A bench of Justice R M Lodha and Justice Shiva Kirti Singh said that 157 new chemical entities which were cleared for clinical trials in December 31, 2012, would be reviewed by the two apex committees.

"It is not possible to pass any order in respect of the clinical trials of 157 new chemical entities. We are not passing any order. You will tell us the findings of the apex committee and the technical committee," the bench told Additional Solicitor General Siddarth Luthra who had appeared for the government.

Reviewing the clearance for clinical trials of 157 new chemical entities by the National Drugs Advisory Committee and the Drug Controller General of India, the court said the technical and apex committees would look into the assessment of risk versus benefits to the patients, innovation through existing therapeutic options and the unmet medical needs of the country.

The court said that the apex committee will examine whether the new chemical entities that are being put to clinical trials are actually required in the country.

In respect of five other new chemical entities for which approval has been granted for the clinical trials in 2013, the court accepted the statement of Luthra which said that appropriate directions will be issued with regard to audio visual recording of the consent of the subject participating in such trials.

The court directed that such documents in the wake of the video recording shall be preserved and the principle of confidentiality and transparency would be observed.

In the course of the arguments, senior counsel Colin Gonsales informed the court of the Aug 30 report of the Parliamentary Standing Committee which had made damning findings about the working of the office of the Drug Controller General.

He said that the Standing Committee has said that it were the invisible hands that were writing the report and were being approved by the office of the DCGI.

At this, Justice Lodha said, "We should have a balanced approach. These are the issues where you can't have one sides approach. We should allay their (of the petitioner) apprehensions reasonably. The clinical trials should help us."

Gonsalves said that the ministry of health and family welfare was using a committee headed by Ranjir Roy Chaudhury to derail the regime set up by the Standing Committee. He sought the disclosure of the 162 new chemical entities.

Assailing the position of Chaudhury, Gonsalves said that he wanted to make India a hub of clinical trials even in the phase I and Phase II in which healthy people are subjected to the testing of the new chemical entities.

The next hearing of the matter will take place December 16.


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