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Supreme Court seeks firm set-up to regulate new drugs’ clinical trials

New Delhi: The Supreme Court on Friday asked the central government to discuss with states all facets of a legal framework to regulate and monitor clinical trials of new drugs by foreign firms across India.

A bench of Justice R M Lodha and Justice Madan B Lokur also asked petitioner Swasthya Adhikar Manch, the National Human Rights Commission (NHRC), NGOs and other organisations to submit their suggestions for strengthening the legal regime to regulate clinical trials so as to minimise the harm to the patients upon whom the new drugs were being tested.

The court asked the union health secretary to call a meeting of the chief secretaries/health secretaries of the states and union territories and report to it on the outcome as it directed the next hearing on September 24.

The court’s order came on a public interest litigation by Swasthya Adhikar Manch of Indore and others who sought a halt to “unethical” clinical trials by multinational drug companies of their new products in India and treating of Indian patients as guinea pigs.

Complimenting the NGO and others for focusing on the issue, Justice Lodha said: “Your efforts have brought some changes. They (government) have become conscious of difficulties or the problems people are facing.”

Noting that the central government has taken some measures to strengthen the mechanism to regulate the clinical trials, the court said: “What we are interested in is that what has happened in the past should not get repeated. Arrest the recurrence of death and side effects because of clinical trials.”

The court’s observation came after Additional Solicitor General Siddhartha Luthra told the court that the government was bringing amendments to the law that will put in place a stringent regulatory mechanism and provide for punitive punishment for those violating it.

He told the court that amendments would be effected in the monsoon session of parliament.

Making clear that it was up to the government to take the call to put in place a strong legal regime to regulate the clinical trials, the court said that alternatively it will have to step in.

In the course of the hearing, the court asked Luthra why can’t there be a committee to oversee the clinical trials.

“Why don’t you consider constitution of an oversight committee to oversee all such clinical trials?” it asked.

“Technology must grow”, Justice Lodha said, adding that “regulation has to be in such a way that no harm is caused (to the patients that was being tested upon) or it is minimized”.

The court’s observation came in response to Luthra’s submission that the available medicines had to develop to treat new strains of diseases. He said that people suffering from ailments defying treatments volunteer to be tested on new medicines.

Senior counsel Colin Gonsalves, appearing for one of the petitioners, said the statutory provision for regulating clinical trials was good but was not being enforced.

On the other hand, senior counsel Sanjay Parikh told the court that there was nothing new in the government response and it was same as it had given to the Parliamentary Standing Committee on Health.

“New chemical entities that have not been tested should not be allowed to be tested in India as they were resulting in deaths,” Parikh said, alleging that in fact it were the drug companies that were authoring reports on their drugs on which the drug controller was putting his signatures. [IANS]

2 Comments

  1. Nipun Nipun Sunday, July 28, 2013

    The rate of adverse events or deaths DURiNG a trial ( NOT DUE to trial) can be easily compared between different countries by simply looking at data of randomised clinical trials results published in peer reviewed journals. It so transpires that they are are really same between India and other developed or developing countries. Then why this hue and cry as if deaths are occurring only in INDIA ?
    Only two percent of the socalled guineapigs are from india while the rest are from rich,developed,white nations,the home countries of villainous MNCs.
    We have happily been reaping the benefits of clinical research on white guineapigs for so many decades,as one after other new advances in drugs occurred . Only in last six years participation of India has increased from nearly zero to merely two percent and question is being asked ‘why our people are being subjected to the risks?’

  2. Anvita Anvita Sunday, July 28, 2013

    It is a wrong perception that there is no good law or regulations or guidelines or monitoring system for conduct and oversight of clinical trials in India. It is not denied that there is and will always remain scope for continuous improvement. Things do evolve with time. However it is doubtful that the socalled activists are responsible for better changes; often they sensationalise the issues and put up a distorted negative perspective only.
    The most glaring,unscientific and unfortunate example is equating all or most of the deaths or Serious Adverse Events during participation in a trial as being DUE to participation in a trial . Such events are very rare during a trial,more rare than those occurring outside the trial in routine treatment and certainly not counting those caused by quakes or simply lack of medical facilities due to poor infrastructure of health facilities in public sector.
    The activists have maligned the Reseach community in INDIA, insulted hundreds of thousands of patients particicipating in trials by calling them guineapigs and vitiated the fiduciary trust relationship between doctors and patients by launching a campaign of slender and libel against good honest doctors and by misguiding a few patients or caregivers into signing on dotted line beneath complaint letters against doctors by luring patient hundreds of thousands of rupees in compensation,while no such rightful claim existed.
    Any new drug needs to be retested in India again,even if it has been approved in other developed or developing countries. There can be ethnic,racial or pharmacogenomic reasons for differences in response to drugs. It is a euphemism or ‘politically correct cliche’ to say that MNCs are ‘using’ poor,illiterate,rural population for testing their ‘hidden,mysterious,dangerous’ drugs. The fact of the matter is that investigational drugs have passed through rigorous earlier phases for safety and efficacy.
    The Parliamentary Standing Committee for Ministry of Health has lamented that most of the drug trials in India are currently being carried out in corporate hospitals in metro cities,while more should be done in government medical colleges so that wider section of population be represented in research .

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