NPPA fixes retail price of 12 formulations, Details

Published On 2021-06-06 06:00 GMT   |   Update On 2023-10-13 11:35 GMT

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), Ministry of Chemicals and Fertilizers, Government of India, has fixed the retail price of 12 formulations, including those used to treat angina pectoris, high blood pressure, human immunodeficiency virus (HIV) infection, and type 2 diabetes.

These include Archimedis Healthcare and Lupin's Ivabradine Hydrochloride and Metoprolol Tartrate combination tablet which is used in the treatment of Angina, Ravenbhel/Neomac Pharmaceutical's Telmisartan, Cilnidipine & Metoprolol (ER) fixed dose combination tablet that helps to lower high blood pressure and prevent stroke and heart attack.

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In addition to this, the list also includes Skymap Pharmaceutical's antibiotic combination Doxycycline & Lactic Acid Bacillus Capsule, Hetero/Cipla's antiviral drug combination Darunavir and Ritonavir tablet, Stedman Pharmaceutical's Povidone-Iodine gargle 0.5% w/v .

Further, the list contains the popular anti-diabetic drug combination Teneligliptin and Metformin HCL Tablet marketed by Morepen Laboratories and Abbott Healthcare.

This price fixation is followed by the decisions made by the National Pharmaceutical Pricing Authority at its 87th Authority meeting held on 27th of May 2021, where the Authority discussed retail price fixation of new drugs falling under the purview of Para 2 (u) of DPCO, 2013 and approved the retail prices of new drugs under Para 5 and 15 of the DPCO 2013.

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. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), 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.

Ivabradine Hydrochloride

+ Metoprolol Tartrate Tablet

Each film coated tablet contains: Ivabradine Hydrochloride eq. to Ivabradine 5 mg + Metoprolol Tartrate IP 25 mg

1 Tablet

M/s Archimedis Healthcare Pvt. Ltd.

/ M/s Lupin Limited

15.75

2.

Ivabradine Hydrochloride

+ Metoprolol Tartrate Tablet

Each film coated tablet contains: Ivabradine Hydrochloride eq. to

Ivabradine 5 mg + Metoprolol Tartrate IP 50 mg

1 Tablet

M/s Archimedis Healthcare Pvt. Ltd.

/ M/s Lupin Limited

18.14

3.

Telmisartan, Cilnidipine & Metoprolol (ER) Tablet

Each film coated tablet contains: Telmisartan IP 40mg, Cilnidipine IP 10mg

Metoprolol Succinate IP 23.75mg eq. to Metoprolol Tartrate (as extended release) 25mg

1 Tablet

M/s Ravenbhel Healthcare Pvt. Ltd.

/ M/s Neomac Pharmaceuticals Pvt. Ltd.

10.16

4.

Telmisartan, Cilnidipine & Metoprolol (ER) Tablet

Each film coated tablet contains: Telmisartan IP 40mg, Cilnidipine IP 10mg

Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate (as extended release) 50mg

1 Tablet

M/s Ravenbhel Healthcare Pvt. Ltd.

/ M/s Neomac Pharmaceuticals Pvt. Ltd.

12.41

5.

Doxycycline & Lactic Acid Bacillus Capsule

Each hard gelatine capsule contains: Doxycycline hyclate IP eq. to Doxycycline (as pellets) 100mg

Lactic Acid Bacillus (As enteric coated pellets) 5 Billion Spores

1

Capsule

M/s Skymap Pharmaceuticals Pvt. Ltd.

6.94

6.

Doxycycline & Lactic Acid Bacillus Capsule

Each hard gelatine capsule contains: Doxycycline hyclate IP eq. to Doxycycline (as pellets) 100mg

Lactic Acid Bacillus (As enteric coated pellets) 5 Billion Spores

1

Capsule

M/s Skymap Pharmaceuticals Pvt. Ltd. / M/s

Glensmith Labs Pvt. Ltd.

6.94

7.

Darunavir + Ritonavir Tablet

Each film coated tablet contains: Darunavir Ethanolate eq. Darunavir IP 600mg

Ritonavir IP 100mg

1 Tablet

M/s Hetero Labs Ltd.

/ M/ Cipla Limited

145.70

8.

Povidone-Iodine gargle 0.5% w/v

Contains:

Povidone Iodine IP 0.5% w/v (available Iodine 0.05% w/v)

1 ML

M/s Stedman

Pharmaceuticals Pvt. Ltd.

0.66

9.

Teneligliptin + Metformin HydrochlorideIP (SR) Tablet

Each uncoated bilayered tablet contains:

Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg

Metformin HydrochlorideIP (As

1 Tablet

M/s Windlas Biotech Pvt. Limited / M/s Abbott Healthcare Limited

11.00

Sl.

No.

Name of the

Formulation / Brand Name

Strength

Unit

Manufacturer &

Marketing Company

Retail

Price (Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

Sustained Release) IP 500mg

10.

Teneligliptin + Metormin HCL (ER) Tablet

Each uncoated bilayered tablet contains:

Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg

Metformin hydrochloride (As Extended Release) IP 500mg

1 Tablet

M/s Morepen Laboratories Limited

10.96

11.

Teneligliptin + Metormin HCL (ER) Tablet

Each uncoated bilayered tablet contains:

Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg

Metformin hydrochloride (As Extended Release) IP 1000mg

1 Tablet

M/s Morepen Laboratories Limited

11.48

12.

Teneligliptin + Metformin Hydrochloride IP (SR) Tablet

Each uncoated bilayered tablet contains:

Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg

Metformin HydrochlorideIP (As Sustained Release) IP 1000mg

1 Tablet

M/s Windlas Biotech Pvt. Limited / M/s Abbott Healthcare Limited

11.48

The notification further added;

(a) The manufacturer of above mentioned formulations i.e. "new drug" under paragraph 2(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 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.

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