Government forms panel to probe drug regulator

Parliamentary Standing Committee report pointed out serious irregularities and serious lapses in clearing new drugs in the grant of approval to new drugs without conducting clinical trials in India

New Delhi: Taking serious note of a Parliamentary Standing Committee report on functioning of Central Drugs Standard Control Organisation (CDSCO), Health and Family Welfare Minister Ghulam Nabi Azad on Friday constituted a panel of experts to look into irregularities in passing new drugs, reports PTI.

The three-member Committee of experts comprising Director General ICMR VM Katoch, President of National Brain Research Centre, Department of Biotechnology, Manesar PN Tandon and former Director of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, SS Aggarwal, has been asked to submit its report within two months.

The Committee has been asked to examine the validity of the scientific and statutory basis adopted for approval of new drugs without conducting clinical trials, outline appropriate measures to bring about systemic improvements in processing and grant of statutory approvals and suggest steps to institutionalise improvements in other procedural aspects of functioning of the CDSCO.

The report has pointed out serious irregularities and serious lapses in clearing new drugs in the grant of approval to new drugs without conducting clinical trials in India.

It also pointed out to a collusive nexus between drug manufacturers, officials of Drugs Control Organisation and medical experts in granting approvals to new drugs and said drugs banned, discarded or withdrawn in developed countries are in circulation in India.

The Parliamentary Standing Committee Report has made recommendations and observations on various aspects such as organisational structure and strength of CDSCO, approval of new drugs, banning of drugs, approval of fixed dose combinations, pharmacovigilance and spurious/sub-standard drugs.

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SC directs CBI probe against BS Yeddyurappa in illegal mining case

The apex court accepted the CEC report, which had pointed out several allegations against Mr Yeddyurappa and corporate entities involving Jindals and Adanis and had recomended a CBI probe

New Delhi: In a setback to Karnataka's former Chief Minister BS Yeddyurappa, the Supreme Court on Friday directed a CBI probe against him for allegedly granting undue favours to firms involved in illegal mining in lieu of donations to a charitable trust run by his kin, reports PTI.

A Special Forest bench headed by Chief Justice SH Kapadia directed the probe agency to carry out the probe uninfluenced by the stature of the person and political clout and corporates involved in the case and file its report by 3rd August.

The bench, also comprising justices Aftab Alam and Swatanter Kumar, stayed all pending proceedings before all judicial forums in connection with the case.

The apex court accepted the 20th April report of the Central Empowered Committee (CEC) which had pointed out several allegations against Mr Yeddyurappa and corporate entities involving Jindals and Adanis and had recomended a CBI probe.

The court also asked the Andhra Pradesh government to cooperate with the CBI in the investigation.

The 20th April report prepared by the CEC in pursuance of the apex court's 10th February order, said there was a scope for expanding the CBI probe against the BJP leader and annexed the documents to support its findings.

The CEC had recommended CBI probe considering the "massive illegalities and illegal mining" found in Karnataka and allegations against the Jindal Group as being "recipient of large quantities of illegally mined material and undue favour being shown to them".

Mr Yeddyurappa's counsel and senior advocate V Giri had earlier argued that merely on the basis of the CEC report, the probe cannot be handed over to the CBI as the Lokayukta police was seized of the matter and the former chief minister had got a relief from the Karnataka High Court against which an appeal is pending before the apex court.

The CEC recommendation for the CBI probe was also opposed by JSW Steel Ltd on the ground that the matter was pending with the state's law enforcing agencies.

The court had earlier this month asked Yeddyurappa to place before it all relevant evidential material along with a note to counter the CEC documents, which "prima facie made out a case for investigation" against him and his kin for alleged "irregularities" and "illegalities" in the mining activities.

The CEC report had found evidence of huge payment made to the trust run by Yeddyurappa's sons and his family received "windfall profits" in land deals in Bangalore involving big mining companies including those of Jindals and Adanis.

The report said during March 2010, Prerana Education Society, "set up by the close relatives of the then chief minister, Karnataka" received donations of Rs10 crore from South West Mining Ltd, a Jindal Group company, despite reporting its own profit for FY10 at only Rs5.73 crore.

"In this context it is of interest to note that during the year 2009-2010 the net profit (after tax) of the said company was only Rs5.73 crore," the report had said, adding such a large donation were not made by the company or by any other Jindal group firm to any other trust or society, not owned, managed or controlled by the Jindal Group.

The report said a Bangalore land deal involved "serious violations of relevant acts and procedural lapses and prima facie misuse of office by the then chief minister, Karnataka thereby enabling his close relatives to make windfall profits and raises grave issues relating to undue favour, ethics and morality".

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