Centralisation is appropriate and essential in domains like public health, environmental regulation and national security. One example where this decentralised model has led to problems is drug regulations. Decentralised regulation of drug safety, efficacy and manufacturing standards can lead to inconsistencies, undermining public health.
The recent scandal involving spurious drugs in Nagpur – in which antibiotics supplied to government hospitals were found to be nothing but talcum powder mixed with starch – exposes flaws in India’s fragmented pharma regulatory system. A system that fails to address drug quality is setting us up for failure, as we push for wider use of generic medications.
India’s drug regulation system allocates limited powers to GoI, with authority decentralised to state drug regulatory authorities (SDRAs). Central Drugs Standard Control Organisation (CDSCO), led by Drugs Controller General of India (DCGI), sets overarching policies, approves new drugs and defines clinical trial standards. However, actual implementation is with states, including licensing, inspections and local enforcement. While CDSCO can issue national-level directives, such as drug bans, these orders rely on state bodies for execution. Therefore, the central authority’s role in influencing the regulatory landscape is advisory and administrative, with SDRAs handling day-to-day regulatory oversight.
The concept of centralising drug administration is decades-old.
Pharmaceutical Enquiry Committee (1954) proposed shifting control over manufacturing, sale and distribution from state authorities to the central drugs controller (India) to ensure ‘better coordination in the administration of the Drugs Act’.The first significant amendment in 1955 centralised critical regulatory powers by shifting licensing and oversight responsibilities from states to GoI, aiming to improve uniformity in drug quality and safety standards nationwide. However, GoI delegated specific powers back to states. This delegation included the authority to license manufacturing facilities, inspect drug quality and regulate distribution within their jurisdictions. The choice created a quasi-centralised model, where central and state governments shared regulatory roles, leading to variability in enforcement across states. Hathi Committee Report (1975) highlighted the urgent need for centralisation in drug control and warned that allowing a state to produce substandard drugs would ‘nullify the measures taken by other states’. The Estimates Committee of the 7th Lok Sabha reinforced this in 1983, urging GoI to assume a stronger role beyond mere advisory, given the need for ‘overall coordination of control’.
Mashelkar Committee (2003) found that, despite Drugs and Cosmetics Act being in place for 56 years, enforcement remained inconsistent across states, and concluded that India’s regulatory challenges stem from core issues, including ‘inadequate or weak drug control infrastructure at the state and central level’, ‘shortage of drug inspectors’, and ‘non-uniformity of enforcement’. Additional factors such as limited testing facilities, a lack of specialised training for regulatory tasks, the absence of a centralised data bank, and unreliable information further weaken the system’s effectiveness.
Substandard and Spurious Drugs Report (2018) by the ministry of health highlighted severe capacity shortfalls in states, with many unable to meet WHO’s good manufacturing practices (GMP) requirements. Further, several reports have found that companies may shift production to states with weaker oversight, producing drugs with minimal compliance to rigorous standards. This regulatory arbitrage lowers drug quality and undermines the reputation of Indian pharma in international markets.
India’s two major attempts to centralise drug regulation, in 2007 and 2013, were dead on arrival. Central Drugs Authority Bill and Drugs and Cosmetics (Amendment) Bill aimed to end the fractured oversight system between CDSCO and state regulators, plagued by inconsistent standards and delays. But state opposition stopped both Bills.
A decisive national debate is overdue. GoI’s drug regulations can’t remain optional. They must be binding to enforce consistency and accountability. Strengthening CDSCO is urgent to unify oversight and guarantee the quality of generics as India moves toward generics prescriptions. If quality control remains weak, the promise of affordable, safe healthcare is at risk.
The writer is OSD, research, EAC-PM
