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POLICY & REGULATIONS

MoHFW seeks ICMR chief’s examination of alleged IMS violations by Nestle
Saturday, 10 August, 2019, 08 : 00 AM [IST]
Ashwani Maindola, New Delhi
The Ministry of Health and Family Welfare (MoHFW) has sought an examination from the director general, Indian Council of Medical Research (ICMR) of the alleged violations of the provisions of the Infant Milk Substitute (IMS) Act by Nestle.

In the letter, Preeti Sudan, secretary, MoHFW, wrote that the Breastfeeding Promotion Network of India (BPNI), which was notified by the Government of India to monitor compliance of the IMS Act, has informed MoHFW regarding violation of IMS Act by Nestle India Limited and five participating hospitals, as per provisions of Section 9(2) of IMS Act, no producer, supplier or distributor referred to in Sub-section (1), shall offer or give any contribution or pecuniary benefits to a health worker or association of health worker, including funding of research work, sponsorship, etc.

The matter was related to a clinical trial conducted by Nestle upon newly-born babies.

In its letter to the ministry of health, BPNI wrote,“Perusal of clinical trial registry maintained by ICMR, has revealed that Nestle India Limited, a producer of IMS, is sponsoring research titled Multi-centric Observestional Study to observe growth in pre-term hospitalised infants, while the study is not even approved by any independent ethics committee.”

Five hospitals were named by the BPNI in the letter. These included Cloudnine Hospital Bengaluru; Institute of Child Health, Kolkata; Manipal Hospital Bangaluru; Sir Ganga Ram Hospital New Delhi, and The Calcutta Medical Research Institute, Kolkata.

Health activists also sounded alarmed over the alleged violations of the IMS Act. Sweta Khandelwal, head, nutrition research and additional professor, PHFI, said, “It is very unfortunate that food industries devise, invest in and/or play into such unethical strategies for commercial gains.”

“It is absolutely unacceptable and unpardonable. Such high levels of conflict of interest in research studies should be avoided at all costs. However, this is not the only company and evidence exists that several of them flout rules easily for profits,” he added.

“The lay public often does not know or understand such gimmicks and are likely to get influenced into buying products which get promoted due to biased study findings,” Khandelwal said.

He added, “This it is the moral duty of research and academic communities to conduct high-quality unbiased uncompromised studies and report findings in an ethical manner. Industry should also not interfere with the quality, conduct design and findings of research studies.”

“Also laws around such actions should be more stringent. Even if laws exist, their implementation is often sub-optimal and full of corruption. So, in addition to strong public health and nutrition laws, we must have a stricter and robust monitoring framework too,” Khandelwal said.

Meanwhile, reacting to the allegations, the Nestle India spokesperson 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).

The 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.

Section 9 of 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.”

The spokesperson added that this study was an institution-based study, all Institutional Ethics Committee approvals have been obtained from the participating sites.

“The letter from MoHFW has requested 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 spokesperson concluded.
 
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