News about "CDSCO"

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 |  184

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 |  116

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 |  193

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 |  161

CDSCO lists 1,700 BIS standards to strengthen medical device compliance and hospital planning

The Central Drugs Standard Control Organisation (CDSCO) has released a comprehensive list of around 1,700 standards developed under the Medical Equipment and Hospital Planning Division (MHD) of the Bureau of Indian Standards (BIS).

CDSCO | 28/10/2025 | By Darshana |  329

CDSCO approves AstraZeneca's Trastuzumab Deruxtecan for More HER2-Positive Tumours

With this, Trastuzumab Deruxtecan becomes India’s first Antibody Drug Conjugate (ADC) approved for a tumour-agnostic indication.

CDSCO | 04/10/2025 | By Dineshwori |  253

CDSCO Clarifies Approval Process for Lyophilized Injection Combi-Packs

The drug regulator has specified when combi-packs of lyophilized injections with diluents will require fresh CDSCO approval and when licenses can be issued directly by State Licensing Authorities.

CDSCO | 30/09/2025 | By Dineshwori |  267

CDSCO Clarifies Regulatory Pathway: Cocrystals of Approved Drugs to Be Treated as New Drugs

The Central Drugs Standard Control Organisation (CDSCO) has issued a clarification stating that cocrystals of already approved active substances will be treated as new drugs under Indian regulations.

CDSCO | 17/09/2025 | By Darshana |  298

CDSCO Invites Recommendations on Braille Labelling and QR Code Features for Medicine Packaging

The Central Drugs Standard Control Organization (CDSCO) has begun discussions on mandating Braille labelling on medicine strips to help visually impaired individuals identify medicines and read key details like expiry dates.

CDSCO | 10/09/2025 | By Dineshwori |  421