For the first time, India’s Central Drugs Standard Control Organization (“CDSCO”) has issued a Draft Guidance on Medical Device Software to regulate software-based medical devices, including AI-based devices. This guidance aims to clarify the classification, licensing, validation, and post-marketing surveillance of Software... Read More
The Government of India has issued the Legal Metrology (Packaged Commodities – “LMPC”) Amendment Rules, 2025, a pivotal reform that exempts medical devices from the purview of the LMPC Rules, 2011. The amendment puts to rest long-standing issues of overlap created by... Read More
India is moving toward an extensive revision of its legal drug-quality measures, which will be aligned with the various drug standards of the US, EU, and Japan. The Indian Pharmacopoeia Commission (IPC) will include new drug quality measures for 123 products and... Read More
India has released a draft bill calling for greater accountability from clinical trial sponsors and contract research organizations (CROs). Companies will need to pay damages and treat participants who suffer from injuries during any trials. If the trial sponsors do not comply, companies would face a... Read More
India’s Union Health Ministry has suggested amending the New Drugs and Clinical Trial Rules, originally issued in 2019, to simplify approvals and encourage pharmaceutical innovation. The modification in the draft would permit drug companies to conduct some of the bioavailability and bioequivalence... Read More
On August 5, 2025, India’s Central Drugs Standard Control Organisation (CDSCO) issued its first formal rule that stipulates how Subject Expert Committees (SECs) must review and approve new drugs, medical devices, and biologics. This policy change aims to resolve long-standing concerns related... Read More
While China has dominated the headlines for new drug research and out-licensing to Western pharmaceutical companies, and will continue to do so in the future, Korea, too, is entering the new drug game. While historically Korean drug companies have mainly focused on making... Read More
Over the past year, India has enacted a series of significant regulatory reforms aimed at boosting the safety, quality, and transparency of its medical device sector. The new regulations and amendments, covering everything from risk-based quality control of imports to enhanced adverse... Read More
Historically known for their strength in generic drug manufacturing, today, Indian pharma firms are increasing their in-licensing transactions with international drug innovators. Big Indian pharma firms such as Cipla, Sun Pharma, and Dr. Reddy’s are acquiring rights to new patented products in the oncology, diabetes, central... Read More
On July 22, the Indian Department of Pharmaceuticals National Pharmaceutical Pricing Authority (NPPA) issued a Memorandum with respect to the maximum retail prices (MRP) for non-scheduled formulations for new drugs and medical devices. Essentially, it states that the NPPA monitors prices, and... Read More