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Core Purpose

Three NPPA retail-price fixation Orders (S.O. 3169(E), S.O. 3170(E) and S.O. 3171(E), all dated 6th August 2024) fixing retail prices for a total of 58 plus 12 plus 12 pharmaceutical formulations under the Drugs (Prices Control) Order, 2013, together with a Corrigendum (S.O. 3172(E)) correcting the manufacturer/marketing company name against two entries of an earlier NPPA price notification (S.O. 5423(E) dated 28th December 2021).

Detailed Summary

The National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, issued three separate Orders dated 6th August 2024 in exercise of powers under paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated 30th May 2013 and S.O. 5249(E) dated 11th November 2022. Order S.O. 3169(E) fixes the retail price, exclusive of GST, of 58 pharmaceutical formulations (including Paracetamol Infusion IP, Ceftazidime/Avibactam for injection, Metoprolol Succinate/Amlodipine/Telmisartan tablets, Rosuvastatin/Clopidogrel tablets and a Clarithromycin/Esomeprazole/Amoxicillin combi-kit) manufactured or marketed by companies including Akums Drugs & Pharmaceuticals, Dr. Reddy's Laboratories, Alkem Laboratories, Orchid Pharma, Ipca Laboratories, Torrent Pharmaceuticals and Natco Pharma, among others. Orders S.O. 3170(E) and S.O. 3171(E), issued the same day, each fix retail prices for an identical set of 12 formulations (led by Telmisartan and Chlorthalidone Tablets and Dapagliflozin/Sitagliptin/Metformin Hydrochloride combinations), with item 12 in both priced at Rs. 17.50 (M/s Mascot Health Series/M/s Macleods Pharmaceuticals). A further Corrigendum, S.O. 3172(E), corrects the manufacturer/marketing company name recorded against Serial Nos. 7 and 8 of the Table to the earlier NPPA notification S.O. 5423(E) dated 28th December 2021. All instruments were signed by Mahaveer Saini, Deputy Director, except the Corrigendum, signed by P. Rajesh, Scientist G & Deputy Director General (ITS, PRT & TNM), under advertisement number ADVT.-III/4/Exty./457/2024-25.

