Out of the contentious 157 clinical trials suspended by the Supreme Court, only 64 were going on at present, the Union health ministry told the Supreme Court as the ongoing case has been posted for hearing after five weeks, thus continuing the uncertainty over the clinical trial approvals in the country.
According to the affidavit submitted by the Ministry in the Apex Court, which took up the case for hearing on Monday, the details were given only about 148 trials whereas the petitioners sought details of remaining trials and other details.
The bench consisting Justice R M Lodha and Justice S K Singh, while allowing the Ministry to file the affidavit, ordered for status quo on the issue. The court on October 21 had asked for re-examining of the approvals granted to 157 applications till the end of December 2012. The writ petition had been filed by Swasthya Adhikar Manch in February, 2012.
As per the previous order, 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.
As per the Ministry affidavit, 35 of the 157 trials were completed while 19 did not begin yet. Eleven were terminated or suspended by 19 were discontinued, leaving only 64 now in progress.
However, the petitioners pointed out that the details about only 148 cases were submitted and no information was filed about the remaining nine cases. Out of 64 global clinical trials, review was done with regard to 50 approvals given by the Technical and Apex Committee, they said.
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, according to a spokesman for the petitioners.
“It may be pointed out that these approvals having been granted till December 31, 2012, 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 in nature,” he said.
In the additional affidavits in March and September 2013, the petitioners had given details of 475 NCEs/NMEs, details of 1323 global clinical trials, 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.
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.