Health Administrator Vol : XIX Number 1: 29-40

CHAPTER – 9
THE SPURIOUS DRUG MENANCE & REMEDY
Shishir Kant Jain*

Abstract:
According to WHO 35% of the world’s spurious drugs are produced in India. The spurious
drugs worth nearly Rs 4000 crores, which is about 20% of the domestic pharmaceutical business,
are manufactured in India. A large quantity of the spurious drugs is also either exported or
smuggled out. It is a shame that USA has put India in 301-watch threat list. The net work of the
illegal trade is protected by some of the politicians having vested interest and the corrupt
officers. Sophisticated equipment is used to produce counterfeit drug and even the experts
cannot distinguish these from the genuine packing. Modern communication system like cellular
phones and Internet are used to avoid detection. Though The Mashelkar committee has
suggested some harsher penalty, yet it is quite mild and the report should be reviewed. A help
of an intelligence agency like CBI is required to expose the nexus of politicians, the corrupt
officers and the manufacturers and traders of the spurious drug. The working of dispensing
chemists should be modernised. The papers regarding the chain of chemist-stockist-
manufacturer should be maintained in order. The government institutions like defence, hospitals,
dispensaries are the dumping ground for the large quantities of spurious drugs and therefore
the purchased drugs should be monitored and tested by an independent agency. The drug
control department should form a separate intelligence wing to handle the spurious drugs
menace and the staff should be trained in detecting the net work and nabbing the culprits.
They should also have an adequate facility to handle the complaints regarding the spurious
drugs and for testing the suspected samples. To make the system more efficient, this facility
should also be run by NGOs and financed by the pharmaceutical manufacturers. The
consumers are required to play pro-active role in protecting themselves and to help in nabbing
the culprits.

advanced countries. The total turnover of the

Introduction:
The drugs and food are essential components of
the health care of the public. The recovery of ailing
patients from illness is directly related to the quality
of drugs they consume. The proliferation of spurious
drug in India is a serious problem for the health of
the people and there is an urgent need to curb it.
India has made a commendable progress in the
field of medicine, surgery and the manufacture of
pharmaceutical preparations, generic drugs and the
incipient. The pharmaceutical companies in India
can be compared with any of the companies in
pharmaceutical companies for domestic market is
estimated to be around 20000 crores (1). The
export is estimated to be around 11000 crores (2).
The illegal production of spurious drugs, cosmetics,
food preparations and raw materials like spices has
always been part of the trade in India. Recently,
due to large volume of sales of pharmaceuticals
and a lucrative business, an illegal production of
spurious drugs have also started on an alarmingly
large scale. According to World Health
Organisation’s. WHO, 2001 statistics, 35% of the
world’s spurious drugs are produced in India,
followed by Nigeria at 23% (3). According to official

* Centre for Civil Society, New Delhi, Fomerly, Chief Executive(Tech) of Cellulose Products of India,
Ltd., Admedabad
29
estimates, the spurious drugs worth nearly Rs 4000
crores, which is 20% of total domestic
pharmaceutical business, is manufactured in India
(3), Fake drugs are an international phenomenon
and they constitute 15% of the international market
(4) Africa and Latin America have already started
to complain about the import of spurious and sub-
standard drugs from India. Since nearly 3-5% of
the drug import in USA is spurious, USA has already
put India in 301-watch threat list a few months ago.
(3). If India is found guilty of exporting spurious drug;
USA would totally ban import of drugs from India. It
is high time that India should take concrete steps
to neutralize the spurious drug racket and especially
in the export market in order to uphold the high
image and to safeguard the interests of genuine
manufacturers and traders.
Meanings & Definitions:
Dictionary meaning: Webster’s unabridged, second
edition, 1983:
Spurious – false, counterfeit, not genuine
Adulterate – to corrupt, debase, or make impure
by adding a poor or improper substance; as to
adulterate liquors, to adulterate drugs.
Sub-standard – below standard, below a standard
established to law.
