Last Updated on January 13, 2026 by The Health Master
CDSCO
The Central Drugs Standard Control Organisation (CDSCO), the national drug regulatory agency of India has made a vital change in policies with an intent to improve its performance and response times dramatically.
The official delegation of substantial licensing authority powers to Joint Drug Controllers (India) comes at a crucial time to expedite approvals for drug import licenses and facilitate faster obligations for important serious adverse events (SAE).
Given that all such crucial considerations need to be managed at present by the Drugs Controller General of India (DCGI), this is a final shift in the longstanding, highly centralized operations reigning up until now.
Which powers have been delegated?
According to the official Office Order from the DCGI’s front, specific powers have been transferred and will have a significant impact.
This is intended to alleviate the burden from the office of the top regulator and empower the Joint Drug Controllers for timely receipt and response times relative to the pharmaceutical industry.
The specific powers transferred for regulatory empowerment include:
- Import License for Drugs for Human Use: Approvals via India for much-needed drugs on an international scale.
- License for Blood Stem Cell Products: A necessary approval given how complicated and relatively new these products can be.
- Approvals of New Sites for Clinical Trials: Approvals for sites where necessary Clinical Trials can occur.
Decisions for Serious Adverse Events
In addition to these approvals, there’s one part of the process which was previously regulated under extra cautionary circumstances that will now benefit as well: Serious Adverse Events (SAE).
These events are unfortunate situations that arise during clinical trials or even Bioavailability/Bioequivalence (BA-BE) studies.
They are life-threatening incidents (death) or life-changing incidents (disability).
Thus, the new mandate transfers powers to assess and address SAE compensations over time with timely recommendations relative to existing provisions.
This means that approval for compensation payments will now be more quickly addressed as previously they took too long.
The more promptly SAE are addressed, the better for ethical compliance for clinical trial participants. (High CPC Keyword: SAE Compensation Payout)
Ease of Doing Business
According to industry experts, the delegation is a major benefit to a complicated ecosystem of the entire pharmaceutical industry, with a senior drug controller stating that it makes sense how all players will benefit from such changes.
In addition, the CDSCO has improved its accountability as a result, which complements the aims of the Indian Government as a whole.
By facilitating easier connections with major decision makers, it provides a more reputable stance on the “Ease of Doing Business” campaign in India and thus makes international investments much more attractive.
Coupled with the Make in India initiative by expediting approvals with the potential for accountability, national businesses will find similar benefits when manufacturing.
Q1: What does this “delegation of LA powers” mean for a pharmaceutical company?
A: This now means that the authority to provide a license (LA – Licensing Authority) is no longer solely sanctioned by the DCGI but has been approved for several Joint Drug Controllers. This means that turnaround times for pharmaceutical companies may be much shorter when it comes to drug import licenses and manufacturing approvals within India.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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