Health dept calls for Rs 100 cr investment

The Department of Health has prepared the Cabinet note on the proposed central licensing system for pharmaceutical manufacture, which calls for setting up of National Drug Authority (NDA) as per the recommendations of the Mashelkar Committee.

The Cabinet note, prepared by a team headed by the health joint secretary with inputs from drug regulatory experts, has suggested that it would require an additional workforce of 300 officials, including drug inspectors and administrative staff, apart from the existing strength of 400-odd personnel with the Central Drug Standards Control Organisation (CDSCO).

The report has also suggested that it would require an investment of over Rs 100 crore to set up new infrastructure, in addition to the four zonal offices of CDSCO.

As per its recommendation, the CDSCO will be transformed into NDA, which will have powers to not only approve new drugs and clear clinical trials along with other clearances like drug imports etc, but also issue manufacturing licences and plant approvals.

For this, the central department needs to be expanded in terms of personnel strength as well as infrastructure. At present, the CDSCO, which is headed by the Drug Controller General of India (DCGI), has only four zonal offices.

These offices are located at the four metro cities of New Delhi, Kolkata, Mumbai and Chennai and are headed by the respective deputy drug controllers.

An official at CDSCO said the report was to be submitted to the Prime Minister's Office (PMO) for final recommendations.

The PMO and the Planning Commission, following the Mashelkar Committee recommendations, had asked the department of health to make an analysis of the same from an operational perspective.

As per the Mashelkar Committee on drug administration and standardisation, the responsibility of issuing drug manufacturing licences, which at present lies with the respective state drug controllers, is to be shifted to a central body after the formation of the National Drug Authority.

The idea was mooted by the committee to standardise licensing procedures by bringing it under a single agency, which would make the licensing more accountable and help eliminate instances of substandard and spurious drugs coming into the market.

However, the proposal was opposed by most of the state drug control departments as it would result in limiting their powers to only issuing licences for drug trade and retail inspections.