Definitions:
Drugs & Cosmetics Act, 1940: revised, Act 68 of
1982, S.6, and w.e.f 01.02.1983 (24)
Spurious Drugs – For the purposes of this chapter,
a drug shall deemed to be spurious –
(a) If it is imported under a name which belongs
to another drug; or
(b) If it is an imitation of, or is a substitute for,
another drug or resembles another drug in a
manner likely to deceive or bears upon it or
upon its label or container the name of another
drug unless it is plainly and conspicuously
marked so as to reveal its true character and
its lack of identity with such other drug: or
(c) If the label or container bears the name of an
individual or company purporting to be the
manufacturer of the drug, which individual or
company is fictitious or does not exist; or
30
(d) If it has been substituted wholly or in part by
another drug or substance; or
(e) If it purports to be the product of a
manufacturer of whom it is not truly a product
Adulterated drugs – For the purposes of this
chapter, a drug shall be deemed to be adultered –
(a) If it consists, in whole or in part, of any filthy,
putrid or decomposed substance; or
(b) If it has been prepared, packed or stored under
insanitary conditions whereby it may have
been contaminated with filth or whereby it may
have been rendered injurious to health; or
(c) If its container is composed in whole or in part,
of any poisonous or deleterious substance
which may render the contents injurious to
health; or
(d) If it bears or contains, for purposes of colouring
only, a colour other than one which is
prescribed; or
(e) If it contains any harmful or toxic substance
which may render it injurious to health; or
(f) If any substance has been mixed therewith so
as to reduce its quality or strength.
World Health Organisation (WHO)
According to WHO (9), counterfeit medicines
that which is deliberately or fraudulently mislabeled
with respect to identity and/or source.
The Global Trade in Spurious drug:
The global trade (6) in counterfeit drug is
estimated to be around 20 billion USD and is one of
the fastest growing grey economies – after
prostitution, narcotics, terrorism and arms trade.
Nearly 10% of the international trade in
pharmaceuticals is attributed to the fake drug. The
counterfeit drug has resulted in tragedies. In 1995,
a multinational drug company in Philippines
discovered spurious asthma inhaler in the market.
In 1995, in Nigeria, fake drug killed 2500 people,
which were infected by meningitis. In May 2000,
many people died in Cambodia, from spurious drug
meant to treat malaria. In 1995, 89 people in Haiti
died after consuming spurious paracetamol
preparation. The preparation contained diethylene
glycol, which is a toxic chemical. Fake Artesunate
is increasing the incidence of malaria in south-
east Asia. A report published in The Lancet
suggests that fake Artesunate ranged from 11%
in Thailand to 64% in Vietnam. In May 2001,
Colombia’s National Institute for the Supervision
of Medication & Foods (INVIMA) discovered a
thriving illegal drug operation in Bosa, a poor
neighbourhood of Bogota and found that sale of
fake drug was as lucrative as the cocaine
business in Latin America, In Russia, counterfeit
drug has increased 10 times since 1998 and cover
about 7% of the total market. Most of these drugs
are life saving drugs like antibiotics, insulin and
drugs for heart diseases. More than 60% of the
drugs sold are the fake versions of Russian
brands. The fake drugs are also intruding in the
treatment of tuberculosis in east Europe. AIDS
in Africa and Thailand and infectious diseases in
South America and in the poor regions of Africa.
In Vietnam and Myanmar, according to WHO more
than 40% of antibiotics that are imported from India
and as much as 11% of antibiotics in the market
are fake or substandard.
A large quantity of spurious drug from India
and Indian subcontinent is dumped in Africa,
especially Nigeria, Kenya, Tanzania and their
neighbouring countries. A raid at an illegal
warehouse in Nigeria revealed that the labels of
Actifed and Menstrogen were forged and the
packets revealed the names of firms of Indian
manufacturers.
In July 2000, Italian authorities seized two
tons of raw materials, meant for the manufacture
of counterfeit drug, transported from India and
China. The counterfeit drug was to be packaged
in Europe and sold in North and South America.
About 5-8% of total drug imported in USA is
either counterfeit or substandard.
In 1996, Flavine International, a US based
Pharmaceutical company, admitted that they had
been importing nine counterfeit drugs including
Gentamycin, an antibiotic, from number of years.
31
The food and Drugs Administration (FDA), Maryland,
USA, believes that counterfeit Gentamycin may have
been responsible for as many as 66 deaths and
hundreds of severe reactions.
The Effect of Spurious Drugs on Health of
People:
It is difficult to ascertain a precise effect of a
spurious drug on health of a person for the following
reasons:
a. It is not known at the time of consumption of
medicine that it is a spurious drug. Therefore,
if the drug is not effective a patient usually thinks
that the diagnosis is wrong and either he
consults another physician or ends up having
a series of diagnostic tests including x-rays,
ultra sound, MRI etc resulting in an increased
medical expenses, mental agony and absence
from work or studies.
b. If there are certain toxic effects of the medicine
then it is usually assigned to an allergic reaction
of the medicine and the physician might change
the medicine. The toxic medicine is then
completely forgotten and is not pursued any
futher.
c. If the medicine is fatal then usually the death is
assigned to the disease or the negligence of a
doctor or the hospital
Even when spurious drugs do not endanger life
(3) they can leave the patient seriously ill and those
with inadequate potency can induce drug resistant
bacteria i.e, they will not respond even when right
medicine in right dosage is given.
