[e-drug] Indian Drug Regulation: Light at the End of the Tunnel in 2012?

["Wilbert Bannenberg" <wjb@wxs.nl>]

E-DRUG: Indian Drug Regulation: Light at the End of the Tunnel in 2012?
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[India is changing the way its drug registration is working. This could be a
welcome move. Below a Government Press Release, Thursday, January 11, 2007,
and some comments; discussion welcome; WB]

QUOTE

The Cabinet of the Government of India today gave its approval to the
following proposals :

a) Setting up of Central Drugs Authority of India as an autonomous
organization under the Ministry of Health & Family, Welfare to be located at
the Food and Drug Bhawan, New Delhi

b) Upgradation of the post of Drug Controller (India) from the present level
of the grade of Joint Secretary to the Addl. Secretary to the Govt. of
India.

c) Revival of one post of Additional Drugs Controller (India) (AYUSH) in the
grade of Joint Secretary to Government of  India. 

d) Creation of one post of Additional Drugs Controller (India) in the grade
of Joint Secretary to the Government of India.

(ii) A phased five year transition from the present system of grant of
manufacturing licences to a complete central licensing of drug manufacturing
units from State to Union Government. 

(iii) Amending the Drugs & Cosmetics Act, 1940 by introducing, the Drugs &
Cosmetics Amendment Bill, 2006 in Winter Session of the Parliament with
such changes, as required.

This decision will facilitate upgradation of national drugs regulator,
uniformity of licensing and enforcement and improvement in quality & safety
of drugs. 

UNQUOTE

Comment

This decision has huge implications for Drug Regulation in India. At present
there are 25+ States and 5+ Union Territories each having their own Drug
Controller supposedly acting the under the Guidance of the Central Authority
of the Drug Controller General of  India. However since there is no
montoring, and action if there are lapses, the system simply does not work.

With this centralisation there is a possibility of uniform standards being
brought in - the States will have an implementing function rather than
acting independently. 

The Drug Controller General of  India will have a higher position in the
Ministry of Health and therefore be able to function better. 

The Drug Controller will get more human resources and facilities. Hopefully
this will lead to a better overall situation with more essential drugs and
better pricing. 

However some questions still remain - Pharmaceutical pricing is still with
Ministry of Chemicals and Fertilizers. Will that Ministry still remain the
predominant influence on the Pharmaceutical Industry? How can the health
aspect of medicines be increased in Drug Regulation? At present it is
Industrial aspect that is predominant. 

It is possible to get a much bigger health focus into the whole Medicines
situation in India. This will have a huge impact on the estimated 2/3 of the
population that does not have regular access to Essential Medicine. There
will only be a marginal effect on the profitability and contribution of the
Pharmaceutical Industry to the national economy of India. These are
important as the Industry cannot be for health only.

The question is, will this rebalancing be done? The millions in India await

---------
Wilbert Bannenberg, E-drug moderator
Email: wjb@planet.nl