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LATEST NEWS UPDATES | House panel: Government clearing harmful drugs -Rupali Mukherjee

House panel: Government clearing harmful drugs -Rupali Mukherjee

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published Published on Apr 27, 2013   modified Modified on Apr 27, 2013
-The Times of India


MUMBAI: You could be popping certain pills and combinations that are illegally approved, harmful, cleared without proper clinical trials or even banned in the US and other countries. Delivering a severe rap on the government's knuckles, a parliamentary standing committee on health has charged it with "dilly-dallying and procrastination'' over serious irregularities in approval of life-saving medicines, not following the global ban on harmful drugs, and failing to stop the marketing of 33 drugs which were approved without clinical trials. The ministry failed to issue orders to stop the marketing of these 33 drugs even after a span of seven months of the matter coming to light, and in most cases it failed to take any decisive action in the interest of patients, the committee said in its 66th report tabled in the Rajya Sabha on Friday.

Hitting out at the appointment of a plethora of committees to stall decisions, it also pointed to the ministry's "collusion with the intention to save the guilty''. The committee asked the government "to follow global best practice in at least two burning cases-analgin and buclizine".

In a rebuttal of the action taken by the government on the functioning of the Central Drugs Standard Control Organization ( CDSCO)-which approves all drugs in the country-based on the recommendations of the 59th parliamentary report submitted in May last year, the committee has said the ministry should "apply, albeit belatedly, this global best practice immediately in two burning cases-analgin and buclizine".

The government, in its action taken report submitted in December last year, had said that it would suspend marketing approval of all drugs prohibited for sale in other countries like the US, the UK and Australia besides the EU. The committee noted in the report that "the continued marketing of analgin, discarded the world over, is a matter of grave concern" and putting analgin under so-called "focused pharmacovigilance'' is nothing but a diversionary tactic.

Also, in another drug, buclizine, administered to children as an appetite improver, the report says that ministry has "failed to act on a proven case of gross illegality'' by referring it to a review committee. It asked the government to review the approval given on the drug. In the case of letrozole (innovator Novartis) too, the committee said that the ministry has failed to take action in this very open-and-shut case of impropriety and criminal lapse.

The 66th report reviews the action taken by the government on the 59th report tabled last year in May on the functioning of the drug controller's office in the health ministry.

In the case of 39 drugs approved without clinical trials and certain harmful fixed dose combinations, the committee has dismissed the government's reply, questioning why even after several months, these drugs continue to be marketed with impunity. It says "this inaction has led to unhindered marketing of these drugs with unknown and unspecified risks to unsuspecting people".

In the case of 33-odd new drugs approved between 2008 and 2010 without conducting clinical trials on Indian patients, the committee said nothing concrete has been done even after a lapse of more than seven months, and the government plans to refer it to yet another committee.

However, the committee has appreciated the government's efforts in examining applications for new drugs including fixed dose combinations.


The Times of India, 27 April, 2013, http://timesofindia.indiatimes.com/india/House-panel-Government-clearing-harmful-drugs/articleshow/19749593.cms


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