Occasionally certain cases are reported which
indicate the presence of a spurious drug. Some of
the instances are given as follows:
? A lady had a long history of epilepsy (3). She
was under medical treatment and free of
seizures for the last four years. She got one
after taking medicine from a new source.
? A person was sick and was asked to take
certain antibiotics. When his condition did not
improve even after a week, the antibiotics were
 changed one after another. Nothing worked
and ultimately the patient died.
? A lady, a high B.P. patient was all right with the
medicines. Suddenly her B.P. became erratic
and she required immediate hospitalisation.
? One Lakhpatraj Mehta filed a PIL at Mumbai
high court (7) whose son Alpesh passed away
after being administered a life saving injection
‘Imipenum’. Expressing a serious concern
over the circulation of spurious drugs in the
open market, the Mumbai HC directed
Maharashtra Government to file a report within
three months giving statistics on complaints
received about fake medicines from general
public and action taken by the authorities
during January 2002 to August 2003. The
cash memo of the injection did not specify the
date of manufacture, batch number and expiry
date. The Food and Drugs Controller
registered a case against the chemist on
October 23, 2002 and his licence was also
cancelled. However, a minister stayed the
decision to cancel the licence.
? A lady was admitted to a private hospital in
Chennai for a minor surgery (8). The surgery
went off well until an injection of Ceftazidine,
to prevent infection was given, when the
patient suddenly developed the complications.
On testing the seized vials, the active
ingredient was found to be nil.
? 33 children died within 3 days of consuming a
cough expectorant containing diethylene
glycol manufactured by a Gurgaon Company
(6). They developed high fever and had a
kidney failure.
We come across hundreds of such cases in
every day life. However there is a lack of
awareness of the existence of spurious and
adulterated medicines by a large section of people
and therefore the people, doctors and hospitals are
not adequately alert. The public administration lacks
the competence and the will to deal with the
menace and moreover unless the moral standards
of administration and politicians are high one
32
cannot depend upon them. Therefore the public is
required to be more alert in this regard and device
their own methods of safeguard themselves.
Modus Operandi:
The spurious drug business is flourishing
mostly in northern India. The states of Punjab,
Haryana, Himachal Pradesh, Delhi, Uttar Pradesh,
Bihar, Gujarat and to some extent Madhya Pradesh
have a large numbers of spurious drug
manufacturing units. In U.P. the major sale of
spurious drug takes place in Agra, Lucknow and
Varanasi (4). The fake medicines are circulated to
the whole country and also to neighbouring
countries like Bangladesh and Myanmar (17).
Nearly one fourth of durgs seized in Delhi and
Haryana are found to have Russian markings. Delhi
is a hub for the thriving market. A large number of
cheap tourist hotels in the congested Paharganj
and Karol bagh areas are found to cater the traffic
from Uzbekistan, Kazakhstan and other CIS
nations. A middleman picks up the consignment
from these hotels and money with the tourists
changes hands smoothly (8). According to a recent
newspaper report, Aligarh has of late emerged as
the main centre from where such drugs are being
brought into Delhi and the nearby areas, and
pushed into circulation (1), Bathinda has emerged
as haven for the manufacture of spurious drug. The
location of the town is beneficial for the smugglers
as the district shares its border with Haryana and
Rajasthan (19).
Many of the international woman couriers
indulge in prostitution to earn money and to please
the custom officials to smuggle the spurious drugs.
After reaching their destination like Tashkent these
couriers hand over the smuggled drugs to the local
traders which, sell them after putting Russian
markings (8).
More than half of the country’s spurious drug
trade is conducted at Bhagirath Palace, Delhi (9).
As per the estimate of CII (The Confederation of
Indian Industries), spurious drugs worth 2500
crores are annually thrown into the market from
Bhagirath Palace, the wholesale market of drugs
(1). In 1997 there were 198 pharmaceutical
distributors at Bhagirath Palace, which shot up to
693 in 2001 (17). Raising the issue in Delhi
legislative assembly, Ms. Kiran Chaudhary said that
the racket of producing and distributing spurious
drugs was thriving in the capital and the
Government was turning a blind eye to it. Citing a
recent incident, Ms Chaudhary said 54 samples
were lifted, during a surprise raid, from Bhagirath
Palace and out of them only four were found to be
genuine. This indicated the state of affairs in the
administration and called for more vigil. She
pointed out that cases have come to light where
even reputed companies have been found to be
involved in the manufacture of spurious drug (21).
