The National Biotechnology Regulatory Authority (NBRA) will streamline the process of regulatory approval for biotech products through a single window agency. Biotech products are more complex than small drug molecules and more specialized information needs to be considered during the approval process to decide whether they are safe, efficacious and suitable for human use.

With the NBRA coming into force, the regulatory approval pathway will be well defined. It is extremely advantageous for the biotech industry to have a meaningful regulatory pathway, before product development as it would remove uncertainty in terms of both timelines to market and possibility of obtaining final product approval. All these factors have a significant impact on the cost of the final product, Shrikumar Suryanarayan, director- general, Association of Biotechnology Led Entrepreneurs (ABLE) told Pharmabiz.

The current system of regulatory approval for biotech products is split among various government agencies: Review Committee on Genetic Manipulation (RCGM), Genetic Engineering Approval Committee (GEAC) and Drugs Controller General of India (DCGI). Ad hoc committees are convened on a case-by-case basis to look into the approvals, which leads to non-uniform standards of approval.

Therefore, the proposed NBRA is a move in the right direction for the country and ABLE is extremely supportive of this move by the government. In fact, ABLE took the initiative and invited the Department of Biotechnology to unveil its NBRA strategy document in a special session convened at Bangalore Bio held between April 24 and 26, 2008. Subsequent to this, several consultative sessions were held across the country involving more than 435 stakeholders, including industry and non-governmental organizations, informed Suryanarayan.

From a public perspective, NBRA can ensure that biotech drugs will be subjected to uniform and high safety standards. Moreover, products that have been developed and approved under a regulatory regime that is considered world-class, will automatically be considered favourably for approval outside of India also. Indian companies would be able to use data generated in India for international marketing and development applications.

The draft of the NBRA formation is placed in the public domain for comments till the end-of-the-month. The Authority will come into force hopefully by the year-end.

The NBRA act will make provisions to ensure the smooth transition of products that are already in the DCGI regulatory pipeline. Transfers will be automatic and will be notified. The whole intention will be to make it smooth and easy for companies, stated the ABLE DG.

Without a doubt, NBRA will make it easier to develop novel biotech products, making India far more competitive in this high-technology area. The interest of the public will also be protected as the Government can ensure that a smooth and speedy approval of biotech products including critical and safe life-saving innovations that can be introduced at a faster pace.

India is one of the first countries to have a dedicated NBRA. In formulating the NBRA, the Department of Biotechnology is not only consulting extensively within India, but has also studied various regulatory agencies around the world to devise the best model, added Suryanarayan.