News about Quality / GMP

CDSCO Launches Nationwide Inspections of Drug Manufacturing Units After Cough Syrup Deaths

The Central Drugs Standard Control Organisation (CDSCO) has initiated risk-based inspections of drug manufacturing units in six Indian states following reports of child fatalities linked to contaminated cough syrups.

Quality / GMP | 06/10/2025 | By Darshana |  258

Contaminated Cough Syrup Deaths: Centre Directs Drug Manufacturers to Strictly Comply with Revised GMP Norms

Following reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups, the Union Health Ministry has directed all pharmaceutical manufacturers to strictly comply with the Revised Schedule M for Good Manufacturing Practices (GMP).

Quality / GMP | 06/10/2025 | By Dineshwori |  118

US FDA Classifies Lupin's Pithampur Unit-2 as Official Action Indicated

The US Food and Drug Administration (FDA) has concluded its inspection of Lupin’s Pithampur Unit-2 manufacturing facility, issuing a Form 483 with four observations.

Quality / GMP | 04/10/2025 | By Dineshwori |  350

Supriya Lifescience Secures WHO GMP Certification for Ambernath Facility

The WHO certification for Supriya Lifescience paves way for commercial formulations’ production with INR 500 crore revenue potential.

Quality / GMP | 04/10/2025 | By Dineshwori |  153

French Court Orders Sanofi to Pay Euro 177 Million for Anti-Competitive Practices Over Plavix

A French court has ordered Sanofi to pay 177 million euro after ruling that the company engaged in anti-competitive behaviour to protect sales of its blockbuster blood thinner, Plavix. The decision follows a long-running investigation into allegations that Sanofi misled doctors and pharmacists about the safety of generic versions of the drug.

Quality / GMP | 25/09/2025 | By Darshana |  288

ICMR and CDSCO Release First Set of 39 Standard IVD Evaluation Protocols

Standard In-Vitro Diagnostic (IVD) Evaluation Protocols, jointly developed by ICMR and CDSCO, include protocols for performance evaluation of IVD kits used for detecting tuberculosis, malaria, dengue, chikungunya, Zika virus, typhoid fever, various respiratory viruses, Chandipura virus, and Nipah virus.

Quality / GMP | 19/09/2025 | By Dineshwori |  265

India Now Among Top Global Reporters of Drug Adverse Events, Says DCGI

India has emerged as one of the top global contributors in reporting adverse drug events, according to Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI). He made the remarks during the inauguration of the 5th National Pharmacovigilance Week in New Delhi.

Quality / GMP | 18/09/2025 | By Darshana

NATCO Pharma's Kothur Facility Receives FDA EIR with VAI Classification

The US Food and Drug Administration (FDA) has completed an inspection at NATCO Pharma’s Pharma division located in Kothur, Hyderabad, India.

Quality / GMP | 18/09/2025 | By Dineshwori |  317

AVITA Medical Receives CE Mark for RECELL GO

With the CE Mark secured, AVITA Medical will begin commercialisation of RECELL GO in select European countries, including Germany, Italy and the United Kingdom, in collaboration with burn centres and clinical partners.

Quality / GMP | 17/09/2025 | By Dineshwori

Alembic Pharmaceuticals Receives US FDA Compliance Report for Panelav API Facilities

Alembic Pharmaceuticals has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the inspection conducted at its API-I and API-II facilities in Panelav, Gujarat.

Quality / GMP | 15/09/2025 | By Dineshwori |  233