Law Updates

The Ministry of Chemicals and Fertilizers, through the Department of Pharmaceuticals, released an addendum on 4th November 2025. The National Pharmaceutical Pricing Authority (NPPA) updated its earlier orders related to the ceiling price fixation of scheduled IV fluid formulations with special features. This new order adds five manufacturers and marketers to Table B under the existing NPPA order. 

The new entries include IV Tech Healthcare, Safal Lifescience Pvt. Ltd., One Drip Healthcare Pvt. Ltd., Life Infusion Pharmaceuticals Pvt. Ltd., Virchow Biotech Pvt. Ltd., Klokter Life Sciences Pvt. Ltd., and Zee Laboratories Ltd. Each company has been assigned specific applicable formulations from Table A, defining which IV fluid variants fall under NPPA’s controlled pricing. Clauses (h5) to (h8) specify these details, ensuring that only certain formulations are subject to the notified ceiling prices. 

For instance, IV Tech Healthcare and Life Infusion Pharmaceuticals can apply ceiling prices only for formulations at serial numbers 1, 2, 3, 4, 5, 7, and 8. Similarly, Virchow Biotech, Safal Lifescience, and Klokter Life Sciences have defined applicable formulations based on their product categories. This NPPA update ensures uniform pricing and transparency across the pharmaceutical market, preventing overpricing of essential IV fluids and promoting fair access to life-saving medicines in India.

The National Pharmaceutical Pricing Authority (NPPA) has issued an update to its earlier Gazette notifications, 3000(E) dated July 4, 2025, and 3977(E) dated August 29, 2025, concerning the ceiling price fixation of scheduled I.V. fluid formulations (non-glass with special features). The update introduces four new clauses: (h5), (h6), (h7), and (h8).

Under clause (h5), for M/s IV Tech Healthcare and M/s Life Infusion Pharmaceuticals Pvt. Ltd., only formulations listed at Serial Numbers 1, 2, 3, 4, 5, 7, and 8 of Table A are covered. Clause (h6) applies to M/s Safal Lifescience Pvt. Ltd. and M/s One Drip Healthcare Pvt. Ltd., limiting applicable formulations to Serial Numbers 2, 4, 5, and 7. Clause (h7) specifies that for M/s Virchow Biotech Pvt. Ltd., formulations under Serial Numbers 1, 2, 4, 5, 6, 7, and 8 are valid. Clause (h8) states that M/s Klokter Life Sciences Pvt. Ltd. and M/s Zee Laboratories Ltd. are covered only for formulations numbered 2, 4, and 7.

These additions strengthen compliance and bring greater clarity to price applicability.

The National Pharmaceutical Pricing Authority (NPPA) has issued a new order under the Drugs (Prices Control) Order, 2013, fixing retail prices for certain new drug formulations. Manufacturers are directed to set retail prices as mentioned in the official table and may add GST only if it is actually payable to the government.

As per DPCO provisions, manufacturers must issue a price list in Form V and submit it through IPDMS, along with copies to the State Drug Controller and dealers. Retailers and dealers are required to display the approved price list and any supplementary lists prominently at their business premises.

The fixed retail price applies only to manufacturers or marketers who have obtained approval through Form I and hold valid manufacturing licenses. Any violation or overcharging will require repayment with interest under DPCO 2013 and the Essential Commodities Act, 1955. Earlier price orders for the same formulations stand superseded following this notification.

The National Pharmaceutical Pricing Authority (NPPA), under the Ministry of Chemicals and Fertilizers, has issued a new order on November 4, 2025, revising the ceiling prices of several key medicines under the Drugs (Prices Control) Order, 2013 (DPCO 2013). The updated list includes Riboflavin tablets (10mg), Peritoneal dialysis solution, Ethyl alcohol (70%), and Human Normal Immunoglobulin in various strengths. 

The revised ceiling prices range from 0.22 to 478.57 rupees per unit, excluding Goods and Services Tax (GST). Manufacturers selling these scheduled formulations must ensure that their prices do not exceed the fixed ceiling price plus applicable GST. If a manufacturer’s existing price is lower than the new ceiling, it must remain unchanged. Manufacturers are also required to submit updated price lists in Form-V through the Integrated Pharmaceutical Database Management System (IPDMS) and share copies with the State Drug Controllers and dealers. Retailers must display the price lists prominently for public access. 

The order also mandates quarterly production and sales returns in Form-III and prior intimation for any discontinuation of products. Non-compliance with these provisions will result in the recovery of overcharged amounts, along with interest, under the Essential Commodities Act, 1955. The revised prices replace previous price orders to maintain uniformity, affordability, and transparency in pharmaceutical pricing across India. This move by NPPA ensures fair pricing of essential medicines, strengthens consumer protection, and reinforces government efforts to make vital drugs accessible and affordable for all citizens.

The National Pharmaceutical Pricing Authority (NPPA) has issued an important update to its earlier orders dated 27th March 2025 and 3976(E) dated 29th August 2025, regarding the ceiling price fixation of scheduled formulation packs for I.V. fluids (non-glass with special features).

The latest change introduces two new entries in Table ‘B’. Sl. No. 12 now includes M/s IV Tech Healthcare with its Twin Port Euro Head Bottles, while Sl. No.13 adds M/s Life Infusion Pharmaceuticals Pvt. Ltd. for Dual Port Plastic (PP) Bottles.

Furthermore, two new clauses, (e3) and (e4), have been inserted after clause (e2). For IV Tech Healthcare, ceiling prices will apply only to formulations listed at Sl. No. 1, 2, and 4 of Table A. For Life Infusion Pharmaceuticals, prices apply to formulations at Sl. No. 1, 2, 4, and 6.

This update ensures consistent pricing for I.V. fluid formulations and maintains fair trade practices within the pharmaceutical manufacturing sector.

The Food Safety and Standards Authority of India (FSSAI) has officially notified the Food Safety and Standards (Import) First Amendment Regulations, 2025. These amendments, approved by the Central Government, will take effect from May 1, 2026. The update follows the draft notification released on October 3, 2024, which invited public feedback and was later finalized after considering the suggestions received.

The amendment introduces significant changes to Regulation 10 of the 2017 Import Regulations. It specifies that the manuals of methods of analysis, updated or adopted by FSSAI, must be used for testing imported food samples. If a particular method is unavailable in these manuals, laboratories may follow validated methods from recognized international standards such as AOAC, ISO, BIS, Codex Alimentarius, or other equivalent agencies.

Additionally, laboratories are now required to issue analysis reports in Form 2 within five days of receiving the samples, ensuring faster and more transparent reporting for import compliance.