The government institutions like defence,
hospitals, dispensaries etc make bulk purchases
of drugs through the tender system and settle for
the lowest bids. Due to the presence of corrupt
purchase officials in these deals and in the absence
of any appropriate system of monitoring the quality
of drug, spurious and sub-standard drugs find the
way into these places (3,14).
Most of the spurious drug manufacturers do
not register their companies with the drug controller
and it is difficult to detect them. Some of the
licensed manufacturers, which operate the legal
business, produce counterfeit drugs and it makes
the matter even more complicated (11, 13).
The manufacturer of spurious drugs are
equipped with the latest techniques like desk-top
publishing (DTP) to copy any innovations to
reproduce exact replicas of new packaging labels
and holograms. The reproduction is so perfect that
even the experts cannot tell the counterfeit from
the genuine packing. The manufactures and
traders use modern communication system like
cellular phones and Internet to avoid detection. The
production is also carried out at different locations
for the same reason. Due to a high margin of profit
the producers of spurious drugs are rich and they
are able to pay handsome amount to the corrupt
officers (11,13). They are using chalk powder, saw
dust, salt, jaggery etc for producing spurious durgs
(10). These products may not produce adverse
effects on the health of consumers and are being
used to reduce the penalty in case they are caught.
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The counterfeit drugs are no longer restricted
to tablets and capsules of antibiotics, antiprotozoa,
anit-malarial, hormones, steroids etc but are
covering inhalers, sophisticated injections and
expensive tablets used for the treatment of cancer
(5). Recently the lifestyle drugs have also come
into its fold. They include, health tonics, fairness
lotions, pills for body building and impotence drug
or erectile dysfunction drug like Viagra (6,10).
These drugs are taken by a large number of people
and therefore can affect a large population of the
world.
Recycling is one of the common practices
adopted by small timers engaged in the
manufacture of spurious drug (16). The recycling
is mostly used in products like powder injections,
e.g., beta-lactam antibiotics, which are expensive,
and over-the-counter products like Iodex,
Gripewater, cough syrups, pain balms, analgesics,
anti-inflammatory tablets etc. An individual having
knowledge of marketing of pharmaceuticals carries
out this business. The process involves collection
of used vials with intact labels, removing the
closures, filling the containers with enough material
and resealing it by using hand operated sealing
machines. The activities are restricted to two or
three districts and don’t have a large networking.
It’s a cottage level operation involving small quantity
of product. The products are sold to hospitals,
nursing homes and practicing quacks.
Another method in this trade is refilling and re-
labelling (16). The culprits identify the expensive
branded drugs and substitute them with cheaper
drugs having the same composition, remove the
labels from the recycled bottles or vials, pack the
cheaper products and affix the label of the branded
product, e.g., Garamycin injection. Sometimes the
packing may look similar to the branded or a
generic product in appearance, but may contain a
cheaper generic drug e.g., Indomethacin capsules
relabeled as Chloramphenicol capsules.
‘Phensedyl’, a cough syrup, is a trade mark of
Nicholas Piramal. The people in North-eastern
states get empty bottles from Bangladesh and they
sell after refilling them with higher content of
narcotics (3). The counterfeit version is sold as
‘Phensedyl plus’ and is supplemented with extra
doses of narcotic codeine (9). The spurious drugs,
which are cheaper substitutes of biotech drugs like
Neupogen are available at nearly half the price from
across the border and are smuggled into India (3).
The reuse of drugs past their expiry date is
yet another method used by these people (3).
Mostly they are circulated in areas where the
people are illiterate.
Some of the dispensing chemists are also
partners in this racket as they get 1000 to 5000%
margins from the spurious drug manufacturer (13).
The counterfeiters prey more on the
vulnerable semi-literate and illiterate belts where
people think that the death is due to the disease
and not due to the drug (13).
The entire spurious drug industry managed
to flourish mainly due to two factors, first due to
the incompetent or corrupt bureaucrats and
secondly due to the political support. Besides,
making punishment more severe, it is essential to
tighten the noose around the corrupt people in the
establishment who abet such activities and to
expose the politicians, who support the trade (15).
In September, 2000 when the drug control authority
raided at Sitamarhi in the state of Bihar and made
four arrests, the greatest resistance came from
people close to a Member of Parliament (17).
During 2000-2001, only 11 drug samples were
found to be spurious in Delhi (21) while the illegal
trade is flourishing here.
