Microbiological quality control of non-sterile pediatric pharmaceutical products

Abstract

Pharmaceutical pediatric products—whether sterile or non-sterile—must meet the relevant microbiological quality standards to ensure safety and efficacy. During production and use, many pharmaceutical pediatric products are vulnerable to contamination from a wide range of microbial species. Young children under 5 years of age and infants are particularly vulnerable to harmful and accidental infections due to their immature immune systems and limited prior exposure to antigens. When these young children consume pharmaceutical preparations of inadequate microbiological quality, they may be exposed to serious health risks. Maintaining the safety and efficacy of non-sterile pediatric pharmaceutical products, as well as safeguarding children’s health, depends on their microbiological quality. Pharmaceutical pediatric products are widely used in India; therefore, it is essential to assess their microbiological quality and overall safety. This study examines the microbiological quality of 26 pediatric drug products. Using compendial methods, the pediatric drug products were analyzed for the presence of specified microorganisms, total yeast and mold count, and total aerobic microbial count. Based on the study’s findings, three of the pediatric drug products showed microbial contamination levels above the maximum acceptable limits specified in the Indian Pharmacopoeia. The pediatric drug products under examination did not contain the specified microorganisms, including Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa. It is advised that current good manufacturing practices and appropriate hygiene measures be strictly followed when manufacturing, handling, and dispensing these products; therefore, microbial quality control is crucial to prevent contaminated products from reaching the market and to protect public health.

Keywords

Microbial contamination / Pediatric drug products / Microorganism / Total aerobic microbial count / Total yeast and mold counts

Acknowledgments

The authors would like to thank the Indian Pharmacopoeia Commission, Ghaziabad (under the Ministry of Health and Family Welfare [MoHFW]), GoI, for providing the laboratory facilities.

Funding

None.

Conflict of interest

The authors declare they have no competing interests.

Author contributions

Conceptualization: Anil Kumar Teotia, Prasad Thota, Vivekanandan Kalaiselvan
Formal analysis: Deeksha Verma, Prasad Thota
Investigation: Manoj Pandey
Methodology: Prasad Thota, Manoj Pandey
Writing–original draft: Deeksha Verma
Writing–review & editing: Deeksha Verma, Prasad Thota, Sanjay Mendiratta

Ethics approval and consent to participate

Not applicable.

Consent for publication

Not applicable.

Availability of data

Not applicable.

References

[1] Gholizadeh-Hashjin A , Lotfipour F , Hallaj-Nezhadi S . Quality control of non-sterile drug product according to United States’ pharmacopeia instruction. Iran J Med Microbiol. 2019; 13(5): 321-345. doi: 10.30699/ijmm.13.5.321

[2] Poy MJC , Ramírez CC , Di Lauro SXG , et al. Microbiological quality of pediatric oral liquid formulations. Farm Hosp. 2016; 40(5): 427-435. doi: 10.7399/fh.2016.40.51041

[3] Olaitan MO , Muhammad B . Assessment of microbiological quality of syrup and water used in pharmaceutical industries in Kano State, Nigeria. Ife J Sci. 2018; 20(1): 119. doi: 10.4314/ijs.v20i1.12

[4] Khana M , Singh Y , Meenal Khana C , Teotia U . Effect of storage on microbialquality of non-sterile liquid dosage form. J Pharmacog Phytochem. 2018; 7(2): 479-481.

[5] Khanom S , Kanta Das K , Noor R , Banik S . Microbiological Analysis of Liquid Oral Drugs Available In Bangladesh; 2013. Available from: https://www.researchgate.net/publication/256324356 [Last accessed on 2025 Aug 01].

[6] Murtaza G , Ahmed Khan M , Zeb-Un-Nisa M , Shafiq S . A review on the microbial contamination in the non-sterile pharmaceutical products. Pharm Sci Technol. 2021; 5(2): 68. doi: 10.11648/j.pst.20210502.17

[7] El-Houssieny RS , Aboulwafa MM , Elkhatib WF , Hassouna NAH . Recovery and detection of microbial contaminants in some non-sterile pharmaceutical products. Arch Clin Microbiol. 2013; 4(6): 1-14. doi: 10.3823/278

[8] Al-kaf AG , Alghalibi SM , Edrees WH . Microbial and physicochemical assays of paracetamol in different brands of analgesic syrups sold in Sana’a City-Yemen. J Pharm Pharmacogn Res. 2015; 3(1): 6-12. doi: 10.56499/jppres14.026_3.1.6

[9] Thota P . “Prevalence of microbial contaminants in non-sterile pharmaceutical antacids.” Biomed J Sci Tech Res. 2023; 50(3): 41695-41700. doi: 10.26717/bjstr.2023.50.007959

[10] Indian Pharmacopoeia Commission . Microbial Contamination in Nonsterile Products. 8 ^th ed. Vol. 2.2.9. Uttar Pradesh: Indian Pharmacopoeia Commission; 2022. p. 40-52.

[11] Indian Pharmacopoeia Commission . Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests and Examination of Non-Sterile Products: Test for Specified Microorganisms. 11 ^th ed. Uttar Pradesh: Indian Pharmacopoeia Commission.

[12] Myemba DT , Bwire GM , Sangeda RZ . Microbiological quality of selected local and imported non-sterile pharmaceutical products in Dar es Salaam, Tanzania. Infect Drug Resist. 2022; 15: 2021-2034. doi: 10.2147/IDR.S355331

[13] Taysir Alsaleem A , Faihan Obaid AH , Olayan Alribi Alruwaili R , et al. Investigation of the Microbial Contamination of Pharmaceutical Products. Lett High Energy Phys. 2023; 23(4): 421-436.

[14] Conway J , Bero L , Ondari C , Wasan KM . Review of the quality of pediatric medications in developing countries. J Pharm Sci. 2013; 102(5): 1419-1433. doi: 10.1002/jps.23474

[15] Sudeshika SHT , Panagoda GJ , Tennakoon IUK . Microbiological quality of paediatric oral liquid drug formulations during consumption. Int J Sci Res Publ. 2014; 4(9): 2.

[16] Opoku S , Nyanor I . Qualitative and quantitative microbiological studies of paediatric artemether-lumefantrine dry powders and paracetamol syrups obtained from selected drug stores in Accra, Ghana. J Trop Med. 2019; 2019: 7062016. doi: 10.1155/2019/7062016

[17] Buhlmann X . Method for Microbiological Testing of Nonsterile Pharmaceuticals. Vol. 16. 1968. Available from: https://journals.asm.org/journal/am [Last accessed on 2025 Aug 01].

[18] McKinnon BT , Avis KE . IRIMER membrane filtration of pharmaceutical solutions. Am J Hosp Pharm. 1993; 50: 1921-1936. doi: 10.1093/ajhp/50.9.1921

[19] Ratajczak M , Kubicka MM , Kamińska D , Sawicka P , Długaszewska J . Microbiological quality of non-sterile pharmaceutical products. Saudi Pharm J. 2015; 23(3): 303-307. doi: 10.1016/j.jsps.2014.1101

[20] Gamal M , Sangar B . Microbial Evaluation of Some Non-Sterile Pharmaceutical Preparations Commonly Used at Al-Khoms Market, Libya. Vo. 8. 2019. Available from: https://www.com/internationalscholarsjournals.org [Last accessed on 2025 Aug 01].

[21] WHO . WHO Alert Over India-Made Cough Syrups after Deaths in The Gambia. United States: BBC.