New drug regulator on US FDA lines

A Cabinet note is being prepared on a national drug regulation authority, expected to be on the lines of the US Food and Drug Administration.

The Minister of Health & Family Welfare, A Ramadoss had recently announced in Parliament the move to set up such an authority.

The note will be ready next week and sent to the finance ministry. The Cabinet is likely to take it up next month, according to an official in the Chemicals and Petrochemicals ministry.

The drug authority is going to be modelled largely on the recommendations of the Mashelkar Committee, which gave some far-reaching comments in the fields of regulating spurious drugs menace, besides strengthening drug regulatory structure at both the State and Central level.

The proposed drug authority is expected to remodel the office of Drug Controller General of India with greater autonomy, better infrastructure and larger technical staff. There are likely to be some modifications in the reporting system and organisational structure as well.

The attempts would be to eventually come up with a US Food & Drug Administration kind of a structure, commented another official who is informed of the process.