During late January 2012, a

fake medicine A counterfeit medication or a counterfeit drug is a medication or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. A counterfeit drug may contain inappropriate qua ...

crisis at the

Punjab Institute of Cardiology Punjab Institute of Cardiology (PIC), located in Lahore, Pakistan, is a 347-bed tertiary care hospital providing nationwide comprehensive cardiac care services. Services provided This hospital services include cardiac emergency, OPD, diagnostic ...

(PIC) hospital in the

Lahore Lahore ( ; pnb, ; ur, ) is the second most populous city in Pakistan after Karachi and 26th most populous city in the world, with a population of over 13 million. It is the capital of the province of Punjab where it is the largest city. ...

region of

Punjab Punjab (; Punjabi: پنجاب ; ਪੰਜਾਬ ; ; also romanised as ''Panjāb'' or ''Panj-Āb'') is a geopolitical, cultural, and historical region in South Asia, specifically in the northern part of the Indian subcontinent, comprising ...

Pakistan Pakistan ( ur, ), officially the Islamic Republic of Pakistan ( ur, , label=none), is a country in South Asia. It is the world's List of countries and dependencies by population, fifth-most populous country, with a population of almost 24 ...

, claimed the lives of over 100 heart patients. According to various reports, the incident involved patients who had been receiving treatment at the hospital and had been prescribed with counterfeit antihypertensive medicines. The

Federal Investigation Agency The Federal Investigation Agency ( ur, ; reporting name: FIA) is a border control, criminal investigation, counter-intelligence and security agency under the control of the Interior Secretary of Pakistan, tasked with investigative jurisdictio ...

carried out an inquiry into the incident, and identified the factory of Efroze Chemicals in

Karachi Karachi (; ur, ; ; ) is the most populous city in Pakistan and 12th most populous city in the world, with a population of over 20 million. It is situated at the southern tip of the country along the Arabian Sea coast. It is the former cap ...

as the producer of the Isotab tablets contaminated with

pyrimethamine Pyrimethamine, sold under the brand name Daraprim among others, is a medication used with leucovorin (leucovorin is used to decrease side effects of pyrimethamine; it does not have intrinsic anti-parasitic activity) to treat the parasitic disea ...

.WHO says drug caused PIC deaths
/ref> The factory was sealed, and the names of the factory owners were put on the

Exit Control List The Exit Control Lists (ECL; ur, ) is a system of border control maintained by the Government of Pakistan under Exit from Pakistan (Control) Ordinance, 1981. The people on the list are prohibited from leaving Pakistan. Priorities 1. Exit from P ...

(ECL).

Crisis

In mid-January 2012, several cardiac patients registered with the Punjab Institute of Cardiology (PIC) started showing up at different public and private hospitals in Lahore after having a sudden drop in platelets and white blood cells and bleeding from different parts of the body. The doctors initially took the symptoms as that of

dengue Dengue fever is a mosquito-borne tropical disease caused by the dengue virus. Symptoms typically begin three to fourteen days after infection. These may include a high fever, headache, vomiting, muscle and joint pains, and a characteristic ...

outbreak that had hit the city in the fall of 2011. However, it was soon realized that the symptoms were seen in a PIC cohort and were more consistent of a drug reaction. Suspect drugs included Isotab (

isosorbide mononitrate Isosorbide mononitrate, sold under many brand names, is a medication used for heart-related chest pain (angina), heart failure and esophageal spasms. It can be used both to treat and to prevent heart-related chest pain; however, it is generally l ...

), Lipitor (

atorvastatin calcium Atorvastatin is a statin medication used to prevent cardiovascular disease in those at high risk and to treat abnormal lipid levels. For the prevention of cardiovascular disease, statins are a first-line treatment. It is taken by mouth. Commo ...

), Cardiovestin (

simvastatin Simvastatin, sold under the brand name Zocor among others, is a statin, a type of lipid-lowering medication. It is used along with exercise, diet, and weight loss to decrease elevated lipid levels. It is also used to decrease the risk of heart ...

), Alfagril (

clopidogrel Clopidogrel — sold under the brand name Plavix, among others — is an antiplatelet medication used to reduce the risk of heart disease and stroke in those at high risk. It is also used together with aspirin in heart attacks and following t ...

), Concort (

amlodipine Amlodipine, sold under the brand name Norvasc among others, is a calcium channel blocker medication used to treat high blood pressure and coronary artery disease. It is taken by mouth. Common side effects include swelling, feeling tired, ab ...

), and Soloprin (

aspirin Aspirin, also known as acetylsalicylic acid (ASA), is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and/or inflammation, and as an antithrombotic. Specific inflammatory conditions which aspirin is used to treat inc ...

