Central Drugs Standard Control Organisation (CDSCO) will not review or recall the 33 controversial drugs which were reportedly cleared without clinical trials on Indian patients during the period of January 2008 to October 2010.
The regulatory authorities are of the view that all approvals given by the competent authority so far were 'in order' and there was no need to re-examine the approvals given or recall any particular drug from the market on the grounds of errors in approval process, highly placed sources confirmed.
Hence, there will be no action with regard to the 33 controversial drugs as of now, unless there would be specific instruction from the higher authorities, namely the Health Ministry, to do so. “As far as we are concerned, there is no need for review now as we found them to be completely in order,” sources said.
There was mounting pressure from the public interest groups and others on taking action against the controversial drugs in the wake of the Parliamentary Standing Committee on Health submitting a report claiming that these drugs were approved without proper trials on Indian patients.
The authorities do not want to make a precedent by re-examining the approvals given by the past Drug Controllers and court fresh controversies, as the matter was still under review by a high-level panel set up by the Health Ministry which has to submit an action taken report to the Parliamentary panel as per the stipulations.
As per existing rules, a new drug licence is valid for four years since the approval and the CDSCO will consider the cases of these drugs only when the applications come up again for renewal, unless stirred by the Ministry to take any measures before.
The expert committee, comprising Dr V M Katoch, secretary and DG, ICMR, Dr P N Tandon, president, National Brain Research Centre, Department of Biotechnology, Manesar and Dr S S Aggarwal, former director, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, has been asked to examine the validity of the scientific and statutory basis adopted for approval of new drugs without clinical trials, outline appropriate measures to bring about systemic improvements in the processing and grant of statutory approvals and suggest steps to institutionalise improvements in other procedural aspects of functioning of the CDSCO. The Committee has been asked to submit its report within a period of two months. Further action would be taken based on the report of the panel.
The drugs in question include everolimus by Novartis, colistimethate by Cipla, exemestane by Pharmacia, buclizine by UCB, pemetrexid by Eli Lilly, aliskiren by Novartis, pentosan by West Coast, ambrisentan by GlaxoSmithKline, ademetionine by Akums, pirfenidone by Cipla, and FDC of Pregabalin, ethylcobolamine, Alpha Lipoic Acid, pyridoxine and folic acid by Theon, dronedarone of Sanofi, aliskiran of Novartis, irsogladine of Macleods, everolimus of Novartis, pemetexid of Eli Lilly and FDC of Pregabalin with other agents.