REPORT NO. 327

PARLIAMENT OF RAJYA SABHA

DEPARTMENT-RELATED PARLIAMENTARY STANDING COMMITTEE ON SCIENCE & TECHNOLOGY, ENVIRONMENT, FORESTS AND CLIMATE CHANGE

THREE HUNDRED TWENTY SEVENTH REPORT

DEMANDS FOR GRANTS (2020-2021) OF THE DEPARTMENT OF BIOTECHNOLOGY (DEMAND NO. 88)

th (Presented to the Rajya Sabha on 6 March, 2020) (Laid on the Table of on 6th March, 2020)

Rajya Sabha Secretariat, New Delhi March, 2020/ Phalguna, 1941 (Saka)

Website : http://rajyasabha.nic.in Email: [email protected]

Hindi version of this publication is also available

PARLIAMENT OF INDIA RAJYA SABHA

DEPARTMENT-RELATED PARLIAMENTARY STANDING COMMITTEE ON SCIENCE & TECHNOLOGY, ENVIRONMENT, FORESTS AND CLIMATE CHANGE

THREE HUNDRED TWENTY SEVENTH REPORT

DEMANDS FOR GRANTS (2020-2021) OF THE DEPARTMENT OF BIOTECHNOLOGY (DEMAND NO. 88)

th (Presented to the Rajya Sabha on 6 March, 2020) (Laid on the Table of Lok Sabha on 6th March, 2020)

Rajya Sabha Secretariat, New Delhi March, 2020/ Phalguna, 1941 (Saka)

C O N T E N T S

PAGES 1. COMPOSITION OF THE COMMITTEE (i)

2. INTRODUCTION (ii)

*3. ACRONYMS

4. REPORT 1-10

*5. RECOMMENDATIONS/OBSERVATIONS-AT A GLANCE

*6. MINUTES

______

* To be appended at printing stage

COMPOSITION OF THE COMMITTEE (2019-20) (Constituted on 13th September, 2019)

1. Shri Jairam Ramesh -- Chairman

RAJYA SABHA 2. Shri Anil Baluni 3. Shri R.S. Bharathi 4. Shrimati Vandana Chavan 5. Shri Hishey Lachungpa 6. Shri Parimal Nathwani 7. Shri Bhaskar Rao Nekkanti 8. Shri Ashwini Vaishnaw 9. Shri Ravi Prakash Verma 10. Shri Binoy Viswam LOK SABHA 11. Shri Guharam Ajgalley 12. Shri Pradan Baruah 13. Shri E.T. Mohammed Basheer 14. Shri Jashvantsinh Sumanbhai Bhabhor 15. Shri Sudarshan Bhagat 16. Shri Rameshbhai Lavjibhai Dhaduk 17. Shri Anantkumar Hegde 18. Shrimati Jyotsna Charandas Mahant 19. Dr. Swami Sakshiji Maharaj 20. Shri Asaduddin Owaisi 21. Shri S.R. Parthiban 22. Dr. Ranjan Singh Rajkumar 23. Shri Kotha Prabhakar Reddy 24. Dr. Jayanta Kumar Roy 25. Shrimati (Banerjee) 26. Shri Mahesh Sahoo 27. Shri Francisco Cosme Sardinha 28. Shri Anurag Sharma 29. Shri Ram Shiromani 30. Shri Kirti Vardhan Singh 31. Dr. Ramapati Ram Tripathi ______SECRETARIAT Smt. Sunita Sekaran, Joint Secretary Shri T. N. Pandey, Director Shri S. Rangarajan, Additional Director Shri Rajiv Saxena, Under Secretary Shri Harish Kumar, Committee Officer Shri Ankit Chansoria, Assistant Committee Officer (i) INTRODUCTION

I, the Chairman of the Department-related Parliamentary Standing Committee on Science & Technology, Environment, Forests and Climate Change, having been authorised by the Committee to present the Report on its behalf, present this Three Hundred Twenty Seventh Report of the Committee. This Report deals with the detailed Demands for Grants (2020-2021) of the Department of Biotechnology (Demand No.88).

2. In the meeting of the Committee held on the 17th February, 2020, the Secretary and other officers of the Department of Biotechnology gave an overview of the various activities of the Department and the Members sought clarifications on various aspects of the performance of the Department to enable it to scrutinise the Demands for Grants.

