ICMR orders closure of two Nestle-funded studies

The Indian Council of Medical Research (ICMR) has ordered the termination of two studies funded by baby food manufacturer Nestle for violating Indian law.

The apex medical research body asked the Clinical Trial Registry of India (CTRI) to stop the two ongoing multi-centric trials, sponsored by Nestec— a subsidiary of Nestle— as they go against the Indian Milk Substitute (IMS) Act.

This is the third Nestle-backed research study stopped by ICMR after violations were brought to the Union Health Ministry's notice by an NGO, Breastfeeding Promotion Network of India, which monitors compliance to the IMS act.

The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply, and Distribution) Act, 1992, as amended in 2003 has a section preventing baby food manufacturers to undertake any step that can influence the doctors including research.

“No producer, supplier or distributor (of baby foods) 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,” says Section 9.2 of the IMS Act.

This provision was violated in the two studies titled Infant Feeding Practice and Gut Comfort: A Multi-country, Cross-sectional Observational Study and Study of milk composition from adequately nourished and undernourished mothers, Funded by Nestec, the two clinical trials were registered in December 2018 and November 2014 respectively.

The CTRI has now been directed to take action on the basis of a recent ICMR report on a third study, funded by Nestle. Weeks ago, the medical research council unanimously decided to terminate the study titled, Growth and nutritional bio-markers in preterm infants in NICU – a Multicentric Study in India. It was registered in December 2018.

The Drugs Controller General of India (DCGI) has now been advised to check how the institutional ethics committees permitted the trials in the first place.

The DCGI has been asked to examine whether the institutional ethics committees were constituted in accordance with the law.

The company, on its part, argues that the law should be seen in entirety as there are clauses in the legislation that prohibit financial inducements and gifts given for the “purpose of promoting” milk substitute products and not applicable to academic research.

The ICMR, however, holds a different view. It recommends invoking the prosecution provisions against the company to “act as a deterrent for similar acts of commission and omission in the future.”

“The government should initiate legal actions as recommended by the ICMR. The research on babies should be funded by public money and not by companies with competing for interest,” Arun Gupta, central coordinator of BPNI, told DH.