New Delhi: A sweeping overhaul is in the works to streamline the process of approval of drugs and medical devices in India, wherein the focus is to converge various online channels into a single platform for industry players.
For years, the Central Drugs Standard Control Organisation (CDSCO), the country’s top drug regulatory body, has been attempting to move all licensing and approvals online. However, several pharma and medical devices manufacturers have reported technical issues on various online channels, leaving their approval applications in limbo.
Now, CDSCO is preparing for a complete digital overhaul as it invited bids 13 April for the selection of a software service provider to build the Digital Drugs Regulatory System (DDRS), an online platform for the regulation of drugs and medical devices.
The platform, according to the proposal, is meant to replace the current fragmented licensing and approval process with a single, fully digital regulatory system. The system will cover all product categories, including drugs, biologicals, medical devices, cosmetics, veterinary products, and emerging therapies, regulated by central and state licensing authorities.
CDSCO’s proposal describes DDRS as India’s Digital Public Infrastructure (DPI) for regulatory systems—comparable to how Aadhaar and Unified Payments Interface (UPI) transformed identity verification and payments.
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How approvals work currently
Before this plan for a complete overhaul emerged, CDSCO had attempted to move approval and certification processes online. But instead of building one integrated system, it built several, each solving a different problem.
For instance, the System for Unmanned Gateways Approval of Manufacturers (SUGAM) portal, launched in November 2015, is the primary e-governance system to manage import licenses, new drugs, and clinical trials. It also functions as a repository for permissions and licenses issued by state authorities.
MD Online, CDSCO’s official e-governance portal, was built to streamline regulatory processes related to medical devices, pharmaceuticals, and cosmetics.
SUGAM LABS is an online portal launched in September 2023 by CDSCO to integrate and automate the workflows of its drug testing laboratories. It manages the end-to-end testing process for medical products — including drugs, vaccines, cosmetics, and medical devices — ensuring they meet prescribed quality specifications, and enables real-time tracking of testing status across CDSCO’s network of Central, Regional, and State Drug Testing Laboratories.
The Online National Drugs License System, or ONDLS, was built as a single-window platform for state authorities to process manufacturing and sales licences and also handles export-related certifications such as quality compliance certificates and product approval documents required by importing countries.
The result, as Drug Controller General of India Dr. Rajeev Singh Raghuvanshi put it earlier this year, is a system that “has lived its life.” CDSCO’s official bid document, reviewed by ThePrint, admits the portals “have been mostly developed and implemented in silos.”
Approvals & tech glitches
The fragmentation plays out daily. A company submits data digitally on one portal; an officer at another desk manually re-verifies the same information. In states where adoption of the central portals has been patchy, some of this coordination still happens over phone calls and emails.
Bhavin Mehta, vice-chairperson of Pharmexcil, the body representing India’s pharmaceutical exporters, elaborated the challenges.
“The present framework still involves significant manual intervention despite digitisation. Repeated verification of the same data, inconsistent adoption across states, and limited interoperability between systems can slow down approvals and impact planning for compliant companies, particularly exporters working against strict global timelines,” he told ThePrint.
Similarly, Rajiv Nath, forum coordinator at AiMED, an umbrella association of Indian manufacturers of medical devices including consumables, disposables, equipment, instruments, diagnostics, and implants, summarised what companies have to deal with on a day-to-day basis.
“Current pain points in online licensing include fragmented portals like SUGAM, MD Online, ONDLS; inconsistent document uploads; lack of real-time status tracking; limited integration with state systems; and frequent downtime delaying approvals,” he told ThePrint.
The most pointed complaints have come from companies using ONDLS to apply for two certifications—WHO-GMP certificates and Certificates of Pharmaceutical Product, or CoPP— that are essential for export of drugs.
A WHO-GMP certificate is a globally recognised proof that a manufacturing facility meets international quality standards. Without it, the Indian companies cannot sell medicines to most regulated markets. A CoPP is a document that tells an importing country that a particular drug is approved in India and provides the evidence to back it up. Both are mandatory for export, and are routed through ONDLS.
Industry sources told ThePrint of several systemic problems with the ONDLS system. For instance, the portal pulls up manufacturing licence numbers from the wrong state, meaning an application can show a licence belonging to an entirely different company in a different jurisdiction.
Once an application is filed, there is no visible status update, leaving companies unable to tell whether their submission is moving forward or stuck in a queue, it is learnt. Besides, a mandatory export declaration called Form 51—a brand name declaration required at the time of filing—cannot be downloaded from the portal at all, the sources said.
“ONDLS, for various reasons, have ended up delaying the approval process—often stretching it to as long as six months, even though it should ideally be completed within 45 days,” an industry source said. “It is high time the CDSCO steps in, engages with stakeholders, and resolves the multiple issues affecting the system.”
These concerns, the industry sources said, are being compiled and will be formally presented to CDSCO.
Single platform to fully digitise approvals
In mid-April, CDSCO invited bids to select a software service provider to build the platform. The Request for Proposal (RFP) was issued 13 April, with a submission deadline of 13 May. The full system is to be delivered in a phased manner over 18 months.
Instead of multiple central and state portals, the system will provide a single unified platform. A company can submit an application once, and the data will automatically flow to connected systems such as Goods and Services Tax (GST), Customs, and the Indian Council of Medical Research (ICMR).
The system will track approval timelines, which will be visible to applicants, ensuring transparency. In addition, the entire drug supply chain— from manufacturer to pharmacy shelf — will be logged at every stage by all stakeholders involved.
Under the proposed DDRS, all approvals— from manufacturing licences and import permissions to export certifications—will move to one single online platform.
“If implemented well, it can help create a more integrated, transparent, and time-bound regulatory architecture that not only strengthens oversight but also materially improves ease of doing business,” Mehta said.
Nath called it a step in the right direction, but flagged what is needed for it to actually work in practice. “We recommend a single-window, paperless workflow with auto-alerts, standardised data fields, and interoperable state-Centre architecture.”
“Industry stands ready to collaborate on user-testing and mapping MedTech-specific approval pathways to ensure DDRS is efficient, transparent, and globally aligned,” he added.
The proposal acknowledges that success will depend on migrating data from existing CDSCO portals—Sugam, Sugam Labs, MD Online, and ONDLS—along with consistent onboarding of state authorities.
(Edited by Tony Rai)
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