Clinical trials should be for our benefit, not for MNCs: Court. Supreme Court blocks 157 clinical trials, says must follow new regime
The fate of 157 government-approved global clinical trials seemed uncertain on Monday with the Supreme Court ordering the Centre to wait for its nod while the authorities re-examine the cases under the new regulatory regime and satisfy the court on the issue of safety of the subjects and their benefits to India.
Making it clear that clinical trials being conducted in India must be done for the benefit of the people here, a bench of Justices R M Lodha and S K Singh directed the government to put 157 of the 162 approved trials through the stringent new three-tier test.
The Indian Express had reported that of the 162 approvals granted by the Drug Controller General of India till August 31 this year, 157 trials were cleared in 2012, after a nod from just the New Drug Advisory Committees (NDACs). This meant they escaped the new regulatory regime — the three-tier test which was put in place following the SC’s order in January.
Only five trials were cleared from January 1-August 31 this year, when the requests were also examined by the technical and apex committee, besides the NDACs.
After Additional Solicitor General Sidharth Luthra admitted that 157 approvals were not evaluated by the technical and apex committees, the bench asked him to get it done and submit the reports to the court by December 16.
“The committees shall keep in view all the relevant aspects of clinical trials and efficacy data, particularly in terms of assessment of risk vs benefits to patients, innovation vis-a-vis existing therapeutic options, and medical needs of the country,” it said. The bench clarified that it will not pass any order on carrying out these 157 trials till it is satisfied that the safety of the subjects was not being jeopardised and the trials would benefit India.
On the remaining five trials, the bench said they could be proceeded with, but only after “proper framework is in place concerning audio-video recording for informed consent of the subjects and presentation of requisite documents while adhering to the principle of confidentiality.”
Luthra assured that administrative orders or amendments in the relevant rules shall be considered by the government to ensure audio-video recording in all the cases even as the bench cautioned that any “laxity” or “inaction” by them would only delay the trials.
The court also said the contention that investigators, who inquire into cases of adverse events during and after such trials, were hired by the pharmaceutical companies and were paid by them was an “area of concern”. “If investigators are paid by the companies, there is likelihood that serious adverse events will not be duly reported. Let there be a panel of independent investigators who can be paid by the government and the list of such persons can be updated periodically,” it said. Luthra concurred with the court and said the government would consider this suggestion.
In March, the Centre had disclosed that at least 80 people had died due to illegal clinical trials in the last seven years. It said there were 2,644 “serious adverse events” of deaths during clinical trials during 2005-2012. Of these, 80 have been attributed to clinical trials, while the other deaths could be due to terminal illnesses or other life-threatening diseases.
Clinical trials in the country must be to help the people and must not be allowed for the benefit of multinational companies, the Supreme Court said on Monday, while holding that the norms formulated by the Centre are “deficient” in protecting the people’s rights.
While allowing trials for five entities, the apex court said no trial of new drugs will be allowed till the consent of people being subjected to the trial is recorded in audio/visual form. The Court refused to pass an order on 157 drugs that were allowed by the Centre.
“The norms themselves are deficient and cannot ensure that untoward incidents do not take place. You (the Centre) should have a balanced approach and you cannot take a one-sided view. The regime must be fool-proof,” a bench headed by Justice R.M. Lodha said.
It ordered that clinical trials for the 157 drugs must be cleared by the technical and apex committees set up by the Centre for this purpose.
Not Guinea pigs
The court was hearing PILs filed by a doctor, Anand Rai, and an NGO, Swasthya Adhikar Manch, alleging large-scale clinical drug trials across the country by multinational pharmaceutical firms using Indian citizens as guinea-pigs. The Bench directed the committees to evaluate applications for clinical trials of drugs and take decisions by assessing the risk and benefit aspects and the people’s medical needs.
“In light of the above, it is not possible to pass an order regarding the 157 drugs. It can be considered only after the reports of the technical and apex committees are submitted,” the Bench said, adding: “With regard to five cases the trial is permitted.”
Investigators
The Bench also said the government should appoint a panel of investigators to probe cases of clinical trials.
“How to ensure that the rights of people who are subjected to clinical trial are not jeopardised? What is the mechanism in place to protect their lives and avoid serious side-effects?” the Bench asked the Centre.
Additional Solicitor-General Siddharth Luthra submitted that the Centre is committed to putting in place a proper mechanism and the law has to be amended for the purpose; this is under consideration.
