While conducting such clinical trials, the approval of the Drug Controller General of India (DCGI) is required. “In the application, Nestle mentions that regulatory clearance from DCGI is not required. So, who then monitors such trials? Also, the application does not disclose who all are there in the ethics committee within these hospitals to approve such trials. Are there paediatricians, nutritional experts and what expertise do they have for approving such trials. In fact, the trial was conducted at Calcutta Medical Research Institute even before the in-house ethics committee approved the trial,” underscored Nidhi.

“The Ministry has directed ICMR to regulate a trial that is already underway. The question is how are such trials happening under the watch of ICMR? You can’t regulate a trial retrospectively. It has to be done before the trials begin,” explained Dr Sylvia Karpagam, public health doctor and researcher.

“This is not the first time that Nestle has tried to enter the market. They don’t follow protocols. They have been trying to bring in un-regulated baby food into the market. This research has not even been approved by an independent ethics committee. Nestle is violating the IMS Act. They should adhere to the law. We are talking about food for infants,” observes Karpagam.

“When such trials are held, doctors get monetary benefits. They begin to promote powder food for babies even when it is not necessary. They keep telling the mother that the baby is not being fed well. There is no need for any other liquid or powder for a baby till six months,” says Karpagam.

Unregulated clinical trials are a norm in India. “In a report by PricewaterhouseCoopers on emerging markets in India, it had stated that the country is a good ground for clinical trial,” highlighted Karpagam.

According to a Supreme Court ruling, clinical trials can be approved in India only in three instances. If it is related to an unmet medical need of the country; In case of innovations vs existing therapy and on basis of the risk benefit analysis.

“Nestle’s clinical trials don’t fall under any of these categories. It is not a ‘need’. Here, premature babies are being put at risk. The country spends crores to improve infant mortality rates and here babies are put at risk with this trial. Moreover, Nestle has only commercial interests on its mind,” insists Nidhi.