3. The Committee expresses its thanks to the officers of the Department for replying to the clarifications sought by the Members and placing before it the required material to enable it to scrutinise the Demands for Grants of the Department of Biotechnology.

4. The Committee considered and adopted the draft Report in its meeting held on the 4th March, 2020.

(JAIRAM RAMESH) NEW DELHI; Chairman, March 4, 2020 Department-related Parliamentary Standing Committee on Phalguna 141941 (Saka) Science & Technol ogy, Environment, Forests and Climate Change, Rajya Sabha.

(ii)

REPORT

1 The Department-related Parliamentary Standing Committee on Science & Technology, Environment, Forests and Climate Change considered the Demands for Grants 2020-21 of the Department of Biotechnology in its meeting held on the 17th February 2020. 2 BUDGETARY DETAILS FOR THE FINANCIAL YEAR 2019-20 AND ALLOCATION FOR 2020-21 2.1 The following table gives the details of the B.E., R.E. and actual expenditure of the Department in 2019-20 and budgetary allocations made to the Department for B.E. 2020-21: (Rupees in crore)

B.E. allocations 2019-20 made for Sl.No Name of Schemes year 2020- 21

B.E. R.E. Actual*

1. Secretariat 32.31 32.31 26.65 36.48

2. Biotechnology 1474.97 1315.34 1072.06 1580.00 Research and Development

3. Industrial & 280.20 230.70 192.97 322.67 Entrepreneurship Development

4. Autonomous 792.86 802.75 685.4 847.61 Institutions & PSU

Total 2580.34 2381.10 1983.33 2786.76

*Till 10.02.2020 2.2 The Committee was informed that the Department has been allocated Rs.256.74 crore less than what it had proposed for B.E. 2020-21. Upon enquiry by the Committee regarding the impact of this difference between the budgetary allocation made and budgetary allocation proposed, the Department submitted that this difference is not substantial and hence it would not have significant impact on implementation of major programs. The Department also informed that during the implementation of the Department‟s programmes, any additional funds, if required, would be requested at the R.E. stage. 2.3 The Committee notes that the Department has been allocated a total amount of Rs. 2786.76 crore in BE 2020-21 which is Rs. 405.66 crore (or 17 percent) higher than the allocation of Rs. 2381.10 crore at RE stage in 2019-20. The Committee also notes that this has been the highest increase in B.E. allocations since the last 5 years. 2.4 The Committee takes note that this increased allocation will be utilised for the new initiatives that the Department is planning to undertake across all concerned domains. It was informed by the Department that an additional amount of Rs. 160 crore in BE 2020-21 over BE 2019-20 was requested to cover establishment of new Bioinformatics Centre, UMMID Centres, Data Centres and to meet requirement of second release of Earth Bio-genome project, Microbiome project and Marine Bio-resource Network Program. The Committee was further informed that the programs on Artificial Intelligence and Cancer Imaging which have already been initiated would require an additional budget. An additional amount of Rs. 134.83 crores was requested in BE 2020-21 over BE 2019-20 for implementation of the programs on Biotechnology URJIT Cluster and phase II of Biotechnology AcE fund program. Further, additional budget is also required for meeting the commitment for ongoing projects and new projects being sanctioned during the year under PPP program, Biotechnology Park and cluster programs. 2.5 The Committee takes note of the new initiatives envisioned by the Department and extends its full support to the Department in achieving its goals. The Committee also recommends that the Department should collaborate with the private sector, start-ups and young researchers/innovators in the implementation of its initiatives, especially for programmes on Artificial Intelligence, Image recognition, Bio-genome project and Data Centres. SCHEMES OF THE DEPARTMENT 3 Biotechnology Research and Development: The Committee notes that the main objectives of the scheme are to support Investigator-initiated Research and Development, promote and nurture scientific excellence across all fields of life science research and create manpower and infrastructure base for life science research. 3.1 The Committee was informed by the Department that the scheme has an allocation of Rs.1315.34 crore at R.E. 2019-20 stage whereas the budgetary allocation for fiscal year 2020-21 is Rs.1580.00 crore which is Rs.265 crore more than the RE 2019-20. 3.2 The Committee notes that the B.E. 2020-21 allocation under this scheme is 20.12 percent higher than allocation at R.E. 2019-20. The Committee hopes that this increase in funds will be used judiciously and efficiently to carry out the new initiatives of the Department. 3.3 The Committee appreciates the GARBH-ini(interdisciplinary Group for Advanced Research in BirtH outcomes- DBT India Initiative) initiative of the Department and hopes the Mission would be able to achieve its targets. The Committee recommends that the Department may integrate its efforts with the Ministry of Health and Family Welfare for seamless translation of academic research into products that can be used by the healthcare system. The Committee also recommends that a deep-dive be carried out into the reasons for genetic disorders, especially relating to environmental pollution and nutritional factors. This information may be utilised by other stakeholders, and relevant and timely preventive actions can be taken. 3.4 The Committee appreciates the Department’s vision for launching the Mission on Antimicrobial Resistance (AMR). The Committee also recommends that a region-wise study be carried out and the most vulnerable population be identified so that the utilisation of funds can be targeted. The Committee expects the Department to engage start-ups, SMEs and individual researchers/innovators extensively in this programme, especially with respect to using modern techniques such as data analysis, artificial intelligence and risk modeling. 3.5 The Committee, recommends the Department to collaborate its efforts with those of other stakeholder Ministries/Departments and dovetail funds across different Ministries/Departments under similar missions. 4 Industrial & Entrepreneurship Development: The Committee notes that the scheme aims to promote biotechnology research, translation, innovation and entrepreneurial ecosystem through various initiatives involving development and operations of bio-clusters, bio-technology parks and public private partnerships aimed at creating infrastructure fostering Bio-entrepreneurship. 4.1 The Committee was informed that the scheme has an allocation of Rs.230.70 crore at R.E. 2019-20 stage and the budgetary allocation for FY 2020-21 is Rs.322.67 crore which is Rs.92 crore more than the R.E. 2019-20. The major focus is on building new clusters and developing the translational ecosystem, and with the increased provided at B.E. stage, the activities will not suffer however, any additional funds as required will be requested for at R.E. stage. 4.2 The Committee was also informed about the following major achievements of Biotech Parks/incubation centres during the last two years:

