[india-drug] Central licensing for drug manufacture

[Sunitha Srinivas <s.srinivas@ru.ac.za>]

(Source: 
http://www.expresspharmapulse.com/20030403/cover1.shtml
Thanks?..SS

Idrug participants are urged to please take this discussion forward by
sharing their views regarding the various options we should try in
order to curb the problem of spurious drugs in India. It is a big
menance and needs workable solutions. Technical coordinators from all
states under DSPRUD may please share their experiences with what each
state is doing about this issue. Thanks. Looking forward to a fruitful
discussion....SS)


Mashelkar Panel calls for central licensing for drug manufacture
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Ananth Iyer - Mumbai


The 14-member Expert Committee, constituted by the Health ministry and
chaired by Dr R A Mashelkar to examine drug regulatory issues including
the problem of spurious drugs, has called for centralisation of the
issuance of manufacturing licence for drugs and pharmaceuticals, it is
learnt. At present, state drug control departments or the state food
and drug administrations are the licensing authorities.

At its first meeting held in Delhi on 21 March 2003, the Committee
agreed on the need to have a certain degree of uniformity in
regulations for issuing manufacturing licences, informed sources told
Express Pharma Pulse.

The Committee has formed two groups - one comprising industry
representatives and the other of drug control officers - to examine
this proposal and come out with final recommendations, it is learnt.
Besides uniformity, the Committee believes that a central licensing
authority might also help in tackling the issue of irrational
combinations. It is alleged that the standards and controls vary in
each state and this is the root cause for the spread of irrational
combinations in the market place.

Meanwhile, the drug industry has responded favourably to the proposal.
The only concern is the manpower and infrastructure, which the industry
feels needs to be strengthened if licensing is to be centralized. ?We
support the Mashelkar Committee proposal provided zonal and regional
offices are set up with adequate manpower support,? Yogin Majmudar,
president of Indian Drug Manufacturer?s Association said. ?OPPI has no
problems as long as sufficient infrastructure support is created for
effective implementation,? Dr Ajit Dangi, director general, OPPI said.




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