Two studies related to new mothers and babies, sponsored by Switzerland-based multi-national Nestle, have been found illegal by the Indian Council of Medical Research (ICMR). The research body noted this after forming a committee to discuss the issue.
The two studies were titled - ‘Study of milk composition from adequately nourished and undernourished mothers,’ and ‘Infant feeding practice and gut comfort: A multi-country-sectional observation.’
In the first study, it was proposed to collect breast milk samples of 260 new mothers between 18 to 40 years over six months to analyse it’s components like fat, lactose, energy, solid and crude proteins.
This was to be conducted in Adhithya Adhikari Hospital in Mysore, Bharati Hospital in Pune, Mazumdar Shaw Medical Centre in Bangalore and Gangaram Hospital in New Delhi.
The second study proposed to enroll 4000 new borns between 37 to 42 weeks who are being exclusively breastfed or are on exclusive formula feeding for ascertaining their gut comfort in five countries – Egypt, India, Indonesia, Malaysia and Pakistan. In India, Chennai-based Apollo Childrens Hospital, Thane-based Dr Praveen Gokhale’s Clinic and Dr LH Hiranandani Hospital as well as Kolkata-based ICH Hospital, were participating in the study.
‘Studies to be terminated immediately’
The ICMR committee noted, “The studies in question are violative of Section 9(2) of Infant Milk Substitute Act 1993 as amended in 2003, given the fact that the study falls under the definition of research work, and the study is funded and sponsored by Nestle India, which is a producer, supplier/distributor of Infant Milk Substitutes.”
The committee has further stated that these studies should be terminated immediately. It has opined that the investigators of the studies should be asked to change the registration status to ‘terminated,’ under the Clinical Trials Registry of India (CTRI), which keeps a record of all ongoing trials in India.
The committee has also said that the Drug Controller General of India (DCGI) should examine whether the respective instituitional ethics committees which permitted these studies were constituted in accordance with existing regulations. It has also asked for an explanation so as to how such a study which is in violation with the law, was permitted in the first place by hospitals.
The ICMR committee has asked for sensitisation of the CTRI regarding provisions of IMS Act. It said that if the CTRI believes there is an infringement of the Act in an Indian study which has been submitted to them for registration, then it should defer registering such a study and bring it to the notice of appropriate authorities.