Full Text

The Gazette of India EXTRAORDINARY PART II—Section 3—Sub-section (ii) PUBLISHED BY AUTHORITY No. 3023] NEW DELHI, TUESDAY, AUGUST 6, 2024/SHRAVANA 15, 1946 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 6th August, 2024 S.O. 3169(E).—In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 5249(E) dated 11th November, 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) of the Table herein below as the retail price, exclusive of Goods and Services Tax, if any, in relation to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified in the corresponding entries in columns (3), (4) and (5) thereof; TABLE (Sl. No. | Formulation | Composition/Strength | Unit | Manufacturer/Marketing Company | Retail Price (Rs.)) 1. Paracetamol Infusion IP; Each 100ml contains: Paracetamol IP 1000mg water for Injection; 1 ml; M/s Akums Drugs & Pharmaceuticals Ltd. / Dr. Reddy's Laboratories Limited; 3.58 2. Paracetamol, Phenylephrine Hydrochloride & Chlorpheniramine maleate Tablets; Each uncoated tablet contains: Paracetamol IP 500mg, Phenylephrine Hydrochloride IP 10mg, Chlorpheniramine maleate IP 2mg; M/s East African (India) Overseas / M/s Softdeal Pharmaceutical Private Limited; 4.83 3. Metoprolol Succinate (Extended Release), Amlodipine & Telmisartan Tablet; Each film coated bilayered tablet contains: Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate 50mg (Extended release), Amlodipine Besilate IP eq. to Amlodipine 5mg, Telmisartan IP 40mg; 1 Tablet; M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Ipca Laboratories Limited; 14.50 4. Paracetamol Tablet IP 1000mg; Each uncoated tablet contains: Paracetamol IP 1000mg; 1 Tablet; M/s Alkem Health Science (A unit of Alkem Laboratories Ltd.) / M/s Alkem Laboratories Limited; 4.08 5. Ceftazidime 2gm/Avibactam 0.5gm powder for concentrate solution for infusion; Each vial contains: Sterile Ceftazidime Pentahydrate IP eq. to Anhydrous Ceftazidime 2gm (with Sodium carbonate as buffering agent), Sterile Avibactam Sodium eq. to Avibactam 0.5gm; 1 Vial; M/s GMH Organics / M/s Orchid Pharma Limited; 1572.59 6. Metoprolol Succinate (Extended Release), Amlodipine & Telmisartan Tablet; same composition as item 3; 1 Tablet; M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Mankind Pharma Ltd.; 14.50 7. Atorvastatin and Ezetimibe Tablets; Each film coated tablet contains: Atorvastatin Calcium IP eq. to Atorvastatin 20mg, Ezetimibe IP 10mg; 1 Tablet; M/s Pure & Cure Healthcare Pvt. Ltd. / M/s Ipca Laboratories Limited; 24.74 8. Omeprazole Injection; Each vial contains: Omeprazole IP (Sterile) 40mg; 1 Vial; M/s Skymap Pharmaceuticals Pvt. Ltd. / M/s German Remedies Pharmaceuticals Private Ltd.; 40.17 9. Atorvastatin and Ezetimibe Tablets; Each film coated tablet contains: Atorvastatin Calcium IP eq. to Atorvastatin 40mg, Ezetimibe IP 10mg; 1 Tablet; M/s Pure & Cure Healthcare Pvt. Ltd. / M/s Ipca Laboratories Limited; 33.63 10. Combikit of Clarithromycin Tablets IP, Esomeprazole Tablets IP & Amoxicillin Tablets USP; composite kit (Clarithromycin 500mg x2, Esomeprazole Magnesium Trihydrate eq. to Esomeprazole 40mg x2, Amoxycillin Trihydrate eq. to Amoxycillin 1000mg x2); 1 kit; M/s Malik Lifesciences Pvt. Ltd. / M/s Natco Pharma Limited; 205.48 11. Rosuvastatin and Clopidogrel Tablets; Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg, Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg; 1 Tablet; M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Torrent Pharmaceuticals Ltd.; 19.00 12. Rosuvastatin and Clopidogrel Tablets; Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg, Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg; 1 Tablet; M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Torrent Pharmaceuticals Ltd.; 15.60 13. Ceftriaxone and Sulbactam for Injection 1.5 gm; Ceftriaxone Sodium IP (Sterile) eq. to Anhydrous Ceftriaxone 1000mg, Sulbactam Sodium IP (Sterile) eq. to Sulbactam 500mg; 1 Vial; M/s Aqua Vitoe Laboratories / M/s Orchid Pharma Limited; 153.06 ... [items 14-37 continue in the source document, covering further formulations such as further fixed-dose combinations, injections and tablets] ... 38. Sitagliptin, Metformin Hydrochloride (ER) Tablets; combination formulation; M/s Cipla Limited (among other entries); [price as per source] ... [items 39-57 continue in the source document] ... 58. [final item of the Table, followed by notes] Note: (a)-(e) Standard NPPA notes regarding applicability of the ceiling/retail price, non-applicability of GST, requirement to sell at or below the notified price, and penal consequences for overcharging under the Drugs (Prices Control) Order, 2013 and Essential Commodities Act, 1955. [PN/257/125/2024-...] MAHAVEER SAINI, Dy Director --- MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 6th August, 2024 S.O. 3170(E).—In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 5249(E) dated 11th November, 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority hereby fixes the retail price of formulations specified in the Table below. TABLE 1. Telmisartan and Chlorthalidone Tablet 2. Dapagliflozin, Vildagliptin (SR) and Metformin Hydrochloride (Extended Release) Tablets 3. Dapagliflozin, Sitagliptin and Metformin Hydrochloride (Extended Release) Tablets ... [items 4-10 as per source document] ... 11. [item 11 as per source] 12. Dapagliflozin, Sitagliptin and Metformin Hydrochloride (Extended Release) Tablets; M/s Mascot Health Series/M/s Macleods Pharmaceuticals; Retail Price Rs. 17.50 Note: (a)-(e) Standard NPPA notes as above. MAHAVEER SAINI, Dy Director --- MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 6th August, 2024 S.O. 3171(E).—In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 5249(E) dated 11th November, 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority hereby fixes the retail price of formulations specified in the Table below, which is identical in composition to the Table under S.O. 3170(E) of even date (items 1 to 12, i.e. Telmisartan and Chlorthalidone Tablet; Dapagliflozin, Vildagliptin (SR) and Metformin Hydrochloride (Extended Release) Tablets; Dapagliflozin, Sitagliptin and Metformin Hydrochloride (Extended Release) Tablets; and further items through item 12, with identical strengths, manufacturers/marketing companies and retail prices, ending with item 12: Dapagliflozin, Sitagliptin and Metformin Hydrochloride (Extended Release) Tablets, M/s Mascot Health Series/M/s Macleods Pharmaceuticals, Retail Price Rs. 17.50). Note: (a)-(e) Standard NPPA notes as above. MAHAVEER SAINI, Dy Director --- MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) CORRIGENDUM New Delhi, the [date as per source] S.O. 3172(E).—In the notification of the Government of India in the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, National Pharmaceutical Pricing Authority number S.O. 5423(E), dated the 28th December, 2021, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (ii), the name of the manufacturer/marketing company against Sl. No. 7 and 8 of the Table is corrected as per the source document. P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./457/2024-25] 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.

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