Question : Genome India Project

(a) the current status of the ‘Genome India’ project including the number of people who have participated in it so far and the extent to which genome sequencing targets have been accomplished;
(b) whether as part of the AtmaNirbhar Bharat initiative, the Government labs have been barred from placing orders under Rs. 200 crore to import plastics and other materials required for genome sequencing thereby obstructing the ongoing progress of the project, if so, the details thereof and response of the Government thereto;
(c) whether the Government has identified alternative local sources for such materials and conducted a feasibility analysis for the same; and
(d) the details of proposed organisations having access to the data under the said project and the ethical guidelines being followed in the project to prevent misuse of data?

MINISTER OF HEALTH AND FAMILY WELFARE; MINISTER OF SCIENCE AND TECHNOLOGY; AND MINISTER OF EARTH SCIENCES
(DR. HARSH VARDHAN)

(a), (b), (c) & (d): A Statement is laid on the Table of the House.

STATEMENT IN RESPECT OF LOK SABHA STARRED QUESTION *347 TO BE ANSWERED ON 19/03/2021 REGARDING ‘GENOME INDIA PROJECT’
(a) In the Genome India Project so far, 4745 individuals have been recruited for the study. 759 samples out of these have undergone Whole Genome Sequencing (WGS) and 1161 samples have undergone Genome-Wide Association Study (GWAS) on high throughput arrays.

(b)& (c)The Department of Expenditure (DoE), Government of India vide OM No. F.12/17/2019-PPD dated 15.05.2020 amended Rule 161(iv)(b) of General Financial Rules (GFRs) 2017 stipulating that no Global Tender Enquiry (GTE) shall be invited for tenders upto Rs. 200 crores or such limit as may be prescribed by Department of Expenditure from time to time. However, in exceptional cases, where the Ministry or Department feels that there are special reasons for GTE, it may record its detailed justification and seek prior approval for relaxation to the above rules for the Competent Authority. Further, Department of Expenditure vide OM No. F.20/45/2020-PPD dated 08.01.2021 stipulated that for procurement of specialized equipment required for research purposes and spares & consumables for such equipment uptoRs. 200 crores for the use of educational and research institutes, Secretary of concerned Administrative Ministry/ Department shall be the Competent Authority to approve issue of GTEs.

The Genome India Project was sanctioned in mid-January 2020. The project was already started before issue of the said OM of DoE. The project progress was initially slowed down due to COVID-19 pandemic, and was not obstructed due to the government order on GTE. Now, the pace at which the Genome India project is progressing is reassuring that it would be completed well in time.
(d) All information about the subjects is anonymized and given a barcode. Thus, the privacy of the individuals is protected as mandated by ethical guidelines. Samples, socio-demographic information, phenotypic data, and genetic data are being barcoded and stripped of all identifying information (anonymized) of the participant and stored in a secure manner. Only properly anonymized data is being made available to researchers and investigators of this project as per the standard operating procedure of the project.

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