2012-Pakistan Fake Medicine Crisis

Presented to: Dr. Namra Khan

Presented by:

Aliha Akhtar (6123)

Maria Hameed (6132)
Naina Eman (6198)
Ezzah Babar (6103)
Syeda Noor Ul Huda (6158)
Contents to be covered

● Introduction of case
● Inquiry
● Contraventions
● Mechanism of causing illness
● Treatment
● Cuprit
● International reaction

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Maria Hameed 6132
(Introduction)

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Fake medicine crises 2012 in Lahore PIC

● Claimed the lives of over 100 heart patients.

● Counterfeit antihypertensive medicine given.
● triggered a serious adverse reaction
● Deposited itself in the bone marrow. 
● The drug was provided free of cost to poor patients

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● Suspected medicines were:
■ Isotab (isosorbide mononitrate)
■ Lipitor (atorvastatin calcium)
■ Cardiovestin (simvastatin)
■ Alfagril (clopidogrel)
■ Concort (amlodipine)
■ Soloprin (aspirin)

● Pateints suffered from a sudden drop in platelets and white blood cells and bleeding from different parts of the body.

● Symptoms of the disease were a severe chest infection, change in skin colour/pigmentation, and blood vomiting.

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 ● The doctors initially took the symptoms as
that of dengue

● But the realized that the symptoms were seen

in a PIC cohort and were more consistent of a
drug reaction.

Crisis ● As a result, the Department of Health

constituted a high-powered committee to
probe the incident.
Patient’s statement:

"No-one contacted me about the drugs," he said. "I only

stopped taking them on Tuesday, when I saw ads on
TV."

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Aliha Akhtar 6123
(Inquiry)

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Inquiry report by WHO

● ‘The World Health Organization (WHO), too, has blamed Isotab for the death of
more than 200 patients of the Punjab Institute of Cardiology in Lahore in early 2012,
saying that a 25kg drum of pyrimethamine had been mixed ‘accidentally’ into a batch
of the cardiac medicine during manufacturing in Karachi.’
DAWN , March 2021

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WHO’s report

● “200 people died and around 1,000 became seriously ill’’

● Contaminated cardiac medicine – Isotab – manufactured by Efroze, a Karachi-based
company. The contaminated drug was later distributed by the PIC to its patients.
●  WHO praised the Punjab government for immediately retrieving drugs distributed to
46,000 patients. “The WHO has described it as world’s largest retrieval of drugs so
far,” 

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● 8.8 million Isotab tablets were manufactured
■ 400,000 of these were declared contaminated
■ 100,000 had been distributed to patients registered with the PIC when deaths were reported.

● By mid-January, 25 people had died from this mysterious illness

● Hundreds more crowded emergency rooms throughout the city

● These patients had been taking locally-manufactured cardiovascular medication distributed free by the PIC..

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● British Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom indicated
that one of the five suspected drugs - Isotab - was contaminated. 

● Punjab health secretary immediately recalled five suspected drugs distributed to around 46,000 patients.

● Central Drugs Laboratory in Karachi also verified the presence of pyrimethamine used in certain
combinations to treat malaria in a sample of the Isotab tablet (20 mg).

● The laboratory also declared a batch of Alfagril as substandard

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Naina Eman (6198)
(Contraventions)

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Contraventions/Offences
There were four types of contraventions/offences

Counterfeit Expired Substandard

Adulteration
drug License drug

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Penalties
According to Drug Act, 1976 (section 27):
____________Counterfeit
Drugs________________
Sub-section (2); Clause (a)
Whoever by himself or by any other person on his behalf--
● Imports, manufactures for sale or sells any
counterfeit drug
Shall be punishable with imprisonment for a term which
may extend to seven years [or with fine which may extend
to one lakh rupees or with both ]
________________Adulteration____________
______
Sub-section (2); Clause (e)
Whoever by himself or by any other person on his behalf--
● Exports, imports, manufactures for sale or sells any
substance, which should not actually be its component,
has been mixed or packed so as to reduce its quality or
strength (i-e; adulterated) or for which any such
substance has been substituted wholly or in part
Shall be punishable with imprisonment for a term which may
extend to seven years [or with fine which may extend to one
lakh rupees or with both ]
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Penalties
_______________Expired License
____________
Sub-section (1); Clause (b)
Whoever by himself or by any other person on his
behalf--
● Manufactures for sale without a license
Shall be punishable with imprisonment for a term
which shall not be less than three years or more
than ten years and with fine which may extend to
one lakh rupees
____________Substandard drug
____________
Sub-section (3a)
Whoever by himself or by any other person on his behalf--
● Exports, imports, manufactures for sale or sells any
substandard drug
Shall be punishable with imprisonment for a term which
may extend to five years but which shall not be less than
six months and with fine which may extend to fifty million
rupees but which shall not be less than ten million rupees
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 Ezzah Babar (6103)
(Mechanism & Treatment)

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The United Kingdom Medicines and Healthcare Products Regulatory Agency

● On January 31 Agency announced that it had identified the contaminant.

● Large quantities of anti-parasitic drug pyrimethamine were found in a batch of

cardiovascular medication called Isotab.

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Mechanism of causing illness

● Fourteen times above the normal dosage level, pyrimethamine was causing severe
folate deficiency
■ Destroying platelets in bone marrow
■ Triggering heavy internal bleeding

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Treatment of patients

● Fortunately, high doses of calcium folinate can reverse the toxic effects of the
overdose

● Hospitals were able to start treating patients immediately.

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 “We were very lucky that the entire
batch of contaminated drugs was
distributed from just one hospital and
that it is one of the few in Lahore that
WHO’s uses electronic records so patients
could be traced more easily. It was also
statement fortunate that the contaminant was
identified quickly and a cure was
known and available immediately.
Many lives were saved once the
contaminant was identified,”
Michael Deats (WHO’s Department of
Essential Medicines and Health Products)

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Noor UL Huda (6158)
(Government Action)

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Government’s action

● Announced a compensation of Rs. 500,000 each for the victims' families.

● Arrested some people reportedly involved in the distribution of the medicine

● Cases were also registered against three pharmaceutical companies who made the
medicine

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Culprit

● License of the companies was expired but still making medicines

● One of them is Efroze pharmaceuticals
● Raw material seized , Official website blocked, Factory sealed
● Placed the name of company in ECL

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 Following the incident, Sri Lanka banned its

International import of medicines from Pakistan as a

precautionary measure.

Reaction Moreover, the World Health Organisation

issued a global drug safety alert (no.125)
calling for increased vigilance on the use of
Isotab manufactured by Efroze Chemicals.

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References

● Manual of drug laws

● https://
www.dawn.com/news/797093/who-says-drug-caused-pic-deaths
● https://dbpedia.org/page/
2012_Pakistan_fake_medicine_crisis

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Thank You!

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