Regulating pharma, beyond manufacturing quality

GoI's plan to strengthen Central Drugs Standard Control Organisation (CDSCO) to meet global standards as indicated by Nirmala Sitharaman in her budget speech was long overdue. It's time to undertake an overhaul, as that seems to be the only way to ensure a pharma sector regulator fit for purpose. The regulatory approach must shift from an overwhelming focus on manufacturing to public health, putting the spotlight on quality and drug efficacy. This shift will be reflected in the choice of personnel. At present, CDSCO is manned by bureaucracy specialising in pharmacy. Global practice has been to staff drug regulators with multidisciplinary teams, while leaving operations to a doctor. This will lead to a holistic evaluation of drug manufacturing.

Unlike other sectors, pharma doesn't have a regulator separate from government - CDSCO is attached to Directorate General of Health Services. For it to be effective, CDSCO must be recast as an independent regulator. Currently, CDSCO oversees imports, approvals to new drugs and manufacturing licences for a limited number of them. Meanwhile, state regulators oversee manufacturing licences and pharmacies in the state. State drugs standard control organisations are independent of CDSCO. This overlap in jurisdictions adversely impacts compliance. A system where the central and state regulators work in tandem and serve as a checks-and-balances mechanism can address quality issues beguiling segments of the sector.

Modern regulation needs a modern legal structure that provides oversight to an increasingly complex industry, while protecting public health and patients' rights. GoI has recognised the need for a regulator in line with global best practices and standards. Now to avoid half measures.