Law Updates

The National Pharmaceutical Pricing Authority (NPPA), exercising powers under paragraphs 5, 11, and 15 of the Drugs (Prices Control) Order, 2013, has notified the fixation of retail prices for specified new drug formulations. The prices, exclusive of Goods and Services Tax, apply to the formulations listed with defined strength, unit, manufacturer, and marketing company. Manufacturers of drugs classified as “new drugs” under DPCO 2013 must strictly adhere to the notified retail price. GST may be added only if it is actually paid or payable to the government.

Retail prices for individual packs must be calculated as per paragraph 11 of DPCO 2013. Manufacturers are required to issue and submit price lists in Form V through the Integrated Pharmaceutical Database Management System and share copies with State Drug Controllers and dealers. Retailers and dealers must prominently display these price lists at their business premises.

The applicability of the notified price is limited to manufacturers or marketers who have applied for price fixation or revision and fulfilled all statutory requirements, including valid licensing approvals. Non-compliance will attract recovery of overcharged amounts with interest under DPCO 2013 and the Essential Commodities Act, 1955. Prior price orders for the same formulations stand superseded.

The Ministry of Power issued a new notification on 23 December 2025 under the Energy Conservation Act, 2001. This notification updates the rules for distribution transformers in India. The amendment was made after consultation with the Bureau of Energy Efficiency.

All distribution transformers manufactured, sold, or purchased in India must now meet strict energy efficiency rules. Each transformer must pass type tests for load loss, no-load loss, and short-circuit impedance as per IS 2026 (Part 1):2011. BIS certification has become compulsory for every distribution transformer. The notification also extends existing star rating timelines from 2025 to 2026. A new Table 4 has been added. This table defines standard energy losses for distribution transformers up to 11 kV class. These limits apply from 1 January 2027 to 31 December 2029. The table covers ratings from 16 kVA to 2500 kVA and sets clear loss limits for 1-star to 5-star transformers at both 50% and 100% load.

For transformer ratings not listed, BIS-certified energy efficiency levels will apply. This amendment improves power efficiency, reduces energy waste, and strengthens transformer quality across India. It also supports national energy conservation goals and long-term power sector sustainability.

The Directorate General of Foreign Trade (DGFT) has notified an amendment to the Import Policy under Chapter 29 of ITC (HS) 2022, Schedule-I, with immediate effect. The notification has been issued by exercising powers granted under Sections 3 and 5 of the Foreign Trade (Development & Regulation) Act, 1992, read with the Foreign Trade Policy 2023.

Through this amendment, DGFT has introduced Policy Condition No. 07 to regulate imports of Potassium Clavulanate, diluted Potassium Clavulanate, and specified intermediates based on CIF value. Imports of diluted Potassium Clavulanate with a CIF value below USD 77 per kg and Potassium Clavulanate below USD 180 per kg have been placed under the “Restricted” category until 30 November 2026. Further, imports of intermediates used in the manufacture of Clavulanic Acid or Potassium Clavulanate, priced below USD 92 per kg, are also restricted for the same period.

These restrictions do not apply to Advance Authorisation holders, Export Oriented Units, or SEZ units, provided the imported goods are not supplied to the Domestic Tariff Area. Relevant ITC (HS) codes have been amended accordingly.

The Ministry of Commerce & Industry has amended Para 4.63 of the Foreign Trade Policy 2023, effective immediately. Under the reviewed provision, imports made under Diamond Imprest Authorisation (DIA) continue to be exempt from Basic Customs Duty, Additional Customs Duty, Education Cess, Anti-dumping Duty, Countervailing Duty, Safeguard Duty, and Transition Product Specific Safeguard Duty, wherever applicable. The key update now also exempts DIA imports from the Integrated Tax and Compensation Cess as levied under sub-sections (7) and (9) of section 3 of the Customs Tariff Act, 1975. This change clarifies that the full spectrum of statutory duties and cesses will not apply to goods imported under DIA, reducing the overall tax burden for eligible importers in the diamond sector.

The amendment has been issued under the powers of Sections 3 and 5 of the Foreign Trade (Development and Regulation) Act, 1992, and paragraph 1.02 of the Foreign Trade Policy 2023, with approval from the Minister of Commerce & Industry. The practical effect is broader duty relief to support competitiveness in the import and processing of rough diamonds.

The Government of India has introduced a new Risk Classification Module on the CDSCO Online System for Medical Devices. This update simplifies the approval process and makes it easier to classify medical devices that are not listed in the CDSCO published classification list. The module became active on 27 November 2025 under the Medical Device Rules, 2017. Any applicant can now submit device details through the CDSCO medical device portal to get the correct risk category for the product. This new system supports faster regulatory review, improves compliance, and helps ensure the safe use of medical devices across the country. The change also supports better transparency and smoother processing of applications for medical device risk classification.

The Hand Tools (Quality Control) Order, 2025 sets new rules to improve the safety and quality of hand tools sold in India. The Ministry of Commerce and Industry issued this order under the Bureau of Indian Standards Act, 2016. The order will start on 1 October 2026 and will apply to several common hand tools like pipe wrenches, open-jaw spanners, ring spanners, pliers, and adjustable wrenches. Each tool must follow the matching Indian Standard and carry the BIS Standard Mark under a licence issued by the Bureau of Indian Standards.

The order lists important standards such as IS 4003 (Part 1 and 2) for pipe wrenches, IS 2028 for open-jaw spanners, IS 2029 for ring spanners, IS 6149 for adjustable wrenches, and IS 3650 for cutting pliers. Large industries must follow the rules from October 2026, while small enterprises get time till 1 January 2027, and micro enterprises get time till 1 April 2027. This phased start supports smaller units so they can upgrade their systems without pressure.

The order does not apply to items made for export. Manufacturers can also import up to 200 units of hand tools each year for research and development without BIS certification, but these items must be scrapped later and cannot be sold.

The Bureau of Indian Standards will act as the main authority to certify and enforce these rules. Any violation of this order will lead to punishment under the BIS Act, 2016. The new framework aims to raise product quality, create safer tools, and strengthen consumer trust across the country.