A Nestle-sponsored trial has blatantly violated Indian law as a CRO, local research sites and investigators conducted clinical trials on 75 premature babies in five hospitals on substitutes for breast milk in complete contravention of the infant Mil Substitutes Act. The study was titled “Multicentric Observational Study to Observe Growth in Preterm Hospitalized Infants.”
Advocacy Group identifies the Act
The Breastfeeding Promotion Network of India (BPNI) found the clinical trial and complained to the ministry of health and family welfare. Upon notice, Preeti Sudan, Health Secretary, directed the ICMR Director Balram Bhargava to monitor compliance of the clinical trial within the law, reports the National Herald of India. ICRM was reprimanded for not enforcing their duties. Nestle is in violation of Section 9(2) of the IMS Act, according to the report from the National Herald of India.
The National Herald of India reported that the clinical trial was conducted on 75 premature babies between the age of 28-34 weeks. The sponsor, Swiss-based Nestle, sought to assess the growth and feeding intolerance in preterm infants. The protocol included an exclusion that an infant could not be fed a milk substitute within 48 hours after birth, however, upon the third day the trial design opened up access to the preterm infants to administer milk substitute.
The Culpable Value Chain
If this legal violation is true, there must be accountability not only with the sponsor but, importantly, with the clinical research site and even regulators that may have looked the other way within ICMR. Dr. Monjoni Mitra of Medclin Research represents the coordinator and research director for this trial. The five participating hospitals, all privately held, which undoubtedly have culpability should these allegations be true include:
- CloudNine Hospital (Bengaluru)—“the best pregnancy maternity care in India”
- Institute of Child Health (Kolkata)—“one of the first pediatric institutes in India”
- Manipal Hospital (Bengaluru)—“best hospital in Bengaluru”
- Sir Ganga Ram Hospital (New Delhi)—“committed to world class research”
- Calcutta Medical Research Institute (Kolkata)—“good health starts with great care”
The lead physicians involved with this study include:
- R. Kishore Kumar
- Apurba Ghosh
- Ravi Shankar Swamy
- Neelam Kher
- Saugata Acharyya
Why Is there Such a Law
Premature babies are in a precarious state. First and foremost, they probably shouldn’t be in a food product study regardless of law—just plain ethics would lead one to a different conclusion than these hospitals and doctors made. Was there money involved? Preterm babies must be taken care of with extreme care. Protective laws are there for a reason.
Nestle Seeks Market Expansion
Nestle is one of the largest food companies in the world. They have sought to enter and expand in the Indian market, which is approaching 1.4 billion—a massive market. Apparently, according to quotes in the National Herald of India, their research wasn’t even approved by an independent ethics committee (what we would call an IRB in the U.S.). This by itself is outrageous. We do not think Nestle leadership would be aware of this kind of egregious error.
Clinical Trials Rules in India
India’s clinical trials past is haunted with legal and ethical violations. Then, perhaps, the Indian Supreme Court went too far over-regulating in reaction to some traumatic situations, including deaths. The Indian Supreme Court rules that clinical trials can be approved in India only in three situations: 1) if it is related to an unmet medical need of the country; 2) in case of innovations vs. existing therapy and 3) on basis of the risk benefit analysis.
But, as reported in this story, the Indian norm increasingly becomes unregulated clinical trials. A report by PricewaterhouseCoopers on emerging markets in India touts the fertile grounds for clinical trials.
Apparently, Nestle’s study didn’t fit into any of these categories.
The Fall Guy (or Gal in this case)
There must be at least one fall guy in this story. Probably suiting would be CRO Medclin Research.
After all, they are the ones that Nestle paid to organize this study. Nestle potentially has a defense—the sites and investigators listed above—probably not.
What does Medclin Research Private Limited do? “A clinical research organization has been developed with a team of astute medical professionals and allied subjects in relevant areas. Originally an academic CRO formed in 2006, they undoubtedly started off good but at least some of their executives, especially Dr. Monjoni Mitra, need to be held accountable should these allegations be proven true in the courts.
Who is Dr. Mitra? Well, first, she is now on the TrialSite News investigator watch data base. She is a founding member of Medlcin Research and Associate Professor of Child Health, Kolkata. She has been active in immunization programs and studies and has published numerous papers. We at TrialSite New would think she would be well-versed in Indian clinical trials law.
Good Sponsors; Good Sites; Good Investigators
Markets become more intelligent by the day; with internet, smart phones, and social media, the world becomes a much smaller place. For example, the individuals listed in this story are being put on the TrialSite News Site Watch and Investigator Watch database. That’s right. We have a data base that not only factors in previous incidents, warning letters and the like; in real time, we are always adding to the list. It is unfortunate that the world’s biggest actors conspire to add to our list.
After all, there are a lot of really fantastic sponsors, sites, and investigators. They believe in not only what they are doing but in the legal, ethical and moral frameworks that govern clinical research. And this is kind of our point. Quality, safety and productivity are a culture; a mind-set; and a way of being and seeing the world—not merely a checklist to cover on’s proverbial butt. The longer term, well-intentioned and ethical producers will generate more value to society—it may not always translate to immediate cash—but for a clinical research program led to build greater, more enduring, longer-term outlooks—based on localization of ethics, morals and principals and adherence to rule of law, the returns are enduring.