India’s federal Health and Family Welfare Ministry has rebuked its Medical Research body for laxity in allowing Swiss food and beverage company Nestle to sponsor clinical trials on premature babies illegally using substitutes for breast milk, the National Herald reported.
According to the media outlet, under the research project sponsored by Nestle, clinical trials were carried out on 75 premature babies in five different hospitals in breach of the Infant Milk Substitutes Act.
The Act stipulates that “No producer, supplier or distributor shall offer or give any contribution or pecuniary benefit to a health worker on any association of health workers, including funding of seminar, meeting, conference, educational course, contest, fellowship, research work or sponsorship.”
The Ministry has reprimanded the head of the Indian Council of Medical Research (ICMR) for not adhering to the law, while allowing the research to take place. The trial was reportedly conducted on babies between the age of 28-34 weeks to assess the growth and feeding intolerance in preterm infants. The trial suggested that the infant could be given a milk substitute instead of breast milk.
The Health Ministry has asked ICMR, the main body in India for the formulation, coordination and promotion of biomedical research to ensure that all such clinical trials are first screened for infringements of the Infant Milk Substitutes Act.
Amulya Nidhi, Co-Convenor of Swasth Adhikar Manch (Health Rights Forum), a voluntary body fighting for health rights said the Supreme Court of India had laid down strict rules for the conduct of clinical trials in a 2013 case.
“….clinical trial of new chemical entity shall be conducted strictly in accord with the procedure prescribed in Schedule ‘Y’ of Drugs and Cosmetics Act, 1940 under the direct supervision of the Secretary, Ministry of Health and Family Welfare,” Nidhi said.
Nidhi questioned ICMR, a state-funded body itself for violating the rules made by its parent ministry on breast feeding. “It is illegal on the part of ICMR to approve such a research project,” he added.
Nestle has yet to comment on the accusations.
