Microbial Count of Non-sterile Pharmaceutical Products Sold in Pakistan

Abstract

Aims: To explore the microbiological quality of tablets in blister-packed, manufactured and marketed in Pakistan in order to assess Good Manufacturing Practice (GMP) by national and multinational pharmaceutical industries in the country. Methods: For this research we have purchased 50 different tablets (registered brands) blister-packed from community pharmacies in Lahore. 15 products brands were multinational, 15 were national and 20 brands were from local pharmaceuticals. All these tablets were investigated for total bacterial count and the presence of specified microorganism (Escherichia coli) using compendial procedures. In order to determine batch to batch variation in the numeric data obtained for the 3 packs purchased for each brand, statistical analysis to establish the deviation from the mean count was carried out using t- test with the aid of Sigma Plot software. Differences were considered as statistically significance at p < 0.05. Results: 24% of the products (12 from 50 items) showed microbial contamination within normal range while 76% products (38 items) showed microbial count out of the normal range. In 20% of the products (10 items) Escherichia coli were the most obnoxious bacteria that were found. One company manufactured a product with the high proportion of stratified bacteria especially Escherichia coli. Conclusion: Our study showed that blister-packed tablets produced by Pakistani pharmaceutical companies are within acceptable microbiological quality but the detection of microbial load in some brands were very close to the maximum allowable limit,. However, we observed that some local brands 24% are not within acceptable range of microbes. Therefore, we recommend the need for improved adherence to GMP in the country.