E-DRUG: Banning of medicines in India (4)
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[The Chinese official was hanged a couple of weeks ago. Although he was the top official of the regulatory agency, death penalty can never be defended. The Chinese trade in substandard, fake and adulterated products has received much media attention and a Google search will probably give many hints. I would recommend also to look at Ms Xiao Xia Hu's presentation at the HAI conference 2006, please use these links:
http://www.haiweb.org/haiconference2007/index.php#showContent3
http://www.haiweb.org/haiconference2006/speakers/Xiao-Xia-Hu.ppt
Please remember to repair links. KM]
Hi
Dr Pipasha has commended the Chinese Government "for mooting out the death penalty to the Chinese Drug Regulator for unethical practices compromising patient safety". If it is really implemented, this calls for appreciation. I request you to kindly provide the detailed reference of this for activist use. I would also like to know if anyone has been served with such capital award till now.
From India some have started taking a stand in recent years, which shows the genuine concern for the issues. Being the facilitator for international PRDUC course at IIHM Jaipur, India, my experience and learning from participants of other developing countries forces me to doubt that in developing countries from where nothing is reported, things are better. Public silence is deceptive and can not be taken as the benchmark for satisfactory performance of medical profession, pharmaceutical companies or local DRAs.
I have never seen any medical representative distributing ADR reporting forms in India. Our experience with deceptive medicine promotion is that even MNC/TNC pharma companies operating in India, do not respond when we question them for unethical practices. Should their silence be taken as acceptance of having faltered or being above board and ethical?
Dr Vijay Thawani,MD,
India
vijaythawani@rediffmail.com
E-DRUG: Banning of medicines in India (5)
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[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. Moderator]
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.
Thanks
Rakesh Chaurasia
Macleodspharma
rakeshchaurasia@macleodspharma.com
[added by moderator. Future postings will be rejected unless signature is added]