Sl. Biotechnology Parks/Incubators Achievements No.

1 Biotech Park, Lucknow , Uttar Pradesh No. of start ups - 62 No. of Start ups graduated - 37 2 Guwahati Biotech Park, Assam No. of jobs created - 273 3 Biotechnology Incubation Centre, (Combined achievements across all Cochin, Kerala 5 biotechnology parks) 4 Biotechnology Incubation Centre, Hyderabad

5 Bangalore Bioinnovation Centre, Bengaluru

4.3 The Committee was also informed that the Department aims to establish India as a USD 100 Billion Bio-Manufacturing Hub.It has proposed to support 3000 start-ups, 60 incubation centres and take forward at least 25 new products / technologies for commercialisation. 4.4 The Budget Estimates, Revised Estimates and actual expenditure, year-wise, for the year 2018-19, 2019-20 and the Budget Estimates for the year 2020-21 for the scheme Industrial & Entrepreneurship Development of the Department of Biotechnology are as under: (Rupees in crore) Year Budget Revised Actual Percentage Utilisation (of Estimates Estimates Expenditure R.E)

2018-19 249.24 244.26 244.23 99.98

2019-20 280.20 230.70 192.97* 83.64

2020-21 322.67 ------

* As on 10th February, 2020 4.5 The Committee recommends that since a major focus of this scheme is to nurture entrepreneurship and propel industrial development, the Department should raise private investment from industry stakeholders to augment its financial resources. This would also result in a more integrated approach and translate into better academia-industry collaboration. 4.6 The Committee notes the achievements of the Golden Jubilee Biotech Park for Women established at Chennai, which presently has close to 400 women entrepreneurs and technocrats and houses more than 13 companies towards translating research into products and services for the rural areas. The Committee recommends the Department to expand the outreach of these products and technologies, with the help of other stakeholder Ministries/Departments along with NGOs working in the rural sector involving women self-help groups. 4.7 The Committee notes that the five bio-technology parks mentioned above have been able to incubate only 62 start-ups over the last 2 years, out of which only 37 have graduated. The Committee notes the limited progress and therefore, recommends that the Department should enhance its outreach activities with schools, colleges and universities in attracting more start-ups. The Committee also recommends that the Department should collaborate with other incubation and start-up mentorship programmes of the government as well as the private sector thereby benefitting a larger base of entrepreneurs. 5 HUMAN RESOURCE DEVELOPMENT AND CAPACITY BUILDING 5.1 The Committee was informed that the Human Resource Development and Capacity Development initiatives of the Department are a part of its umbrella scheme „Biotechnology Research and Development‟. Under the HRD program 72 courses supported in Universities / Institutions 829 ongoing fellows and 113new fellows have been supported under DBT-JRF program, 185 Researchers have been supported under DBT – RA program. Further, Skill Vigyan in Life Science and Biotechnology program has been implemented in 6 States S&T Council. 5.2 The Department provided the details of publications, patents and technologies generated (FY 2018-19 to 2019-20) upto 31.01.2020 as an outcome of support to biotechnology R&D projects, as a result of the initiatives of the Department in Human Resource and Capacity Development, as below:

Financia Number of Number of Technologies Total Manpower l Year Publications Patents filed/ developed/ projects trained Granted commercialised supported

2018-19 1489 73 11 2868 2911

2019- 1500 46 34 2822 1955 20*

* as on 10th February, 2020

