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The Standing Committee on Health and Family Welfare has instructed the Centre to take legal action against a US agency, Programme for Appropriate Technology in Health (PATH), for violating clinical trial norms in India.
In its report about the deaths of some female children and adolescents in Khammam district of Andhra Pradesh after being administered Human Papilloma Virus (HPV) vaccines by PATH in 2010, the committee observed that the agency showed gross violation of the concept and legal requirement of consent from study subjects for clinical trials.
The Committee, headed by senior Bahujan Samaj Party MP Brajesh Pathak, said it finds the entire matter very intriguing and fishy. “Had PATH been successful in getting the HPV vaccine included in the universal immunisation programme of the concerned countries, this would have generated windfall profit for the 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 report added.
Raising concern that PATH may follow the same strategy in Uganda, Vietnam and Peru, the committee urged the Government to take up the matter with the Governments of these countries through diplomatic channels.
The Committee said the representatives of the Indian Council for Medical Research, instead of ensuring highest levels of ethical standards in research studies, acted at the behest of PATH in promoting the interests of manufacturers of the HPV Vaccine. “The Committee fails to understand as to why ICMR took so much interest and initiative in this project when the safety, efficacy and introduction of vaccines in India are handled by National Technical Advisory Group on Immunisation,” the report said.
PATH, meanwhile, said it is troubled by the report’s “inaccurate characterisation” of important works. It said in a statement that the project in India was part of a four-country project to explore suitable vaccine delivery strategies against Human Papilloma Virus (HPV), the primary cause of cervical cancer.
jigeesh.am@thehindu.co.in
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