A committee constituted by the Indian Council for Medical Research (ICMR) has concluded that the company’s sponsorship of a five-hospital study violates India’s law on infant milk substitutes. The committee has recommended immediate termination of the study and prosecution of the violators (researchers and company). The development comes even as two more instances of Nestle sponsoring clinical trials have been brought to the attention of ICMR .

The Breastfeeding Promotion Network of India (BPNI), notified by the government to monitor compliance of the Infant Milk Substitutes (IMS) Act, had brought the five-hospital study to the notice of the health ministry and the ICMR on July 17.

The health ministry wrote to the ICMR on August 2 asking for the complaint to be examined and for necessary action. The ministry also sought steps “to ensure that all trials in future are screened for any infringement of the IMS Act”.

Two other studies that BPNI wrote about to ICMR on August 26 involved subsidiaries of Nestle. These are a multi-country observational study on infant feeding registered in December 2018 that lists Societe des Produits Nestle in Switzerland as its primary sponsor and another observational study on composition of milk of nourished and under-nourished mothers with funding and sponsorship of Nestec Ltd of Switzerland, which was registered in 2014. Both studies include several well-known hospitals such as Apollo Childrens Hospital, Chennai, Sir Ganga Ram Hospital, Delhi, Hiranandani Hospital, Thane, and a Bangalore hospital of the Narayana Health Group.

The ICMR constituted a committee, which in its report stated that “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”.

Section 9(2) of the Act states: “No producer, supplier or distributor shall offer or give any contribution or pecuniary benefit to a health worker or any association of health workers, including funding of seminar, meeting, conference, educational course, contest, fellowship, research work or sponsorship.”

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 stated that the Drug Controller General of India (DCGI) should examine 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. Nestle has been arguing that its sponsorship of such studies does not amount to violating the IMS Act.

Trials sponsored by Nestle or its subsidiary

Registered in 2014- - Study of milk composition from adequately nourished and undernourished mothers

Sponsor-Nestec Ltd, CH-1800 Vevey, Switzerland

Dr Sarika Prasad- Adhithya Adhikari Hospital, Mysore

Dr Nandini Malshe- Bharati Hospital & Research Centre Main Building

Dr Anil Kumar Sapare- Mazumdar Shaw Medical Centre, Narayana Hrudayalaya, Bangalore

Dr Neelam Kler- Sir Ganga Ram Hospital, New Delhi

Registered in December 2018- Infant feeding practice and Gut comfort: Multi-country, cross-sectional observational study

Dr K Dhanasekhar- Apollo Childrens Hospital, Chennai

Dr Praveen Gokhale- Dr Praveen Gokhale’s Children’s Clinic and 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

Dr R Kishore Kumar- Cloudnine Hospital Bangalore

Dr Apurba Ghosh- Institute of Child Health, Kolkata

Dr Ravi Shankar Swamy- Manipal Hospital, Bangalore

Dr Neelam Kler- Sir Ganga Ram Hospital New Delhi

Dr Saugata Acharyya- The Calcutta Medical Research Institute, Kolkata

