5.5 crore allegedly paid to Government doctors alone
Coming down heavily on the Indian Government for its failure to stop illegal clinical trials of untested drugs by multinational firms, the Supreme Court of India recently said such trials are creating ‘havoc’ and causing the death of many citizens. The apex court accused the Government of going into ‘deep slumber’ on the issue and blamed the establishment for failing to put in place proper mechanisms to stop ‘rackets’ of global firms which are involved in conducting illegal clinical trials.
In its interim order, a bench of justices R M Lodha and A R Dave said that all clinical trials will be done under the supervision of the Health Secretary of India. “You have to protect health of citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stayed,” said the bench.
Dr. Amit Sengupta of Delhi Science Forum and leading figure of Peoples Health Movement in India, said that the flood gates opened in 2005 when India changed the rules regulating clinical trials in the country. According to Sengupta the result of this change in the law has been spectacular. In 2005, less than a 100 trials were being conducted in India while the number rose to 250 by 1997-98. Explaining the boom in clinical trials in the country, Dr. Sengupta said while the capacity and capability have increased, the sudden rise in number of trials far outstrips the enhancement in capacity and capability.
“The sudden boom in clinical trials can be explained precisely because of the incapacity to regulate clinical trials. Companies are rushing to India to conduct trials which they would have problems in justifying in their home countries. This is happening in a situation where most patients in India are particularly vulnerable because they have poor or no access to public health facilities. Thus, poor and vulnerable patients sign up for trials as they see this as the only opportunity to access treatment for their disease,” Sengupta explains.
Pulling up the Government after it was contended that various Committees have been set up to look into the matter and that it will come back to the court after receiving suggestions from them, the court asked the Government to handle the ‘menace’ with urgency. “You can get back to the court but what about those people who are losing their lives in such clinical trials. People who lost their lives can’t get their lives back,” the bench observed.
Blaming the Government for ‘shying away’ from responding to its queries while noting that the affidavit filed by the Centre was not in consonance with its earlier order, the bench said it is very easy to form a Committee or a commission. “It is the best way to divert attention on important issues,” the bench said. Earlier, in October 2012, the Supreme Court had sought the reply of the Centre and various State Governments on the allegation that human beings were being used as guinea pigs for clinical trials by drug manufacturers.
During the hearing of a public interest litigation (PIL), filed by an Indore based NGO — Swasthya Adhikar Manch, alleging mass clinical drug trials across the country by the drug companies using Indian citizens as guinea pigs in those tests, the court had directed the Union Government to bring to light the details of the deaths, if any, and the side effects and compensation, if any, paid to the victims or their family members.
The NGO had alleged that the clinical trials by many drug companies were going on indiscriminately in various States of the country. Refraining from passing any blanket ban on the trials, the court had sought a comprehensive reply from the Centre on various issues.
The Parliamentary Standing Committee on Health and Family Welfare has raised various issues pertaining to the functioning of the Central Drugs Standard Control Organisation (CDSCO), including allegations on CDSCO’s approval of drugs without clinical trials.
This came as the Government put out the number for people who have died during the course of clinical trial of drugs in India during 2011. India’s Health Minister, Ghulam Nabi Azad informed Parliament that 438 people had died of Serious Adverse Events (SAEs) during clinical trials in the past year. “As per available data, the number of Serious Adverse Events of deaths in clinical trials reported during 2011 were 438,” the Minister said. While over half these deaths were from trials conducted by foreign pharmaceutical companies, 16 people died due to Serious Adverse Events (SAEs), the Minister added.
Clinical trials can be initiated only after the approval of the Central Drugs Standard Control Organisation (CDSCO) and the respective Ethics Committee. In all trials, a freely given informed written consent is required to be obtained from people participating in the study trial, the minister informed law-makers. In its 59th report on the functioning of CDSCO, the Standing Committee came down heavily on CDSCO for its approval for new drugs based on non-clinical data.
