Two foreign biomedical entities conducted what they have described as the largest genomics study so far on Indian populations without mandatory approval from a government screening panel, scientists have alleged, citing documents obtained under the Right to Information Act.

Researchers with the US-based Regeneron Genetics Centre and the Singapore-based Global Gene Corp have analysed the genomes of 15,514 people from Gujarat, Karnataka, Maharashtra, Rajasthan and Uttar Pradesh to “tease apart” genetic differences across these five linguistic and sociocultural groups.

But the Indian Council of Medical Research, the country’s apex health research agency, has said that neither Regeneron nor Global Gene Corp had sent any proposal on the study to the Health Ministry’s Screening Committee (HMSC), a panel that needs to approve international research proposals.

The HMSC is an institutional mechanism working since the 1980s that evaluates research proposals on the basis of scientific significance, justification for foreign collaboration and national health priorities as well as the angles of national security and sensitivity.

“It is surprising that foreign research entities have been able to conduct such a large study involving thousands of genome samples without mandatory HMSC clearance,” said Vinod Scaria, a genomics scientist at the government-run Indian Institute of Genomics and Integrative Biology (IGIB), New Delhi.

The ICMR, responding to queries filed by Scaria under the RTI Act, has said no proposal from any Indian investigator, Regeneron, or Global Gene Corp had been submitted to the HMSC and neither HMSC nor the ICMR was aware of the study. The ICMR said it was not aware of any “alternative” avenues for studies on Indian human biological samples without the required HMSC clearance for international studies.

This newspaper sent email queries to Regeneron and Anuva, previously known as Global Gene Corp, seeking their perspectives on the ICMR observations. Regeneron responded.

In an email response, Regeneron said its collaborator Anuva had “collected and transferred the referenced samples for sequencing under the collaboration”.

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

The query to Anuva had not evoked any response till Friday night.

A media release issued by Global Gene Corp and the Regeneron Genomics Centre in March 2018 indicated that their genomics project had the approval of India’s National Investment Promotion and Facilitation Agency, a unit under the Union commerce ministry.

“Invest India is supporting Global Gene in building worldclass capabilities in Mumbai and Ahmedabad. We believe genomics will help India achieve a paradigm shift in healthcare,” the media release had quoted an Invest India official as saying.

The release had also quoted Alan Shuldiner, vice-president and co-head of the Regeneron Genomics Centre, as saying that a deeper understanding of the genetic architecture and disease burden in populations across the Indian subcontinent will “enable the identification of novel genes associated with many rare and common diseases, potentially facilitating therapeutic development, diagnosis, and delivery of precision medicine”.

Scientists and health research officials say the HMSC is tasked with examining proposals to determine that they adhere to protocols governing the ethics of research on humans and to ensure that India’s contributions are acknowledged if the research yields any commercial benefits.

The HMSC panel includes officials from the health, external affairs, finance, science and technology ministries, the department of health research, and the directorate-general of armed forces medical services, among others.

Scaria said that posts on Twitter in October this year describing some of the study’s content presented at a meeting of the Genomics Society in the US had alerted him to the project and prompted him to send RTI queries to the ICMR.