A clinical trial sponsored by infant milk substitutes and infant foods maker Nestle has violated Indian law under the Infant Milk Substitutes (IMS) Act.
The research was titled ‘Multicentric Observational Study to Observe Growth in Preterm hospitalized infants’.
The Breastfeeding Promotion Network of India (BPNI) has confirmed that Nestle India conducted clinical trials on 75 premature babies in five hospitals on substitutes for breast milk.
The trial was supported by five major hospitals in India namely, Cloud nine Hospital in Bangalore, Institute of Child Health in Kolkata, Manipal Hospital in Bangalore, Sir Ganga Ram Hospital in New Delhi, and the Calcutta Medical Research Institute in Kolkata.
The issue came to light when BPNI examined the ICMR Clinical Trial Registry maintained by the Indian Council of Medical Research (ICMR).
BPNI central coordinator Dr Arun Gupta said: “This is a gross and blatant violation of the IMS Act, and attracts the section 9.2, demanding strict action by the authorities.
“The hospital receiving such monetary or material Support need to be aware that violation of the IMS Act is a criminal offence; cognisable under IPC.”
According to the Indian law, manufacturers are prohibited from sponsoring or funding medical research or financing any part of the health care system.
BPNI has written a letter informing the Indian Ministry of Health and Family Welfare regarding the violation of the act.
The health ministry has ordered the ICMR to examine the compliant and take necessary action, as well as to screen all future trials for any infringement of the act.