India’s ICMR panel calls for termination of the Nestle sponsor clinical trial for milk substitutes. It has ruled that the Swiss company’s sponsorship of a five-hospital study violates India’s law on infant milk substitutes. ICMR is recommending not only immediate termination of the clinical trial but also the prosecution of the violators (researchers and company). This development occurs even as more examples of ongoing examples of Nestle sponsoring clinical trials has been identified by the government reports the Times of India.
TrialSite News SiteWatch Covered this Story
TrialSite News covered this topic in early August when it was apparent that a rogue CRO clinical investigator was conducting Nestle sponsored research on premature infants for baby food product—despite clear laws in India governing such behavior.
We suspected that at least the local CRO (Medclin Research) and five hospitals appeared to be complicit in violating the Indian Infant Milk Substitutes Act. The study was titled “Multicentric Observational Study to Observe Growth in Preterm Hospitalized Infants.” We contemplated that perhaps Nestle was too far removed from the study as a company that size with such sophistication wouldn’t knowingly violate such a national law.
Recent Updates: Nestle & Research Sites on Prosecution List
Now it turns out that ICMR organized a committee for an extensive probe into the Nestle study we covered—as well as two additional studies sponsored by Nestle. The Times of India reports that the ICMR constitutes a committee, which in its report stated that “complaint is well-founded” and hence the “study is violative of section 9(2) of the IMS Act” and moreover that the observational study was directly sponsored and funded by Nestle.
The Times of India reports that the committee recommended the prosecution of the violators for purposes of serving as a deterrent for future actions. Nestle’s position in India has been that just because it sponsors such a trial doesn’t mean it has violated the IMS Act.
The List for SiteWatch Challenged
The Times of India went on to list the trials sponsored by Nestle or its subsidiary and includes the providers/research sites and investigators TrialSite News included in its last article on this topic. The list includes:
Registered in 2014: Study of Milk Composition from adequately nourished & undernourished mothers
- Dr. Sarika Prasad—Adhitya Adhikari Hospital, Mysore
- Dr. Nandini Maishe—Bharati Hospital & Research Center, Main Building
- Dr. Anil Kumar Sapare—Mazumdar Shaw Medical Centre, Narayana Hrudayalaya, Bangalore
- Dr. Neelam Kler—Sir Ganga Ram Hospital, New Delhi
Registered in 2018—Infant feeding practice and Gut comfort: Multi-country, cross-sectional observational study
- Dr. K Dhanasekhar, Apollo Children’s Hospital, Chennai
- Dr. Praveen Gokhale, Dr. Praveen Gokhale’s Children’s Clinic & Vaccination Centre, Thane
- Dr. Praveen Gokhale, Dr. L.H. Hiranandani Hospital, Thane
- Dr. Monjori Mitra—ICH Hospital, Kolkata
Registered in December 2018, Multicentric Observational study to observe growth in preterm hospitalized infants (the original study TrialSite News covered)
- R. Kishore Kumar
- Apurba Ghosh
- Ravi Shankar Swamy
- Neelam Kher
- Saugata Acharyya
The Institutions involved with this study as reported in our last article.
CloudNine Hospital (Bengaluru)— “the best pregnancy maternity care in India”
Institute of Child Health (Kolkata)—“one of the first pediatric institutes in India”
Manipal Hospital (Bengaluru)—“best hospital in Bengaluru”
Sir Ganga Ram Hospital (New Delhi)—“committed to world-class research”
Calcutta Medical Research Institute—“good health starts with great care”
It would appear that the Indian government will prosecute those that are involved with what appears to be a case of violation of Indian law on behalf of Nestle and a dozen-plus Indian research centers and clinical investigators/physicians. TrialSite News SiteWatch exists to track clinical research sites’ actions—whether good or not good—and report on those actions. For a site to be placed on the “Leading Sites” or “Challenged Sites” isn’t indicative of an entire organization—it merely represents either a positive or a negative data point. In this case, we register these Indian institutions on our Site Watch Challenged Sites. We recommend global commercial sponsors factor in this incident and request an explanation prior to contracting with these groups for any future clinical trials in India.Source: The Times of India