Drug quality and safety issues in India

Maulik Chokshi, Rahul Mongia and Vasudha Wattal
Working Paper 310
September 2015

Today, the global pharmaceutical product value chain is becoming increasingly complex and
this has led to the emergence of ‘multiple quality standards’ for medicines. But this nonuniformity
in the quality of medicine is also contingent upon both the regulatory milieu in the
country of manufacture and the export destination of a pharmaceutical product. The focus of
this paper is upon the domestic pharmaceutical market in India, where policy makers often
face a trade-off between what has been called ‘high quality’ and ‘affordable quality’
medicines. With India being recognised as the pharmacy of the developing world, it is
believed that there is need for strict quality specification and enforcement within the country
in the first place. Against this background, there have been several reports where doubts
have been raised regarding quality of medicines available in India. This paper, by mapping
the perspectives of several stakeholders, attempts to bring clarity on issues related to poor
quality medicines and suggest institutional reforms in the Indian regulatory regime, looking
at good and bad practices followed both domestically and internationally.