News about "CDSCO"

CDSCO Cracks Down on Unlicensed IVF Medical Devices

The Central Drugs Standard Control Organisation (CDSCO) has directed its zonal and sub-zonal offices, along with State Licensing Authorities (SLAs), to maintain strict vigilance against the sale of unlicensed medical devices used in In Vitro Fertilisation (IVF) and Assisted Reproductive Technology (ART) procedures.

CDSCO | 30/03/2026 | By Darshana

CDSCO Approves AstraZeneca Pharma India's Durvalumab for uHCC Treatment

AstraZeneca Pharma India has received CDSCO approval for durvalumab to treat unresectable hepatocellular carcinoma (uHCC), a major global health concern as HCC ranks among the most common and deadliest cancers worldwide.

CDSCO | 18/03/2026 | By Akanki

ACC Extends Dr Rajeev Singh Raghuvanshi's appointment as Drugs Controller (India) for One Year

Dr Rajeev Singh Raghuvanshi receives a second one-year extension as head of CDSCO amid ongoing regulatory reforms and Schedule M implementation.

CDSCO | 02/03/2026 | By News Bureau |  332

CDSCO to Outsource GMP Audits and Add 1,500 Experts to Boost Scientific Oversight

Central Drugs Standard Control Organisation has announced plans to strengthen its regulatory framework by outsourcing Good Manufacturing Practice (GMP) audits to accredited third-party agencies and expanding its scientific workforce by approximately 1,500 experts.

CDSCO | 24/02/2026 | By Darshana |  201

CDSCO Flags 240 Drug Samples as Not of Standard Quality in January 2026

Central Drugs Standard Control Organisation has reported that 240 drug samples tested across India in January 2026 were found to be Not of Standard Quality (NSQ). Of these, 68 samples were identified by Central Drugs Laboratories, while 172 were flagged by State Drugs Testing Laboratories.

CDSCO | 23/02/2026 | By Darshana |  488

Union Budget Boosts Pharma with Biopharma Shakti with Outlay of INR 10,000 Crore

Union Finance Minister Nirmala Sitharaman unveiled multiple initiatives for pharma and life sciences in budget 2026–27, including Biopharma Shakti, NIPER expansion, CDSCO strengthening and new investments, to position India as a global biopharma hub.

CDSCO | 01/02/2026 | By News Bureau |  226

Union Health Ministry Revises NDCT Rules

The Union Health Ministry has notified amendments to the NDCT Rules, 2019 to ease compliance and speed up drug development, introducing a prior-intimation mechanism in place of licensing, waiving permissions for select low-risk BA/BE studies, and cutting test licence processing timelines to 45 days.

CDSCO | 28/01/2026 | By News Bureau

CDSCO Flags 167 Drug Samples as Substandard, Seven Found Spurious

India’s drug regulator has identified 167 medicine samples that failed quality tests and classified seven additional samples as spurious during routine surveillance conducted in December. The findings were released as part of the Central Drugs Standard Control Organisation’s (CDSCO) monthly drug alert.

CDSCO | 22/01/2026 | By Darshana |  169

CDSCO Flags 205 Not of Standard Quality Drug Samples in November Despite Data Gaps from States

Even as data submissions were pending from nearly 18 states and five Union Territories, the Central Drugs Standard Control Organisation (CDSCO) reported a total of 205 drug samples as Not of Standard Quality (NSQ) during November 2025.

CDSCO | 26/12/2025 | By Darshana |  287

Parliamentary Panel Calls for Faster, Fully Digitised Medical Device Approvals at CDSCO

The Parliamentary Standing Committee on Health and Family Welfare has urged the Department of Health to ensure complete digitisation and automation of the medical device licensing process at the Central Drugs Standard Control Organisation (CDSCO).

CDSCO | 16/12/2025 | By Darshana |  203