Press release |3 May 2018 | Jaipur: It has been more than 2 weeks since the Malpani Hospital incident has been published which highlighted the unethical clinical trials conducted on more than 20 healthy people without their consent resulting in adverse health conditions in the majority of them. Inspite of strong protests by the civil society, so far the government bodies responsible for monitoring of clinical trials have not taken any actions against those guilty.

Manch had filed a complaint about the whole incident on 21st May 2018 to the Chief Minister of Rajasthan, Secretary to Ministry of Health and Family Welfare, Drug Controller General of India and National Human Rights Commission. Subsequent to the complaint letter, Statements of the victims were also presented to the above mentioned authorities.

Victims of the unethical drug trial – Sohanlal, Omaram and Kaluram – has clearly stated that they were made part of this trial without being given any information, nor there was any form of informed consent on their behalf. Still, some of the victims of the trial are yet to recover from the adverse side effects, yet the health department has not made any effort to do a health check-up of the victims. They are still awaiting any form of treatment on behalf of the government or from the Malpani Hospital.

It may be noted that as per the guidelines issued by the Government as well as the Honourable Supreme Court, all people taking part in clinical trials in India, are to be provided detailed written information about the trial including the risk involved for participation and their right to withdrawal anytime during the trial.

This Malpani Hospital incident is being investigated by Drug Controller (CDCSO), but the report is yet to be made public. This incident brings forth the violation of Drug and Cosmetic Act, Ethical Guidelines for Bio-Medical Research in Human Participants, ICMR guidelines of 2006, Medical Council of India Professional Conduct and Ethical Guidelines 2002, and the conditions listed in the Approval Letter issued by CDCSO to Glenmark. It is illegal to lure healthy people by promising them job and money and making them part of the clinical trial.  So far the statements were given by the victims, Malpani Hospital Management and the information given by various media reports, clearly gives the shows that this whole incident is very unethical and illegal. Yet, the lack of any response or action on the part of the authorities creates enough doubt on the investigation process and poses the question whether this delay is to protect those guilty.

Rajasthan Government in its affidavit to the Honourable Supreme Court has acknowledged that there were 386 adverse health events (there were 95 deaths and 291 serious adverse events SAEs) due to clinical trials that took place between 2005 and June 2012 in the state. RTI and information received various sources indicate that there have been a total number of 24117 cases of deaths (4534)and serious adverse effects(SAEs-19583) due to the clinical trial conducted between January 2005 to September 2016 around the country.

As per the 30th January 2013 affidavit filed by Rajasthan Government to the Supreme Court, it has acknowledged that it the primary responsibility of the state government to protect the health of the clinical trial participants of the state, then why it has so far not canceled the license of the Malpani Hospital. In yet another affidavit, the Rajasthan Government has said that it would bring total transparency in the clinical trial process in the state. The Malpani hospital incident lacks any kind of transparency, yet no action has been taken by the government. An affidavit by the state government had said that it is going to give compensation to 2 victims of clinical trial and the investigation is underway in another two cases related to compensation. Swasthya Adhikar Manch demands that those investigations be made public. Presently, 214 trials are being conducted in the state, mostly in Jaipur and Bikaner district places.

As per the directions of the Honourable Supreme Court, clinical trials can be conducted in India only on the following 3 conditions – 1) Gain outnumbering the risk, 2) Unmet need of the country and 3) Innovation vs existing therapy. Any other trial, without adhering to the above conditions cannot be conducted.

As per the Directives of the Supreme Court, State Government in its 1st February 2013 notification and subsequent other gazette notifications, has highlighted the need for proper informed consent, compensation and other rights of the clinical trial participants, but so far at the implementation level nothing can be seen and a large number of clinical trials are being conducted in the state without any consideration of the above-mentioned directives.

Swasthya Adhikar Manch and Rajasthan Nagrik Manch demand the following from the state government:

1.      Immediately suspend all the trials being conducted by Glenmark in India

2.      Cancel the license of Malpani Hospital and immediately stop all the clinical trials being conducted in that hospital

3.      Immediately provide proper treatment to the victims and should be paid compensation as per the directives of the government

4.      Immediate filing of FIR against all the guilty doctors, hospital management, Glenmark officials and other officials associated with this trial (CTRI/2018/01/011109) and start criminal proceedings against them.

5.      Conduct an independent inquiry against all the “Ongoing trials’ in the state, so that no one in future becomes a victim of the unethical clinical trial.

6.      All trials conducted in the state from 2005 to April 2018, should be made public with detailed information of each trail which should include – trials sites/hospitals, partner organizations, sponsors, names of the principal investigator, any adverse events (adverse health impact and death separately) and the present status of the trial.

7.      Reports of the investigation done so far should be made public immediately.

Swasthya Adhikar Manch will present this case in the ongoing PIL that it had filed in the Supreme Court against unethical drug trial.

Yours Faithfully

R. C. Sharma, Basant Haryana, Anil Goswami, Amulya Nidhi, Chinmay Mishra, Shelley Saha,  Pardeep Gehlot, Kailash Meena