2012 Pakistan fake medicine crisis
During late January 2012, a
According to various reports, the incident involved patients who had been receiving treatment at the hospital and had been prescribed with counterfeit antihypertensive medicines.[1] The Federal Investigation Agency carried out an inquiry into the incident, and identified the factory of Efroze Chemicals in Karachi as the producer of the Isotab tablets contaminated with pyrimethamine.[2] The factory was sealed, and the names of the factory owners were put on the Exit Control List (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 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.[2]
Suspect drugs included Isotab (
The spurious medicine(s) triggered a serious adverse reaction by depositing itself in the
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
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 markets.[7] As the death toll exceeded one hundred, the Lahore High Court ordered respondents involved in the case to file their replies by the 30 January 2012.[8]
Tests performed by the British Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom 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. The presence of pyrimethamine proved to be toxic.[9] Tests done at the 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.[10]
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
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 banned its import of medicines from Pakistan as a precautionary measure.[12] 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.[13]
See also
- Counterfeit consumer goods
- Counterfeit medications
- Drug fraud
- Health care fraud
- Pharmaceutical fraud
References
- ^ a b "About 100 people have died from spurious antihypertensives in Lahore". Thenews.com.pk. 2012-01-24. Retrieved 2012-01-31.
- ^ a b WHO says drug caused PIC deaths
- ^ a b Usman, Ali (24 January 2012). "PIC free medicine: As deaths soar past 80, authorities remained clueless – The Express Tribune". Tribune.com.pk. Retrieved 2012-01-31.
- ^ a b Web Desk (2012-01-26). "Fake medicine: Unofficial death toll reaches 112 – The Express Tribune". Tribune.com.pk. Retrieved 2012-01-31.
- ^ Jaffery, Owais (28 January 2012). "Free medicine: Multan sees first fatality from contaminated drugs – The Express Tribune". Tribune.com.pk. Retrieved 2012-01-31.
- ^ Usman, Ali (22 January 2012). "Free medicine saga: Malik directs FIA to investigate – The Express Tribune". Tribune.com.pk. Retrieved 2012-01-31.
- ^ Kharal, Asad (2012-01-26). "Free medicine disaster: Lab with expired licence supplied PIC – The Express Tribune". Tribune.com.pk. Retrieved 2012-01-31.
- ^ Web Desk (2012-01-26). "Free medicine: LHC orders respondents to file reply by January 30 – The Express Tribune". Tribune.com.pk. Retrieved 2012-01-31.
- ^ "Tests in UK identify drug which caused havoc in Lahore | Newspaper". Dawn.Com. 2 February 2012. Retrieved 2012-02-04.
- ^ "CDL tests also find Isotab adulterated | Newspaper". Dawn.Com. 3 February 2012. Retrieved 2012-02-04.
- ^ "Isotab Contamination with pyrimethamine issu: FIA seals three firms manufacturing deadly Isotab – PakMed Info Forum". Pakmed.net. 2012-01-31. Archived from the original on 2016-03-04. Retrieved 2012-02-04.
- ^ Wasif, Sehrish (2012-01-31). "Sri Lanka bans import of Pakistani medicines – The Express Tribune". Tribune.com.pk. Retrieved 2012-02-04.
- ^ "WHO bans Pakistani medicine Isotab". The News Tribe. Archived from the original on 2012-02-04. Retrieved 2012-02-04.