NPPA fixes retail price of 20 drugs including FDCs for Blood pressure control, dual antiplatelet

New Delhi: Through a recent notification, the government regulatory agency, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 20 drug formulations under the Drugs (Prices Control) Order, 2013 exclusive of goods and services tax (GST).

Many medicines whose price have been fixed by NPPA include fixed-dose combination and other medicines to control Blood Pressure, dual antiplatelet therapy, cold medication, epilepsy, IBD medications, antibiotics and more

The drug formulations whose price has been fixed include combinations of Teneligliptin + Metformin Tablet; Paracetamol + Phenylephrine + Caffeine (Anhydrous) + Diphenhydramine Tablet; Clopidogrel + Aspirin tablet and others.

Notable drug makers inclusive of Sun Pharma, Emcure Pharma, Dr Reddy's Lab, Cipla, Akums Drugs, Torrent Pharma, Zydus Healthcare, Hetero Labs, Intas Pharma and others are responsible for the manufacture of these formulations.

Many FDC whose price have been fixed are commonly used. For instance, Clopidogrel in combination with Aspirin tablet is used to treat worsening chest pain (new heart attack, unstable angina) and to keep blood vessels open and prevent blood clots after certain procedures (such as a cardiac stent).

While another combination of Medoxomil + Amlodipine + Hydrochlorothiazide Tablet manufactured by Hyderabad based Dr Reddy's under the trademark Trisertain is indicated for treating is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

The detail of the medicines issued by NPPA reads;

