News about "CDSCO"

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

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 |  219

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 |  233

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 |  182

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 |  236

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 |  356

AstraZeneca Rolls Out Anti-Complement Therapy for aHUS and PNH

AstraZeneca India launches Eculizumab (300 mg, 10 mg/ml), the first approved anti-complement therapy in India for the treatment of atypical Haemolytic Uremic Syndrome (aHUS) and Paroxysmal Nocturnal Hemoglobinuria (PNH), following CDSCO approval in January 2025 for import, sale and distribution.

CDSCO | 09/09/2025 | By Dineshwori |  113

CDSCO Flags 143 Drug Samples as Substandard in July, Eight Found Spurious

In its routine quality surveillance for July, the Central Drugs Standard Control Organisation (CDSCO) reported that 143 drug samples failed to meet quality standards, while eight were identified as spurious.

CDSCO | 29/08/2025 | By Darshana |  163

AstraZeneca Gains CDSCO Nod for Import of Eculizumab in India

Eculizumab is a monoclonal antibody used to treat Paroxysmal Nocturnal Hemoglobinuria (PNH) and Atypical Hemolytic Uremic Syndrome (aHUS) by inhibiting complement-mediated thrombotic microangiopathy.

CDSCO | 18/01/2025 | By Aishwarya |  273

AstraZeneca India Secures CDSCO Approval for Durvalumab

AstraZeneca Pharma India has been granted permission to import for sale and distribution of Durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution for infusion from the Central Drugs Standard Control Organisation (CDSCO).

CDSCO | 27/09/2024 | By Aishwarya |  399