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

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]