“New drugs are approved by the CDSCO based on non-clinical data, clinical data of safety and efficacy of drug, regulatory status in other countries etc.,” the Committee has pointed out. Earlier, the Government had constituted Committees of experts for giving their opinions and recommendations to CDSCO in respect of investigational new drugs and new drug proposals. This was necessitated as the Parliamentary Standing Committee had raised various issues pertaining to the functioning of the CDSCO. It had pointed out to instance of approval of drugs without clinical trials by CDSCO.
The Committee is also examining the validity of the scientific and statutory basis adopted for approval of new drugs without phase-III clinical trials on the Indian population. The Committee’s report is now lying with the Health Ministry. In the interim, the Government has said that approvals and permissions for conducting clinical trials will now make it mandatory on pharmaceutical companies to provide complete medical care as well as compensation for the injury or death in the case of any mishap during the course of the trial.
The country’s National Human Rights Commission has constituted an expert Committee to frame guidelines for clinical drug trials, following unethical complaints. “NHRC has constituted an expert Committee for framing of some guidelines for clinical trials of drugs in the country,” said a statement from the commission. “The commission has also decided to intervene in the case relating to the clinical trials of drugs pending before the Supreme Court,”
NHRC has also involved itself in a public interest litigation pertaining to clinical trials of drugs, following a report from the Economic Offences Wing (EOW) last year that said that 32 people had died between 2006 and 2010 because of the illegal clinical trial of medicines. The EOW report said that the drugs had maimed for life 49 other “human guinea pigs”, who unknowingly “volunteered” for the experiments.
MP Shifts Illegal Drug Trial Blame On Centre
The Madhya Pradesh Government told the Supreme Court clinical trials by drug companies on humans in the State were done without its knowledge as they were conducted with the Centre’s approval. Responding to a public interest litigation (PIL), alleging the trials were done in violation of the prescribed procedure, the State admitted that some of the doctors conducting the trials worked at Government hospitals and were currently facing disciplinary proceedings.
“Unfortunately maximum cases of clinical trials have been reported from MP. But, the Centre is responsible for it as such trials are permitted under the Drugs and Cosmetics Act by the DGCI. States have no role in it” the court was told.
Taking a serious view of the allegations by an NGO Swasthya Adhikar Manch, a bench of Justice RM Lodha and Justice AR Dave sought details of clinical trials conducted in the country since January 1, 2005, of the deaths and side-effects, if any, due to such trials.
The court also wants to know whether compensation has been paid to those who suffered set-backs and to the family of those who died during the trials. It also expanded the scope of the PIL and issued notices to all States for their response.
In a detailed affidavit, the MP Government claimed it suspended clinical trial in the State in August 2010, on learning about it through media reports. The State added it had already initiated disciplinary inquiries regarding financial irregularities and foreign trips without permission against the erring Government doctors. With regard to private practitioners, the State had lodged complaints with the Medical Council of India.
The Supreme Court has now issued notice on a PIL seeking a proper regulatory framework to check rampant illegal and unethical clinical trials on adults, children and even mentally ill persons. India had even permitted Phase-I trial, which meant the trial of a medicine on a human being first. There were more than 100 Contract Research Organisations in the country offering clinical trials at a low cost, the petitioners said.
A study had revealed that informed consent before trial was not being taken, compensation being denied and the loopholes in the functioning of the Drug Controller General of India were being exploited. “In conducting these trials, the doctors, with the sole aim of making money, grossly compromise with ethical medical practices,” the report said. “The inaction of the Government in not banning/ restricting these clinical trials violates Article 14 of the Constitution,” it said.
Media reports highlighted how Government doctors in Indore conducted clinical trials on 1,883 unsuspecting patients many of whom suffered from side effects and some died. The State Government ordered a probe, but let off 12 doctors with a paltry fine of Rs. 5,000 . According to a recent investigation by BBC Newsnight, “India’s poor were possibly used in illegal drug trials without their consent.”
