The writ petition filed by Swasthya Adhikar Manch came up for hearing on Junly 26th before the bench of the Supreme Court consisting of Justice R.M Lodha and Justice Madan B. Lokur. This case was filed in February, 2012 and this is the sixth hearing of the case, last hearing was held on 3rd January, 2013.

In the last hearing, the Hon’ble Supreme Court had directed the Director General, Health Services or the Secretary Ministry of Health to file an affidavit on different aspects concerning the Clinical trials of New Chemical Entities, in particular the deaths and adverse impacts that have taken place from 2005 to June, 2012. The Court had also issued notices to all States and UT’s for filing status report on the ongoing clinical trials. Accordingly, reply from 16 States/UTs were filed. All the States/UTs stated that they have no role to play in the clinical trials or their approvals. The additional affidavit was filed by the Secretary, Ministry of Health and Family Welfare on the four issues raised by the Hon’ble court in its order dated 8th October, 2013.

In the additional affidavit filed by the Ministry of Health and Family Affairs it was stated that out of 475 New Chemical Entities only 17 were approved for marketing which comes to less than 4%. But in these clinical trials 2644 persons died out of which only 80 deaths were attributed to clinical trials. Similarly, out of 11972 SAEs, 506 alone were attributed to clinical trials. In the earlier affidavit filed by the Additional DGC(I) it was admitted that the data has been provided by the private firms.

Today, the Additional Solicitor General appearing for the Ministry admitted that the said data was provided by the Companies and that DGC(I) has no data of its own. Therefore, it cannot be said that how many out of 2644 died because of clinical trial and out of 19772 how many suffered SAEs because out of clinical trials. Therefore, it is obvious that the companies have fudged the data to escape the liability. More shocking fact related to the table given by the Ministry regarding deaths attributable to clinical trials and the compensation paid from 2008 to upto June, 2012.

The Petitioners in their rejoinder affidavit pointed out that though the Ministry of Health and Family Welfare had mentioned 164 deaths in the year 2012, out of which 125 died on account of clinical trial of Rivoroxaben by Bayer, in the letter which was written by Ministry of Health and Family Welfare dated 26.04.2011 to the Lok Sabha Secretariat as many as 671 cases of death in the Year,2010 alone were reported. According, to the list provided in Annexure B to the said letter, in case of deaths which had taken place due to trial of Rivoraxaban the reason mentioned was cardiac arrest and the said reason was said to be not related to clinical trial. Out of 125 deaths which had taken place due to Rivoraxaban, Bayer paid compensation to only 5. From the said annexure B it also came out that other companies also participated in clinical trials of new chemical entities but their names have not been mentioned by the Ministry in the additional affidavit. The drug company- Sanofi did clinical trials because of which 135 persons died whereas in the additional affidavit only 5 deaths have been mentioned in the additional affidavit. As per Annexure B, 89 deaths took place in 2010 alone due to clinical trials as against 80 which Ministry of Health and Family Welfare claimed from year 2005 to 2012. The list of drug companies that conducted the trials included several pharmaceutical companies such Bayer, Eli Lilly, Pfizer, Sanofi Intas, Merck, Boahringer, Astrazeneca etc. The name of one of the pharmaceutical company- Novartis was missing from the list.

Counsel for Swasthya Adhikar Manch- Mr. Sanjay Parikh mentioned that the reason for so many deaths is because NCEs are being tested on Indian citizens without following the regulations and taking necessary precautions. It was also urged by the Counsel that the clinical trial of NCEs is not at all beneficial to the Country and therefore, should not be allowed.

The Hon’ble Court while passing the order noted the contention that one of the problematic areas is that the NCEs and its regulation and other one is proper monitoring. The Petitioner had also pointed out that during the entire process of clinical trial there is no check by the Drug Authorities and the entire process of clinical trial is given in hands of Sponsor, Investigator appointed by Sponsor, Expert Committee appointed by Sponsor, therefore, no independent person gets any information about causes of death and causes of SAEs. Because of this serious lacuna, manipulation of data takes place. After the deaths/SAEs are caused the Drug Company without paying any compensation goes away with the data. Therefore, neither the country nor the citizens are benefitted. Even if the medicine is ultimately approved, citizens have to pay at the same cost as others have to pay in any other country in Asia.

Advocate Shri Sanjay Parikh also drew attention of the Court to the fact that Jan,2013 onwards i.e. last six months there has been no improvement as regards clinical trial of NCEs/NMEs and protection of patients. The Rules have not resulted in any enhanced benefit to patients. It was also stated that in Cases of death where no investigation/ inquiry has been conducted, post mortem are not being done by the Authorities, even when the existing rules provide that.

As per the letter dated 26.04.2011 written by the Ministry to Lok Sabha Secretariat, from the year,2005 to 2010 alone 1243 global clinical trials have been permitted. In the year, 2006 alone 671 death have occurred. The list annexed with the letter accepts that 89 deaths were related to clinical trials in the year,2011. Out of 26 cases entitled for compensation details of only 19 persons were given. Out of the 19 persons only three have peen paid compensation.

In the other letter dated 06.06.2011 mentions that out of 645 cases of death response has been received only in 300 cases and out of 300 in only 2 cases compensation and treatment expenses have been paid.

NHRC also intervened in the case and stated that the NHRC has also formulated some suggestions regarding strengthening regulations for the conduct of Clinical trials in the interest of patients and wishes to submit its report.

Hon’ble Supreme Court hence reiterated that India is becoming heaven for MNCs pharma industries to conduct clinical trials but are proving hell to the Country. The Court then directed the Ministry of Health and Family Welfare to organize a meeting of all Chief Secretaries/ Secretaries of Department of Health of all States/UTs within 4 weeks to discuss the present legal framework related to clinical trials .The Court also stated that the Ministry may consider the suggestions from NGOs, NHRC & other bodies in this regard.

The Court directed the Ministry to file affidavit after the meeting is convened and regulation is put in place.

The Hon’ble Supreme Court also acknowledged and appreciated that because of the efforts made by the Petitioner Swasthya Adhikar Manch , the regulatory framework and changes in conduct of clinical trials has taken place.

Mr. Sanjay Parikh also represented the Bhopal Gas Peedith Mahila Udyog Sangathan (BGPMUS) and the Bhopal Gas Peedith Sangarsh Sahayog Samiti (BGPSSS) who are interveners in this case.
Swasthya Adhikar Manch has regularly brought to notice the fact that Indian citizens are being exploited by multinational drug companies using the loopholes and lacunae in law and regulatory framework.
The next hearing scheduled for 24th Sep 2013.
AmulyaNidhi (9425311547) ChinmayMishra (9893278855) – SAM
N.D.Jayaprakash (9968014630)-BGPSSS, AbdulJabbar (9406511720)-BGPMUS
[email protected])
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