Aditi Tandon
Tribune News Service
New Delhi, August 3
The government today ordered a probe into a clinical trial being sponsored by Nestle India, asking the apex medical research regulator ICMR to investigate the matter and take action.
The directions were issued by the Health Ministry after evidence that Nestle India was in alleged violation of the Indian law that prohibits producers of baby foods from extending pecuniary benefits or other contributions to health workers or associations of health workers namely doctors and hospitals caring for mother and infants.
The directions from Health Secretary Preeti Sudan followed a complaint to the government by the Breastfeeding Promotion Network of India (BPNI), notified by the Centre to monitor the compliance of the Indian Milk Substitutes Act 2003 that prevents baby food makers from sponsoring or supporting research.
While evaluating this law, came across a Nestle-sponsored trial registered with the ICMR’s Clinical Trial Registry.
“The BPNI has found that the principal investigator of the trial (registered with ICMR’s clinical trials registry) is Dr Monjori Mitra, Trial Coordinator of Medclin Research, and five hospitals are participating in the trial. The primary sponsor of the trial is Nestle India. Get the matter examined and take necessary action to comply with the provisions of the IMS Act and ensure that all trials in future are screened for any infringement of the IMS Act,” Health Secretary Preei Sudan wrote to ICMR DG Balram Bhargava after Health Minister Harsh Vardhan’s intervention.
The BPNI alert to the ministry said Nestle India was flouting the stringent Indian law by financing five hospitals for a research trial. The law bars such financing of any part of the healthcare system.
“The ICMR Clinical Trial Registry has a registered trial titled ‘Multicentric Observational Study’, to observe growth among preterm hospitalised infants, which is being sponsored by Nestle India Limited, a producer of infant milk substitutes and infant foods,” said Dr Arun Gupta, head of the BPNI.
He said under the Indian law Nestle India can’t be the primary sponsor and source of monetary or material support to such research.
“Five premier hospitals benefiting from the sponsorship are — Cloudnine Hospital Bengaluru; Institute of Child Health, Kolkata; Manipal Hospital, Bengaluru; Sir Ganga Ram Hospital, New Delhi, and Calcutta Medical Research Institute, Kolkata,” the BPNI alert said. It added that the research was not approved by independent ethics committees.
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