Another reason for the increase in the illegal
trade is the delay in justice in the courts and release
of culprits on bail, due to which they manage to
restart the business. A total of 1291 cases relating
to drug & cosmetics including 43 cases of spurious
drug are pending in Maharashtra courts as on
31.3.1997 (22).
The spurious drugs are not restricted to
allopathic medicines alone, in April 2003 the Delhi
police arrested one Dr H K Sachdeva who was
allegedly involved in the manufacture and sale of
spurious homeopathic medicines. Similar cases
34
have also been reported relating to sale of spurious
Ayurvedic and Unani medicines (4).
Recent Cases of Arrest:
Though there are only a few cases, which have
come to light, yet they reveal certain significant
details of the operation of manufacturers and
distributors of spurious drugs. A few such cases
are described as follows:
A transcript from a hearing in a Washington Court
(6):
“On May 17th, 2002 seven individuals and five
companies were indicted by a New York grand jury
and charged with manufacturing counterfeit Viagra
and selling it over the Internet. The investigation
covered a 17-month period during which
investigators purchased 28,000 bogus Viagra
tablets from China and India. Wholesalers in Hong
Kong and resellers in Florida, Nevada, and
Colorado operate hand-in-glove. The wholesalers
were also linked with a counterfeit product that was
found in three cities in China. Another aspect of
this case involved G. Vishwanath of Benzo
Chemical industry in India who sold a tablet-
punching machine that weighed 1,500 pounds to
undercover operators and offered a constant
supply of tablets blend for his customers to
manufacture his own Viagra. Those indicated
bragged that they could deliver 2.5 million
counterfeit Viagra tablets to New York each month.
Ingenious criminals were able to import counterfeit
medicine notwithstanding the current regulations
and border controls. Any lessening of those
regulations and controls will expose American
consumers to an unacceptable level of risk.”
In September, 2000 Delhi police (6,8) arrested
four Uzbek women and an Indian, Chander
Prakash Marwah, possessing 800 kg of spurious
drugs worth Rs 2 million, which they were trying to
smuggle out. The supply of the spurious drugs
was traced to Unisul Pvt Ltd., located at Sonepat.
The packaging were marked in Russian and Uzbek.
The Indian customs officials were involved in the
smuggling racket. The Uzbek women had come
to India to sell the Chinese silk. They made 22
trips to India during the past 18 months before they
were caught. On the information provided by
Marwah the police jointly with FDA, Delhi raided
their manufacturing bases at Sonepat. Faridabad
and Nangli Devat (a village on the outskirts of Delhi).
They found that several consignments of spurious
drugs were lying in the premises, which were ready
for shipment.
Crystal Pharmaceuticals (8), an Ambala based
company, was charged in a Tamil Nadu court for
producing fake doxycycline, amoxycilin,
erythromycin, contrimoxazole and dexamethasone.
The seized samples had the original labels and
packing. The laboratory tests revealed that they
had zero active ingredients. When a sealed strip
of doxycycline was opened in the court and the
two halves of capsule separated the content of the
capsule was found to be turmeric powder and not
the medicine.
Mehngi P.K., owner of The Duefil Laboratories
runs his business from Bhagirath Palace, Delhi and
has a manufacturing unit at Jaipur, Rajasthan. He
was arrested in 1979 on charges of manufacturing
fake drugs. Not only he was released on bail, he
also resumed his business while the case is
pending in the court (9).
In March, 2003 (12) the Delhi Police have
arrested one member of a gang, Deva Singh alias
R K Mishra from Jahngirpuri, which was involved
in the manufacture of fake drugs. They seized
from him a consignment of spurious medicine worth
Rs 5 lakhs, which was heading to Varanasi. The
medicines were Ampoxin – 500 (Trade Mark of
Unichem Laboratories and manufactured by them
at Solan, HP) and Sporidex-500 ( TM of Ranbaxy
Laboratories and manufactured by them at Okhla.
New Delhi). The medicines were manufactured in
Himachal Pradesh. Deva Singh worked as a
conduit-cum-commission agent. The racket is
spread across Himachal Pradesh, Haryana and
Delhi. Most of the persons involved in the trade
operate under false names and addresses. Earlier,
Deva worked at a fake drug manufacturing unit at
Bhiwadi, Rajasthan. The factory had to be shut
down after raid by police. After that Deva joined
one Rakesh Gupta alias Dahiya at Sonepat and
35
became a commission agent for the spurious
drugs. Further investigations in this case are on.
