The Parliamentary Standing Committee on health & family welfare has brought out last week a highly damaging report on the working of India’s apex drug control authority, Central Drug Standard Control Organization. The conclusion of the committee’s report is that there exists a collusive nexus between medical experts, pharmaceutical companies and the CDSCO officials while approving drugs for marketing in the country. The report points to the murky deals between the pharmaceutical companies and the regulatory officials in getting approved the dangerous chemicals as drugs in India. The Parliamentary panel sought details for 42 drugs approved for marketing by the office of the Drug Controller General of India in recent years. Of these drugs, 11 were found to have been approved without phase-III trials. CDSCO also approved 33 new drugs (including Cipla Ltd’s colistimethate and pirfenidone, Novartis Pharmaceuticals’s aliskiren and GlaxoSmithKline’s ambrisentan) between January 2008 and October 2010 without conducting any clinical trials. In many of these cases, no opinion was sought from medical experts, a statutory requirement. The Panel found that four drugs were approved by non-medical staff of CDSCO without the mandatory clinical trials or opinion from medical experts. It is really strange that country's health minister and top officials in the ministry were totally unaware of these illegal practices for such a long time.
Soon after the Parliamentary Panel’s report appeared in all national dailies, the Union health ministry constituted a committee to suggest measures to improve the functioning of the office of CDSCO and DCGI. The three-member committee includes V.M. Katoch, director general of the Indian Council of Medical Research, P.N. Tandon, president of the National Brain Research Centre and S.S. Aggarwal, former director of the Sanjay Gandhi Postgraduate Institute of Medical Sciences in Lucknow. This panel is also expected to look into specific cases against medical experts and suggest actions to be taken by the Medical Council of India. Many members of the medical community are guilty for endorsing the pharmaceutical companies' views of drugs without conforming to procedures. Now, the fact is that many drugs without assessing their safety and efficacy are already there in the market and people are taking them. It is quite difficult to gauge how many people might have already injured and suffering due to intake of such untested drugs. One immediate remedial action the government should take is to recall all those drugs approved without the due process of regulatory clearance. That needs to be done immediately so that at least further damage to the health of the patients can be contained. Stringent actions against the companies, medical experts and officials involved in this racket have also to be taken without delay.