NEW DELHI - Two recent reports by international health organizations have
highlighted the disquieting magnitude of the counterfeit drugs market in India.
The Organization for Economic Cooperation and Development (OECD) reckons that
75% of the world's total supply of fake drugs can be traced to India. The World
Health Organization (WHO) pegs the figure at 35%.
Between 10 and 30% of all pharmaceuticals in developing countries are
counterfeit, according to the 2006 WHO figures cited in the OECD report, which
estimates that India is the biggest culprit in the spurious drugs market though
other countries such as Egypt (7%) and China (6%) contribute to this
menace. OECD asserts that counterfeiters include medical professionals such as
pharmacists and physicians, organized crime syndicates, bogus pharmaceutical
companies, corrupt officials and terrorist organizations.
These groups, according to the OECD, are targeting a slew of modern drugs in
areas like cancer, erectile dysfunction, cardiology, cholesterol lowering,
hypertension and genitourinary infections.
"A worrisome trend is that counterfeits are increasingly being detected as
having entered the supply chain of some of the most regulated jurisdictions,"
said the OECD. During a survey conducted by the organization amongst
pharmaceutical manufacturers in 2005, one company reported an increase in the
existence of counterfeit active pharmaceutical ingredients (APIs) and increased
difficulties in distinguishing between the genuine and the counterfeit
material.
"Today, few jurisdictions, whether developed or developing, are immune from
counterfeit pharmaceuticals and the infringement of intellectual property
rights," warned the OECD. The trade has serious and obvious health implications
as well. Overall, the OECD reckons that the annual value of international trade
in counterfeited consumer goods, including medicines, is US$200 billion, an
amount equivalent to 2% of world trade and higher than the gross domestic
product of 150 countries.
In 2003, the Coalition for Intellectual Property Rights, an independent Russian
group, conducted a survey that found that 12% of the prescription drugs
distributed in Russia were counterfeit. The United States has also had a
growing problem with counterfeit drugs, and to help address it, the US Food and
Drug Administration (FDA) held a Congressional hearing in 2005 to review the
situation. The US is an especially attractive market for counterfeiters because
40% of worldwide annual prescription drug sales were sold there in 2007.
This is not the first time the Indian government has faced flak for its
unchecked manufacture and circulation of spurious drugs. The Associated
Chambers of Commerce and Industry of India (ASSOCHAM) has estimated that the
annual rate of growth of the fake drugs market in India is 25% and worth
US$34.9 billion. Typically, the Indian health ministry refutes this by saying
that only some 8% of drugs in India are suspect.
So who's telling the truth? Contradictions abound on this point and to set the
record straight, the Drug Controller-General's office in India will embark upon
the world's largest study to assess the size of the Indian fake drugs market.
The study will document the testing of 31,000 samples of 61 drug brands from
nine therapeutic categories covering medications to treat tuberculosis,
allergies, diabetes, cardiovascular disease, malaria and other common ailments
as well as preparations that contain multivitamins.
"The main problem in India is that we lack quality infrastructure to test the
quality and purity of drugs," said Akhil Bharadwaj, a New Delhi-based
pharmacist. "While our drug pricing is tightly controlled, our drugs' quality
remains unmonitored by a registered central agency. Most of our laboratories
are ill-equipped and operate in unhygienic conditions. In such a bleak
scenario, quality doesn't figure."
This is a pity because India is also a leading source of high-quality drugs
sold by legitimate drug manufacturers, including most leading brand-name drug
makers operating in the US and Europe. But the shadow cast by the counterfeit
drugs market is sullying its reputation. Fake drugs also endanger the lives of
scores of hapless patients. Indeed there have been many cases of diabetics
dying after being dispensed spurious insulin and TB patients becoming seriously
ill or even dying due to consumption of fake drugs.
Another dangerous offshoot of administering below-par AIDS, TB or malaria
drugs, say doctors, is that this leads the virus to mutate, triggering drug
resistance. Ultimately, this resistance not only renders the medicine
ineffective but sometimes also fatal. Drug resistance is already on the upswing
globally. A World Bank study has shown that the increase in drug resistance to
AIDS in the UK was 17% for the period 2001-2003 and 24% in the US between
2001-2002. Overall, it estimates that over 20% of the two million patients
(some 4,00,000 people) under treatment in developing countries are now drug
resistant.
To counter this, the WHO established the International Medical Products
Anti-Counterfeiting Taskforce (IMPACT) in 2006. But as experts point out, the
problem is not limited to outright fakes. Urgent attention also needs to be
given to sub-standard drugs manufactured in many African and Asian countries
that rarely meet the high standards of safe medicines. Nor are these drugs
tested by independent regulatory authorities.
It augurs well for the global pharmaceutical industry that the European
Commission is including strong Independent Property Rights chapters in all its
new series of free trade agreements with India, Korea, the Association of South
East Asian Nations and Latin America.
India, for its part, should set in place foolproof mechanisms to protect its
own products from being counterfeited and shore up its intellectual property
rights systems to deter fakes from entering its markets. Tightening laws and
meting out stringent punishments to the culprits will also act as effective
deterrents.
On a more proactive level, the Indian government, which regulates domestic drug
prices, can even offer a premium to companies that have their factories
approved regularly by foreign inspectors. Encouraging pharmaceutical companies
to spend more on research and development and employing more in-house
scientists can act as other safety mechanisms to discourage the manufacture and
circulation of spurious drugs.
New Delhi-based independent journalist Neeta Lal has had her work
published in over 70 publications across 20 countries.
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