Gazette Tracker
Gazette Tracker

Core Purpose

The National Pharmaceutical Pricing Authority fixes revised ceiling prices for Carboplatin 10 mg/ml Injection and Cisplatin 1 mg/ml Injection in public interest, exercising extraordinary powers under paragraph 19 of the Drugs (Prices Control) Order, 2013.

Detailed Summary

The Ministry of Chemicals and Fertilizers (Department of Pharmaceuticals), National Pharmaceutical Pricing Authority (NPPA), issued Order S.O. 3004(E) on June 11, 2026, to fix revised ceiling prices for Carboplatin 10 mg/ml Injection and Cisplatin 1 mg/ml Injection. This action is taken in exercise of extraordinary powers in public interest, conferred by paragraph 19 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated May 30, 2013, issued by the Ministry of Chemicals and Fertilizers, which delegated powers under Section 3 and 5 of the Essential Commodities Act, 1955 to NPPA. The decision supersedes previous orders, specifically S.O. 1575(E) dated March 25, 2026, for these formulations. The revision was prompted by applications citing increased costs of Active Pharmaceutical Ingredients (API), production, and adverse exchange rates, leading to manufacturing unviability. The Committee on Affordable Medicines and Health Products (CAMHP), NITI Aayog, had previously recommended a 50% increase in ceiling prices in 2019, and NPPA's own Committee for paragraph 19 cases, in its 8th meeting on May 18, 2026, recommended upward revision for these specific essential oncology medicines. Concerns about shortages and supply disruptions of Carboplatin and Cisplatin, critical for cancer treatment, and substantial increases in their API prices from 2021-2022 to 2025-2026, were noted. The Authority allowed a one-time 50% increase over prevailing ceiling prices. The new ceiling price (exclusive of Goods and Services Tax) for Carboplatin Injection 10 mg/ml is Rs. 90.74 per ML, and for Cisplatin Injection 1 mg/ml is Rs. 10.89 per ML. The revised ceiling prices will be reviewed after six months, or earlier. Manufacturers are required to revise prices downward if higher than the new ceiling, add GST only if actually paid, calculate pack prices per paragraph 11 of DPCO, 2013, and issue price lists in Form-V to NPPA (through IPDMS), State Drug Controller, and dealers per paragraph 24. They must also furnish quarterly returns in Form-III and inform of discontinuation in Form-IV at least six months prior. Non-compliance will result in penalties under DPCO, 2013, read with the Essential Commodities Act, 1955.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-12062026-273373 EXTRAORDINARY PART IIโ€”Section 3โ€”Sub-section (ii) PUBLISHED BY AUTHORITY No. 2906] NEW DELHI, THURSDAY, JUNE 11, 2026/JYAISTHA 21, 1948 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICALS PRICING AUTHORITY) ORDER New Delhi, the 11th June, 2026 S.O. 3004(E). - Whereas the National Pharmaceutical Pricing Authority (NPPA) was established vide the Resolution of the Government of India in the Ministry of Chemicals and Fertilizers No. 33/7/97-PI.I dated 29th August, 1997, inter-alia, to fix prices and notify the changes therein, if any, of bulk drugs and formulations, monitor the prices of non-scheduled drugs and formulations and oversee the implementation of the provisions of the Drugs (Price Control) Order (DPCO); 2. And whereas, the Ministry of Chemicals and Fertilizers vide S.O.1394 (E) dated the 30th May, 2013, in exercise of the powers conferred by Section 3 and 5 of Essential Commodities Act, 1955 has delegated the powers in respect of specified paragraphs of the DPCO, 2013, including paragraph 19 of the said Order to be exercised by the NPPA on behalf of the Central Government; 3. And whereas, NPPA has been receiving applications for upward price revision under paragraph 19 of DPCO, 2013 citing various reasons like increase in cost of Active Pharmaceutical Ingredients, increase in cost of production, exchange rates etc. resulting in unviability in sustainable production and marketing of the drugs; 4. And whereas, in 2019, Committee on Affordable Medicines and Health Products (CAMHP, earlier known as SCAMHP), NITI Aayog, Government of India provided guidance on the modalities/ methodology to be followed. CAMHP in its 2nd meeting held on 07.11.2019 recommended an increase of 50% in the ceiling prices and also authorized NPPA to examine additional formulations / molecules experiencing similar issues of manufacturing unviability due to low prices and apply upward price revision on principles determined by CAMHP; 5. And whereas, the Authority, based on the said guidance, has previously allowed one-time upward revision of ceiling prices for certain essential scheduled formulations in public interest to ensure their continued availability in the market; 6. And whereas, NPPA examined applications relating to Carboplatin 10 mg/ml Injection and Cisplatin 1 mg/ml Injection based on data and information available with NPPA and submissions made by applicant companies, including information relating to trends in API prices during the period 2021-2022 to 2025-2026; 7. And whereas, the Committee constituted