India’s drug approval system set for big digital overhaul to weed out multiple portals, glitches, delays

The Central Drugs Standard Control Organisation (CDSCO) issued a Request for Proposal on April 13, 2026, to select a software provider for building a unified...

What Happened

The Central Drugs Standard Control Organisation (CDSCO) issued a Request for Proposal on April 13, 2026, to select a software provider for building a unified Digital Drugs Regulatory System (DDRS), marking the most comprehensive overhaul of India's drug regulatory digital infrastructure.
The existing system is fragmented across multiple disconnected portals: SUGAM (new drug and import license applications, launched 2015), MD Online (medical devices and cosmetics), SUGAM LABS (drug testing laboratories, 2023), and ONDLS (state-level manufacturing licenses and export certifications).
Industry stakeholders have flagged persistent technical failures including license numbers being pulled from wrong states, absent status-update visibility, missing export declaration forms, and approval timelines stretching to six months instead of the mandated 45 days on the ONDLS portal.
The proposed DDRS will consolidate all approvals into a single portal with automatic data flow to GST, Customs, and ICMR systems, and real-time supply chain tracking from manufacturer to pharmacy.
The overhaul is to be delivered in phases over 18 months, with a proposal submission deadline of May 13, 2026.

Static Topic Bridges

CDSCO: Mandate and Regulatory Authority

The Central Drugs Standard Control Organisation (CDSCO), operating under the Directorate General of Health Services within the Ministry of Health and Family Welfare, is India's National Regulatory Authority (NRA) for drugs, cosmetics, medical devices, and clinical trials. Its primary statutory basis is the Drugs and Cosmetics Act, 1940, which empowers it to regulate drug imports, approve new drugs, set quality standards, and coordinate with State Drug Control Organisations.

Drugs and Cosmetics Act, 1940: Principal legislation governing manufacture, distribution, sale, import, and export of drugs and cosmetics in India.
CDSCO headquarters: FDA Bhawan, Kotla Road, New Delhi; six zonal offices, four sub-zonal offices, 13 port offices, and seven laboratories.
Functions: Approval of new drugs and clinical trials; regulation of medical devices and cosmetics; laying down quality standards; regulating drug imports; providing expert oversight to state drug controllers.
The Drug Controller General of India (DCGI) heads CDSCO and is the national-level authority for new drug approvals and clinical trial permissions.
Schedule H and Schedule H1 of the Drugs and Cosmetics Rules, 1945: Prescription-only drugs list; H1 covers higher-risk antibiotics and controlled substances with stricter dispensing rules.

Connection to this news: The DDRS overhaul is an attempt to modernise CDSCO's operational framework, reducing manual intervention and inter-portal fragmentation that currently undermines timely drug approvals.

Drug Regulation in India: Dual Licensing Structure

India operates a dual licensing structure for drugs: the Central Government (through CDSCO/DCGI) handles approvals for new drugs, clinical trials, import licenses, and blood products, while State Drug Control Organisations handle manufacturing and retail sale licenses. This division of authority — rooted in the Seventh Schedule's concurrent list framework — creates coordination challenges, which the ONDLS and DDRS are designed to address.

Entry 19, Concurrent List (List III): "Drugs and poisons" — both Parliament and State Legislatures can legislate; central law prevails in case of conflict.
New Drug Definition (under Drugs and Cosmetics Rules): Covers drugs not used in India to any significant extent, drugs with new claims, or drugs used for a new indication.
New Drug Approval (NDA) process under CDSCO: Pre-submission meeting → application on SUGAM → technical review → clinical data review → approval or rejection.
Medical Devices Rules, 2017 (amended 2020): Brought medical devices fully under CDSCO regulation, requiring registration on MD Online portal.

Connection to this news: The DDRS consolidation will bridge the central-state licensing gap by integrating ONDLS (state-level licenses) with SUGAM (central approvals) into a single system, reducing duplication and processing delays.

E-Governance in Regulatory Bodies: Principles and Challenges

The CDSCO digital overhaul reflects broader principles of e-governance reform — shifting from manual, paper-based processes to digitised, integrated service delivery. Key frameworks guiding such reforms include the National e-Governance Plan (NeGP), the Digital India programme (launched 2015), and the principle of "single-window clearance" for regulatory approvals.

Digital India Programme (2015): Seven pillars including digital infrastructure, e-services delivery, and digital literacy.
Single-window clearance: Government policy to reduce approval silos; DDRS applies this to drug regulation.
A persistent barrier in Indian regulatory digitisation is "portal proliferation" — multiple standalone systems without interoperability, creating redundant data entry and verification cycles.
DDRS will integrate with GST Network, Indian Customs EDI System, and ICMR databases — a model of horizontal integration across government systems.

Connection to this news: The DDRS project directly addresses portal proliferation in drug regulation, aiming to eliminate the "significant manual intervention despite digitisation" identified by industry.

Key Facts & Data

CDSCO: Under Directorate General of Health Services, Ministry of Health and Family Welfare; statutory basis: Drugs and Cosmetics Act, 1940.
SUGAM portal: Launched November 14, 2015; handles new drug applications, import licenses, clinical trials.
ONDLS: State-level manufacturing and export licenses; mandated 45-day approval timeline frequently missed.
DDRS (Digital Drugs Regulatory System): Single unified portal to replace SUGAM, MD Online, SUGAM LABS, and ONDLS.
RFP issued: April 13, 2026; proposal deadline May 13, 2026; 18-month phased delivery.
Drug regulation: Concurrent List Entry 19 (List III, Seventh Schedule).
DCGI: Head of CDSCO; apex authority for new drug approvals and clinical trial clearances in India.
Schedule H1: Prescription-only list for high-risk antibiotics; requires enumerating pharmacist details at point of sale.