Thursday, January 12, 2023

NPPA fixes Retail Price of 10 formulations: December 2022
Download notification No. S.O. 5937(E) dt 19-12-2022, the link is given below: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed the retail price of 10 formulations:

Download notification No. S.O. 5937(E) dt 19-12-2022

This price fixation followed the decision of the 105th Authority meeting on December 15, 2022.

-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.Name of the Formulation / Brand NameStrengthUnitManufacturer & Marketing CompanyRetail Price (Rs.)(1)(2)(3)(4)(5)(6)1.Amoxycillin and Potassium Clavulanate Oral Suspension IPEach Combi pack contains: (A) Amoxycillin and Potassium Clavulanate Oral Suspension IP Composition: Each 5ml of Reconstituted suspension contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 600mg Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 42.9mg (B) 2 Ampoule of 25ml each of Sterile Water for Reconstitution of Dry SyrupCombi PackM/s Malik Lifesciences Pvt. Ltd. / M/s Abbott Healthcare Pvt. Ltd.168.432.Metformin Hydrochloride (SR), Glimepiride and Voglibose TabletsEach uncoated bilayered tablet contains: Metformin Hydrochloride IP 1000mg (as Sustained Release form) Glimepiride IP 1mg Voglibose IP 0.2mg1 TabletM/s Akums Drugs & Pharmaceuticals Ltd. / M/s Abbott Healthcare Pvt. Ltd.11.603.Metformin Hydrochloride (SR), Glimepiride and Voglibose TabletsEach uncoated bilayered tablet contains: Metformin Hydrochloride IP 1000mg (as Sustained Release form) Glimepiride IP 2mg Voglibose IP 0.2mg1 TabletM/s Akums Drugs & Pharmaceuticals Ltd. / M/s Abbott Healthcare Pvt. Ltd.13.184.Ceftazidime and Avibactam powder for concentrate for solution for infusionEach vial contains: Ceftazidime (pentahydrate) IP eq. to Ceftazidime 2mg Avibactam Sodium eq. to Avibactam 0.5gm Sodium content approx. 148mg (6.4meq)/vialPer VialM/s Cipla Limited2500.005.Moxifloxacin Hydrochloride and Loteprednol Ophthalmic SuspensionComposition: Moxifloxacin Hydrochloride IP eq. to Moxifloxacin 0.5% w/v Loteprednol Etabonate 0.5% w/v (Sterile & Micronized) Sterile aqueous buffered vehicle q.s.      Per mlM/s Pure and Cure Healthcare Pvt. Ltd. / M/s Cipla Limited27.436.Itraconazole Capsules 65mg (Supra- Bioavailable Formulation)Each hard gelatin capsule contains: Itraconazole BP 65mg  1 CapsuleM/s Ravenbhel Healthcare Pvt. Ltd. / M/s Mankind Pharma Ltd.11.607.Acetylcysteine & Acebrophylline TabletsEach film coated tablet contains: Acetylcysteine BP 600mg Acebrophylline 100mg    1 TabletM/s Pure and Care Healthcare Pvt. Ltd. / M/s Cadila Pharmaceuticals Limited14.918.Paracetamol, Phenylephrine Hydrochloride, Caffeine & Diphenhydramin e Hydrochloride TabletsEach uncoated tablet contains: Paracetamol IP 500mg Phenylephrine HCl IP 5mg Caffeine IP 30mg Diphenhydramine HCl IP 25mg      1 TabletM/s Dallas Drugs Pvt. Ltd. / M/s Micro Labs Pvt. Ltd.2.769.Rabeprazole and Ondansetron tabletsEach Enteric coated tablet contains: Rabeprazole Sodium IP 20mg Ondansetron Hydrochloride IP eq. to Ondansetron 4mg    1 TabletM/s Dallas Drugs Pvt. Ltd. / M/s Micro Labs Pvt. Ltd.5.9010.Amoxycillin and Potassium Clavulanate Oral Suspension IPEach 5ml of Reconstituted suspension contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 600mg Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 42.9mg    Per Vial (50ml)M/s Malik Lifesciences Pvt. Ltd. / M/s Zuventus Healthcare Limited168.43

Note:(a) The manufacturer of the above-mentioned formulations, i.e., the “new drug” under paragraph 2(1)(u) of the DPCO, 2013 shall fix the retail price as specified in column (6) of the table hereinabove.

(b) The manufacturer may add Goods and Services Tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (6) of the above said table.

(c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (6) of the above table as per provisions contained in paragraph 11 of the DPCO, 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.

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(d) As per para 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 ofthe premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

(e) The above mentioned retail price is applicable only to the individual manufacturer / marketer as mentioned above i.e.. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013 and subject to fulfilment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules,including manufacturing license permission from the competent authority, i.e., the central or state licensing authority, as may be applicable, by the concerned manufacturer/marketing company.

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(f) In case the retail price of any of the aforesaid formulations is not complied with, as per the instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.

(g) Consequent to the fixation of retail price of such formulation as specified in column (2) of the above table with the strength and name of Manufacturer & Marketing Companies specified in the corresponding entries in Column (3) & (5) thereof, the price order(s) fixing the retail price of the formulation with specified strength for that Manufacturer & MarketingCompanies as specified in corresponding entries in Columns (2), (3), and (5) thereof, if any, issued prior to this notification, stand superseded.

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