The Breastfeeding Promotion Network of India (BPNI) has found a violation in a clinical trial conducted by the Indian branch of Swiss food company Nestle, alerting officials from the Ministry of Health and Family Welfare. The issue will now be brought before the Indian Council of Medical Research which will examine the case and take the necessary measures.
Nestle had conducted a trial on 75 premature babies in five different hospitals throughout India. The study aimed to understand the growth and feeding patterns in preterm infants, who generally cannot tolerate feeds the same way that term babies can. As per the trial’s findings, it was suggested that from the third day of birth onwards, the newborn could be given a milk substitute instead of breastmilk.
When the study was brought to the attention of the BPNI, before the findings could be validated, it was found that Nestle was in direct violation of the Infant Milk Substitutes (IMS) Act. Section 9 (2) of the Act 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 seminars, meetings, conferences, educational course, contest, fellowship, research work or sponsorship.”
What this essentially means is that Nestle is not allowed to provide any of its products to an individual healthcare worker or their family, with the intent of promoting the product. Furthermore, the BPNI has noted in a letter written to Union Health Minister Dr Harsh Vardhan that the research was not even cleared or approved by an ethics committee.
“Perusal of the Clinical Trial Registry maintained by the Indian Council of Medical Research (ICMR) has revealed that Nestle India Limited, a producer of infant milk substitutes is sponsoring research titled ‘Multicentric Observational Study to Observe Growth in preterm hospitalized infants’ in the following hospitals,” reads the letter from BPNI to the Health Minister.
The research 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, however, it has been pointed out that this research began without Nestle having received permission.
Public health expert Dr Sylvia Karpagam points out that the Ministry has asked the ICMR to regulate a trial which has already begun without any permissions.
“This is not the first time that Nestle has tried to enter the market. They don’t follow protocols. They have been trying to bring in un-regulated baby food into the market. This research has not even been approved by an independent ethics committee. Nestle is violating the IMS Act. They should adhere to the law. We are talking about food for infants,” she reportedly said.
Nestle, however, has denied the allegations.
"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 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 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 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," stated the company spokesperson to TNM in an email.
In January, Nestle was under the scanner for the same reasons after allegations that the company had been influencing doctors to recommend the company’s baby products (including milk powder for infants) to parents.