NPPA fixes retail price of 10 combo drugs including Metformin, Rosuvastatin; Details

Published On 2019-08-16 10:31 GMT   |   Update On 2021-08-16 09:36 GMT

New Delhi: Through a recent notification, the apex drug price regulatory agency, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 10 drug formulations under the Drugs Prices Control Order (DPCO), 2013, exclusive of goods and services tax (GST).


The formulations whose prices have been fixed by NPPA include Metformin, Telmisartan, Rosuvastatin and others in combination with other formulations. A few of the combinations included in the list are Rosuvastatin + Clopidogrel Capsule, Metformin + Glimepiride Tablet (Glyciphage – G 0.5mg), Telmisartan + Amlodipine + Hydrochlorothiazide tablet and so on.


Various drugmakers in the country including Sun Pharma, Intas Pharma, Cipla, Akums Drugs, Cadila Healthcare, Abbott and others are involved in manufacturing the said formulations under different brand names.


For instance, the combination of Metformin + Glimepiride Tablet is sold under the brand name GLYCIPHAGE-G2 which is used to treat Type 2 Diabetes while Rosuvastatin + Clopidogrel Capsule manufactured by Intas Pharma and others is used for heart attack prevention and high cholesterol. It prevents the platelets from sticking together and decreases the formation of harmful blood clots.


Similarly, the combination of Telmisartan + Amlodipine + Hydrochlorothiazide tablet is indicated for the treatment of Hypertension (high blood pressure). The combination is manufactured by Sun Pharma and is sold under the brand name Teleact Trio Tab.


The details of the list of all 10 formulations released by NPPA read;






































































































Sl.

No.
Name of the

Formulation / Brand Name
StrengthUnitManufacturer &

Marketing Company
Retail

Price (Rs.)
(1)(2)(3)(4)(5)(6)
1.Telmisartan + Amlodipine + Hydrochlorothiazide tabletEach un coated tablet contains: Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg

Hydrochlorothiazide IP 12.5mg




1 Tablet
M/s Sun Pharma Laboratories Limited / M/s Sun Pharmaceuticals

Industries Limited
8.11
2.Telmisartan + Hydrochlorothiazide tabletEach un coated tablet contains: Telmisartan IP 40mg, Hydrochlorothiazide IP 12.5mg



1 Tablet
M/s Sun Pharma Laboratories Limited / M/s Sun

Pharmaceuticals Industries Limited
8.55
3.Telmisartan + Amlodipine tabletEach uncoated tablet contains: Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg



1 Tablet
M/s Sun Pharma Laboratories Limited / M/s Sun Pharmaceuticals

Industries Limited
8.14
4.Metoprolol + Ramipril TabletEach film coated bilayered tablet contains:

Metoprolol Succinate IP 23.75mg eq. to Metoprolol Tartrate 25mg (as prolonged Release Form),

Ramipril IP 2.5mg




1 Tablet




M/s Micro Labs Limited
10.26
5.Rosuvastatin + Clopidogrel CapsuleEach hard gelatine capsule contains:

Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (as a film coated tablet),

Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (as two film coated tablet),




1 Capsule


M/s Safetab Life Science / M/s Intas Pharmaceuticals Limited
13.85
6.Rosuvastatin + Clopidogrel CapsuleEach hard gelatine capsule contains:

Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (as two film coated tablet),

Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (as two film coated tablet),






1 Capsule




M/s Safetab Life Science / M/s Intas Pharmaceuticals Limited
18.04
7.Amoxycillin + Potassium Clavulanate Suspenssion(a) Each 5ml of reconstituted suspension contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 400mg,

Potassium Clavulanate Diluted IP eq. to Clavulanic acid 57mg,

(b) Sterile water for Injection IP 30ml for reconstitution.




Per ml Suspension


M/s Medicef Pharma / M/s Cadila Pharmaceuticals Limited
3.55
8.Metformin + Glimepiride Tablet (Glyciphage – G 0.5mg)Each uncoated bilayered tablet contains:

Metformin Hydrochloride IP 500mg, (in prolonged release form)

Glimepiride 0.5mg




1 Tablet
M/s Swiss Garnier Biotech Pvt. Ltd.

/M/s Franco-India Pharmaceuticals Pvt. Ltd.
3.65
9.Diclofenac + Absolute Alcohol SpraySpray contains:

Diclofenac Diethylamine IP 4.64% w/v (eq. to Diclofenac Sodium IP 4.00%w/v), Absolute Alcohol IP 10.00% v/v in topical Solution Base (Non-

Aqueous)




Per ml Spray
M/s Akums Drugs and Pharmaceuticals Limited / M/s Abbott Healthcare Pvt. Ltd.6.60
10.Formoteraol Fumarate + Beclomethasone Dipropionate InhalerEach actuation Delivers contains: Formoterol Fumarate Dihydrate IP 6mcg,

Beclomethasone Dipropionate IP 100mcg

Supended in Propellants HFA134a qs.




Per Metered dose




M/s Cipla Limited
1.46

The NPPA notice further added;




  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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


Also Read: NPPA fixes retail price of 9 combo drugs including Metformin, Paracetamol; Details

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