CDSCO Urges States to Fast-Track Onboarding on Sugam Labs Portal

The latest communication calls for the process to be expedited so that the portal can become operational across all jurisdictions.

The Central Drugs Standard Control Organisation (CDSCO) has renewed its appeal to States and Union Territories (UTs) to accelerate onboarding on the Sugam Labs portal, following limited progress despite an earlier request.

The regulator has asked state drug authorities to submit the required details of their officials and Drug Testing Laboratories (DTLs) to enable the platform's wider implementation.

Developed by the Centre for Development of Advanced Computing (C-DAC) under the Digital India initiative, the Sugam Labs portal has been operational since September 2023. It was introduced to integrate drug testing laboratories under CDSCO and digitise workflows for testing medical products, including drugs, vaccines, cosmetics and medical devices.

In a recent communication to state and UT drug controllers, Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi highlighted the slow response to the onboarding exercise.

“It is observed that, so far, onboarding requests have been received from 16 States/UTs. Out of which only 5 states have completed the onboarding progress. The responses regarding the onboarding of the remaining states/UTs are still awaited,” he said.

The regulator had previously written to States and UTs on September 24, requesting them to initiate onboarding of their officials and respective DTLs.

The latest communication calls for the process to be expedited so that the portal can become operational across all jurisdictions.

The Sugam Labs portal provides an integrated digital workflow connecting CDSCO, State Food and Drug Administrations, drug inspectors, regulatory offices, state zones and sub-zones, and DTLs.

It supports end-to-end management of regulatory activities, covering sample collection and registration, laboratory testing, result approval, report generation, and subsequent enforcement and legal action.

According to the DCGI, wider adoption of the platform will also improve the monthly compilation of Not of Standard Quality (NSQ) data through automation, which is an important part of drug quality oversight, helping regulators track products that fail to meet prescribed quality standards.

The push for onboarding was also raised during the 70th meeting of the Drugs Consultative Committee (DCC) on September 18. The committee advises the Central and state governments on matters relating to drug regulation and its uniform implementation.

During the meeting, the DCGI called on state and UT drug controllers to adopt Sugam Labs for digital management of regulatory enforcement, sampling, laboratory testing and post-marketing surveillance.

Moreover, the DCC recommended that States develop internal standard operating procedures to prioritise critical, life-saving and urgent public-health samples according to available capacity.

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