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[e-drug] Banning of medicines in India (5)

E-DRUG: Banning of medicines in India (5)

[A few comments have been inserted by moderator]

Dear Sir,

I want to make following suggestion:

1. Preparation of National Formulary (NF)of India. It will help Drug
regulatory authorities to re-confirm the Medicinal products and various
combination/ composition essential for Indian citizen.

2. A rule needs to be in place to allow a maximum of 4 brand names for the
medicine identified in NF and not more than 10 manufacturer from each state
of India should be allowed to manufacture a given composition in generic
name. This is possible only if a master databank is established for all the
manufacturer/ importer operating in India and their valid manufacturing
licence with qualitative & quantitaive composition.
[This sounds like the old 'need clause' which unfortunately the country whcih 
used it, had to abolish in the early 90's. Now it is free for all as long as 
you conform to set registration criteria. Moderator]

3. Cancelling the licence of irrational composition/ combinations
[Cancelling licensies already issued has proved extremely difficult in 
developed countries. Instead, the manufacturers are asked to add safety 
warnings. Company profit overrules patient safety nowadays unfortunately. 

4. Rule to be in place to restrict the number of manufacturing licences to
each manufacturing unit. State FDA to furnish a report addressing the GMP
compliance status of manufacturing units to Central FDA periodically.
Central FDA should release a summary opinion at least twice a year in
leading national news papers in English and regional language.
[Fulfilling GMP is important and must be enforced by the authorities. 
Unfortunately, corruption prevails in too many countries, as was the case in 
China. Moderator]

5. Manufacturing licence of any manufacturing unit with 2 consecutive
adverse opinion from Central FDA should be cancelled till correction is
done. All these to be informed to the people of nation.

This is all possible with some planning and determination. In India we now
have enough manufacturing units and infrastructure to cater the need of
Indian citizen at affordable cost. Indian now need assurance of quality not
from manufacturer but from Regulators.


Rakesh Chaurasia
[added by moderator. Future postings will be rejected unless signature is added]

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