by the Authority for examination of cases under paragraph 19 of the Drugs (Prices Control) Order, 2013, in its 8th meeting held on 18.05.2026 considered the applications and recommended that Carboplatin 10 mg/ml Injection and Cisplatin 1 mg/ml Injection may be considered for an appropriate upward price revision; 8. And whereas, the Authority noted concerns regarding shortage and supply disruptions of Carboplatin and Cisplatin formulations, which are essential oncology medicines used in the treatment of various cancers, as highlighted by healthcare institutions, oncologists, manufacturers and other stakeholders; 9. And whereas, the Authority further noted that the prices of Carboplatin API and Cisplatin API have reportedly increased substantially during recent years, adversely impacting the viability of production and supply of these formulations; 10. And whereas, the Authority observed that uninterrupted availability of Carboplatin and Cisplatin formulations is critical for public health and patient care and that non-availability of such formulations may lead to disruption of treatment and compel patients to shift to costlier alternatives, wherever available; 11. And whereas, the Authority, after deliberating upon the recommendations of the Committee constituted under paragraph 19 of the Drugs (Prices Control) Order, 2013, the reported shortages, increase in API and other input costs, and the need to ensure continued availability of these critical oncology medicines, invoked the extraordinary powers in public interest under paragraph 19 of the said Order for upward revision of the ceiling prices of the said formulations by allowing a one-time increase of 50% over the prevailing ceiling prices; and further decided that, in view of the wide fluctuations in raw material prices, the revised ceiling prices shall be reviewed after six months, or earlier, as warranted; 12. Now, therefore, in exercise of extra ordinary powers in public interest, conferred by paragraph 19 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order(s) of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. Number and date specified in column no. 6(a) & 6(b) mentioned in the table below, the National Pharmaceutical Pricing Authority, hereby fixes the prices as specified in column (5) of the Table below as ceiling prices exclusive of Goods and Services Tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof: TABLE +-----+-----------------------------------+------------------------+----------+---------------------------------+-------------------------+----------------+ | Sl. | Name of the | Dosage form & Strength | Unit | Approved revised Ceiling Price | Existing S.O. No. | Date | | No. | Scheduled Formulation | | | (Rs.) | | | +=====+===================================+========================+==========+=================================+=========================+================+ | (1) | (2) | (3) | (4) | (5) | 6(a) | 6(b) | +-----+-----------------------------------+------------------------+----------+---------------------------------+-------------------------+----------------+ | 1. | Carboplatin | Injection 10 mg/ml | Per ML | 90.74 | 1575(E) Sl. No. 141 | 25.03.2026 | +-----+-----------------------------------+------------------------+----------+---------------------------------+-------------------------+----------------+ | 2. | Cisplatin | Injection 1 mg/ml | Per ML | 10.89 | 1575(E) Sl. No. 182 | 25.03.2026 | +-----+-----------------------------------+------------------------+----------+---------------------------------+-------------------------+----------------+ Note: (a) All manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus Goods and Services Tax as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified in column (5) in the above table plus Goods and Services Tax as applicable, if any. (b) The provisions of paragraph 13(2) of DPCO 2013 would not be applicable on the ceiling price specified in column (5) in respect of the formulations with dosage & strength mentioned in column (2) and (3) respectively. (c) The manufacturers may add Goods and Services Tax only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (5) of the above said table. (d) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form-V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. (e) As per paragraph 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same. (f) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table launches a new drug as per paragraph 2(1)(u) of the DPCO, 2013 such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013. (g) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of production and / or import of scheduled formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (h) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955. (i) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded. [PN/279/147/2026/F/ F. No. 8(147)/2026/DP/Div-II/NPPA] BHIVA RAM YADAV, Assistant Director Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

Never miss important gazettes

Create a free account to save gazettes, add notes, and get email alerts for keywords you care about.

Sign Up Free