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Table 2 Summary of published data on the situation regarding poor-quality of medicines in Pakistan

From: Regulatory framework in Pakistan: situation analysis of medicine quality and future recommendations

A. International media reports Reference
1. Media Reports on Medicine Quality: Focusing on USAID-assisted countries (2003–2011) [16 counterfeit cases] [63]
2. Stopping fake drugs from Pakistan is too late for victims (2012) [counterfeit drug trafficking cases] [64]
3. Inside deadly Pakistan counterfeit drug trade (2015) [capacity of regulation and provision of quality medicines] [65]
B. Case reports and drug alerts  
4. Contaminated drugs are held responsible for 120 deaths in Pakistan (2012) [high dose of pyrimethamine found in cardiovascular drugs isosorbide dinitrate (Isotab), claiming life of more than 120 people] [34]
5. WHO drug alert 125 [contamination of batch J093 of Isotab (isosorbide mononitrate) for precaution against the wider circulation of the batch] [66]
6. WHO drug alert 126 - Levomethorphan contamination in dextromethorphan cough syrup (2012) [Levomethorphan was found in API supplied by the Kanduskar Laboratories, India] [35]
C. Analysis of cases of poor-quality medicines  
7. Epidemic of Plasmodium falciparum malaria involving substandard antimalarial drugs, Pakistan (2003) [generic antimalarial tablets failed the dissolution test and had high content of active ingredient]. [67]
8. Pakistan’s deadly cocktail of substandard drugs (March 2012) [chaotic transition of powers and the cases of contaminated drug] [20]
9. Batch J093: Pathology of negligence (2013) [Judicial report of contaminated cardiovascular drug case with evaluation of the regulatory capacity and recommendations to prevent and handle such incidences in future] [19]
D. Case referenced in scientific reviews on quality of medicine  
10. Drug regulators study global treaty to tackle counterfeit drugs (2004) [40–50%] [56]
11. How to achieve international action on falsified and substandard medicines (2012) [Discusses the 2012 fake drug crisis as a possible medicine falsification case if proven that the faulty batch found was found out of specification in the in-house quality control testing and was deliberately allowed to be distributed to hospital] [4]
12. Substandard drugs: a potential crisis for public health (2014) [2]
13. The essential medicines on universal health coverage (2017) [includes fake drug crisis as the major cases of poor-quality medicines in the recent years] [38]
E. Prevalence studies on medicine quality involving pharmaceutical analysis  
14. Pharmaceutical quality of ceftriaxone generic drug products compared with Rocephin®. [34 generics including 6 products from Pakistan were evaluated on basis of Roche standards and compendial specifications. Overall, sterility test failed for 4 samples and unknown impurity monitored by Roche was found in 5 samples in concentration range of 0.39–1.26%. 30 samples failed the clarity test by USP and 33 products had higher concentration of thiotriazinone (0.22–0.94%, limit ≤0.2%).Tricef® from Ali Gohar (Pakistan) failed the assay and content uniformity test, also showing percentage content of thiotriazinone (0.94%) and unknown impurities (1.26%) [2/6]] [68]
15. Ofloxacin; Laboratory evaluation of the antibacterial activity of 34 brands representing 31 manufacturers available in Pakistan (2004) [3/34 did not show required antimicrobial activity] [69]
16. Quality of ceftriaxone injections reality and resonance (2008) [57]
17. [15.6% failure rate for ceftriaxone injection]