Thursday, May 10, 2012

Drugs Banned in West Approved in India

http://www.tribuneindia.com/2012/20120510/nation.htm#4


New Delhi, May 9
Drugs which developed countries have banned or withdrawn from markets over safety concerns are in open and brazen circulation in India.

In a damning indictment of the Health Ministry and Drug Controller General of India for compromising safety of Indians by disregarding regulatory procedures in respect of new drugs discovered outside India, the Parliamentary Standing Committee on Health has documented 42 cases where drug approvals were given in shocking violation of Drug and Cosmetic Act procedures. The committee blamed the drug manufacturers-medical experts nexus for this ill.

Between 2001 and 2010, DCGI approved 2,167 new drugs manufactured outside India for marketing in India. Of these, the committee selected 2 per cent - 42 drugs - for monitoring whether rules were followed. The Ministry said it could not produce documentation for three controversial, banned drugs which the West never allowed marketing permission. Pefloxacin, Iomefloxacin and Sparofloxacin were barred from marketing in the US, UK, Canada, Australia and developed nations; developing nations discontinued their marketing later on.

In India, these drugs are on sale. When questioned, the DCGI said their files were “untraceable”. “These drugs were approved on different dates. We doubt if their disappearances were accidental,” the committee said in its report to Parliament.

Of the 39 drugs whose documentations are available, 13 in sale in India don’t have marketing permission in the West. None of these drugs (among them buxlizine, an appetite stimulant; nimuselid injection; Dozoflylline; Foxed Dose Combination of Pregabalin with other agents; FDC of Ofloxacin with Ornodazole -have no relevance to India.

In case of 11 drugs — 28 pc (Everolimus made by Novartis; Colistimethate made by Cipla; Exemestane of Pharmacia; Ademetionine of Akums) — mandatory Phase III clinical trials were never done. In two drugs, trials were conducted patients less than 100 as mandated under rules.
In case of 25 drugs (64 per cent), opinion of medically qualified experts was not obtained before approval and in case of 14 drugs, only three experts were consulted as against the practice in the West of consulting several experts. The US Food and Drug Administration Office constituted a panel of 37 experts to review the dose of popular pain killer paracetamol.

The committee noted 33 new drugs were approved between January 2008 and October 2010 without conducting India-specific trials though these drugs were tried in other countries. “Health Secretary says in cases where foreign drugs were approved without clinical trials in India, most drugs were approved in other nations after multinational clinical trials and were in public interest. This remark is not accompanied by scientific evidence,” the committee said. It said none of these 33 drugs belonged to category of emergency treatments such as bird flu or swine flu and can’t be justified to be in public interest.
DRUG CONTROLLER ELIGIBILTY: B PHARMA!In the US, Chief of FDA, the drug regulator, is a top public health professional who was, in 1997, called in by the then US President to serve as Assistant Secretary in the US Department of Health. The present incumbent is an experienced medical doctor and scientist. But in India, the Drug Controller General’s minimum prescribed qualification is B Pharma. “We fail to understand how a B Pharma is being equated to an MD in Pharmacology or Microbiology. Considering pharma industry is growing at an annual rate of 10 per cent, qualifications of DCGI need urgent revision to bring in people who have clinical or research experience on drugs that super-specialists can prescribe,” the panel said. The DCGI is, on an average, granting one drug approval a month.

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