News about Regulation

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 |  442

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 |  152

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 |  457

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 |  200

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 |  169

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 |  348

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 |  255

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 |  283

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 |  220

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 |  295