National Control Laboratories in quality healthcare-a roadblock for substandard biopharmaceuticals.

Substandard or spurious drugs are a global problem with respect to Health and Economic burden. The impact is higher when medicines are from the category of life-saving drugs, essential medicines or high cost targeted medical treatment. Biopharmaceuticals are one such class of drugs where Quality testing plays a pivotal role to stop substandard drugs from reaching the patient. This study of 17,451 samples has highlighted the trend of occurrence of substandard biologicals (2.34%) over a decade (2011-2021) and the importance of continuous and complete evaluation of such Biopharmaceuticals. More such National Control Laboratories (NCL) should be involved in cross-checking the quality of the increasing number of biopharmaceuticals present in the market which are released only on the basis of the onsite inspection and dossier reviews. This will help the Regulators to ensure the readiness for testing the newer biologicals, devise effective policies for better health care initiatives and keep the substandard biopharmaceuticals at bay.

Genotyping & diagnostic methods for hepatitis C virus: A need of low-resource countries.

Hepatitis C virus (HCV) infection is a blood borne and transfusion-transmitted infection (TTI). It has emerged as one of the major health challenges worldwide. In India, around 12-18 million peoples are infected with HCV, but in terms of prevalence percentage, its looks moderate due to large population. The burden of the HCV infection increases due to lack of foolproof screening of blood and blood products before transfusion. The qualified screening and quantification of HCV play an important role in diagnosis and treatment of HCV-related diseases. If identified early, HCV infection can be managed and treated by recently available antiviral therapies with fewer side effects. However, its identification at chronic phase makes its treatment very challenging and sometimes ineffective. The drugs therapy for HCV infection treatment is also dependent on its genotype. Different genotypes of HCV differ from each other at genomic level. The RNA viruses (such as HCV) are evolving perpetually due to interaction and integration among people from different regions and countries which lead to varying therapeutic response in HCV-infected patients in different geographical regions. Therefore, proper diagnosis for infecting virus and then exact determination of genotype become important for targeted treatment. This review summarizes the general information on HCV, and methods used for its diagnosis and genotyping.