[Ip-health] Pharmabiz- DCGI should make concrete efforts to define counterfeit drugs in accordance with WHO norms: Dr Jagashetty

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DCGI should make concrete efforts to define counterfeit drugs in
accordance with WHO norms: Dr Jagashetty

Friday, January 15, 2010 08:00 IST
Nandita Vijay, Bangalore

The Drugs Controller General of India (DCGI) should make quick efforts
to define 'counterfeit' drugs according to the World Health Organization
(WHO) norms. Currently, there is no definition for counterfeit drugs as
far as India is concerned. But there is a big hue and cry about the
circulation of counterfeit medicines without authenticated documents in
the country, according to Dr BR Jagashetty, Karnataka Drugs Controller.

There is both concern from consumers and panic by the pharma industry on
the allegation of counterfeit drugs produced or circulated in India.
However, the Drugs & Cosmetics Act only carries definitions of spurious,
misbranded and adulterated drugs under Section 17 for the domestic
market and Section 9 for imports.

It has been reported that in a survey carried out by the Central Drugs
Standard Control Organization (CDSCO) last year, prevalence of spurious
drugs sold across pharmacy outlets in the country was estimated at 0.046
percent. But in a study by WHO undertaken by the International
Pharmaceutical Federation, 3.1 per cent of drugs from India were
counterfeit based on packaging and fake contents.

"Such information is misleading. Therefore, it should be the prerogative
of the DCGI to vehemently prevent use of the word 'counterfeit' in the
context of drug quality," he added.

According to the Karnataka drugs controller, factors which encourage the
spurious drugs are weak legislation and regulation, lack of cooperation
or coordination with regulators between Centre and states or two states,
prevalence of corruption and difference of interest. There could also be
commercial gain on the part of pharma manufacturers and high cost of
drugs that could make companies and distributors to be associated with
products of poor quality.

There are several questions posed before regulators on the definition of
counterfeit drugs and its presence in the market. These include: Whether
substandard drugs could come under counterfeit category; availability of
good quality counterfeit drugs; whether counterfeit drugs are a big
problem and what varieties of drugs are counterfeit; etc. Further there
are also queries on the kind of efforts needed to ensure high quality,
safe and efficacious drugs in the market and on the possibility of a
licensed pharma manufacturer producing substandard and counterfeit
drugs, etc, he stated.

In order to put things in perspective, Karnataka drugs control
department is working towards setting up a Committee which will have
representatives from pharma industry, trade and consumers to be actively
involved in controlling the presence of spurious drugs, said Dr
Jagashetty.



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