New Delhi, Jul 5 (PTI) The Supreme Court today sought responses from the Centre and the Christian Medical College at Vellore on a PIL seeking complete centre-wise results of the clinical trial of anti-diarrhoea vaccine Rotavac. Rotavirus vaccine, Rotavac, claims that it protects children from viruses, which are the leading cause of severe diarrhoea among them. Besides the medical college, a bench of
Justices Madan B Lokur and R K Agrawal also issued notices to Ministry of Health and Family Welfare, Department of Bio-Technology (DBT) of Ministry of Science and Technology on the plea filed by S Srinivasan, Managing Trustee of LOCOST (Low Cost Standard Therapeutics), based in Vadodara, Gujarat.
The plea has sought direction to the Centre and others to make public the "segregated data" on the results of third phase of clinical trial of Rotavac involving 6799 infants.
The trials were conducted at three centres in Delhi, Pune and Vellore to gauge safety and efficacy of the vaccine, the plea claimed.
The plea filed through advocates Prashant Bhushan and Neha Rathi said the segregated data was crucial to know if the vaccine is safe in all areas or if some groups are more "susceptible to adverse effects of the vaccine".
The plea stated that the data should have been examined by National Technical Advisory Group on Immunization (NTAGI) in "public interest but such is the secrecy surrounding it, it has not been provided even to this apex body".
"Issue an appropriate direction to respondents (Centre and others) to provide the petitioner the complete segregated results (centre-wise data) of the clinical trial of Rotavac vaccine conducted in all three centres, including the number of intussusceptions in the two-year trial period at each centre.
"Direct respondents to place before NTAGI the complete segregated results of the clinical trial of Rotavac vaccine for examination and scrutiny," the plea said.
It also sought a direction for framing of guidelines regarding publication of complete and segregated research results in clinical trials on humans, in accordance with WHO statement of April 2015 on the issue. (More) PTI MNL PPS SJK RKS ARC
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