India needs to be prepared with a sound and solid regulatory enforcements to compete in the global market. The country is being recognized as hub for clinical research and contract research.

The pharma sector must gear up for high technology process analytical systems to compete with the international majors. In this connection, the Indian Pharmaceutical Congress Association will present a White Paper on the road map of the sector to the government before March 2007.

The paper broadly outlines the objectives of the charter Pharma Vision 2020, devised by the Indian Pharmaceutical Congress Association with the pharma industry and pharmacy professionals.

"We are looking at what India needs and how the government should gear up for this, stated Drugs controller General of India M Venkateswarlu at a press conclave during the 58th IPC held at Mumbai.

Pharma Vision 2020 is creating a regulatory framework, which is transparent and easy to follow. As India makes advances in science and technology, there is a need to move away from the archaic systems, stated the DCGI.

The road amp envisages the \roles for realizing the Vision 2020. The industry needs to take advantage of the recent advances in biotechnology and information technology to keep ahead.

Over he next five years, India will mature even further in drug discovery, clinical trials and process formulation. It is now emerging as a major player for conducting clinical research from phase I to phase IV. It is also recognized as major manufacturer of generics in the US and Europe markets. In the patent regime, the industry will have to explore business models to survive.

In such a scenario, efforts are on to address the regulatory issues in drug development and clinical research. There is a need to implement the Mashelkar Committee recommendations and constitute the Central Drug Authority at the earliest, stated Subodh Priolkar, president IPA.

Referring to the medical devices divisions to be created under the Central Drugs Association, the DCGI said that 98 per cent of the medical devices in the country and a system is being developed to assess the quality standards maintained in the products which are sold in the country.