ICMR asked to get the trial examined

A prominent manufacturer of infant milk substitute is now under the Union Health Ministry’s scanner for sponsoring a research titled “Multicentric Observational Study to Observe Growth in Preterm hospitalised infants” in alleged violation of rules in five hospitals across the country.

The manufacturer, Nestle India Ltd., conducted clinical trials on 75 premature babies in five hospitals on substitutes for breast milk in complete contravention of the The Infant Milk Substitutes, Feeding Bottles, and Infant Foods (Regulation Of Production, Supply And Distribution) Act 1992 And Amendment Act 2003( IMS Act).

The alleged violation was found by the Breastfeeding Promotion Network of India (BPNI) on screening the trial registry of the Indian Council of Medical Research (ICMR).

The BPNI complained to Union Health Minister Harsh Vardhan on July 17 alleging that the company had violated Section 9(2) of the IMS Act.

This Section states that no producer, supplier or distributor shall offer or give any contribution or pecuniary benefit to a health worker or any association of health workers, including funding of seminar, meeting, conferences, educational course, contest, fellowship, research work or sponsorship.

Following the complaint, Union Health Secretary Preeti Sudan on Friday (August 2) directed ICMR Director Balram Bhargava to “get the trial examined and take necessary action to comply with the provisions of the IMS Act”.

She has also directed Prof. Bhargava to ensure that all such clinical trials are first screened for infringement of the IMS Act in future.

Dr Monjori Mitra of Medclin Research Pvt Ltd. is the trial co-ordinator and research director of the clinical trial number — CTRI/2018/12/016715 — registered under the Clinical Trial Registry of the ICMR . The five hospitals which participated in the research — Cloudnine Hospital (Bengaluru), Institute of Child Health (Kolkata), Manipal Hospital (Bengaluru), Sir Ganga Ram Hospital (New Delhi) and Calcutta Medical Research Institute (Kolkata) — are private institutions.

Amulya Nidhi, Co-convenor of the Swasthya Adhikar Manch, alleged this clinical trial was “only to put our children’s health at risk for the benefit of corporates like Nestle”.

Nestle’s Response

Responding to the allegations, a spokesperson for Nestle India emphasised that the company always complied with all laws and regulations including the IMS Act.

In a statement, the spokesperson said the objective of the clinical study was to encourage science-based research and all Institutional Ethics Committee approvals had been obtained from the participating sites.

“The letter from the Ministry of Health and Family Welfare (MoHFW) has requested the Indian Council of Medical Research (ICMR) to examine the matter. Nestlé India will provide all its support on this issue to ICMR and we are confident of our position,” the statement from the company said.