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INVESTIGATION:
SPURIOUS DRUGS
Deadly
Doses
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"No
medicine should be purchased without obtaining a bill."
OM PRAKASH SETH
Pharma dealer, Delhi |
Another
firm, Ambala-based fly-by-night operator Crystal Pharmaceuticals, faces
legal action for stuffing its Ampicillin tablets with turmeric. In Delhi
31 seizures have taken place since April 1999. In the biggest such raid
during this period, the Drug Control Department picked up four popular
but spurious brands (Perinorm, Ciprofloxacin, Cifron and Pyrazenamide)
from an Okhla unit. In Bihar, at least 25 licences have been cancelled
since April 2000. Samples of large quantities of Vitazyme and Corex have
failed laboratory tests as no active constituent was available.
What is
shocking is that the spurious medicine mafia enjoys political support.
On September 26, when the drugs control authorities moved in for raids
at Sitamarhi in Bihar and arrested four persons, the greatest resistance
came from political goondas close to an RJD MP. "We are concerned
about the political patronage the drug mafia receives," rails H.R.
Khusrokhan, Glaxo managing director and IPA president. Following the December
raids in Delhi, there are indications that one of the arrested may be
close to a Union minister who allegedly runs a fake drugs plant.
The collusion
is all pervasive. In Karnataka, the report of the Estimates Committee
of the Ninth Assembly on Health and Family Welfare spelt out that Rs 3
crore was spent by the Government for establishing intravenous fluid plants
in 10 state-run hospitals. Within months, though, all the state-run bottling
units became defunct, allowing a clutch of private operators to push in
unlabelled bottles at over twice the market price (Rs 12 against Rs 5).
Despite
the seemingly high number of raids, the enforcement machinery of the Government
is not adequately equipped to tackle the crisis. It's like waging a war
against a deadly enemy but providing guns to only a few. Of 70 districts
in Uttar Pradesh, 12 do not even have a single drug inspector. In Lucknow,
the state capital, there are only two inspectors to monitor 400 medical
stores and 26 manufacturing units-the Central Government guidelines stipulate
at least one inspector for every 100 stores. The city's drug lab, which
can handle only 1,000 samples a year, does not have modern testing facilities,
yet is ruthlessly pummelled with 4,000 samples over 12 months. "We
are helpless," regrets Laxman Prasad, assistant drugs controller.
"Our machinery to combat spurious drugs is in a shambles."
In Delhi
there are around 9,000 sales units but only about 17 drug inspectors in
place. "When we catch a person we usually get him convicted, but
are we really able to do much?" asks Ravi Kant, assistant drugs controller
in the capital. In Karnataka the posts of drug inspectors have been frozen;
there are only 25 at present, vastly inadequate to deal with the issue.
"Our department is grossly understaffed. This is our biggest problem,"
admits, R. Ananda Rajashekhar, the state's drug controller. In Bihar for
every raid carried out, 10 aren't. And in Tamil Nadu the number of drug
inspectors (71) has remained unaltered over the past 30 years during which
the number of firms has gone up five times.
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CASE
STUDY
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Heli kools, Bhopal: The 14-year-old school-girl suffered an
upset stomach coupled with acute pain after a picnic, following
which she popped the analgesic Combiflam, among other tablets. A
day later, her haemoglobin count fell to a critical 3-the normal
range is 10-14. Her kidneys too got affected. According to the doctor
who attended on Heli, her condition could not have deteriorated
so rapidly unless the analgesic was spurious and its contents had
eaten into her body's immune system. Thankfully Heli is now limping
back to normalcy.
"I
couldn't believe Heli could fall so sick after popping analgesics."
V. Kulshrestha, Heli's father
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Yet, for
all the ills that plague the manufacturing-distribution-enforcement system,
it is the industry that is partly to blame for the state of affairs. Top
multinational and national firms usually place orders on batch numbers
with sole licensees. Very often some of these licensees use the batch
numbers to produce additional medicine, without genuine contents, and
push them in the market through well-established channels (involving wholesalers
and retailers) and make huge profits. But the firms do not cut their links
with the culpable licensees. "We are exploring this angle seriously,"
says Dinesh Bhatt, DCP, who led the raids against Jindal. The problem
of a large number of chemists (almost 100 per cent in rural belts and
small towns) not providing any bills, or substituting prescribed medicines,
is worrying. "Multinationals must do away with sole licensees and
no medicines must be accepted without bills if we are serious about combating
this cancer," says Om Prakash Seth, anti-spurious drugs crusader
and president of the Delhi Pharmaceutical Dealers' Association.
The problem
is the dimensions of the crime are not yet known. And the industry is
still foggy. The IPA only last month appointed a task force headed by
former CBI director Vijay Karan to go into all aspects of the issue. "An
indepth study is required," proffers K. Chellappan, dean, Madras
Medical College. Among other initiatives, the Organisation of Pharmaceutical
Producers of India (OPPI) has tied up with the Geneva-based Pharmaceutical
Institute to set up its own intelligence network to counter the menace.
The IMA, on its part, is trying to galvanise its district branches to
alert the masses.
Yet, this
is only a small beginning and much screams for attention. The law for
one-Drugs and Cosmetics Act, 1940-needs amendment to include harsher provisions.
From Khusrokhan and Habil Khorakhiwala, CMD, Wockhardt, to Ajay Dangi,
DG, OPPI, everyone is agreed on this count. "Death sentence must
be made the law for anyone found peddling spurious drugs. You cannot play
with peoples' lives and get away with it," says Dangi. "You
cannot pardon those who cheat by not providing the right quality ingredient
in right quantity," echoes Harsh Vardhan, regional adviser to the
who. In Delhi, eight persons were convicted under the Act this year but
were only sentenced till the rising of the court-for a few hours. The
unfortunate outcome: they are possibly back in business and the menace
continues unchecked.
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THE
PRESCRIPTION
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- Raids
against fake drug manufacturers have been on the rise but the
big fish must be netted.
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The enforcement machinery needs to be strengthened.
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The Drugs and Cosmetics Act requires immediate amendment.
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The industry should stop dealing with sole licensees making brands
that get faked. Political patronage too should be checked.
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THE
AILMENT
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- Fake
drugs roughly have a Rs 1,500 crore share of the Rs 20,000 crore
pharma-ceutical market.
- One
in every five strips of popular medicine is fake.
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Genuine batch numbers are used by the drug mafia.
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The fake drugs are made in Delhi, Haryana, Uttar Pradesh, Bihar
and Tamil Nadu.
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