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NPPA Fixes Retail Price of 15 Formulation, Detail

New Delhi: Through a recent notification, the National Pharmaceuticals Pricing Authority (NPPA) has fixed the retail of 15 scheduled formulations including Amoxycillin and Potassium Clavulanate Oral Suspension, Aceclofenac and Paracetamol Tablets, Pantoprazole (EC) and Levosulpiride (SR) Capsules and others.

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This came in line with the decision of the 112 Authority meeting held on the 1st of May 2023, where the retail price fixation of 15 scheduled formulations was discussed.

The list of 15 formulations includes Malik Lifesciences & Dr Reddy's Laboratories Limited's Amoxycillin and Potassium Clavulanate Oral Suspension, East African (India) Overseas & Alkem Laboratories' Paracetamol, Phenylephrine Hydrochloride & Chlorpheniramine ine maleate Tablets, Theon Pharmaceuticals & FDC Limited's Amoxycillin & Potassium Clavulanate Tablets, Skymap Pharmaceuticals & German Remedies Pharmaceutical's Ofloxacin and Betamethasone e Sodium Phosphate Eye/ Ear Drops, Windlas Biotech &Torrent Pharmaceuticals' Tranexamic Acid and Etamsylate Tablets, Aagya Biotech & German Remedies Pharmaceutical's Aceclofenac and Paracetamol Tablets, Akums Drugs & Pharmaceuticals & Emcure Pharmaceutical's Calcium, Vitamin D3, Mecobalamin, L-Methylfolate Calcium & Pyridoxal-5- Phosphate Tablets, Ravenbhel Healthcare & Aristo Pharmaceutical's Itraconazole Capsules 65mg (Supra- Bioavailable Formulation), Alaina Healthcare & Abbott Healthcare's Chlorhexidine gluconate, Metronidazole and Lignocain Hydrochloride Gel, Ravenbhel Healthcare & Emcure Pharmaceuticals Itraconazole Capsules 65mg (Supra- Bioavailable Formulation) and Itraconazole Capsules 130mg (Supra- Bioavailable Formulation), Theon Pharmaceuticals & Cadila Pharmaceutical's Pantoprazole (EC) and Levosulpiride (SR) Capsules, AXA Parenterals & Themis Medicare's Linezolid Infusion, Swiss Garniers Biotech & Zydus Healthcare's Bisoprolol Fumarate and Amlodipine Tablets, Pure and Cure Healthcare & Zydus Healthcare's FDC Alpha Lipoic Acid plus Mecobalamin plus Myo-Inositol plus Folic Acid + Pyridoxine Hydrochloride plus Chromium Picolinate and Benfortiamine Tablets.

The notice declared that in the 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 to 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;

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

(Combi pack with Sterile Water for Reconstitution of Dry Syrup)

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 Ampoules of sterile water for reconstitution of dry syrup

each ampoule contains: sterile water for injection IP 25ml

Each Combi Pack

M/s Malik Lifesciences Pvt. Ltd. / M/s Dr. Reddy's Laboratories Limited

162.1

1

2

Paracetamol, Phenylephrine Hydrochloride & Chlorpheniram ine maleate

Tablets

Each uncoated tablet contains:

Paracetamol IP 500mg Phenylephrine Hydrochloride IP 10mg Chlorpheniramine maleate IP 2mg

1 Tablet

M/s East African (India) Overseas

/ M/s Alkem Laboratories Ltd.

4.42

Sl. No

.

Name of the Formulation / Brand Name

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

3

Amoxycillin & Potassium Clavulanate Tablets IP

Each film coated tablet contains:

Amoxycillin Trihydrate IP eq. to Amoxycillin 875mg

Potassium Clavulanate Diluted IP eq. to Clavulanic Acid 125mg

1 Tablet

M/s Theon Pharmaceuticals Limited / M/s FDC Limited

33.92

4

Ofloxacin and Betamethason e Sodium Phosphat Eye

/ Ear Drops

Composition: Ofloxacin IP 0.3% w/v

Betamethasone Sodium Phosphate IP 0.1% w/v Benzalkonium Chloride Solution IP 0.02% v/v (As preservative)

1 ml

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

Pvt. Ltd.

1.45

5

Tranexamic Acid and Etamsylate Tablets

Each film coated tablet contains:

Etamsylate BP 250mg Tranexamic Acid IP 500mg.

1 Tablet

M/s Windlas Biotech Pvt. Ltd.