5.3 The Committee notes that the number of patents applied for and the number of manpower trained has decreased. The Committee, recommends the Department to further align the targets of the initiatives under the Human Resources and Capacity Development scheme with the larger R&D outcomes such as patents applied and granted, research papers published and technologies commercialised. 5.4 During the meeting, the Committee enquired from the Department regarding the impact of withdrawal of tax incentives on R&D activities, especially with respect to the private sector. It was informed that the withdrawal of tax incentive on R&D has negatively affected R&D investment in the private sector in India. The Committee was further informed that the stringent regulations in the country on conducting clinical trials, as well as the withdrawal of exemptions by the government on the funds spent by the private sector has led the biotech and pharma companies to move their R&D activities outside India. 5.5 The Committee recommends that the Department should take up the issue of tax exemption on R&D, issue of over-regulation in clinical trials and exemptions on the funds spent on acquiring patents with the Ministry/Department concerned. 6 NATIONAL BIOPHARMA MISSION 6.1 The Committee was informed that the National Biopharma Mission is a mission programme of the Department under the umbrella scheme „Biotechnology Research and Development‟. The Biotechnology Industry Research Assistance Council (BIRAC) is implementing the National Biopharma Mission for accelerating early development of biopharmaceuticals. The mission is being implemented since 2017. The major initiatives under this mission focus on developing: i. specific products- Vaccines, Bio-similars and Medical devices, ii. shared facilities, iii. skill development, and iv. Technology transfer to strengthening the ecosystem for affordable product development. 6.2 The expenditure during the year 2017-18, 2018-19, 2019-20 towards the mission and proposed allocation for FY 2020-21 is given below, by the Department: (Rupees in crore)

Name of the sub Expenditure during the Last 3 BE 2020-21 Years (Rs. In crore) Scheme/programmes

2017- 2018- 2019-20 (till 18 19 10.02.2020)

National BioPharma Mission 5.00 145.00 140.15 300.00

6.3 The Committee acknowledges the efforts put by the Department towards the National Biopharma mission. The Committee is happy to note that the allocation towards this Mission for B.E. 2020-21 has been increased to Rs.300 crore. This Committee feels that this budgetary allocation would be sufficient to achieve the planned targets of the Department under this Mission. 6.4 The Committee commends the efforts put by the Department under this Mission with regard to development of vaccines for dengue, cholera, universal flu and pneumococcal vaccine. The Committee acknowledges the efforts of the Department in developing bio-similars for the treatment of diabetes, cancer, and arthritis. The Committee hopes that with the efforts of the Department towards developing low cost technologies for diagnosis and cheaper and effective bio-therapeutics including pharmaceutical drugs and implants, the cost of medical care will come down in the near future. The Committee, therefore, extends its full support to the Department towards actualisation of its targets. 7. ENTREPRENEURSHIP DEVELOPMENT 7.1 The Committee was informed that the Department has taken various initiatives under its program „Entrepreneurship Development‟. This programme is a part of the umbrella scheme „Industrial and Entrepreneurship Development‟. Biotechnology Industry Research Assistance Council (BIRAC), a section 8 company which is also a public sector undertaking of Department of Biotechnology, is supporting start-ups, entrepreneurs, SMEs to undertake strategic research to develop affordable and sustainable innovations in biotechnology sector. The various initiatives of the Department towards promoting entrepreneurship include BioNEST, SEED Fund, and Biotechnology Innovation Fund –AcE. 7.2 Details of BIRAC‟s achievement of its targets of 2019-20 till 31st January, 2020 are mentioned below:

