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Clinical trials should be for Indians’ benefit: Supreme Court

New Delhi: The clinical trials of 162 new chemical entities will continue to be on the hold as Supreme Court on Monday said that the technical committee and the apex committee will examine the benefits of these trials for the country.

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 Siddharth 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 vs benefits to the patients, innovation vis-a-vis existing therapeutic options and the unmet medical needs of the country.

The court said 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 Gonsalves informed the court of the August 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-sided 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 Dr Ranjit 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 Dr 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 on December 16. [IANS]

4 Comments

  1. Dr KRJOHN Dr KRJOHN Thursday, October 31, 2013

    The clinical trial scenario in India should improve by more high quality indigenous developed studies which conforms to the needs of Indian patients. We should be driven by Indian scientists in universities with ethical principles bringing in relationship with ethical partners for Drug development. The benefits of such indigenous research should not be denied to requirements for high quality patient care.

  2. G.Saikumar G.Saikumar Sunday, October 27, 2013

    A section of private media campaigning against clinical drug trials is ridiculous. Instead of blaming DGCI for corrupt practice while granting permissions and not properly monitoring the clinical drug trials,they are finding fault with doctors for side effects and patients complaints to the press.There is a feeling among many doctors that a section of private print and electronic media wants to control clinical drug trials just as central ministry is controlling MCI through nominated members.I fully agree with the court that any drug trial conducted on Indian soil should benefit Indians also.

  3. Pavani M Pavani M Saturday, October 26, 2013

    The approvals for any work in India by the regulatory authorities are mostly influenced by the money or politicians or both.Finding fault with DGCI for approvals of clinical drug trials is unfortunate.Already regulatory authorities like MCI are under government control.What good MCI under central health ministry did for better medical education in our country is already well known.Clinical drug trials are important tools to know the safety and efficacy of new drugs being developed.A section of private media is spitting venom on those conducting clinical drug trials but does not bother about more than 1000 deaths per day due to TB or untold suffering or unrecorded deaths in rural areas by quacks who experiment humans with substandard or fake drugs.This is because government hospitals are not providing effective treatment facilities or no government action against quacks. DGCI or MCI were not punished for their wrong doings. Only the doctors are held responsible if something goes wrong during clinical drug trials.Already,some private TV channels and news papers are terrifying people by passing on bad information but the truth is that unless large scale clinical studies are conducted to bring new drugs,many people will die of disease once the bacteria become resistant to currently available drugs.

  4. Dr KRJOHN Dr KRJOHN Wednesday, October 23, 2013

    Thank you for the information about the mobile clinic form GE
    we have plans to provide point of contact care
    Kindly arrange to provide a quotation for the same
    or give me details of the email contact
    Dr KR JOHN
    Professor and Head
    Dept of community medicine
    SRM medical college

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