The Indian Council of Medical research has ordered terminating two clinical trials on baby foods funded by Nestle for violating the Indian law. 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 issue was raised by Dr Arun Gupta, a paediatrician from the Breastfeeding Promotion Network of India (BPNI). BPNI has been notified by the government to monitor acts of compliance or non-compliance of the Infant Milk Substitutes (IMS) Act. Dr Gupta pointed out that the Nesle and the Nestec, it’s subsidiary, were infringing the IMS Act. According to his opinion, 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”, he adds.
The Infant Milk Substitutes, Feeding Bottles and Infant Foods act of 1992, as amended in 2003, has a section which prevents baby food manufacturers from undertaking any steps which can influence the doctors including research. One of Nestle’s research was about the growth in pre-term babies. But this was not approved by an independent ethics committee. Another two trials, sponsored by a Nestle subsidiary called Nestec was about a study of milk composition from adequately nourished and undernourished mothers and on infant feeding practice and gut-comfort.
Now, the clinical trial registry of India has been directed to take action based on a recent ICMR report on a third study, funded by nestle. 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. Also, ICMR recommends invoking the prosecution provisions against the company to “act as a deterrent for similar acts of commission and omission in the future.”
At the same time, the company 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 study by Nestle was being done in five premier hospitals, including Cloudnine Hospital (Bangalore), Institute of Child Health (Kolkata), Manipal Hospital, (Bangalore), Sir Ganga Ram Hospital (New Delhi) and the Calcutta Medical Research Institute (Kolkata). The studies by Nestec have institutions from Mysore, Pune, Bangalore, Delhi, Chennai, Mumbai and Kolkata participating.
Source: The Wire, Deccan Herald.