No Government Permission, But Two Foreign Firms Collected Indians’ Genome Data
In a recent development, it has been alleged by a section of Indian scientists that two biomedical companies from the US and Singapore conducted a major study involving genetic data of more than 15,000 Indians without obtaining the necessary clearances from the government. These allegations have prompted a demand for a thorough investigation into the matter.
The study, carried out by New York-based Regeneron and Global Gene Corporation (now known as Anuva), Singapore, was presented at a scientific conference in Los Angeles in late October. The researchers collected samples from various states in India, including Rajasthan, Maharashtra, Uttar Pradesh, Gujarat, and Karnataka. The study aimed to explore genetic variations within the Indian sub-populations and was described as the largest of its kind to date.
However, in response to a Right to Information (RTI) query, the Union government categorically denied giving permission to the two companies for collecting gene data. It is mandatory for every foreign project involving Indian human biological material to obtain clearance from the Health Ministry’s Screening Committee in order to prevent the misuse of such samples, including genomics data. Even if an Indian research partner is
involved, HMSC clearances are still required. In this case, the Indian Council of Medical Research (ICMR), which acts as the technical arm for the HMSC, stated that no proposal from either Regeneron Genetics or Global Gene Corp Pvt Ltd was submitted to the committee. The ICMR also claimed to be unaware of the study altogether.The alleged unauthorized collection of genetic data by these companies has raised concerns among Indian scientists. Vinod Scaria, a senior scientist at the Institute of Genomics and Integrative Biology in Delhi, expressed his concerns by saying, “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.” He further emphasized the need for a fair investigation into the matter and urged for clarity on how the samples were collected and what ethical clearances were obtained. Scaria believes that oversight is necessary for all Indian genetic research involving human samples due to the commercial potential of such discoveries.
When approached for clarification, a representative from Regeneron stated that their collaborator, Anuva (previously known as Global Gene Corp), was responsible for collecting and transferring the samples for sequencing under the collaboration. Regeneron emphasized their commitment to data privacy and participant consent, stating that they take these matters extremely seriously. They also stated that they hold their collaborators to the same high standard. However, Anuva did not respond to queries from media outlets.
The presentation of the study at the annual meeting of the American Society of Human Genetics created a stir among geneticists, as the researchers claimed that it was the largest genetic study of Indian sub-populations to date. The initial results presented by Manav Kapoor, a Regeneron scientist and corresponding author of the study, received praise from his team members, who expressed their belief that as the sample sizes increase, the results will become even more significant. The researchers also mentioned that the study could help identify specific genetic factors associated with illnesses like cardiovascular disease and vertigo in the Indian population.
In conclusion, the alleged unauthorized collection of Indians’ genome data by two foreign companies has raised concerns among Indian scientists. The lack of government permission and mandatory clearances for the study has triggered a demand for a thorough investigation to ensure the ethical and legal aspects of such research are stringent and properly followed.
