indian Express | Published: May 21, 2012 3:12:25 am

Drug regulation is a mess. Everyone who propped up this irresponsible system is to blame

Last week,a parliamentary standing committee on health delivered a thoroughly damaging report on the state of drug regulation in India,and the collusion between the regulator,industry and the medical profession that puts patients last. Over 118 pages,it said that the Drug Controller General of India (DCGI) and the Drug Standards Control Organisation (DSCO) have betrayed their regulatory responsibility in the manner in which they granted approvals. Now,several senior doctors,rebuked for letting their connections with pharmaceutical companies affect their drug endorsements,beg to differ. According to them,regulation is not their problem,and doctors’ opinions are irrelevant to the introduction of drugs in the Indian market.

Except not. The committee found that many drugs were being marketed before they had been put through the required clinical trials (Novartis’s Everolimus,Eli Lilly’s Pemetexid,for instance),and several drugs banned in other markets were bought and sold here. The law mandates that any new drug introduced in India must be put through local Phase 3 clinical trials,on at least 100 people. Instead,using a “public interest” escape route,the DSCO had waived the clinical trial requirement without being able to back up its decisions. Regulatory dossiers were missing for several drugs,and in many cases,approvals were granted by non-technical staff. When expert opinion was consulted,it was seemingly dictated by what the report calls the “invisible hand” of pharma companies,sometimes the testimonials echoing each other word-for-word. In one case,with Thermis Medicare Ltd,the regulator asked the company to select its own experts,and bring their opinion to it. To be fair,there are reasons for this sloppiness — while the pharma industry is exploding,and the DSCO’s workload is growing by 20 per cent every year,it lacks the staff and infrastructure,advisers and independent testing labs to do its job.

This is not a moment to blame each other. Doctors have been part of this corrupt edifice,along with companies and regulatory officials. Medicines,after all,are an area where consumers are not equipped to make informed decisions. They rely on those who know better to look out for their interests. And they have been sorely let down.

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