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.
The plea urged the apex court to set aside the Delhi High
Court's October 2015 order dismissing a plea to restrain the Centre from conducting any further clinical trials of rotavirus vaccine in India.
The high court order had come on a plea filed by Dr Jacob Puliyel, a member of NTAGI, seeking to restrain the government from moving on to phase IV trials in which over one lakh children would be administered the vaccine.
Puliyel in his plea had also sought directions to provide complete data of the multi-centre clinical trials of the vaccine.
The high court, however, had said that NTAGI, which is the highest technical advisory body in the country on immunisation, on being satisfied about its efficacy and safety, recommended introduction of the vaccine in question for National Immunisation Programme.
Meanwhile, Srinivasan, the petitioner before the apex court, submitted that not providing the complete results of the clinical trials involving human beings was in violation of ethics of medical research and global norms governing such trials.
On March 26, Ministry of Health officially launched rotavirus vaccine to combat deaths in infants caused due to diarrhea. Before the launch of the vaccine, a clinical trial (phase III) was conducted between 2011 and 2013 at Delhi, Pune and Vellore to gauge the efficacy and safety of the vaccine.
Under this clinical trial, 6799 infants were administered the said vaccine to ensure its safety in terms of the number of intussusceptions in the two year trial period.
Intussusceptions are intestinal obstructions that may need an urgent surgery to prevent death among infants and is diagnosed by ultrasound examination, the plea said.