The drugs have been sent for the chemical
analysis. However, it seems that the seized drugs
contain chalk powder only.
The Delhi police busted a racket of spurious
drug distribution and arrested two shopkeepers
Shanraj Jindal, a resident of Panipat and Raghu
Raj Gupta, a resident of Bihar in North-west Delhi.
The kingpin, Harminder Singh, a resident of
Paschim Vihar, is absconding. The police seized
301 packets of Glizid tablets, a medicine for
diabetes and Nimulid, a pain reliever. These
medicines are registered products of Panacea
Biotech. The police also seized 15 kg of wrappers
and foils of various companies like Nise and
Ranbaxy from Harminder’s residence. The value
of seized goods is estimated to be around Rs 3
lakhs (18).
During December, 2000 the police arrested
two persons including a local politician at Noida
and seized 20 lakh worth of fake Tulsi zarda,
pouches and wrappers. The case is cited to show
the involvement of a politician (20).
On August 19, 2003 Delhi police arrested one
Mahesh Kumar Goswami, the manufacturer of
spurious medicines and a resident of Agra, while
selling the drug at Nizamuddin railway station. A
decoy customer struck the deal and police arrested
him on completion of the transaction. The police
seized 12 bags containing 500 different types of
medicines including tablets, capsules and injection
vials of different brands worth Rs 3.5 million. All
the medicines were found to be fake. Kumar used
to come to Delhi for at least 12 times in a month in
order to sell the drug. The purchaser would meet
him at the railway station (23).
One Krishan Kumar was arrested at Bathinda
for manufacturing spurious drug under the brand
name of ‘Kamini’ which is a trade name of Multani
Pharmaceuticals, New Delhi. The police also
seized fake labels, stoppers, 124 packed tablets
and number of empty bottles (19).
The Mashelkar Committee Report:
The Mashelkar Committee report (25)
submitted to the Union Health Ministry on August
12, 2003, advised strong action against those
manufacturing and selling spurious drugs. Dr R A
Mashelkar, Director General, Council of Scientific
and Industrial Research (CSIR) and Scientific
Advisor to the Prime Minister, made the following
recommendations in the report.
? Upgrading the Central Drug Standards Control
Organisation (CDSCO) to monitor the menace
should form a Central Drug Administration
(CDA).
? The penalty for manufacture and sale of
spurious drugs should be enhanced from five
years to not less than seven years.
? The maximum penalty for manufacture and
sale of spurious drugs causing grievous hurt
or death should be enhanced from life
imprisonment to death.
? A provision should be made in the Drug and
Cosmetics Act declaring all offences related
to spurious drugs as cognizable and non-
bailable.
? A fine of Rs. One lakh or up to three times the
worth of the spurious drugs held by a seller
should be charged (12).
? Police authorities and drugs inspectors should
be authorized to file prosecutions under the
Drugs and Cosmetics Act
Name of Officer Designation
B A Waghmare Asst.Commissioner(I.B)
G.K.Vakharia Drugs Inspector (I.B)
N M Gandhi Drugs Inspector (I.B)
K G Gadewar Drugs Inspector (I.B)
36
? A separate provision should be made for
speedy trials of such offences.
? No court lower than a Sessions court should
try these offences.
? State governments should strengthen and
support their drug control organizations.
? Industry and trade associations should play
an active role to arrest the menace.
The Consumer Guidance Society of India,
Mumbai
http://www.cgsiindia.org/forum.html#forum
In case of suspected Food and drug
adulteration. Write to the state health authority.
Retain samples where possible (26).
Address the complaints regarding Food, Drug
& Cosmetics to the following:
Food & Drugs Administration
Survey NO. 341 Bandra Kurla Complex
Bandra (E), Mumbai 400 051
Tel No. 26422361/65
Thane: Tel. No. 2531 1988
In order to curb the menace, the Central
Government has constituted a committee to study
the problem of spurious drugs. The following
officers of FDA, Maharashtra are identified as the
nodal officers;
Telephone Number/s Residential
Office
26592519-Direct
26592361-65 Extn. 362 28330977
“ Extn 366 25394915
“ 25895028
“ 25980524
Proposals to curb the proliferation of spurious drug
menace:
(a) CBI: The major hurdles in catching the
spurious drug manufacturers and traders are
the corrupt administrative and custom officials
and the politicians having vested interest in
the trade. They, instead of controlling the
menace, protect the culprits. Moreover the
smuggling of spurious drugs out of the borders
of India on such a large scale cannot take
place without the help of underground Mafia,
custom officials and the importers. The nexus
of politicians, administrative officials or custom
officials with the manufacturers and traders
of spurious drugs can only be exposed by
investigative agencies like CBI. If the CBI is
able to catch the big fish it will have a direct
impact on arresting the illegal trade.