Sl. Evaluation Criteria Targets (2019- Total No. 20) Achievements (Till 31.01.2020)

1 Number of Incubators 50 47

2 Number of Incubatees 500 475

3 Number of projects getting fund 25 16 from partnered funding (i.e. other than BIRAC/DBT)

4 Number of beneficiaries 475 453

7.3 The following table gives about the allocation of funds towards nurturing start-ups and entrepreneurship in the last five years i.e. during 2015-2020:

Sl. Scheme Funds Committeed so far No. (Rupees in crore)

1. BIG 230.00

2. BioNEST 279.00

3. SEED Fund 30.00

4. LEAP Fund 24.50

5. AcE Fund 150.00

6. SITARE 18.00

7. E -YUVA 11.83

8. BIRAC -TiE WInER(Women 2.25 in Entrepreneurial Research) Award

7.4 The annual report of the Department for the year 2018-19 mentions that 41 bio-incubators have been established. The Committee notes that the target set for the year 2019-20 was to increase the number of bio-incubators to 50. The Committee notes that till 31.01.2020, 47 bio-incubators have been established. 7.5 The Committee notes the increase in the number of bio-incubators established as compared to the year 2018-19. During the last five years, BIRAC has established a total of 47 bio-incubators across the country. The Committee notes that the Department is slightly behind its own target of establishing a total of 50 bio-incubators by the year 2019-20. The Committee recommends the Department to take measures to achieve its target. 7.6 The Committee applauds the efforts of BIRAC in promoting entrepreneurship and creating a nurturing start-up ecosystem. The Committee highlights the fact that BIRAC is a Section-8 company and therefore, it is well received by the private investors and industry. The equity- holding model of BIRAC has proven to be successful and the Committee acknowledges that better management has led to efficient and optimal utilisation of funds, thereby creating on-ground impact. The Committee, therefore, recommends the Department to analyse the possibility of creating more such Special Purpose Vehicles (SPV) for its other Missions and replicate the success story. The Committee also recommends that the Department may share its knowledge, experience and best practices of managing SPVs such as BIRAC with other scientific Ministries/Departments in order to encourage them to adopt this method. 7.7 The Committee notes that under the SEED Fund (Sustainable Entrepreneurship and Enterprise Development Fund) initiative, 40 start-ups have received BIRAC SEED fund so far. The Committee observes that under this initiative each start-up receives funding of upto Rs.30 lakhs. Hence, the maximum expenditure that the Department may have incurred is Rs.12 crore which is less than half of the fund, i.e. Rs.30 crore, committed by the Department under this initiative. The Committee expresses its dissatisfaction over this sub-optimal utilisation of funds. The Committee also expresses its displeasure over the low numbers of start-ups that have benefitted under this initiative. The Committee recommends that the Department should take necessary steps in reaching out to more number of start-ups and budding entrepreneurs/researchers thereby increasing the number of beneficiaries under this initiative. 7.8 The Department had set the target for the year 2019-20 at getting 25 projects funded from partnered funding sources, i.e. other than BIRAC/DBT. Till 31.01.2020, the Department has funded only 16 projects. It seems highly unlikely that the Department would be able to achieve its target of 25 projects by the end of the financial year 2019-20. The Committee recommends necessary corrective action to avoid this in the future. 8. AUTONOMOUS INSTITUTIONS 8.1 The Committee was informed that the Department has set up 15 theme based autonomous institutions and is also supporting one International Centre. Along with this, the Department has 3 Public Sector Units, namely, (i) Bharat Immunologicals and Biologicals Corporation Limited (BIBCOL), (ii) Indian Vaccines Corporation Limited, and (iii) Biotechnology Industry Research Assistance Council (BIRAC). 8.2 The Committee was informed that lump-sum funds are allocated for 16 Autonomous Institutes under the Department and funds are released to each of those Autonomous Institutes based on their requirement. The Committee was further informed, that the B.E. allocations under the head “Assistance to Autonomous Institutions” for the year 2020-21 is Rs.847.61 crore, which is Rs.75.86 crore higher as compared to R.E. 2019-20 of Rs.771.75 crore. The actual release of the funds allocated for the years 2017-18, 2018-19 and 2019-20 against the above mentioned allocations are as under: (Rupees in crore)

