Nestle, 5 Top Hospitals Including Gangaram, Manipal under scanner over clinical trials on 75 premature infants: Govt asks ICMR to probe
New Delhi: Indian arm of Swiss food giant, Nestle has fallen under the Government's lens for allegedly sponsoring research in five Indian hospitals and conducting clinical trials on 75 premature infants in violation of Infant Milk Substitutes(IMS) Act. Ordering a probe in this regard, the Union Health Ministry has directed the apex medical research regulator, Indian Council of Medical Research (ICMR) to investigate the matter and take necessary action.
The leading manufacturer of infant milk substitutes and infant foods, including Lactogen and Nan, has been allegedly found to sponsor research in hospitals namely Cloudnine Hospital (Bengaluru), Institute of Child Health (Kolkata), Manipal Hospital (Bengaluru), Sir Ganga Ram Hospital (New Delhi) and Calcutta Medical Research Institute (Kolkata).
The order came following an alert flagged by an NGO, Breastfeeding Promotion Network of India (BPNI), that discovered the alleged violation of Section 9(2) of the IMS Act, on screening the trial registry of the ICMR.
Under this Act, producers, suppliers or distributors of infant milk substitutes cannot
"offer or give contributions or pecuniary benefits to health workers or any associations of health workers, including funding of seminar, meeting, conference, educational course, contest, fellowship, research work or sponsorship".
Section 9 of the IMS Act states that 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.
As per BPNI's complaint, Nestle India was allegedly ridiculing the stringent Indian law by financing and providing material support to five hospitals for a research trial titled, "Multicentric Observational Study to Observe Growth in Preterm hospitalized infants". Dr Monjoni Mitra of Medclin Research is the trial co-ordinator and research director of the trial registered under the ICMR.
The trial was conducted on 75 premature babies between the age of 28-34 weeks. The objective of the study was to assess the growth and feeding patterns in preterm infants. One of the exclusions was that the babies could not be fed milk substitute within 48 hours of birth, but from the third day onwards, the trial suggested that the infant could be given a milk substitute instead of breast milk.
According to the law, all clinical trials conducted in India must obtain permission from the Drug Controller General of India (DCGI), however, it has been pointed out that this research began without Nestle having received permission by any independent ethics committee.
However, speaking to Deccan Herald Dr Anoop Amarnath, chief of clinical services, Manipal Hospital denied any such wrongdoing.
"There are absolutely no such nutritional studies being approved or carried out at any of our hospitals. We encourage breastfeeding and are one of the few centres who have specialised lactation consultants to promote breastfeeding, " Dr Amarnath told Deccan Herald.
On receiving the complaint, Union Health Secretary Preeti Sudan on Friday (August 2) directed ICMR Director Balram Bhargava to "get the trial examined and take necessary action to comply with the provisions of the IMS Act".
She further directed Prof. Bhargava to ensure that all such clinical trials are first screened for infringement of the IMS Act in future.
Responding to the allegations, a spokesperson for Nestle India emphasised that the company always complied with all laws and regulations including the IMS Act. The company further added that the objective of the clinical study is to encourage science-based research. Moreover, the 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, " reads the company's statement.
Prior to this, in January, Nestle was under Union health Ministry scanner for violating the same law, the IMS Act, over allegations of influencing doctors to recommend its baby products, including infant milk powder, to parents, reports The News Minute.