). The medicines were being distributed by the hospital free of charge mainly to poor people. The total number of people who may be at risk after taking medicine from the hospital may be as high as 46,000 according to one report. The spurious medicine(s) triggered a serious adverse reaction by depositing itself in the

bone marrow Bone marrow is a semi-solid tissue found within the spongy (also known as cancellous) portions of bones. In birds and mammals, bone marrow is the primary site of new blood cell production (or haematopoiesis). It is composed of hematopoietic ce ...

and ending the body's resistance. The generation of

white blood cells White blood cells, also called leukocytes or leucocytes, are the cells of the immune system that are involved in protecting the body against both infectious disease and foreign invaders. All white blood cells are produced and derived from mult ...

stopped in the body. Among the symptoms of the disease were a severe chest infection, change in skin colour/pigmentation, low

platelet Platelets, also called thrombocytes (from Greek θρόμβος, "clot" and κύτος, "cell"), are a component of blood whose function (along with the coagulation factors) is to react to bleeding from blood vessel injury by clumping, thereby ini ...

count and blood vomiting. As a result, the Department of Health constituted a high-powered committee to probe the incident.

Inquiry

Almost all deceased were from the Lahore area. One fatality was also recorded in

Multan Multan (; ) is a city in Punjab, Pakistan, on the bank of the Chenab River. Multan is Pakistan's seventh largest city as per the 2017 census, and the major cultural, religious and economic centre of southern Punjab. Multan is one of the List ...

. The Chief Minister of Punjab

Shahbaz Sharif Mian Muhammad Shehbaz Sharif (Urdu, Punjabi: , ; born 23 September 1951) is a Pakistani politician and businessman who is currently serving as the 23rd Prime Minister of Pakistan, in office since 11 April 2022. He is the current president o ...

vowed "stern action" against those responsible and announced a compensation of

Rs. Rupee is the common name for the currencies of India, Mauritius, Nepal, Pakistan, Seychelles, and Sri Lanka, and of former currencies of Afghanistan, Bahrain, Kuwait, Oman, the United Arab Emirates (as the Gulf rupee), British East Africa, B ...

500,000 each for the affected families. The

(FIA) formed an investigation team to probe the incident on the orders of Minister for Interior

Rehman Malik Abdul Rehman Malik NI ( Punjabi, Urdu: رحمان ملک; born 12 December 1951 – 23 February 2022) was a Pakistani politician and a Federal Investigation Agency officer, having served as the Interior Minister from being appointed on 25 Marc ...

. The team arrested some people reportedly involved in the distribution of the medicine. Cases were also registered against three pharmaceutical companies who made the medicine. Investigations revealed that the license in one of the three pharmaceutical laboratories which supplied the contaminated drugs to the PIC had long expired in April 2011. Despite this, the company continued to manufacture the drugs in bulk and supplied them to government hospitals and

open market The term open market is used generally to refer to an economic situation close to free trade. In a more specific, technical sense, the term refers to interbank trade in securities. In economic theory Economists judge the "openness" of markets a ...

s. As the death toll exceeded one hundred, the

Lahore High Court The Lahore High Court () is based in Lahore, Pakistan. It was established as a high court on 21 March 1882. The Lahore High Court has jurisdiction over Punjab (Pakistan). The High Court's principal seat is in Lahore, but there are benches in th ...

ordered respondents involved in the case to file their replies by the 30 January 2012. Tests performed by the British

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...

(MHRA) in the

United Kingdom The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the continental mainland. It comprises England, Scotland, Wales and North ...

indicated that one of the five suspected drugs - Isotab - was contaminated. The report also showed that Isotab contained pyrimethamine which is in fact used for the treatment of

malaria Malaria is a mosquito-borne infectious disease that affects humans and other animals. Malaria causes symptoms that typically include fever, tiredness, vomiting, and headaches. In severe cases, it can cause jaundice, seizures, coma, or death. S ...

. The presence of pyrimethamine proved to be toxic. Tests done at the Central Drugs Laboratory in

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. The FIA seized raw materials from a Karachi-based factory of Efroze Chemical Industries. The FIA also put the names of owners on the Exit Control List besides blocking the official website of Efroze Chemicals. The sealed factory was located in

Korangi Industrial Area Korangi District ( ur, ) is one of the seven administrative districts of Karachi last modified in 2013, part of the Karachi Division in Sindh, Pakistan. Map of Karachi Division History The district was a part of District East in Karac ...

, Karachi.

Reaction

The Pakistan Medical Association (PMA) condemned the lapse in quality control while acquiring medicines as the main reason for the deaths caused by the drug reaction and has demanded the federal and provincial governments to establish a drug regulatory authority. Following the incident,

Sri Lanka Sri Lanka (, ; si, ශ්‍රී ලංකා, Śrī Laṅkā, translit-std=ISO (); ta, இலங்கை, Ilaṅkai, translit-std=ISO ()), formerly known as Ceylon and officially the Democratic Socialist Republic of Sri Lanka, is an ...

banned its import of medicines from Pakistan as a precautionary measure. Moreover, the

World Health Organisation The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...

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

References

{{DEFAULTSORT:Pakistan fake medicine crisis, 2012 Counterfeit consumer goods Health disasters in Pakistan Pakistani commissions and inquiries Pharmaceutical industry in Pakistan Pharmaceuticals policy 2012 health disasters 2012 in Pakistan

Crisis

Inquiry

Reaction

See also

References