Biotech Industry of India
India’s first biotech firm Biocon was established in 1978. Centre for Cellular and Molecular Biology setup in Hyderabad in 1981, and Department of Biotechnology (DBT) was established in 1986.
Today, India is among the top 12 biotech destinations in the world and ranks third in the Asia-Pacific region. India is also home to second-highest number of USFDA–approved plants, after the USA. The product patent regime was adopted in 2005. In 2013, India became the biggest producer of Hepatitis B vaccine recombinant. The country has potential to become a major producer of transgenic rice.
This sector has grown @ nearly 20% and is expected to reach to size of USD 100 billion by 2025. The Biotech Industry has five segments viz. bio-pharma, bio-services, bio-agri, bio-industrial and bio-informatics. The largest share (64%) is of Bio-pharmaceutical sector.
Key Growth Drivers
The key factors that make this sector grow include growing demand for healthcare services, intensive R&D activities and strong government initiatives. India has a strong pool of scientists and engineers and government has established national research laboratories, centres of academic excellence in biosciences, several medical colleges, educational and training institutes offering degrees and diplomas in biotechnology, bio-informatics and biological sciences. India is also becoming a popular destination for clinical trials and contract research also.
Government Policy
For Pharma Industry, the Government allows 100% FDI under automatic route in Greenfield projects while through government route for brownfield projects.
Biotech Parks
The Biotech Parks in India are PPP projects established with the help of the Department of Biotechnology. Currently, there are around 10 operational and planned Biotech Parks in India. The Operational biotech parks are located at Lucknow in Uttar Pradesh, Bangalore in Karnataka, Kalamassery and Kochi in Kerala, Guwahati in Assam and Chindwara in Madhya Pradesh. The first among them was TICEL Bio Park (Chennai) operational since 2004; followed by Lucknow BT Park, which started operations from 2006.
National Guidelines for Stem Cell Research 2O13
The Government had released these guidelines to ensure that research with human stem cells is conducted in a responsible and ethical manner and complies with all regulatory requirements pertaining to biomedical research in general and of stem cell research in particular.
These guidelines apply to all stakeholders including individual researchers, organizations, sponsors, oversight/regulatory committees and any other associated with both basic and clinical research on all types of human stem cells and their derivatives.
