8th hearing of the writ petition filed by Swasthya Adhikar Manch took place today before the bench of the Supreme Court consisting of Justice R.M Lodha and Justice S.K. Singh. The case was filed in February, 2012 and the last hearing was held on 21st October, 2013.
Pursuant to the last order dated 21st October 2013 the Hon’ble Supreme Court have ordered GoI to reexamine 157 GCT including NCEs/NMEs by Apex and Technical Committees. Therefore, now Apex and technical committee will have to evaluate these 157 clinical trials particularly in terms of - assessment of risk vs. benefits for patients, innovations to existing therapeutic options and benefits to medical needs of the country. It is only after the assessment of apex and technical committee that the question of commencement of 157 approvals will be considered. The Secretary, MOHWF filed an affidavit with regard to approval granted to 157 global clinical trials.
Details of only 148 cases were submitted but with respect to 9 cases status, were not given even though they may have these details.
The Hon’ble Supreme Court continued the suspension of 157 Clinical Trials and allow the MOHFW to file affidavit and rejoinder by Petitioner Swasthya Adhikar Manch.
There is no explanation given in the affidavit with regard to 157 before 31st December 2012 .Out of 64 global clinical trials, review was done with regard to 50 approvals given by the Technical and Apex Committee. In the affidavit details with regard to compliance of three conditions imposed by the Supreme Court in the last order have not been given. The Ministry has also not furnished details as to when approval was granted, when ethics committees were appointed, when investigators were appointed, the name of the molecule which has been approved for clinical trial, places where clinical trials are conducted. It may be pointed out that these approvals having been granted till 31st December2012, none of the precautions were taken and approvals are granted when deficiencies/lacunae were present in the rules. Nothing has been mentioned in the affidavit whether the consents have been granted, approvals were granted by following the proper procedure and they were independent. It was also not mentioned where subjects have suffered SAEs and death taken place during ongoing 64 trials and 35 trials which is already completed. The review done by the Technical Committee and Ethics Committee is therefore, superficial and prefunct in nature. It may be pointed out that in the additional affidavits in March and September 2013 by the Petitioner it was pointed out that details of 475 NCEs/NMEs, , details of 1323 Global clinical trails which was permitted by DCGI, details of 1122 applications received by DCGI and all Minutes of NDAC, Technical and Apex committee. The Petitioner has also asked the details of 2644 deaths, 11972 Serious Adverse Events, details of compensation. These information's sought for by the Petitioner in additional affidavit will be provided by the Respondent.
The Ministry has asked three weeks time to file an affidavit to clarify position with regard to suspended/terminated/discontinued clinical trials. The Supreme Court has permitted the petitioner to file rejoinder affidavit within two weeks thereafter. The Petitioner has also been allowed to seek information from the ministry. The case is therefore adjourned for five weeks. The status which existed on the date of the order dated 21st October 2013 therefore, continues.
Swasthya Adhikar Manch had earlier sent a letter to Secretary MOHFW and also filed affidavit in November 2013 raised serious concerns about Ranjit Roy Chaudhry Expert Committee report. In the present affidavit filed by the MOHFW it is seen that Dr Ranjit Roy Chaudhary is also a member of the Technical Committee which had evaluated 50 cases out of the 157 which clearly indicated the conflict of interest.
Bhopal Gas Peedith Mahila Udyog Sanghathan (BGPMUS) and the Bhopal Gas Peedith Sangharsh Sahayog Samiti (BGPSSS) which had leveled charges against BMHRC in their application have been confirmed in the affidavit filed by MOHFW.
Pursuant to the last order dated 21st October 2013 the Hon’ble Supreme Court have ordered GoI to reexamine 157 GCT including NCEs/NMEs by Apex and Technical Committees. Therefore, now Apex and technical committee will have to evaluate these 157 clinical trials particularly in terms of - assessment of risk vs. benefits for patients, innovations to existing therapeutic options and benefits to medical needs of the country. It is only after the assessment of apex and technical committee that the question of commencement of 157 approvals will be considered. The Secretary, MOHWF filed an affidavit with regard to approval granted to 157 global clinical trials.
Details of only 148 cases were submitted but with respect to 9 cases status, were not given even though they may have these details.
The Hon’ble Supreme Court continued the suspension of 157 Clinical Trials and allow the MOHFW to file affidavit and rejoinder by Petitioner Swasthya Adhikar Manch.
There is no explanation given in the affidavit with regard to 157 before 31st December 2012 .Out of 64 global clinical trials, review was done with regard to 50 approvals given by the Technical and Apex Committee. In the affidavit details with regard to compliance of three conditions imposed by the Supreme Court in the last order have not been given. The Ministry has also not furnished details as to when approval was granted, when ethics committees were appointed, when investigators were appointed, the name of the molecule which has been approved for clinical trial, places where clinical trials are conducted. It may be pointed out that these approvals having been granted till 31st December2012, none of the precautions were taken and approvals are granted when deficiencies/lacunae were present in the rules. Nothing has been mentioned in the affidavit whether the consents have been granted, approvals were granted by following the proper procedure and they were independent. It was also not mentioned where subjects have suffered SAEs and death taken place during ongoing 64 trials and 35 trials which is already completed. The review done by the Technical Committee and Ethics Committee is therefore, superficial and prefunct in nature. It may be pointed out that in the additional affidavits in March and September 2013 by the Petitioner it was pointed out that details of 475 NCEs/NMEs, , details of 1323 Global clinical trails which was permitted by DCGI, details of 1122 applications received by DCGI and all Minutes of NDAC, Technical and Apex committee. The Petitioner has also asked the details of 2644 deaths, 11972 Serious Adverse Events, details of compensation. These information's sought for by the Petitioner in additional affidavit will be provided by the Respondent.
The Ministry has asked three weeks time to file an affidavit to clarify position with regard to suspended/terminated/discontinued clinical trials. The Supreme Court has permitted the petitioner to file rejoinder affidavit within two weeks thereafter. The Petitioner has also been allowed to seek information from the ministry. The case is therefore adjourned for five weeks. The status which existed on the date of the order dated 21st October 2013 therefore, continues.
Swasthya Adhikar Manch had earlier sent a letter to Secretary MOHFW and also filed affidavit in November 2013 raised serious concerns about Ranjit Roy Chaudhry Expert Committee report. In the present affidavit filed by the MOHFW it is seen that Dr Ranjit Roy Chaudhary is also a member of the Technical Committee which had evaluated 50 cases out of the 157 which clearly indicated the conflict of interest.
Bhopal Gas Peedith Mahila Udyog Sanghathan (BGPMUS) and the Bhopal Gas Peedith Sangharsh Sahayog Samiti (BGPSSS) which had leveled charges against BMHRC in their application have been confirmed in the affidavit filed by MOHFW.
