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Govt bracing up to avert shut-down of clinical trials sector following SC order

Joseph Alexander, New Delhi
Monday, October 7, 2013, 08:00 Hrs  [IST]

With the ban by the Supreme Court on all clinical trials is looming, the Government will bank on the recommendations by Prof Ranjit Roy Choudhury committee and the new Drugs and Cosmetic (Amendment) Bill, 2013 to avert the disastrous shut-down of clinical trial industry.

Spurred by the recent strictures by the Supreme Court to stay approvals of 162 trial applications, the Health Ministry is learnt to have taken stock of the situation 'with utmost seriousness' and is planning to convince the court about the mechanism in place to monitor the trials. However, the authorities sounded optimistic that no harsh steps would come from the court.

Sources said the Ministry also held initial consultations with concerned officials to chalk out the strategy before the court when the case would come up after two weeks. The Government is planning to draw up the details of the existing mechanism and ongoing efforts like the new bill and the expert panels to plug the loop-holes. It is also learnt that the Government would place before the court a comprehensive plan to implement the recommendations by the expert panel headed by Prof Choudhury.

“There are sufficient provisions and systems to ensure quality of trials and safety of subjects in the country. Onus on the Government is now to convey these things to the Court,” a senior official observed.

The court, while hearing the case filed by Swasthya Adhikar Manch, in fact wanted to pass a written order to ban the clinical trials. But, the court then allowed two weeks for the government to appraise the safety mechanism in place for monitoring trials with regard to new drugs and chemical entities.

The new bill, now under the scrutiny of the Parliamentary panel, has a separate chapter on clinical trials to put all the existing guidelines and instructions from the Drug Controller General of India under the framework of law. It has comprehensive provisions to monitor the trials and also deciding compensations to the victims.

The expert panel headed by Prof Chaudhury has recommended several changes including creation of a Central Accreditation Council to oversee the accreditation of institutes, clinical investigators and institute ethics committees for clinical trials in the country. It also suggested that trials should be carried out only at centres which have accreditation.

Already there are allegations that the approvals to the clinical trials are coming hard and slow, affecting the overall performance of the clinical trials sector which still is viewed as a highly potential area for India. Besides, the slew of legislations and guidelines has already stopped many prominent overseas CROs to suspend trials in the country. Hence the government is fully aware of the implications of the SC order and gravity of the situation.


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