Some of India’s poorest people may have been used as guinea pigs by drug companies to test new drugs without their prior consent, the BBC Newsnight investigation revealed. The Newsnight investigation heard from families in India who spoke of being given ‘special’ treatment and expensive ‘foreign drugs’ paid for by a ‘special Government fund for poor people’. The report has resulted in growing pressure on drug companies to fully investigate these claims.
One family member of a potential victim, Nitu Sodey, said she took her mother-in-law, Chandrakala Bai, to Maharaja Yeshwantrao Hospital in Indore in May 2009, after Bai was suffering chest pains. Instead of using their BPL (Below the Poverty Line) voucher to pay for their treatment, as they were accustomed, Bai was taken to a private room, normally reserved for upper class patients, and given Tonapofylline which was being tested by Biogen Idec. Sodey told Newsnight that she can’t read and doesn’t remember signing a consent form, nor did she know her mother-in-law was being enrolled in a drug trial.
In India it is illegal to trial a drug on a patient without their prior consent. After suffering heart abnormalities day after being prescribed the drug, Bai was taken off it but then went on to suffer fatal cardiac arrest a month later. She was only 45 years old at the time. The trial was registered in the UK by Biogen Idec, but was later halted due, say the company, to the number of seizures recorded.
One doctor whose name was mentioned repeatedly to Newsnight reporter Sue Lloyd Roberts in relation to suspected non-consensual drug trials is Dr Anil Bharani, who has since been charged by the Government for receiving illegal payments and foreign trips from drug companies. The alarm was first raised by Dr Arnand Rai who became suspicious after he saw poor patients being ushered into the best consulting rooms. After raising questions he was sacked from the hospital.
In 2005 the Indian Government relaxed its drug trial laws. Since then nearly 2,000 trials have taken place, with the number of deaths increasing from 288 in 2008 to 668 in 2010, and then falling to 438 in 2011. According to the Newsnight investigation, there are many stories like Sodey’s but because post-mortems are rarely carried out it is difficult to prove a cause of death. Barrister Satnam Singh Bains, who is looking into several cases, told Newnight that there are real concerns; “About, at the very least, collusion between experts and the drug manufacturers or, at worse, there is a suggestion that there is a fraud taking place – that these reports are being signed off without any independent, clinical scrutiny of their findings in the way that conclusions are expressed.
According to UPI’s Business Correspondent, Indrajit Basu, “The opportunities are huge, multinationals are eager, and India has the skills. And these along with its huge population that’s genetically diverse make India the most fertile ground for multinational companies to outsource clinical drug tests and save huge costs. More importantly, this is one sort of outsourcing which the western world workers aren’t likely to protest. But even as global drug giants are flocking into the country for testing of new drugs on humans, it is also a sort of outsourcing that, fear Indians, is perhaps making the country the greatest source of human guinea pigs for the global drug industry.”
Two of India’s top biotech companies, Hyderabad-based Shanta Biotech and Bangalore-headquartered Biocon India have come under scrutiny after a local non-Government organisation, Aadar Destitute and Old People Home the Supreme alleged recently that these were “openly” conducting illegal clinical trials of new drugs on unsuspecting patients. In what could be seen as a clampdown on clinical research in the country, the Drug Controller General of India has announced that it is working out a policy which demands accreditation of clinical research outfits for obtaining approval on any kind of tests conducted on humans.
PI L AGAINST TESTS : An NGO moves SC in February 2012 alleging illegal clinical trials were conducted on poor people in MP.
DOCTORS INVOLVED : Over 3,000 patients were used for the tests in which 15 Government doctors and about 40 private doctors in 10 private hospitals were allegedly involved.
TARGET GROUP : Trials were allegedly conducted on 233 mentally-ill patients and 1,833 children in the age group of one day to 15 years.
MONEY ALLEGEDLY PAID : Approximately `5.5 cr were paid to the Government Doctors alone.
FRAME NEW GUIDELINES : PIL demands setting up of an expert panel and new guidelines.