The Indian arm of the Swiss food company Nestlé conducted a trial on 75 premature babies in five hospitals across the country. The trial was aimed at understanding the feeding patterns in preterm infants. These babies have different feeding patterns as compared to term babies.
As per the result of this study, Nestlé found that preterm babies may be provided milk substitute in place of breast milk from the third day of birth. The study was titled “Multicentric Observational Study to Observe Growth in Preterm Hospitalized Infants”.
This trial was registered in December 2018 with the Clinical Trial Registry of India (CTRI), maintained by the Indian Council of Medical Research (ICMR), sponsored by Nestlé.
The Breastfeeding Promotion Network of India (BPNI) has found a violation in the trial so conducted. BPNI says that Nestlé was in direct violation of the Infant Milk Substitutes (IMS) Act.
‘Nestlé Violated IMS Act”
BPNI, in its findings, said that the study violated Section 9 (2) of the IMS Act. As per this section, “No person who produces, supplies, distributes or sells infant milk substitutes or feeding bottles or infant foods shall offer or give, directly or indirectly, any financial inducements or gifts to a health worker or to any member of his family for the purpose of promoting the use of such substitutes or bottles or foods.”
This means that producers, suppliers or distributors of milk substitutes like Nestlé itself, shall not sponsor (directly or indirectly) study which aims at promoting the product.
BPNI in its letter to Union Health Minister Dr Harsh Vardhan said that the research was not given a go-ahead by an ethics committee. It has also requested the Health Ministry to stop the research immediately and initiate appropriate action against the company and the hospitals involved.
The five hospitals which participated in the study are-Cloudnine Hospital; Institute of Child Health, Kolkata; Manipal Hospital in Bangalore; Sri Ganga Ram Hospital, New Delhi; and The Calcutta Medical Research Institute, Kolkata.
The company spokesperson of Nestlé, in a statement to The Logical Indian, said, “We would like to emphasise that Nestlé India is always in compliance with all laws and regulations including the Infant Milk Substitutes, Feeding Bottle and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (IMS Act).
Clinical study for the purpose of scientific information is not prohibited under the IMS Act. The IMS Act does not discourage or prohibit the dissemination of scientific information. A mere reading of Section 9 will clearly show that the Act prohibits financial inducement to health workers or any contribution or pecuniary benefit including the funding of seminar, conference etc., only if these are for the purpose of promoting the use of infant milk substitutes, feeding bottles and infant foods. The objective of the clinical study under reference is to encourage science-based research. This study is an institution based study, all Institutional Ethics Committee approvals have 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.”