/ M/s Torrent Pharmaceuticals Ltd.

23.37

6

Aceclofenac and Paracetamol Tablets

Each film coated tablet contains:

Aceclofenac IP 100mg Paracetamol IP 325mg

1 Tablet

M/s Aagya Biotech Pvt. Ltd.

/ M/s German Remedies Pharmaceuticals Pvt. Ltd.

4.83

7

Calcium, Vitamin D3, Mecobalamin, L-Methylfolate Calcium & Pyridoxal-5- Phosphate Tablets

Each film coated tablet contains:

Calcium Carbonate IP 1250mg eq. to Elemntal Calcium 500mg Vitamin D3 IP 2000 IU Mecobalamin IP 1500mcg

L-Methylfolate Calcium 1mg

Pyridoxal-5-Phosphate 20mg

1 Tablet

M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Emcure Pharmaceuticals Ltd.

18.36

8

Itraconazole Capsules 65mg (Supra- Bioavailable

Formulation)

Each hard gelatin capsule contains: Itraconazole BP 65mg

1

Capsule

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Aristo Pharmaceuticals

Pvt. Ltd.

11.94

9

Chlorhexidine gluconate, Metronidazole and

Lignocaine

Composition: Chlorhexidine gluconate solution IP eq. to Chlorhexadine 1 % w/w,

Metronidazole Bezoate

1 GM

M/s Alaina Healthcare Pvt. Ltd. / M/s Abbott Healthcare Pvt.

Ltd.

3.75


Sl. No

.

Name of the Formulation / Brand Name

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

Hydrochloride Gel

IP eq. to Metronidazole 1% w/w

Lignocaine Hydrochloride IP 2% w/w

10

Itraconazole Capsules 65mg (Supra- Bioavailable Formulation)

Each hard gelatin capsule contains:Itraconazole BP 65mg

1

Capsule

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Emcure Pharmaceuticals

Limited

11.94

11

Itraconazole Capsules 130mg (Supra- Bioavailable

Formulation)

Each hard gelatin capsule contains: Itraconazole BP 130mg

1

Capsule

M/s Ravenbhel Healthcare Pvt. Ltd. / M/s Emcure Pharmaceuticals

Limited

20.72

12

Pantoprazole (EC) and Levosulpiride (SR) Capsules

Each hard gelatin capsule contains: Pantoprazole Sodium IP eq. to Pantoprazole 40mg (as enteric coated pellets)

Levosulpiride 75mg (As sustained release

pellets)

1

Capsule

M/s Theon Pharmaceuticals Ltd. / M/s Cadila Pharmaceuticals Ltd.

16.15

13

Linezolid Infusion

Each 100ml contains: Linezolid IP 200mg Dextrose (Anhydrous) 5% w/v

Water for Injection IP

1 ml

M/s AXA Parenterals Ltd.

/ M/s Themis Medicare

Limited

1.36

14

Bisoprolol Fumarate and Amlodipine Tablets

Each film coated tablet contains:

Bisoprolol Fumarate IP 5mg

Amlodipine Besylate IP Eq. to Amlodipine 5mg

1 Tablet

M/s Swiss Garniers Biotech Pvt. Ltd.

/ M/s Zydus Healthcare Limited

8.34

15

Alpha Lipoic Acid + Mecobalamin

+ Myo-Inositol

+ Folic Acid + Pyridoxine Hydrochloride

+ Chromium Picolinate and Benfortiamine Tablets

Each film coated table contains:

Alpha Lipoic Acid IP 200mg Mecobalamin IP 1500mcg

Myo-Inositol IP 100mg Folic Acid IP 1.5mg Pyridoxine Hydrochloride IP 3mg Chromium Picolinate IP eq. to Elemental

1 Tablet

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

22.86

Sl. No

.

Name of the Formulation / Brand Name

Strength

Unit

Manufacturer & Marketing Company

Retail Price (Rs.)

(1)

(2)

(3)

(4)

(5)

(6)

chromium 200mcg Benfortiamine 200mg
The notification further added,
(a) The manufacturer of the 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 the 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 a 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 has 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 the retail price of such formulation as specified in column (2) of the above table with the strength and name of the Manufacturer & Marketing Companies specified in the corresponding entries in Columns (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 Columns (2), (3) and (5) thereof, if any, issued prior to this notification, stand(s) superseded.

Also Read: USFDA nod to physiotherapy monitoring device Pheezee



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NPPA Fixes Retail Price of 15 Formulation, Detail

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