No govt permission, but 2 foreign firms collected Indians’ genome data

Two biomedical companies from the US and Singapore carried out a major study involving genetic data of more than 15,000 Indians without mandatory clearances from the government, a section of Indian scientists have alleged, seeking a probe into the episode.

Carried out by New York-based Regeneron and Global Gene Corporation (now known as Anuva), Singapore, the research was presented at a scientific conference in Los Angeles in late October.

Samples were drawn from Rajasthan, Maharashtra, Uttar Pradesh, Gujarat and Karnataka for the study which was described as the largest of its kind to date to explore genetic variations in Indian sub-populations.

But the Union government, responding to an RTI query, categorically denied giving permissions to the two companies to collect gene data.

Every foreign project involving Indian human biological material requires permission from the Health Ministry’s Screening Committee to check misuse of such samples including genomics data. The HMSC clearances are mandatory even with the involvement of an Indian research partner.

“No proposal from any Indian investigator from Regeneron Genetics or Global Gene Corp Pvt Ltd was submitted to HMSC,” the Indian Council of Medical Research, which acts as the technical arm for the HMSC, said in a RTI response.

The council said neither the HMSC nor the ICMR were aware of the study.

“A pharmaceutical major has taken out 15,000 human samples, did genomes, and gave a talk at the annual meeting of the American Society of Human Genetics without following the rules of the land," said Vinod Scaria, a senior scientist at the Institute of Genomics and Integrative Biology, Delhi.

"This opens up more questions than answers. I hope a fair investigation is initiated on this matter, and the facts brought out.”

Scaria further said: "We don’t know how they collected the samples and what ethical clearances they obtained. An oversight is needed for all Indian genetic research involving human samples because of the commercial potential of such discoveries.”

Asked to clarify, an official from Regeneron, in an email response, told DH, “Our collaborator Anuva (previously known as Global Gene Corp) collected and transferred the referenced samples for sequencing under the collaboration. Accordingly, please direct all questions to Anuva regarding the referenced samples.”

Regeneron said it "takes data privacy and proper participant consent extremely seriously". "We are committed to acting responsibly and safeguarding the data with which we are entrusted. We hold our collaborators to the same standard,” the official said.

Anuva did not respond to DH queries till the time of filing the report.

The presentation made at the annual meeting of the American Society of Human Genetics created a stir among geneticists as the researchers claimed that it was the biggest genetic study of Indian sub-populations.

“The initial results that Manav (Manav Kapoor, a Regeneron scientist and corresponding author of the study) presented look amazing and with increasing sample sizes these results will get even better,” tweeted Veera M Rajagopal, a team member from Regeneron, on Oct 29, underscoring how the research would help identify specific genetic factors linked to illnesses like cardiovascular disease and vertigo among Indians.