[india-drug] Spurious drug survey yet to take off

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

(Source:
http://www.phronline.net/article/detnews.asp?articleid=14587&sectionid=3
Thanks?SS)

Spurious drug survey yet to take off
--------------------------------------
Our Bureau, New Delhi

Even as various industry associations and apex bodies like
Confederation of Indian Industry (CII) and Federation of Indian
Chambers of Commerce and Industry (FICCI) are competing to announce
various forums to eradicate the menace of spurious drugs, the first
ever scientific survey on the actual extent of spurious drug problem in
the country is yet to take off. 

The need for such a survey was highlighted in the interim report of the
Mashelkar Committee on Drug Regulatory Reforms about six months ago and
was duly taken up by the government. 

Though the centre had announced its willingness to grant immediate
funds for the purpose, Delhi Pharmaceutical Trust (DPT), the
organization that was given the task of conducting the survey, is yet
to receive any amount. 

Curiously, Indian pharma seems to be happy with the fear psychosis
caused by the conflicting news about the presence of spurious drugs in
the country. Indian Pharmaceutical Alliance (IPA), the association
representing domestic pharma majors had been in the forefront to
propagate the grave nature of spurious drug presence. 

It was due to the insistence of IPA the Mashelkar Committee, had taken
up spurious drug issue with atmost seriousness, even though the
government records suggested the contrary. However, IPA seems to be so
convinced of the high percentage of spurious drug presence that the
association was not keen on seeing the survey done. 

According to drugs control department statistics, there is no proven
instance of spurious drug detection in 15 states of the country during
the last three years. Spurious medicine was found just once in other
three states during the period. 

The DPT was supposed to come out with a scientific evaluation of the
extent (number of units/brands/amount) and nature (content lower than
claimed or missing or content okay but misusing some other fast selling
brand) of counterfeiting in India. It was also to prepare a
distribution table covering Metros, Suburbs, Rural Areas and Micro
Interior Areas. 

As per DPT plans, the samples collected in the survey will be checked
by the designated lab for physical signs of counterfeiting. The lab
will analyze 100% of suspected samples, 50% of probable suspects and
25% of not suspected specimens. The samples will be analyzed for:
Identification of active ingredients, Content of active ingredients and
Sterility (if applicable). 

The samples will be double blinded through a coding system before they
are sent for analysis. Data obtained will be collated and extrapolated
over each particular product's total sale across respective territory
as well as across the entire country. For obtaining a larger picture
the data will be pooled and extrapolated over country's over all volume
of pharmaceutical products. Data may be stratified to obtain desirable
information perspective. 

While the possibility of such a survey is fast fading, CII Spurious
Drugs Forum members are part of a national initiative headed by Suresh
P Prabhu, ex Union Minister to counter the menace of spurious drugs in
the country. 

The FICCI has also announced their plans for an initiative to form a
National Initiative Against Piracy and Counterfeiting (NIAPC). The
Indian Drug Manufacturers' Association (IDMA) is known to have planned
a seminar on spurious drugs titled, 'Spurious Drugs - A Pernicious
Health Hazard' in Mumbai.


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