Performance Audit of Drugs and Cosmetics Act in Karnataka

Abstract

Performance Audit of Implementation of Drugs and Cosmetics Act in Karnataka covering the period 1997-98 to 2002-03 revealed huge deficiencies in inspection, drawal and analysis of sample drugs and laxity in monitoring compliance with the results of analysis. This indicated that Department of Drugs Control had not discharged enforcement functions effectively. Improper decisions favouring licensees, reporting results of analysis after expiry of validity date of drugs and abnormal delay in a few other cases facilitated marketing of drugs found ‘not of standard’ quality. Drugs Controller had no information regarding number of seizures of sub-standard/ fake drugs. In test-checked Circle Offices, such drugs were seized only in 48 cases (seven per cent) out of 671 ‘not of standard’ drugs. Abnormally low percentage of seizures indicated lack of determination to prevent marketing of drugs found ‘not of standard’ quality. Drug testing laboratory was found deficient in equipment, manpower and methods of analysis, as a result of which 2,032 samples could not be analysed and were given ‘no opinion’ report. Performance of intelligence wing was unsatisfactory considering that action in respect of 826 cases (86 per cent) out of 961 complaints was pending for periods ranging from one to seven years.