E-drug: Re: Substandard and fake drugs
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[This is a follow up to give the abstract of the third article in Lancet
mentioned in the previous posting. I have also copied a posting from the 2
July issue on India's trade in fake drugs. KM]
Lancet 2001; 357: no 9272 (16 June)
Research letters
Fake artesunate in southeast Asia
Paul Newton, Stephane Proux, Michael Green, Frank Smithuis, Jan Rozendaal,
Sompol Prakongpan, Kesinee Chotivanich, Mayfong Mayxay, Sornchai
Looareesuwan, Jeremy Farrar, Francois Nosten, Nicholas J White
Artesunate is a key antimalarial drug in the treatment of
multidrug-resistant Plasmodium falciparum malaria in southeast Asia. We
investigated the distribution of counterfeit artesunate tablets by use of
the validated, simple, and inexpensive Fast Red TR dye technique. We also
aimed to identify distinguishing characteristics of the fake drugs. Of 104
shop-bought "artesunate" samples from Cambodia, Laos, Myanmar (Burma),
Thailand, and Vietnam, 38% did not contain artesunate. Characteristics such
as cost and physical appearance of the tablets and packaging reliably
predicted authenticity. The illicit trade in counterfeit antimalarials is a
great threat to the lives of patients with malaria. The dye test will
assist national malaria control authorities in urgently needed campaigns to
stop this murderous trade.
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Lancet 2001; 357 no 9270: 1776 (2 June)
Policy and people
India's trade in fake drugs--bringing the counterfeiters to book
Opposite the Red Fort in the old quarter of Delhi stands the Bhagirath
Palace--India's biggest wholesale market for medicines and electrical
goods. Today, this one-time royal abode is in the news mainly because it is
the hub of the mushrooming trade in substandard and spurious drugs in south
Asia. As Om Prakash Seth, president of the Delhi Pharmaceutical Dealers
Association, points out: "In 1997, there were 198 pharmaceutical
distributors here [Bhagirath Palace]. Today, that number has shot up to
693." The sheer size of this growing industry means that police raids have
now lost their novelty value. So have the private detectives snooping for
inside information among the maze of crowded lanes and rundown buildings.
The market in fake and substandard pharmaceuticals is not unique to India.
But one widely quoted WHO statistic places this country as the leader, with
as much as 35% of the world's production. During the past 3 years or so a
powerful group of manufacturers have taken over much of the production. The
fake medicines are made largely in the northern states, but they are
circulated countrywide and beyond the borders to Burma and Bangladesh.
There is also evidence that Indian-made fake drugs have also infiltrated
former Soviet states. Last year, four Uzbek women were arrested trying to
transport huge quantities of fake medicines out of India for sale in their
country. Mostly analgesics, the drugs were being manufactured in a factory
in northern India, with packaging marked in Russian and Uzbek.
Subsequently, one of the women alleged collusion of Indian customs
officials in the smuggling racket.
In a country where nearly half the population still cannot read or write
and where consumer awareness is low, the spread of fake and substandard
drugs is a cause for alarm. "In the next 10 years, spurious drugs will be
the single biggest problem" in public health, says Ranjit Roychoudhury,
president of the Delhi Society for the Promotion of the Use of Rational
Drugs. Roychoudhury blames mushrooming garage-based drug manufacturing
outfits, rampant corruption, and lax drug control for the situation.
"Under the Indian Drugs Act, a spurious drugs manufacturer can face an
imprisonment for not less than 3 years and R 5000 (about US$100) fine.
However, unless foolproof evidence is gathered in coordination with the
pharmaceutical industry, the Drugs Controller, and the police, it is
difficult to root out the problem", says Ajit Dangi, director-general of
the Organisation of Pharmaceutical Producers of India (OPPI). OPPI is
collaborating with institutions such as the International Federation of
Pharmaceutical Manufacturers Associations and the Pharmaceutical Security
Institute (Geneva, Switzerland) to set up an intelligence network to
counter the counterfeit drugs trade. To ease identification of genuine
products, "several companies like Glaxo are going in for holograms, special
ink, printed/locked capsules, biocodes, embossing of tablets with a logo,
&c", explains P S Khanna, resident director of OPPI in Delhi. Another
survival strategy has been seeking the help of private detective agencies
or using marketing staff to monitor the trade.
Typically, the problem in India is that, although the relevant laws exist,
they are rarely implemented. With more than 20 000 manufacturers and
inadequate monitoring staff, the central and state regulatory bodies
acknowledge that it is impossible to curb the proliferation of substandard
or counterfeit drugs without the active participation of the industry and
traders. Delhi-based lawyer, Sanjeev Chaswal, says: "The culprits may be
small drug manufacturers with a turnover of R 20-50 million, employing no
more than 20 people. They have licences to make generic drugs but that does
not earn them enough, so they turn to manufacturing fake drugs. Then there
are the shanty factories that are totally unregulated. The law-enforcement
agencies have failed to identify many of these shanty factories." Part of
the problem is that India's counterfeit drug mafia has been clever enough
to split up the process of manufacturing, which helps preserve secrecy. And
the tardy pace of the legal process in India causes cases to drag on for
years.
No country is immune from the threat of counterfeit drugs but those with
weakly regulated pharmaceutical markets suffer most. However even in the
developing world, some are faring better than others. In 1996, a special
law on counterfeit drugs came into force in the Philippines. The
legislation requires random sampling and monitoring of drug quality in
pharmacies and hospitals. In addition, there are heavy penalties for
offenders: from 6 months to life imprisonment along with the equivalent of
a hefty US$25 000 fine.
Although India's pharmaceutical industry has complained vociferously about
the counterfeiters of late, many commentators have pointed out that not
enough was done to stamp out the trade at the start. Today, faced with a
grave situation, nine Indian drug companies have come together under the
aegis of the Indian Pharmaceutical Alliance (IPA). The IPA has hired the
services of two top retired police officials to help the pharmaceutical
industry take on the spurious drug mafia. "One problems is that
intellectual property rights has not been a major concern for the Indian
police", explains Raja Vijay Karan, former director of India's Central
Bureau of Investigation and head of the IPA anti-piracy task force.
In contrast to these expressions of concern, the approach of Delhi's deputy
drug controller, G C Lal, is more measured. "Fake drugs are not Delhi's
problem", he says. Every day I have inspectors going in plain clothes to
Bhagirath Palace. There may have been one or two cases but a lot of the
times it is just old brand rivalry. The big fish cannot bear to find
smaller chaps coming out with similar medicines so they say 'spurious,
duplicate, &c.'" Lal says his job will be made easier in the coming weeks
with more drugs inspectors being hired. But the job can be dangerous. One
of the drug inspectors from Delhi was shot at while he was on an
inspection.
A crucial factor behind the rise of the fake-drug syndicates is their
political support. In September last year, when the pharmaceutical-control
authorities raided Sitamarhi in the state of Bihar and made four arrests,
the greatest resistance came from people close to a Member of Parliament.
Since this collusion is alleged to be all-pervasive, India's trade in fake
drugs seems assured of continued buoyancy.
Patralekha Chatterjee
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