NPPA fixes MRP of 2 combo drugs manufactured by Emcure, Hetero Labs to prevent HIV; 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 2 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 are combination drugs. The combination of Emtricitabine and Tenofovir Tablet is manufactured by Hetero Labs, which is sold under the brand name Tenof EM while Emcure Pharma sells the drug as Tavin EM. The drug is indicated for the treatment of human immunodeficiency virus (HIV) infections. The medicine is not a cure for HIV; it only prevents the virus from multiplying in your body.
The second drug as mentioned in the NPPA notice is a combination of Dolutegravir, Emtricitabine, Tenofovir Alafenamide Tablet, manufactured by Emcure Pharma. The combination is originally manufactured by Mylan and marketed as Descovy.
The details of the NPPA notification read;
|Name of the|
Formulation / Brand Name
|1.||Emtricitabine + Tenofovir Tablet||Each film-coated tablet contains: Emtricitabine IP 200mg.|
Hemifumarate eq. to Tenofovir Alafenamide 25mg
M/s Hetero Labs Ltd.
/ M/s Emcure Pharmaceuticals Ltd.
|2.||Dolutegravir + Emtricitabine + Tenofovir Alafenamide Tablet||Each film coated tablet contains: Dolutegravir Sodium eq. to Dolutegravir 50mg, Emtricitabine IP 200mg, Tenofovir Alafenamide Fumarate|
eq. to Tenofovir Alafenamide 25mg.
M/s Emcure Pharmaceuticals Limited
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The notice further adds;
- 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.
- 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.
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