(b) The Government:
The responsibility to check the menace rests
with the Government. The appointment of
expert committee under the chairmanship of
Dr R A Mashelkar shows their concern. The
committee’s recommendations are given
above. Simply enhancement of penalty is not
going to trap the culprits. The concerted
efforts are required by drug control officers to
nab the culprits. Since it is difficult to establish
that the spurious drug is responsible for the
grievous hurt or death, the introduction of
death penalty is not going to make much
difference to these criminals. The suggested
fine is just a peanut to them. The estimated
sale of spurious drugs in domestic market is
4000 crores. Therefore even if there are 200
big players, the turn over of each on average
would be 20 crores. More over, if on an
average a person purchases Rs 100/- worth
of spurious drug then a population of 40 crores
people annually or about one million/day is
affected. The damage of health of these
people cannot be quantified. A minimum fine
of rupees one crore is suggested. The
maximum fine should be calculated further on
the basis of the capacity of the plant, the
number of drugs manufactured, the type of
37
drugs i.e. whether they are life saving drugs,
number of years they are in business and the
nature of contaminants used in the drugs.
Moreover their whole assets, moveable or
immovable should be confiscated and they
should be debarred from entering the
pharmaceutical business again. The minimum
imprisonment should be enhanced to 10
years. The imprisonment should be enhanced
in lieu of non-payment of fine say one year /
20 lakhs. A part of collection say 25% should
be paid to the victim. The onus of proving
that the spurious drugs have not caused
grievous hurt or death to a person should lie
with the accused. The fine or imprisonment
to the corrupt officers should be more severe
than suggested to the manufacturers and
traders of spurious drugs.
The Government should educate people
through electronic media regarding the circulation
of spurious drugs and the danger they pose to the
health. The Government should declare fabulous
prizes for the informers, whose information may
lead to nab the culprits.
The dispensing chemists are the most
important terminal points in the whole chain as the
people are duped by them to buy the spurious
drugs. The working of the chemists should be
modernised. The integrity of the owner should be
checked before issuing the licence. A person with
a criminal record should be debarred. The
information regarding the stock with details of
manufacturers, batch numbers and expiry dates
etc and the selling should be computerized. The
information regarding the supplier with address,
gate pass number, date etc should be recorded in
the computer. It is very important to establish the
link of the whole chain. The use of computer should
be made mandatory by a specified period. The
chemist shops not issuing cash memo for the sale
should be heavily fined. The cash memo should
clearly show the manufacturer’s name and the
batch number.
To stop proliferation of spurious drugs in
government hospitals, dispensaries, defence etc,
which happen to be the biggest buyers of these,
the following steps should be taken:
a. Purchase the medicines without calling the
tenders.
b. Shortlist the reputed pharmaceutical
companies and procure the latest price lists
of these companies
c. Order the medicines directly from the
companies or their authorized stockists after
negotiating the % discount.
d. An independent agency to draw random
samples for testing immediately after receiving
the consignment in the stores.
To set up a separate intelligence wing, to
handle spurious drugs menace, under Food and
Drugs Control Department. The staff is to be
trained for detecting and catching the spurious drug
manufacturers, stockists, retailers and their links
from personnel handling terrorist, Pakistan ISI,
explosives, narcotics etc as India has gained
expertise in these.
In order to illustrate, the intelligence
department may collect the inputs in the following
manner:
? Intercept, record and interpret the
conversations on telephone and cells of the
distributors/unpopular manufacturers
especially located in the suspected area of
operation like distributors at Bhagirath Palace,
Agra, Lucknow and Varanasi etc and
manufacturers at Aligarh, Agra, Gurgaon,
Sonepat, Bhatinda etc.
? Visit chemist shops especially in the area of
poor and illiterate class of people as consumer,
in plain clothes and purchase the suspected
samples for testing and shadow the delivery
boys of the drugs at the shops.
? Test random samples collected during surprise
visits, from physicians dispensing open tablets
or capsules and the stores of the Government
institutions like defence, hospitals
dispensaries etc.
? Get inputs from physicians, in different
localities, regarding the ineffectiveness or side
effects of a particular brand of medicine they
are prescribing to their patients.
38
After getting sufficient leads, in this way, plan
the systematic operations.
