Government and Biotechnology

Department of Biotechnology is the nodal ministry responsible for issues related to biotechnology in India.

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Timeline

1982	National Biotechnology Board was set up by the government.
1986	It was replaced by the Department of Biotechnology under the Ministry of Science and Technology.

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Aim

• Promote the development of modern biology and biotechnology in the country. 
• Promoting international cooperation in the field of biotechnology.
• Promoting manufacturing activities.

Department of Biotechnology has also set up BIRAC (Biotechnology Industry Research Assistance Council) agency to strengthen and empower emerging biotechnology enterprises to undertake strategic research and innovation.

• Biotech Sector is one of the sunrise sectors in India. 
• Within the Indian biotechnology sector, the major share is that of the biopharma sector accounting for a massive 55% of revenues while bioagri is the distant sector with a 22% share.
• Indian Biotech Sector holds about a 3% share of the global biotech industry.
• Indian Biotech Industry is valued at $ 11 Billion. 
• India has emerged as a leading destination for clinical trials, contract research and manufacturing activities.

The biotech sector comprises five segments – Biopharma, Bio-services, Bio-Agri, Bio-industrial, and Bioinformatics.

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1. Bio-Pharma

• This industry comprises of production of vaccines, bio-similars, regenerative medicine etc.
• Biopharma has a major share in the Indian biotechnology sector, comprising 55% of revenue.
• It has to be noted that India is the supplier of 60% of global vaccines and 22% of global generic drugs.

Example of Indian companies in this sector includes

Serum Institute of India	Largest vaccine producer in the world (including producer of Covishield).
Panacea	One of the largest biopharma companies and producer of Pentavalent Vaccine.
Haffkine	Haffkine Pharmaceutical (Mumbai) is famous for manufacturing oral polio vaccines and anti-snake venom.

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2. Bio-Agri

Bio-Agri companies are associated with GM seeds, bio-fertilizers, bio-pesticides etc.

Prominent companies related to this sector include

Mahyco	– MAHYCO = Maharashtra Hybrid Seeds Company – The company was founded in 1963. – The company has collaborated with various academic institutions and industries for development in the agri-business. Its well-known collaboration is with multinational Monsanto for using Bt Technology in cotton since 1998.
Other	– Andhra Pradesh State Seeds Development Corporation Limited. – JK Agri Genetics Limited – Kalash Seeds Limited – Kaveri Seeds Company Limited – National Seeds Corporation Limited

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3. Bio-Services

It involves industry related to contract manufacturing and clinical research.

Leading Indian companies involved in this include

1. Advinus: Tata company engaged in drug discovery and end to end bio services.
2. GVK Bio: Involved in drug discovery and clinical trials.

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4. Bioinformatics

Bioinformatics is the integration of biotechnology and Information Technology (IT). Indian companies in this field include

1. Tata Elxsi
2. iLABS (Hyderabad)
3. Satyam Computer Services
4. Navya Biologicals

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5. Bio-industrial

The bio-Industrial sector is mainly involved with the production of enzymes and energy generation using biomass and biofuel.

Prominent companies involved in this include

1. Novozyme, Rossari Biotech and Zyrtec: Companies involved in the development and production of industrial enzymes.
2. Hindustan Bioenergy, IKF Green Fuels and  Indian Oil Creda Biofuels: Companies engaged in the production of biofuels.

1. National Biotech Development Strategy

• Aim: Develop India into Manufacturing Hub.
• Primary Focus Areas (4): Food, Health, Clean Energy & Education 
• Target: Develop a $100 billion biotechnology industry in India by 2025. 
• Using startups and incubation centres, this will be achieved by converting scientific studies and technology into viable commercial products. 

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2. National Biopharma Mission

• Under the Mission, Industry and Academia will collaborate for the development of biopharmaceuticals.
• It is assisted by World Bank to create an ecosystem to promote entrepreneurship in the biopharma sector.
• The main focus of the mission includes:-
  1. Development of new vaccines and therapeutics.
  2. Bring centres of excellence in the educational sector together to strengthen current bio clusters.
  3. Attract FDI in the Biopharma sector.
  4. Deliver at last 6 to 10 new products in biopharma in next five years.

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3. The North East States specific schemes

North East is the primary focus in Bio-Pharma sector, and there are special programs for North East like

• Phyto-Pharma Plant Mission   
• Brahmaputra Biodiversity and Biology Boat (B4): Under this program, large boats will be set up in the river with a well-equipped laboratory and cold storage facility to store samples.

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4. Atal Jai Anusandhan Biotech Mission

• Atal Jai Anusandhan Biotech Mission has started with the aim of transforming the health, agriculture and energy sectors in the next 5 years. 
• It has four components
  1. GARBH-ini: To promote Maternal and Child Health  
  2. IndCEPI – To develop affordable vaccines and biofortified wheat to promote nutritional security.
  3. Mission on Anti-Microbial Resistance  
  4. Clean Energy Mission: To promote the invention of innovative technologies to promote Swachh Bharat. 

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5. Foreign Direct Investment

• 100% FDI is allowed for greenfield biotechnology projects. 
• 74% FDI is allowed for brownfield biotechnology projects.

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6. Other Steps

• To financially support the biotech industry, the government has set up a venture capital fund.
• Patents are essential for biotech companies. Indian Parliament has passed the Patents Act, which allows a 20-year patent term in line with the WTO and TRIPS provisions.
• The government is going to amend the Drugs and Cosmetics Act to make it more compatible with the international standards to attract Biotech companies in this sector.

• GEAC works under the Ministry of Environment, Forest and Climate Change and was established under the provisions of GM Rules 1989 of the Environment Protection Act.  
• GEAC is responsible for granting approvals to release genetically engineered organisms and products into the environment, including experimental field trials. It can also punish someone found guilty for environmental damage under Environment Protection Act, 1986.

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Problem with present Process

• Environment Ministry has a veto over the decisions of GEAC. In UPA Regime, Environment Minister Jairam Ramesh vetoed BT Brinjal even after approval by GEAC.
• Since Agriculture is a State Subject, States can refuse approval even after approval by the Environment Ministry.  
• GM crop is an agricultural issue, but the Ministry of Environment is the nodal ministry. 

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Biotechnology Regulatory Authority of India (BRAI) Bill, 2013

• Biotechnology Regulatory Authority of India (BRAI)  will replace GEAC.  
• It will consist of chairperson & 5 members who can be eminent scientists or government officials with experience in the field. 
• It also established an Appellate Authority.  
• The single body will be responsible for any use and clinical trials of Genetically Modified crops, vaccines, drugs etc.

Issues with Bill

• The Bill says that the Tribunal will have jurisdiction over ‘substantial question regarding modern biotechnology’ but fails to explain the term. On the positive side, keeping the term undefined gives flexibility to the judiciary but increases the ambiguity.
• Technical Members of the Tribunal can be eminent scientists or government officials. But the technical expertise of both isn’t the same.
• The Bill doesn’t have the provision of financial liability in case of damage.