News about Regulation

India Introduces Faster Clinical Trial Timelines to Accelerate Drug Development

If regulatory authorities do not respond within this timeframe, approval is automatically deemed granted, helping to reduce unnecessary delays and providing much-needed certainty to the pharmaceutical sector.

Regulation | 02/09/2025 | By Darshana |  540

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.

Regulation | 29/08/2025 | By Darshana |  230

FDA Approves Updated COVID-19 Vaccines with New Access Restrictions for Children and Adults

While seniors retain full access, younger adults and children will now need to demonstrate at least one high-risk health condition—such as asthma or obesity—to qualify for vaccination, significantly narrowing eligibility.

Regulation | 28/08/2025 | By Darshana |  273

Unichem Receives EIR with VAI Status from USFDA for Roha API Facility

Unichem Laboratories has announced that it has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Roha active pharmaceutical ingredients (API) facility.

Regulation | 27/08/2025 | By Dineshwori |  486

Cantargia Secures US Patent for Nadunolimab in Cancer Combination Therapies

Cantargia has announced that the United States Patent and Trademark Office (USPTO) has granted a new patent covering its antibody, nadunolimab.

Regulation | 27/08/2025 | By Dineshwori |  381

AiMeD Urges Balanced Approach to GST Rates on Medical Devices

AiMeD noted that proposed GST changes—to either five percent or 18 percent—both present significant risks requiring nuanced consideration.

Regulation | 27/08/2025 | By Dineshwori |  343

Dr Reddy's Welcomes Unified GST Reform to Support Pharma Manufacturing

Reddy said he expects the reform to address these critical issues, improve medicine affordability, and enhance India’s competitiveness and innovation in the global pharmaceutical supply chain. He emphasised that a reformed GST system would not only benefit patients but also reinforce India’s role in global healthcare security.

Regulation | 27/08/2025 | By Darshana |  298

Eris Lifesciences Secures ANVISA Approval for Sterile Injectable Facility in Ahmedabad

Eris Lifesciences has received Anvisa approval for one of its sterile injectable manufacturing facilities in Ahmedabad, enabling entry into the Brazilian market.

Regulation | 26/08/2025 | By Mrinmoy Dey |  405

CDSCO Cancels Import Registration of Mediderma Products Over Excess Salicylic Acid

The Central Drugs Standard Control Organisation (CDSCO) has cancelled the import registration of certain skincare products from US-based Mediderma after finding salicylic acid levels far above the permissible limit.

Regulation | 26/08/2025 | By Dineshwori |  589

Pharmexcil Calls for GST Parity on APIs and Formulations to Boost Pharma Efficiency

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has called for harmonising GST rates on both active pharmaceutical ingredients (APIs) and finished formulations to streamline compliance and ease financial strain.

Regulation | 26/08/2025 | By Darshana |  398