Streamline clinical trials of vaccines: Par Panel
After indicting a US NGO 'PATH' for conducting clinical trails of HPV vaccines in India "in violation of law and ethical norms", a parliamentary panel has been critical on the role of ICMR and has sought stream lining of the system to ensure such things are not repeated.
New Delhi: After indicting a US NGO 'PATH' for conducting clinical trails of HPV vaccines in India "in violation of law and ethical norms", a parliamentary panel has been critical on the role of ICMR and has sought stream lining of the system to ensure such things are not repeated.
The parliamentary standing committee on Health and Family Welfare, in its report tabled in Parliament today, said the Indian Council of Medical Research (ICMR) should have been careful in such trials as it raises the issue of conflict of interest while appearing as promoter of the induction of such vaccines on one hand and not ensuring monitoring on the other.
It also slammed the Ministry of Health and Family Welfare over the issue.
"The Ministry seems to have conveniently ignored the fact that had the extant rules been followed scrupulously, they would have taken care of the irregularities at the very outset," the panel observed.
In its earlier report in August 2013, the panel had said PATH violated all laws and regulations laid down for clinical trials in this country while conducting HPV vaccines trials in Andhra Pradesh and Gujarat. Clinical trials on the vaccine in US had also led to death of a number of people.
"The government's admission that the association of ICMR in the study as a partner creates doubt and raises the issue of conflict of interest of appearing as promoter of inductions of these vaccines, giving advice of ethics and at the same time not being in a position to ensure monitoring even if it indicates that ICMR should have been more careful in such trials," the panel observed.
The Ministry in its response has said that ICMR had associated itself with the project with an objective of generating information that could be "potentially useful if National Technical Advisory Group on Immunisation (NTGAI) had required such information" of such vaccines in the (immunisation) programme.
It added that ICMR did post-marketing surveillance cum operational research project purely for scientific purpose.
The panel also expressed disappointment over not taking action despite it observing that the Drug Controller General of India (DCGI) had played a a "very questionable" role, the panel said no action has been taken in this regard.
The panel said efforts should be made that ICMR and any of of its scientists should not associate with such projects without prior approval and permission.
It added that had there been no involvement of ICMR, no state government would have permitted the trial conducted by foreign private entity.
The panel said the committee formed under the chairmanship of S S Agarwal, former director of Advanced Centre for Training, Research, Education on Cancer, to probe the matter should submit its report at the earliest.
It also recommended that every clinical trial should be registered with clinical trial registry of India and the DCGI be informed about death or injury during the trial.
"The Committee finds the entire matter very intriguing and fishy. The choice of the countries and population groups, the monopolistic nature, at that point of time, the product being pushed, the unlimited market potential and opportunities in the universal immunisation programmes of the respective countries are all pointers to a well planned scheme to commercially exploit a situation," the panel said.
It added that had PATH been successful in getting HPV vaccine included in universal immunisation programme of the concerned countries, this would have generated a windfall profit for manufacturers by way of automatic sale, year after year, without any promotional or marketing expenses.
"It is well known that once introduced into the immunisation programme it becomes politically impossible to stop any vaccination," the panel said.
The committee is not aware about the strategy followed by PATH in remaining three countries viz, Uganada, Vietnam and Peru.
"The government should take up the matter with the governments of these countries through diplomatic channels to know the truth of the matter and take appropriate necessary action, accordingly," the panel added.