NPPA Fixes Retail Price Of 10 Formulations, Details

Published On 2022-12-20 12:30 GMT   |   Update On 2023-10-18 09:55 GMT

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed retail prices of 10 formulations including antibiotics, antifungals, antidiabetics and others.This came in line with the decision of 105th authority meeting dated 15.12.2022, where the Authority discussed new drug applications for...

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New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed retail prices of 10 formulations including antibiotics, antifungals, antidiabetics and others.

This came in line with the decision of 105th authority meeting dated 15.12.2022, where the Authority discussed new drug applications for price fixation under para 5 and para 15 of DPCO 2013.

The new drugs which retail prices were fixed include Malik Lifesciences/ Abbott Healthcare's Amoxycillin and Potassium Clavulanate Oral Suspension IP, Akums Drugs & Pharmaceuticals/Abbott Healthcare's Metformin Hydrochloride (SR), Glimepiride and Voglibose Tablets, Ravenbhel Healthcare/Mankind Pharma's Itraconazole Capsules 65mg (SupraBioavailable Formulation), Malik Lifesciences/Zuventus Healthcare's Amoxycillin and Potassium Clavulanate Oral Suspension IP.

The list further includes Ceftazidime and Avibactam powder for concentrate for solution for infusion manufactured and marketed by drug major Cipla.

This comes after 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), has fixed, 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;


Sl.

No.

Name of the Formulation /

Brand Name

Strength

Unit

Manufacturer & Marketing Company

Retail Price

(Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

1.

Amoxycillin and Potassium Clavulanate Oral Suspension IP

Each 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 Syrup

M/s Malik Lifesciences Pvt. Ltd. / M/s Abbott Healthcare Pvt. Ltd.

168.43

2

Metformin Hydrochloride (SR), Glimepiride and Voglibose Tablets

Each uncoated bilayered tablet contains: Metformin Hydrochloride IP 1000mg (as Sustained Release form) Glimepiride IP 1mg Voglibose IP 0.2mg

1 Tablet

M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Abbott Healthcare Pvt. Ltd.

11.60

3

Metformin Hydrochloride (SR), Glimepiride and Voglibose Tablets

Each uncoated bilayered tablet contains: Metformin Hydrochloride IP 1000mg (as Sustained Release form) Glimepiride IP 2mg Voglibose IP 0.2mg

1 Tablet

M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Abbott Healthcare Pvt. Ltd.

13.18

4

Ceftazidime and Avibactam powder forconcentrate for solution for infusion

Each vial contains: Ceftazidime (pentahydrate) IP eq. to Ceftazidime 2mg Avibactam Sodium eq. to Avibactam 0.5gm Sodium content approx. 148mg (6.4meq)/vial

Per Vial

M/s Cipla Limited

2500.00

5.

Moxifloxacin Hydrochloride and Loteprednol Ophthalmic Suspension

Composition:

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 ml

M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Cipla Limited

27.43

6.

Itraconazole Capsules 65mg (Supra- Bioavailable

Formulation)

Each hard gelatin capsule contains:

Itraconazole BP 65mg

1

Capsule

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Mankind Pharma Ltd.

11.60

7.

Acetylcysteine & Acebrophylline Tablets

Each film coated tablet contains:

Acetylcysteine BP 600mg Acebrophylline 100mg

1 Tablet

M/s Pure and Care Healthcare Pvt. Ltd. / M/s Cadila Pharmaceuticals

Limited

14.91

8.

Paracetamol, Phenylephrine Hydrochloride, Caffeine & Diphenhydramin e Hydrochloride

Tablets

Each uncoated tablet contains:

Paracetamol IP 500mg Phenylephrine HCl IP 5mg Caffeine IP 30mg Diphenhydramine HCl IP

25mg

1 Tablet

M/s Dallas Drugs Pvt. Ltd. / M/s Micro Labs Pvt. Ltd.

2.76

9.

Rabeprazole and Ondansetron tablets

Each Enteric coated tablet contains:

Rabeprazole Sodium IP 20mg Ondansetron Hydrochloride

IP eq. to Ondansetron 4mg

1 Tablet

M/s Dallas Drugs Pvt. Ltd. / M/s Micro Labs Pvt. Ltd.

5.90

10.

Amoxycillin and Potassium Clavulanate Oral Suspension IP

Each 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 Limited

168.43

The notice further added,

(a) The manufacturer of above-mentioned formulations i.e., "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.

(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 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.

(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/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies.

(f) In case the retail price of any of the aforesaid formulations is not complied with, as per 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 & Marketing Companies as specified in corresponding entries in Column (2), (3) and (5) thereof, if any, issued prior to this notification, stand(s) superseded.

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