To set up a facility under the Drug Control
Department to handle the complaints and to test
the suspected samples from the consumers. The
forms and the addresses, where the complaints
are to be registered, should be available at all the
chemist shops and at the web site of Drug
Controller. The complaint should be registered
properly and the complaint receipt should be given
to the consumer. The reply of the complaint should
be sent to the consumer within a specified period.
(C). Pharmaceutical Companies:
The genuine pharmaceutical companies
should upgrade the technology, from time to time,
for packing their products as to have a lead over
the spurious drugs manufacturers, which copy the
technology as then there will be a lag time before
the latter can acquire the innovation. They should
use holograms, bar-code, special inks for printing,
printed/locked capsules, embossing logo on the
tablets, pilfer proof packing etc to make it difficult
for the small spurious drugs manufacturers to copy.
They should emboss month and year of the date
of manufacture or at least the year on glass bottles
to stop recycling of the bottles.
They should keep proper record of even trusted
distributors and test random samples in their stocks
to eliminate possible mixing of counterfeit drugs as
a matter of routine. They should print a code or
serial numbers on the concealed side of tablets/
capsules strips or label of bottles so that counterfeit
drug manufacturer is not able to print that and the
counterfeit drugs are easily detected even without
testing.
They should write on each label, ‘Causion:
Please destroy the container and the label after
use so that a spurious drug manufacturer does not
use them. This way the people will be educated
regarding circulation of spurious drugs.
(d) The Grievance Cell Operated by a NGO:
Since the government organizations, in
general, are not run efficiently, a private grievance
cell to attend to the complaints of consumers is
proposed. The organization shall have a modern
laboratory equipped with the latest instruments for
quick analysis. The organization is proposed to be
financed by the Indian pharmaceutical companies
on the basis of certain percentage of their turn over.
The infrastructure facility like land, building etc is
to be provided by the government on a nominal
lease. The project cost and the modalities for
working can be planned. Initially only one facility at
New Delhi is proposed. On successful working of
this centre the similar facilities could be built at
Mumbai, Kolkata, Chennai, Bangalore and
Hyderabad etc. The facility would also be helpful in
nabbing the culprits of the illegal trade and would
activate the government organizations due to the
competition. The facility may also have an
intelligence wing as suggested above.
(e) The Protection of the Consumers:
It is a long drawn war against the illegal trade
and the solution depends on the will and
competence of the government authorities, which
have not been very promising in the past. Therefore,
the consumers have to play an active role in
protecting themselves and help nabbing the
culprits. They are required to be vigilant and alert
while purchasing and using the drugs. Some of
the precautions they should observe are given as
follows:
? To buy drugs from reputed and well
established chemists, which issue cash memo
for the purchases.
? To check whether batch number of the
medicine is clearly and correctly written on the
cash memo
? Don’t buy if the packing looks different
? Don’t buy if the packing looks the same but
medicine is other than prescribed
? Don’t buy loose medicine
? Don’t buy if the price on the medicine is lower
than the one at which you purchase normally
? Don’t buy if the spelling of name of the
medicine is different.
? Don’t buy if there is an additional mark along
with the name unless prescribed by your doct
like +, *, ! etc, e.g., in case of Phensedyl and
39
Phensedyl plus, the former is the trade mark
of Nicholas Piramal while the latter is not.
? Avoid doctors, who themselves dispense loose
medicines and don’t write a prescription.
? Don’t buy if the label looks old or is mutilated.
? Check the expiry date and don’t buy beyond
the expiry date.
? In case of an illiterate person get the medicines
checked, before opening, by your doctor or a
literate neighbour
? Destroy the label and the container of the
medicine after use.
Precautions to be observed after consuming
the medicines are given as follows;
? To report to the doctor immediately if there is
some adverse reaction like nausea, headache,
giddiness, pain in heart or stomach etc. If the
doctor says that these reactions are not normal
then either the patient is allergic to the
medicine or it is spurious. Save the unused
medicine and cash memo and complain to
either the manufacturer or the Drug Control
Department.
? If the medicine fails to cure within a specific
period then either the diagnosis is wrong or
the medicine is spurious. Ask the doctor
whether the complaint is to be lodged with the
authority.
? If there is a grievous reaction or death after
consuming the medicine at home or hospital
then the matter should be immediately
reported to the authority for investigation.
? If the consumers and doctors are alert and
the authorities co-operate the illegal trade of
spurious drugs can be made ineffective and
the culprits nabbed.
Acknowledgement:
The author is grateful to Mr Parth J Shah,
President, CCS and Mr Raj Cherubal, Vice
President, CCS for the assignment of this project
and the valuable suggestions especially regarding
the remedy of the menace.
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