Law Updates

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.

The Ministry of Environment, Forest, and Climate Change has extended the timeline for filing returns under EPR for Used Oil. All registered entities that operate under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules must now file the annual returns for FY 2024-25 by 31 December 2025. Earlier, the last date for filing was 30 September 2025.

The Central Pollution Control Board (CPCB) received many requests from different stakeholders working under the EPR for the Used Oil system. They needed more time to complete the return filing process. After examining the matter, the Ministry approved the extension under Rule 30(5) of the HOWM Amendment Rules 2024.

This change helps producers, importers, collection agents, and recyclers meet their EPR responsibilities smoothly. The extension supports safe oil management, better reporting, and full compliance under the EPR for Used Oil framework in India.

The Indian Bureau of Mines has issued a fresh notification amending the fee structure for approving Final Mine Closure Plans. This update has been introduced under Section 18 of the Mines and Minerals (Development and Regulation) Act, 1957, along with Rule 24 of the Mineral Conservation and Development Rules, 2017. The new order substitutes the earlier Gazette notification issued in February 2022, while keeping intact any actions already completed under the previous framework.

As per the revised decision, every Final Mine Closure Plan submitted to the Indian. The Bureau of Mines must now be complemented by a non-refundable fee. This fee applies to all minerals and mining areas covered under the relevant rules. However, the government has allowed a specific relaxation for miners handling Barytes, Felspar, Mica, or Quartz. If the closure plan for these minerals relates to an area up to 10 hectares and is filed on or before 31 December 2025, the payable fee will remain only one thousand rupees.

This update aims to bring clarity, improve regulatory consistency, and ensure that closure plans are submitted with proper accountability.

The Government of Maharashtra has issued the Maharashtra Shops and Establishments (Regulation of Employment and Conditions of Service) Amendment Rules, 2025. These new rules update important points for business units and workers in the state. The main change is that the number of workers for registration increases from ten to twenty. This applies to forms, records, and approvals mentioned under rule 3, rule 8, and rule 11 of the Labour Rules, 2018.

A big focus of the amendment is women worker safety during night shifts from 9:30 p.m. to 7:00 a.m. Shops and establishments must follow strong safety steps. Transport must pick up and drop off women workers directly from their homes. All workplaces must stay bright and safe. Toilets, washrooms, and walking paths must also have enough light. There should always be at least two women working together during the shift. Every eight weeks, women workers and the manager must sit together and talk about any safety problems. The workplace must stay secure, and cameras must record everything. The camera video must be saved for 45 days to keep everyone protected. Written consent from every woman worker must be taken in Form L and kept for three years.

Forms H, J, and K are also updated to match the twenty-worker requirement. The changes help improve labour compliance, workplace safety, and better employment conditions across Maharashtra. These rules support safer work for women and easier standards for businesses in the state.

The Ministry of Chemicals and Fertilizers has issued an important update through the National Pharmaceutical Pricing Authority (NPPA). The ministry has extended the existing ceiling prices for orthopaedic knee implants used in knee replacement procedures. These prices were originally fixed in August 2017 to avoid sudden spikes in treatment costs and have been renewed several times based on public interest.

The earlier extension was valid until 15 November 2025. With the latest order, the same ceiling prices will now continue until 15 November 2026, or until the government releases a new directive. This ensures consistent pricing for hospitals and manufacturers while providing financial safety to patients undergoing knee replacement surgery.

All notes and conditions included in the original 2017 notification will stay active during this extended period. The decision highlights the ministry’s ongoing focus on transparency, fair pricing, and accessible healthcare for those who depend on crucial orthopaedic implants.

The Ministry of Heavy Industries released the Machinery and Electrical Equipment Safety (Omnibus Technical Regulation) Second Amendment Order, 2025. This amendment comes under the BIS Act, 2016. It changes the starting date for mandatory BIS compliance for machinery and electrical equipment. The earlier date of 1st September 2026 has now been replaced. 

The new date for enforcement will come through a future notification in the Official Gazette. The amendment supports public safety and standard compliance in India. The Central Government will decide the final date after consultation with BIS. This step ensures better planning for industries and smooth implementation of product safety rules under the Machinery and Electrical Equipment Safety Order.