Quality of pharma must not be strained

News that 48 common drugs manufactured in India failed to meet quality standards comes as little surprise. The absence of a robust drug regulator resulting in an ineffective compliance mechanism is the root cause for substandard/variations in quality of drugs manufactured by the same company in different locations. GoI’s proposal for a centralised drug registration system can resolve only part of the problem. Instead, GoI needs to replace the existing regulatory system with a modern legal structure that has the capacity to provide oversight to an increasingly complex pharmaceutical industry while protecting public health and patient rights.

Fixing the quality problem will require shifting the regulatory approach from an overwhelming focus on manufacturing to public health. This shift will be reflected in the choice of personnel. At present, the Central Drugs Standard Control Organisation (CDSCO) is manned by a bureaucracy specialising in pharmacy. Global practice has been to staff drug regulators with multidisciplinary teams, while leaving the running of the regulator to a doctor. This will lead to a holistic evaluation of drug manufacturing. For this shift in focus to be effective, an independent regulator is essential. Unlike other sectors, pharma does not have a regulator separate from the government. CDSCO is attached to the Directorate General of Health Services. An arm’s-length relationship is critical for independence and effective oversight.

Addressing the quality issue is essential from a public health perspective and to ensure India’s global primacy in drug manufacturing. To continue being the ‘pharmacy of the world’, this is non-negotiable.