New Delhi: The Indian Council of Medical Research (ICMR) has recommended penalties for two clinical trials on baby foods, funded by Nestle and its subsidiary Nestec, which makes a range of baby food products.
The issue came to light when it was raised by Dr Arun Gupta, a paediatrician from the Breastfeeding Promotion Network of India (BPNI). BPNI has been notified by the government to monitor acts of compliance or non-compliance of the Infant Milk Substitutes (IMS) Act.
Gupta wrote to ICMR stating that Nestle and its subsidiary Nestec were infringing the IMS Act.
One of the trials sponsored by Nestle is about growth in pre-term babies. This was apparently not approved by an independent ethics committee. Another two trials are sponsored by a Nestle subsidiary called Nestec, and is about a study of milk composition from adequately nourished and undernourished mothers and on infant feeding practice and gut-comfort.
The study by Nestle was being done in five premier hospitals, including Cloudnine Hospital (Bangalore), Institute of Child Health (Kolkata), Manipal Hospital, (Bangalore), Sir Ganga Ram Hospital (New Delhi) and the Calcutta Medical Research Institute (Kolkata). The studies by Nestec have institutions from Mysore, Pune, Bangalore, Delhi, Chennai, Mumbai and Kolkata participating.
The ICMR has now taken a unanimous decision and asked India’s clinical trial registry to take action.
The ICMR put together a committee to look into this and found that the complaint raised by BPNI was “well-founded” and that the various studies which the BPNI had flagged off were indeed in violation of the IMS Act.
This is because the IMS Act prohibits the baby food industry from funding research on baby foods in India.
Because of this, the ICMR committee has recommended that the study be terminated immediately and the clinical trial registry reflect this change along with the reason for the change.
The ICMR also says that the Indian drug controller should examine whether there were ethics committees which assessed and allowed the studies and whether those committees were legitimately constituted. The ethics committees also have to explain how they permitted these studies to be conducted even though they violated the IMS Act.
The ICMR also says that the drug controller needs to invoke prosecution of Nestle and Nestec under Sections 20, 21, 22 of the Act. These sections allow for imprisonment up to three years and fines up to Rs 5000, or both.