Law Updates

Subject

Summary: Hospitals and procurement agencies in India often ask for foreign approvals, like the USFDA or CE certification, while buying medical devices. But the Medical Devices Rules, 2017, clearly state that every medical device in India must have a valid license. This rule comes under the Drugs and Cosmetics Act, 1940, to ensure the safety, quality, and correct performance of devices used in healthcare. All medical devices are grouped into four risk classes: Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk), and Class D (high risk). Licensing depends on the risk class. State Licensing Authorities give manufacturing licenses for Class A and Class B devices and sales licenses for all classes. CDSCO gives import licenses for all classes and manufacturing licenses for Class C and Class D devices after a detailed technical check. No medical device can be sold in India without a CDSCO license or a license from a State Licensing Authority. Hence, procurement agencies must make these licenses a compulsory requirement. Any other certification should be treated only as an additional requirement. This helps protect public health and ensures legal compliance in the country.

Subject

Summary: The Central Drugs Standard Control Organisation (CDSCO) has released a detailed draft guidance on regulatory requirements for medical device software under the Medical Devices Rules (MDR), 2017. The document, dated October 21, 2025, clarifies the scope, classification, technical documentation, and quality management requirements for both domestic and overseas manufacturers. The guidance distinguishes between Software in a Medical Device (SiMD), which is integrated with hardware, and Software as a Medical Device (SaMD), which operates independently for medical purposes. Risk classification follows MDR-2017 provisions, with SiMD aligned to the hardware’s risk and SaMD classified based on its role in healthcare decisions, ranging from Class A to Class D. The draft outlines regulatory pathways, clinical investigation requirements, and licensing procedures. Manufacturers must maintain a comprehensive Quality Management System (QMS) and submit detailed technical documentation, including risk management reports and system architecture. Post-market surveillance, adverse event reporting, and corrective actions are mandatory, ensuring patient safety and software reliability. Stakeholders can submit comments within 30 days.

Subject

Summary: The Central Drugs Standard Control Organisation (CDSCO) has launched a Digital Monitoring System through its Online National Drug Licensing System (ONDLS) portal to strengthen oversight of high-risk pharmaceutical solvents. This initiative, communicated via a letter dated October 22, 2025, responds to recent safety concerns, including the detection of Diethylene Glycol (DEG) in cough syrups, which posed major public health risks. Following a high-level meeting chaired by the Union Health Secretary on October 5, 2025, the CDSCO has authorized strict compliance for solvent manufacturers. All manufacturers must now obtain or register their licenses on the ONDLS portal, with existing licensees submitting their current data through the “Old Licence Management” section. Additionally, batch-wise details, including quantity produced, Certificate of Analysis (CoA), and buyer information, must be uploaded. State and UT Drug Controllers are directed to ensure no high-risk solvent batch reaches the market without adherence to these requirements. The updated ONDLS portal is fully operational to secure the pharmaceutical supply chain and protect product quality.

Subject

Summary: The Central Drugs Standard Control Organisation (CDSCO) and the Directorate General of Health Services (DGHS) have issued a circular emphasizing strict compliance with the Drugs Rules, 1945, for testing raw materials and finished formulations. Recent child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups, highlighted concerns about medicine quality. Inspections revealed that some pharmaceutical manufacturers fail to test each batch of excipients, active, and inactive ingredients before production. The Drugs Rules, including rule 74(c) and rule 78(c)(ii), require licensees to test all raw materials and finished products in their own or approved laboratories.  Manufacturers must maintain proper records as per Schedule U. State and UT Drug Controllers are instructed to monitor compliance through inspections, issue circulars, and ensure manufacturers follow robust vendor qualification systems. Only reliable, approved suppliers should provide raw materials and excipients. This measure ensures the safety, quality, and efficacy of medicines, prevents the distribution of substandard drugs, and protects public health. Compliance and vigilant monitoring are critical to maintaining pharmaceutical standards nationwide.