Sl. No.	Name of the Formulation / Brand Name	Strength	Unit	Manufacturer & Marketing Company	Retail Price (Rs.)
(1)	(2)	(3)	(4)	(5)	(6)
1.	Mesalazine Sachet	Each sachet contains: Mesalazine IP 2gm (As Coated Granules)	2gm Sachet	M/s Sun Pharma Laboratories Limited	86.78
2.	Mesalazine Sachet	Each sachet contains: Mesalazine IP 1gm (As Coated Granules)	1gm Sachet	M/s Sun Pharma Laboratories Limited	43.28
3.	Clotrimazole + Beclomethasone + Neomycin Cream	Cream contains: Clotrimazole 1.0% w/w Beclomethasone Dipropionate 0.025% w/w Neomycin Sulphate eq. to Neomycin 0.5%w/w Cream	1 gm	M/s Helios Pharmaceuticals / M/s Emcure Pharmaceuticals Limited	5.34
4.	Telmisartan + Cilnidipine + Chlorthalidone Tablet	Each film coated bilayered tablet contains: Telmisartan IP 40mg, Cilnidipine 10mg, Chlorthalidone IP 6.25mg	1 Tablet	M/s Swiss Garnier Genexiaa Sciences / M/s Cipla Limited	10.72
5.	Telmisartan + Cilnidipine Tablet	Each film coated tablet contains: Telmisartan IP 40mg, Cilnidipine 10mg	1 Tablet	M/s Swiss Garnier Genexiaa Sciences / M/s Cipla Limited	7.66
6.	Paracetamol + Phenylephrine + Caffeine (Anhydrous) + Diphenhydramine Tablet	Each uncoated tablets contains: Paracetamol IP 500mg, Phenylephrine HCL IP 5mg, Caffeine (Anhydrous) IP 30mg, Diphenhydramine HCL IP 25mg,	1 Tablet	M/s Samson Laboratories Pvt. Ltd. / M/s Intas Pharmaceuticals Limited	2.80
7.	Methylcobalamin + Pyridoxine + Folic Acid Tablet	Each film coated tablet contains: Methylcobalamin (Extended Release) IP 1500mcg, Pyridoxine Hydrochloride IP 20mg, Folic Acid IP 5mg	1 Tablet	M/s Tirupati Medicare Ltd. / M/s Cipla Limited	15.00
8.	Olmesartan	Each film coated tablet contains:	1 Tablet	M/s Akums Drugs and	10.54
9.	Olmesartan Medoxomil + Amlodipine + Hydrochlorothiazide Tablet (Trisertain 40)	Each film coated tablet contains: Olmesartan Medoxomil IP 40mg, Amlodipine Besilate IP eq. to Amlodipine 5mg, Hydrochlorothiazide IP 12.5mg	1 Tablet	M/s Akums Drugs and Pharmaceuticals Ltd. / M/s Dr. Reddy's Laboratories Limited	14.56
10.	Olmesartan Medoxomil + Amlodipine Tablet (Olsertain AM 40)	Each film coated tablet contains: Olmesartan Medoxomil IP 40mg, Amlodipine Besilate IP eq. to Amlodipine 5mg,	1 Tablet	M/s Akums Drugs and Pharmaceuticals Ltd. / M/s Dr. Reddy's Laboratories Limited	14.45
11.	Levetiracetam Tablet (Epictal)	Each film coated tablet contains: Levetiracetam IP 1000mg	1 Tablet	M/s Akums Drugs and Pharmaceuticals Ltd. / M/s IPCA Laboratories Limited	24.56
12.	Linezolid + Dextrose Injection (ZIFI TURBO 600)	Each 100ml injection contains: Linezolid IP 200mg Dextrose Anhydrous IP 5mg water for Injection q.s.	Per Pack	M/s Aishwarya Lifesciences / M/s FDC Limited	330.79
13.	Telmisartan + Amlodipine + Chlorthalidone Tablet	Each film coated tablet contains: Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, Chlorthalidone 6.25mg Tablets	1 Tablet	M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Zydus Healthcare Limited	9.30
14.	Telmisartan + Amlodipine + Chlorthalidone Tablet	Each film coated tablet contains: Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, Chlorthalidone 12.5mg Tablets	1 Tablet	M/s Akums Drugs & Pharmaceuticals Ltd. / M/s Zydus Healthcare Limited	9.81
15.	Clopidogrel + Aspirin tablet	Each film coated tablet contains: Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg, Aspirin 75mg	1 Tablet	M/s Rivpra Formulation Pvt. Ltd. / M/s Cadila Pharmaceuticals Limited	3.31
16.	Teneligliptin + Metformin Tablet (TENELICAS M)	Each uncoated bilayered tablet contains: Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg Metformin HCl 500mg (ER)	1 Tablet	M/s Akums Drugs and Pharmaceuticals Ltd. / M/s Anthus Pharmaceuticals Pvt. Ltd.	9.81
17.	Tenofovir Alafenamide Tablet (Tenocruz – AF)	Each film coated tablet contains: Tenofovir Alafenamide Hemifumarate eq. to Tenofovir Alafenamide 25mg	1 Tablet	M/s Hetero Labs Ltd./ M/s Torrent Pharmaceuticals Limited	44.29
18.	Clarithromycin tablet, Esomeprazole Tablet, Amoxycillin Tablet	Each Strip contains: a. Clarithromycin tablets IP 2 tablets: Each enteric coated tablet contains: Clarithromycin IP 500mg b. Esomeprazole Tablets IP 2 Tablets, Each film coated tablet contains: Esomeprazole Magnesium IP eq. to Esomeprazole 40mg, c. Amoxycillin Tablets USP 2 tablets, Each film coated tablet contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 750mg	Per Strip	M/s Malik Lifesciences Pvt. Ltd. / M/s Cipla Limited	136.80
19.	Heavy Magnesium Oxide+ Vitamin C + Niacinamide + Zinc Oxide + Vitamin E + Calcium Pantothenate +Vitamin A + Cupric Oxide + Manganese Sulfate + Thiamine Mononitrate + Riboflavin + Pyridoxine Hydrochloride + Folic Acid + Chromium Picolinate + Biotin + Selenious Acid + Vitamin D3 + Methylcobalamin + L-Glutamic Acid + Dl-Methionime Tablet (One up Gold D)	Each film coated tablet contains: Heavy Magnesium Oxide IP 30mg, Vitamin C IP 100mg, Niacinamide IP 50mg, Zinc Oxide IP Eq. to Elemental Zinc 22.5mg, Vitamin E Acetate IP 25IU, Calcium Pantothenate IP 12.5mg, Vitamin A Concentrate Powder IP 5000IU, Cupric Oxide eq. to Elemental Copper 2.5mg, Manganese Sulfate Usp eq. to Elemental Manganese 2.5mg, Thiamine Mononitrate IP 10mg, Riboflavin IP 10mg, Pyridoxine Hydrochloride IP 3mg, Folic Acid IP 1500mcg, Chromium Picolinate USP eq. to Elemental Chromium 100mcg, Biotin USP 60mcg, Selenious Acid USP eq. to Elemental Selenium 60mcg, Vitamin D3 IP400IU, Methylcobalamin IP 500mcg, L-Glutamic Acid USP 100mg, Dl-Methionime BP 25mg	1 Tablet	M/s Akums Drugs and Pharmaceuticals Limited / M/s Torrent Pharmaceuticals Limited	5.08
20.	Darunavir + Ritonavir Tablet (Danavir 600 R)	Each film coated tablet contains: Darunavir Ethanolate eq. to Darunavir 600mg, Ritonavir 100mg	1 Tablet	M/s Hetero Labs Limited / M/s Hetero Healthcare Limited	160.71

The NPPA notice further reads;

• 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


• 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


• 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


• 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 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,


• 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)

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