News about Regulation

FDA Launches 'Green List' to Crack Down on Illegal GLP-1 API Imports

The US Food and Drug Administration (FDA) has created a new “green list” import alert to stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the US market.

Regulation | 09/09/2025 | By Dineshwori |  966

Alembic Pharmaceuticals Secures USFDA Final Approval for Phytonadione Injectable Emulsion

Alembic Pharmaceuticals has received final USFDA approval for its Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, used in treating and preventing vitamin K deficiency-related conditions.

Regulation | 09/09/2025 | By Mrinmoy Dey |  243

India's drug regulator to ease oversight and deploy AI for greater efficiency

India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), is preparing to introduce fixed timelines for drug approvals and increase the use of artificial intelligence to strengthen efficiency and transparency.

Regulation | 05/09/2025 | By Darshana |  502

Drug and Device Manufacturers Must Value Promotional Samples at Market Entry Price, Government Clarifies

The Indian government has issued a clarification under the Uniform Code for Pharmaceutical Marketing Practices, mandating that drug and medical device manufacturers must value free promotional samples using the same price charged to the stockist or immediate customer.

Regulation | 04/09/2025 | By Darshana |  175

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 |  482

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 |  207

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 |  198

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 |  380

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 |  292

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 |  300