New Delhi: A Parliamentary standing committee says the government should act against a US-based non-profit for allegedly violating Indian laws while conducting clinical trials on hundreds of women and children in Gujarat and Andhra Pradesh—an allegation that is rejected by the American group.

The committee also made grave allegations of impropriety against the Indian Council of Medical Research (ICMR), the nation’s apex body for the formulation, coordination and promotion of biomedical research, and the drugs controller general of India (DCGI).

The committee said PATH carried out phase IV trials of human papilloma virus (HPV) vaccine for cervical cancer as part of a study in 2009. Phase IV safety surveillance is designed to detect any rare or long-term adverse effects over a larger patient population and longer time period than was possible during earlier phases of clinical trials.

PATH said the study was a demonstration project for Merck Ltd’s Gardasil vaccine and GlaxoSmithKline Plc.’s Cervarix vaccine on over 25,000 girls and women.

“We believe that by following the guidance provided by ICMR, as well as two state governments and three ethical review committees, we designed a project that met or exceeded the country’s existing regulatory standards for demonstration projects while providing the greatest health benefit to Indian women," said Amy MacIver, director of media relations at PATH, in a statement issued on Friday.

The study was suspended and an inquiry committee formed in April 2010 following the deaths of seven of those who were administered the vaccines. However, after analysing the seven deaths—five from the Gardasil group and two from the Cervarix group—no common pattern to the deaths was found to suggest these were caused by the vaccines.

In its report presented to the Rajya Sabha on Friday, the committee urged the government to look into the roles of DCGI and ICMR for allegedly turning a blind eye to “irregularities" in the conduct of the trials.

The committee was scathing about ICMR, saying: “In their over-enthusiasm to act as a willing facilitator to the machinations of PATH, they have transgressed into the domain of other agencies which deserves the strongest condemnation and strictest action against them."

It also questioned ICMR’s decision to promote the vaccines for inclusion in the Universal Immunization Programme even before an independent study on their utility and rationale was undertaken.

ICMR dismissed the committee’s criticism. “We have already conducted an inquiry on the deaths of the girls and no link was found between the deaths and the vaccine. The report was submitted to the ministry of health in 2010," said Dr. Tanvir Kaur at the non-communicable diseases division of ICMR.

“The studies carried out by PATH were definitely not clinical trials," she added.

The parliamentary panel also took on DCGI, saying it played a “questionable role". Although DCGI initially maintained that clinical trial rules must be enforced, it stayed silent while the rules and regulations were violated, the panel said.

DCGI chief G.N. Singh responded, “Clinical trial regulations in India were not strict four years ago, but now we have a highly regulated regime."

“We are taking the recommendations of the standing committee report in the right stride and will work on the suggestions. Such problems should not arise in the future," said Singh, who heads the Central Drugs Standard Control Organization (CDSCO) as the DCGI.

The panel alleged that many of the consent forms for the tests had thumb impressions for signatures, or had been signed by hostel wardens. Obtaining informed consent from people participating in such drug studies is essential for clinical trials. In case of minors, forms are to be signed by parents or guardians.

The panel also raised the issue of including vulnerable and tribal populations in the trials, and the lack of preparedness to deal with adverse events.

The PATH statement said, “At the time of its review, ICMR determined the project was a post-licensure observational study and not a clinical trial."

“The demonstration projects in India, Peru, Uganda and Vietnam generated important new evidence on the best ways to introduce HPV vaccines and are informing the work of governments across Africa, Asia, and Latin America to help prevent cervical cancer deaths," PATH said.

The panel asked the ministry of health and family welfare to promptly report PATH’s alleged violations to the World Health Organization and UNICEF (the UN agency for children), and suggested that the National Human Rights Commission also look into the reported violations.

“It is shocking to see how an American organization used surreptitious methods to establish itself in India, performed trials on hundreds of women and children in our country with so many violations, and two of our government agencies rushed to help this organization," said Dr. Chandra M. Gulhati, editor of Monthly Index of Medical Specialities.

India approved 475 clinical trials for “new chemical entities" not used as drugs elsewhere in the world between January 2005 and June 2012, according to documents submitted by DCGI in the Supreme Court.

The documents said 11,972 adverse effects, excluding deaths, were reported in the period, with 506 of these being directly attributable to the trials. They put deaths from trials at 2,644 in the past five years.

In a 3 January ruling, the apex court revoked the powers of the Indian drug regulator to approve trials for new chemical entities, placing the responsibility on the health secretary, who was asked to personally vet all approvals.

On 26 July, the Supreme Court directed the Union government to come up with a new regulatory regime for clinical trials that reflects the concerns of all stakeholders.

The National Institutes of Health (NIH), part of the US department of health and human services, cancelled about 40 ongoing clinical trials in India after the health ministry tightened regulatory norms for trials, Mint reported in July.

The health ministry amended the Drugs and Cosmetics Act with new provisions for regulation and ethical supervision of trials; compensation of trial subjects, and mandatory accreditation of all stakeholders, including institutional review boards, research institutions, sponsors and contract research organizations.

Note: This story has been amended from its original version to clarify the scale of the study conducted by PATH

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