The Parliamentary Standing Committee (PSC), under the chairmanship of Brajesh Pathak, which studied the issue of HPV (human papillomavirus) trials on children in Andhra Pradesh (Khammam district) and Gujarat (Vadodara district) since April 2010, resulting in death of seven children, exposed the failures, irregularities and corruption in the regulatory systems at both Centre and in States.
The PSC was dismayed by the audacity of DCGI (Drug Controller General of India), who merely repeated same old steps proposed to take as if they were new measures. Though these rules were part of the written rules, they were violated. Except for slight amendment in the “Informed Consent Form,” there is nothing new in the action taken report submitted by DCGI.
Dissatisfied with lack of action by the department concerned or DCGI, the PSC questioned it for not fixing accountability on the erring officials/departments for the gross violations during the conduct of study. They questioned casual approach, bureaucratic lack of urgency of DCGI, etc. Ministry should have taken steps to compel the DCGI to comply with the system.
Need for a nodal agency
The Committee expressed serious concern saying if PATH (Programme for Appropriate Technology in Health) can set up an office in India so easily without getting the required mandatory approvals/permissions, then individuals and entities inimical to the interest of the country can do the same, and paper and shell companies can be easily registered in many jurisdictions and then they set up a place of business in India as “Liaison offices” with no questions being asked at any level of regulatory authority. It is surprising that security and intelligence agencies did not raise an eyebrow on the way a foreign entity entered India virtually incognito through the backdoor.
It is apparent that PATH has exploited with impunity the loopholes in our system as also the absence of a nodal point or a single window for maintaining a data bank of foreign entities entering the country for setting up their offices. Given the multiplicity of agencies involved in processing such requests, there is a definite need for a nodal agency which would keep a tab on all such existing and aspiring agencies from the point of view of having obtained all necessary clearances/permissions before commencing their operations in India.
The PSC has strongly recommended constitution of a nodal agency as part of the Ministry of Home Affairs (MHA) in the form of an umbrella agency linked to all the agencies involved in processing such requests. All ministries, departments, agencies, state governments or other entities should be required to share details of all requests or proposals from foreign entities for setting up offices in any form with this nodal agency.
‘Harmful trials’ under the garb of ‘study’
PSC pointed out that ‘PATH’ was carrying out the clinical trials for HPV vaccines in AP and Gujarat under the pretext of observation/ demonstration project in breach of all laws and regulations laid down for clinical trials by the government, with the sole aim of promoting the commercial interests of HPV vaccine manufacturers, who would have reaped windfall profits had PATH been successful in getting the HPV vaccine included in the UIP (Universal Immunization Programme) of the country. This is a serious breach of trust by any entity as the project involved life and safety of girl children and adolescents who were mostly unaware of the implications of vaccination.
Violation of human rights and medical ethics
The violation is also a serious breach of medical ethics. This act of PATH is a clear-cut violation of the human rights of these girl children and adolescents. The Committee criticised it an established case of child abuse. It has recommended action against PATH and wanted the National Human Rights Commission (NHRC) and National Commission for Protection of Children Rights (NCPCR) also to study violation of human rights and child abuse. The National Commission for Women (NCW) should also suo motu take cognisance of this case as all the poor and hapless subjects are females, the PSC said.
The Ministry of Health and Family Welfare should report to international bodies like WHO and UNICEF so as to ensure that appropriate remedial action is initiated against PATH and its associates worldwide. PATH might have violated the laws of the land of origin and, if so, the US government should be persuaded by the Ministry of External Affairs, the PSC felt.
Brinda Karat, Communist Party of India (Marxist) Politburo member and former MP, has demanded action against the officials in ICMR and DCGI for permitting the project in the first place in violation of rules and then subsequently in the conduct of the project including compromising on the issue of informed consent of the subjects. She also demanded compensation of Rs 10 lakh to each of those who were made subjects in these irregular trials in gross violation of their rights, Karat said the fine should be levied by the government on PATH, the two companies and the promoter, and the Gates Foundation. Additional compensation must be given to the families of those children who died during the course of the trial. Recommending blacklisting of PATH, an international nongovernmental organisation that conducted the trials, Karat said it should be barred from any activity in India.
Commissionerate of Health and Family Welfare Joint Director N Balaramaiah said the vaccine trials were irresponsible as no awareness was created among the concerned. AIDWA general secretary Sudha Sundararaman said the vaccine was tried on about 23,000 adolescent girls. Venkatamma, mother of Sarita, who died after taking the vaccine, and a few others of the Bhadrachalam area, where the trials were conducted, narrated their experience with this vaccine. Karat slammed the Indian Council of Medical Research (ICMR), the Drugs Controller General of India (DGCI) and the Ethics Committee at the national and State-levels for permitting vaccine trials without any proof of its efficacy or studies on their side-effects. “All established protocols of biomedical health research were violated in the trials of HPV vaccine,” she alleged.
It is sad that PSC recommendations were negligently ignored by the babus at the Centre. Such clandestine and pseudonymous trials should not be allowed and strict action against officers facilitating should be taken. Any loss of health or life resulting from such illegal clinical trials should lead to quick compensation payments and strict actions.