Why CDSCO and BEE have not kept pace with the industries they oversee

India has earned its place as pharmacy of the world. It's also fast emerging as a hub for clean mobility. But it's lacking leadership in innovation because of institutional reasons. Two regulators - Central Drugs Standard Control Organisation (CDSCO) and Bureau of Energy Efficiency (BEE) - have not kept pace with the industries they oversee. Both are overly bureaucratic and lack the will to be innovative. And both the sectors they govern have become an imperative for India's growth story.

India manufactures roughly a fifth of the world's generic medicines. Yet, in 2023, it accounted for less than 2% of global first-in-class drug launches, China and the US together claiming about 60%. The gap is not in shortage of capital or talent, but in the regulator's scientific capacity.

A sponsor seeking to run an early-phase trial for a cell or gene therapy, RNA-based molecule, or novel biologic confronts a sequence of ad-hoc subject expert committee (SEC) reviews. This leaves it with an unpredictable clock and no dedicated scientific cadre that can evaluate frontier modalities at speed. Innovation and IP naturally migrate to wherever the pathway is fastest and most certain.


CDSCO still faces challenges like chronic understaffing, gaps in technical skills, weak lab infra and fragmented approvals. About a decade back, the organisation was recommended a benchmark of 1 inspector for every 50 manufacturing units. Yet, in end-2023, it carried a strength of barely 200 inspectors against a sanctioned strength of about 500 drug inspectors. Even its digitisation drive produced several overlapping portals that applicants report as glitch-ridden and difficult to comprehend.

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A device-maker - often a startup or small manufacturer already holding a CE mark or US FDA clearance - is made to run a gauntlet of sequential, piecemeal queries, each round adding months of uncertainty. A parliamentary panel had recommended a single consolidated query, time-bound conditional approvals for products already cleared by credible foreign regulators, and AI-assisted pre-screening to compress processing time. The shortfall is in CDSCO's pace of adoption.

In the context of clean mobility, BEE is even worse. Corporate average fuel efficiency (CAFE) norms have governed passenger-vehicle emissions since 2017. Yet, for close to 8 yrs, there's no purpose-built statutory penalty mechanism for non-compliance. A dedicated enforcement framework remains in draft.

Also, implications across successive CAFE drafts have continued to soften emission tolerance, not make them stringent as per global standards. The latest CAFE norms have chosen to extend generous credits to flex-fuel vehicles and plug-in hybrids whose real-world emission gains are far thinner than suggested lab figures. This will only lead to slower e-mobility adoption, and create confusion for the industry.

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The most consequential fixes require no new legislation. This is an execution challenge, not a statutory gap in law. For drug innovation, a workable design already exists, and can be operationalised through inter-agency arrangement. A 2-tier model should be built by pairing CDSCO's licensing and enforcement authority with ICMR's scientific depth. ICMR should front-end early-phase scientific and ethical evaluation, frontier-modality trials, and issue a formal scientific-and-ethics determination within a fixed window of a few weeks.

CDSCO should then proceed with permissions, inspections and pharmacovigilance, which keeps its statutory authority intact and exclusive. A joint scientific review board representing members from both organisations should be constituted under health ministry. An innovation accelerator cell and genuine digital handshake linking the clinical-trial registry and ethics-committee data would convert today's queue-based system into one that is time-bound, transparent and auditable.

GoI has already signalled this direction, compressing key approval timelines and consolidating CDSCO's portals. Because both agencies sit under the same ministry, rules of business already permit collaboration that can be formalised with an MoU.

BEE is also dealing with technical and procedural malaise. As it relies on layered committees and external consultants, it makes norm-setting slow. The institutions need to be staffed with a permanent technical cadre to set norms on evidence, a transparent and time-bound consultation that genuinely weighs stakeholder input without succumbing to paralysis.

It requires a digital monitoring spine linking BEE, state-designated agencies, designated consumers and discoms. A Centre-state joint committee, constituted by notification, would tie norms to time-bound adoption. Energy Conservation Act 2001 and Rules 2025 already empower BEE. What it needs is restructuring from within.

Cost of further delay is not abstract. India's ambition is sound, industry is ready, and GoI has set the reform direction in motion. CDSCO and BEE need to change.