The Indian government has revealed that it will set up a biotechnology regulatory authority that will guide private firms and related bodies to meet the international standards.
According to an official at the Department of Biotechnology (DBT) in India, the department is planning to set up the National Biotechnology Regulatory Board that will supervise and regulate the development of vaccines and drugs prepared from natural sources such as micro-organisms, humans and animals, as reported by ECONOMICTIMES.
As the Indian biotech market recorded growth of 18% in 2008, pharmaceutical companies are eyeing the global biotech drug market worth $65 Billion to extend their functional area. Moreover, DBT spends nearly $200 Million annually to develop biotech resources in the country.
The Drug Controller General of India (DCGI) presently regulates both the pharmaceutical products and biologics in the country and drug manufacturers need to take approval of the Central Drug Quality Regulator for pre-clinical experiments in both types of drugs.
Biotechnology is a rapidly emerging sector and therefore, needs an appropriate regulatory mechanism to sustain the growth pace. A DBT official has said that biologics could not be treated as the conventional chemical-based drugs and should have a different regulatory system.
Meanwhile, the new guidelines will be applied only to the pre-clinical stage and not on the clinical trial. Pre-clinical trial stage is a phase of drug or therapy development in which it could not be tested on humans, while clinical trials involve testing of drugs on humans and their effects.
At present, domestic biotech companies such as Panacea Biotech and Biocon, Wockhardt manufacture biologics like monoclonal antibody products, insulin and vaccines.
According to the Government of India, the country has become a global hub for vaccines, with supply of vaccines to around 140 countries and international organizations such as the World Health Organization. Every third child worldwide takes vaccine produced in India.
Furthermore, biotech research is very critical in the farm sector to raise production in order to meet the rising food demand with growing population.
According to a Research Analyst at RNCOS, "India is recognized for its biotech capabilities throughout the world. After dominating the generic drug sector for more than 10 years, it is time for the Indian companies to shift gear in biotech field to tap the existing opportunities and to lead the global biotherapeutics market. However, there is a need to make investment in active research and development to make the country world leader in biotech industry."
Related Market Research Reports:
Asia Pacific Biotechnology Market (2008-2012)
Global In Vitro Diagnostic Market Analysis
Global Vaccine Market Forecast to 2012
