News about "CDSCO"

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

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

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

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

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 |  201

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 |  249

Hyderabad-based Bharat Biotech recalls typhoid vaccine batch owing to substandard quality

Hyderabad-based Bharat Biotech recalls typhoid vaccine batch owing to substandard quality

CDSCO | 09/06/2023 | By Sudeep Soparkar |  665

Chennai-based Global Pharma Healthcare in radar for exporting contaminated eye drops

The company has exported two consignments of 24 batches of ‘Artificial Tears’ to the US which were manufactured in 2021 and 2022<br />

CDSCO | 06/02/2023 | By Sudeep Soparkar |  754

Aurobindo Pharma JV gets SEC recommendation for pneumococcal 15 valent vaccine

PCV15 vaccine was developed by Tergene Biotech and manufactured at AuroVaccines

CDSCO | 29/12/2022 | By Sudeep Soparkar |  540

Dr Mansukh Mandaviya virtually inaugurates CDSCO Bhawan, South Zone in Chennai

It will facilitate drug, cosmetics safety and regulatory activities of southern States/UTs including Tamil Nadu, Puducherry, Kerala and Lakshadweep<br />

CDSCO | 23/12/2022 | By Sudeep Soparkar |  308