Six months after the Government cleared the proposal, efforts for creation of the much awaited Central Drug Authority of India will be in full swing. A draft amendment to the Drug and Cosmetic Act 1940 was prepared by the Union health ministry to pave way for the setting up of a centralised regulatory system some time back.

A Centralised system for drug licensing in the country is expected to ensure issuing of drug manufacturing licenses from one place. This, in turn, will bring in proper coordination in this key regulatory function. Currently, it is very difficult to keep track of manufacturing licenses issued by various state drug control authorities.

A Bill establishing Central Drug Authority of India is ready and slated for the Monsoon Session of the Parliament, a senior Ministry official told Pharmabiz. Although the Union minister for health Dr Ambumani Ramadoss vowed to see the formation of the authority in six months after the Cabinet cleared it on January 11, it may take some more time to see the centralised system in place.

The monsoon Session is reported to be delay by a month and may start after August 20 and passage of the Bill by both the Houses also will take much more time. Besides, the Bill seeks budgetary support to set up the infrastructure and staff of the authority. It also means further delay.

The bill is learnt to have proposed a five-member apex body with chairman for policy decisions while the CDSCO would be made as its executive arm with Drug Controller having sweeping powers. It will have ten separate divisions and the transition period from the present State-based system to the Central pattern will be five years.

The issuing of manufacturing licences for products in some key therapeutic groups would be transferred to the Central authority from the state drug control departments in the first phase of this move. Manufacturing licences of more therapeutic groups would be brought under the purview in subsequent years.

The centralised regulatory framework is going to be almost as per the recommendations of the Dr R A Mashelkar committee, except its name being changed from National Drug Authority and will be a strong mechanism on the lines of US FDA.

As reported, the CDA will have ten divisions including those dealing with new drugs and clinical trials, for biological and biotechnology products, for pharmacovigilence and drugs safety, for medical devices and diagnostics, quality analysis, Indian systems of medicines, international co-operation and patent for pharmaceutical products.

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