ICMR orders prosecution against Nestle, top Hospitals including Gangaram, Manipal for clinical trial on premature infants
New Delhi: Top-notch hospitals of the country including Manipal Hospital, Ganga Ram Hospital and others have been directed by the Indian Council for Medical Research (ICMR) committee to end the clinical trials on 75 premature infants sponsored by Nestle. The committee noted that the research violates Infant Milk Substitutes(IMS) Act and ordered prosecution of the company and the researchers involved.
This comes following the orders given by the Union Health Secretary Preeti Sudan to ICMR Director Balram Bhargava to "get the trial examined and take necessary action to comply with the provisions of the IMS Act".
The issue was flagged last month 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.
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 allegedly ridiculed 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 leading manufacturer of infant milk substitutes and infant foods, including Lactogen and Nan, was 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 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 had been pointed out that this research has begun without Nestle having received permission by any independent ethics committee.
On receiving the complaint, Union Health Secretary directed ICMR Director Balram Bhargava to "get the trial examined and take necessary action to comply with the provisions of the IMS Act" and also ensure that all such clinical trials are first screened for infringement of the IMS Act in future.
The committee examined the same and submitted its report stating that the "the complaint is well-founded" and that "the study is violative of section 9(2) of the IMS Act" and that it was "funded and sponsored by Nestle India, which is a producer/supplier/ distributor on infant milk substitutes as defined under the Act".
As per a media report by TOI, the ICMR committee recommended termination of the study and for its status in the Clinical Trial Registry of India (CTRI) to show the reasons for termination. It further mentioned that the Drug Controller General of India (DCGI) should investigate whether the respective institutional ethics committees that permitted the studies were constituted in accordance with existing regulations.
It said, "the respective ethics committees may be directed to explain how they permitted such study in violation of the IMS Act".
The committee recommended the prosecution of the violators to serve as a deterrent. However, Nestle has been contending that its sponsorship of such studies does not amount to violating the IMS Act.