1 September 2016
NEW DELHI – Medicines produced in India were found to be safe and effective, a year-long health ministry survey revealed after tests of nearly 50,000 drug samples across the country. The exercise – the first nationwide survey involving government, civil society and pharmacy professionals after 2009 – was kicked off in the wake of rising concerns that several medicines made in India posed risks to patients. The latest findings reiterate the government viewpoint that a negligible portion of the drugs manufactured in India are below the prescribed standards. The results of the detailed report is expected in a month’s time and is expected to help the government understand the measures needed to improve the quality of medicinal products in India, according to a top health ministry official. Substandard drugs are medicines that are of lower quality because of poor manufacturing, quality control, storage or packaging practices. Such drugs are different from spurious drugs, which are mostly imitations of genuine drugs and are often conspicuously labelled to deceive the patient about the ingredients, effects or manufacturer. The latest survey commissioned by the health ministry pegs the number of substandard drugs produced and sold in India at 3.5 per cent – much lower than the proportion of not-of-standard-quality medicines elsewhere in the world, said the official. This result also implies that substandard drugs sold in India has dipped from 2011-2015, when roughly 4 per cent-5 per cent of the total samples tested by the Central Drug Standard Control Organisation (CDSCO) were declared as below standard quality. “What has come out in the survey is that the extent of not-of-standard-quality drugs in India is lesser than the not-of-standard-quality drugs elsewhere in the world. The largely held perception circulating and magnified many times over that India is one of the (biggest) producers of substandard quality of drugs has proven to be wrong,” the official said. For the latest survey, samples from across the country were selected according to a statistical method designed by the Indian Statistical Institute of Hyderabad, said the official. National Accreditation Board for Testing and Calibration Laboratories (NABL)-accredited central and state laboratories were re-equipped with better technology to test these samples on several parameters to ascertain whether they met the desired standards. Routine sampling and tests of drugs by CDSCO usually check the quality of drugs using parameters like dissolution and assay. The latest survey is set to come out at a time when the country’s pharmaceutical industry, including global drug makers, has come under flak for deviating from good manufacturing practices. Many have had to withdraw batches of their widely used medicines (like painkillers) in India, while an expanding number of companies have also been issued warnings and alerts by international regulators.