Clinical trials on preterm babies by Nestle under scanner of ICMR

    The union health ministry has asked the Indian Council for Medical Research to investigate the clinical trials conducted by Nestle India Limited on the pre-term babies at various hospitals in India


    New Delhi: Union health ministry has asked the director of the Indian Council of Medical Research (ICMR) to examine a complaint regarding the violation of Infant Milk Substitutes Act by Nestle India Limited and take necessary action.

    The move came after the Breastfeeding Promotion Network of India (BPNI) that has been tasked by the health ministry to monitor such cases, found that there was an alleged violation in the clinical trial sponsored by the Nestle India in five hospitals.

    Under the Infant Milk Substitutes Act, producers, suppliers or distributors of infant milk substitutes cannot “offer or give contributions or pecuniary benefits to health workers or any associations of health workers, including the funding of seminar, meeting, conference, educational course, contest, fellowship, research work or sponsorship.

    In a letter issued to director of the ICMR, Dr Balram Bhargava on 3rd August, the union health secretary, Preeti Sudan sought a report on the issue. The ministry also asked ICMR to ensure that all trials in the future are screened for infringement of the IMS Act.

    The trial titled “Multicentric Observational Study to Observe Growth in Preterm hospitalized infants” sponsored by the Indian branch of Swiss food company, Nestle was conducted in five hospitals across India: Cloudnine Hospital (Bengaluru), Institute of Child Health (Kolkata), Manipal Hospital (Bengaluru), Sir Ganga Ram Hospital (New Delhi) and Calcutta Medical Research Institute (Kolkata).

    As per the law, all clinical trials conducted in India must obtain permission from the Drug Controller. In this case, it has been alleged that clinical research trials began without appropriate permission.

    Nestle has reportedly denied any wrongdoing and promised full cooperation to the authorities. It has issued a statement that clinical study for the purpose of scientific information was not prohibited under the IMS Act.