Sl. Name of the Autonomous Institution Actual Release Actual Release up No 2018-19 to 31st January 2020 (FY 2019-20)

1 National Institute of Immunology, New Delhi 73.50 77.90

2 National Centre for Cell Science, Pune 61.50 63.00

3 Centre for DNA Finger Printing & Diagnostics, 43.00 42.50 Hyderabad

4 National Brain Research Centre, Manesar, 45.00 27.13 Gurugram

5 National Institute for Plant Genome Research, 38.00 36.84 New Delhi

6 Institute of Bioresources & Sustainable 27.44 27.68 Development, Imphal

7 Institute of Life Sciences, Bhubaneswar 53.64 37.03

8 Translational Health Science & Technology 41.94 31.03 Institute, Faridabad

9 Rajiv Gandhi Centre for Biotechnology, 85.24 93.22 Thiruvananthapuram

10 National Institute of Biomedical Genomics, 26.58 30.00 Kalyani

11 Regional Centre for Biotechnology, Faridabad 33.92 35.70

12 National Agri-Food Biotechnology Institute, 31.48 26.20 Mohali

13 Institute for Stem Cell Research and 82.07 52.92 Regenerative Medicine, Bengaluru

14 National Institute of Animal Biotechnology, 53.50 22.58 Hyderabad 15 Centre of Innovative and Applied Bioprocessing, 12.52 12.17 Mohali

16 International Centre for Genetic Engineering and 38.60 29.75 Biotechnology, New Delhi.

Total allocation 748.98 771.75

Actual Release (1-16) 747.93 645.65*

*Till 31.01.2020 8.3 The Committee notes that during the year 2019-20, the research outcome of DBT‟s Autonomous Institutions has resulted in more than 800 publications and filing of 60 patent applications. 8.4 The Committee acknowledges the flagship initiatives, achievements and proposed activities undertaken by the autonomous institutions of the Department. The Committee, however, requires the Department to furnish complete details like budgetary assistance provided, funds allocated and funds utilised for each of the institutions under the jurisdiction of the Department in its ‘Background Note’ submitted to the Committee in the future. The Committee is of the firm opinion that the Department should be more vigilant while submitting the information for the consideration of the Committee. 9. NEW INITIATIVES AND PROPOSED ACTIVITIES DURING 2020-21 9.1 The Committee notes the new initiatives and proposed activities of the Department for the year 2020-21 which includes improving livestock breed using cattle genomics, development of Marine Bio-resources, development of Phyto pharmaceuticals for the treatment of Diabetes, development of biosensors for identifying pollutants. The Committee appreciates the vision of the Department with respect to healthcare and medical biotechnology with its focus on developing antibodies against diseases relevant to India, research on stem cell therapy and nano-biotechnology, development of cost-effective new drugs against TB, Cardio Vascular Diseases, Chronic Obstructive Pulmonary Diseases and cancer. The Committee also notes and appreciates the efforts of the Department under the GenomeIndia programme. The Committee also notes the contributions of the Department in societal development, especially with respect to initiatives on agriculture, waste management and clean energy. 9.2 The Committee recommends the Department to increase its outreach and market its products and services through innovative methods including digital media. The Department can engage with entrepreneurs and young researchers in charting out a road map with specific outreach targets. This will also benefit the Department by giving spin-offs in efficient funds utilisation and identification of sources for external funds generation.