With every fifth
medicine sold by the Rs 19,000 crore pharmaceuticals industry in the
country a fake, according to a petition filed by Nicholas Piramal’s
Harinder Sikka (in his personal capacity), it is obvious the problem of
counterfeiting is very serious. For, though the Drug Controller General
of India says the problem of counterfeiting is not unique to just the
pharmaceuticals industry, it’s unlikely that using a pirated Windows
will kill you; but if there’s tap water in the adrenaline ampoule
that’s used to revive you after a cardiac arrest, it is certain this is
precisely what will happen.
A BBC documentary on spurious drugs that documents one such case of
fake adrenaline causing death has the Nigerian anti-counterfeiting head
naming India as one of the big suppliers of fake drugs imported into
that country (more on the video later). And a “significant contributing
factor” for India staying on the US special watch list of countries
with poor intellectual property rights compliance, according to the
report released a few days ago, is “the unauthorised use of bulk active
pharmaceutical ingredients (APIs) to manufacture counterfeit
pharmaceuticals”. “Countries must … enforce against the unauthorised
use of APIs domestically and to ensure that they are not exported for
unauthorised use abroad,” the report says.
Most, including Sikka, who won a global anti-counterfeiting award,
presented by none other than Justice KG Balakrishnan (now the Chief
Justice of India), have focused on the lack of drug inspectors in the
country and the handful of government laboratories—we have just 900
inspectors to take care of around 20,000 registered and unregistered
producers and 400,000 chemist shops across the country. But this is
missing the wood for the trees. It is obviously good to have more drug
inspectors and more government laboratories, but what is required is a
more intelligent approach, assuming of course, and that’s a big
assumption, that the government is keen to do anything.
Though it is true spurious drugs are sold in small towns and distant
villages (that’s where having more inspectors can be useful), large
enough sales take place under the very nose of the authorities, and
that is where concentrated action can help. Most of those in the pharma
industry will tell you, for instance, that large proportions of
medicines that are procured in bulk by the armed forces, the CGHS, and
so on are fake—indeed, the government’s system of awarding the tender
to the lowest bidder often results in cases where the bids are lower
than the cost of the active ingredient itself; that the medicine sold
will be spurious, with less or no active ingredient, is obvious.
One solution then is to make it mandatory that all bulk buying of drugs
by the armed forces, the CGHS, big hospitals and so on will have to be
tested, randomly, not by government laboratories but by roping in
private ones as well. Just look at the impact one Centre for Science
and Environment (CSE) has had on the standards for soft drinks and
water as compared to stodgy government laboratories! —and ensuring that
these results are well publicised. Imagine the impact if a sign outside
a big hospital says its medicines are spurious. A good example to
emulate would be that of the public sector oil firm BPCL. At a time
when oil sales were growing quite slowly, sales in select BPCL pumps
rose by several times. This, when the company began its Pure-for-Sure
campaign, promising unadulterated fuel to customers. Apart from
tamper-proof locks on its tankers, the company hired a certifying
agency (in this case, TUV) whose job it was to conduct random checks on
various pumps without even BPCL’s management knowing when and where the
check would take place. To make the system even more strong, make the
head of the organisation caught with fake drugs legally culpable.
This, of course, would also require a big step on the part of the
government, which, till date, continues to prescribe nominal punishment
for counterfeits/spurious drugs—imprisonment of up to three years and a
fine more than Rs 5,000 are clearly not a deterrent, especially when
the crime is non-cognisable and bailable. A new more stringent law was
proposed by the NDA government in December 2003 but never got passed in
the din of the elections, and nothing has been heard of the UPA’s bill
after the standing committee to which it was referred gave its
recommendations in December 2005. Call it government apathy or call it
the power of the big counterfeiting industry, the result is the
same—counterfeiters rule.
In the BBC documentary, the journalist posed as a Chechenyan looking to
buy low-priced fake drugs and secretly filmed the head of one such firm
who openly bragged that he was paying off politicians, including
gifting a Bentley to a former chief minister. He spoke of how,
deliberately, one or two letters in the name of the drug were changed
as this provided protection under the law! The firm, by the way,
continues to do business even today. In another case, reported by this
newspaper, a firm was blacklisted for providing poor-quality (read
spurious) medicine by the government but, within a short while, it was
back to winning government tenders. So the next time your fever doesn’t
respond to medicines, don’t go back to your doctor, visit your chemist
first and have the medicine analysed at a laboratory. You have to fight
for your rights, the government won’t.
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