The Union Cabinet will clear the proposal of the Department of Biotechnology (DBT) for setting up of the BT Regulatory Authority on lines of US FDA within a month. The Authority is expected to be functional within two years, according to Dr MK Bhan, secretary, DBT, government of India.
The biotechnology sector, which has been declared as a sunrise industry, has been receiving the highest allocation of budget for the last three consecutive years. But at present we do not have a regulatory structure with a competent set up. The regulatory board will be a professional body backed by experts including those from the industry who have are armed with the nitty gritties in drug approval. The authority will be backed by a sold training centre which will regularly churn out experts to ensure that there is no shortfall of regulators, stated Dr Bhan, at the inaugural session of the 8th edition of Bangalore Bio 2008, which is being held in Bangalore between April 24-26, at the BICE.
Regulation is one of the critical components required when Indian companies are producing biopharmaceutical products. When regulation is in place it becomes more predictable and easier as many of the personnel on the Board will constitute the industry personnel who will comprehend the requirements required in drug approvals.
With the process is in place, we are looking at creating a solid foundation in the biotechnology sector beginning with training of human resources. The biotechnology Policy is giving high emphasis on human resources. There has been an unprecedented rise in allocation for higher education in this year's budget to the tune of Rs 6,500 crore. This means most states would now have large national universities.
In this regard, DBT is in the process of setting up 16 National Universities and 13 research institutes to be embedded into the University. Of the 13 research institutes, two are in Haryana, one in Punjab and one in Bangalore. This also included the stem cell research institute in Hyderabad university campus, Genetics School in Kolkata and marine biotech in Tamil Nadu. Efforts are also on to expand the Rajiv Gandhi Institute for Higher Technology in Kerala and start a similar initiative in New Delhi.
"Earlier people use to say we had too many universities and now they say there are too few. This change of attitude is tremendous and gives a fillip to improve higher education standards in the country. Knowledge Commission should be given full credit for advocating this point. We are also looking at the universities of a different kind.
It will be more research oriented. Then there will also be a focus on the interdisciplinary education system, stated the DBT secretary.
All these projects have been approved by the Union government and there is no dearth for funds, he added.