NPPA fixes retail price of 7 drug formulations; Details
New Delhi: Through a recent notification, the apex drug price regulatory agency, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 7 drug formulations in exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013.
The price fixed are exclusive of goods and services tax (GST).
The formulations whose prices have been fixed by NPPA include combination drug- Clarithromycin + Esomeprazole + Amoxicillin Tablet; Bictegravir + Emtricitabine + Tenofovir Tablet (TAFFIC), Ranitidine Hydrochloride + Dicyclomine Hydrochloride + Simethicone Tablet; Darunavir + Ritonavir Tablet (DAREIT R); Cefotaxime Sodium Injection; Clobazam Tablet.
Various drugmakers including Sun Pharmaceuticals Ltd.( Sun Pharma), Alkem Lab, Aurobindo Pharma, Emcure Pharma, Hetero Lab, Mankind Pharma, Windlas Biotech and Malik Lifesciences are involved in manufacturing the said formulations under different brand names.
The formulations mentioned in the list include antibiotics, indicated to treat a variety of bacterial infections; an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying; seizures drug and others.
The details of all 07 formulations a mentioned in the list released by the NPPA read;
|Name of the Formulation /|
|Strength||Unit||Manufacturer & Marketing Company||Retail Price|
|1.||Clarithromycin + Esomeprazole + Amoxicillin Tablet||Each Strip Contains:|
A. Clarithromycin IP 2 Tablets Each film coated tablet contains: Clarithromycin IP 500mg,
B. Esomeprazole Tablets IP 2 tablet Each enteric coated tablet contains: Esomeprazole Magnesium Trihydrate IP Eq. to Esomeprazole 40mg
C. Amoxicillin USP 2 Tablets Each film coated tablet contains: Amoxicillin Trihydrate IP eq. to
Each Strip of 6 Tablets
M/s Malik Lifesciences Pvt. Ltd. / M/s Emcure Pharmaceuticals Ltd.
|2.||Bictegravir + Emtricitabine + Tenofovir Tablet (TAFFIC)||Each film coated tablet contains: Bictegravir Sodium eq. to Bictegravir 50mg,|
Emtricitabine IP 200mg.
Tenofovir Alafenamide Hemifumarate eq. to Tenofovir Alafenamide 25mg
|1 Tablet||M/s Hetero Labs Ltd. / M/s Hetero Healthcare Ltd.||130.61|
|3.||Clobazam Tablet||Each uncoated tablet contains: Clobazam IP 7.5mg||1 Tablet||M/s Sun Pharma Laboratories Limited||7.04|
|4.||Clobazam Tablet||Each uncoated tablet contains: Clobazam IP 2.5mg||1 Tablet||M/s Sun Pharma Laboratories Limited||3.02|
|5.||Ranitidine Hydrochloride + Dicyclomine Hydrochloride + Simethicone|
|Each film coated tablet contains: Ranitidine Hydrochloride IP eq. to Ranitidine 150mg|
Dicyclomine Hydrochloride IP 10mg, Simethicone IP 20mg
|1 Tablet||M/s Windlas Biotech Pvt. Ltd. / M/s Mankind Pharma Limited||4.86|
|6.||Darunavir + Ritonavir Tablet (DAREIT R)||Each film coated tablet contains: Darunavir 600mg,|
|1 Tablet||M/s Emcure Pharma Limited / M/s Aurobindo Pharma|
|7.||Cefotaxime Sodium Injection||Each vial contains:|
Cefotaxime Sodium IP eq. to Cefotaxime 2g
|Each Pack (2gm)||M/s Alkem Healthscience / M/s Alkem Laboratories|
1. The manufacturer of the 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.
2. 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
3. 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 dealer
4. 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.
5. 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 fulfillment 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.
6. 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.
7. 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.