New Delhi: Through a recent notice, the drug price regulator National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of Emcure Pharmaceutical’s formulation used to help control HIV infection.
The Ministry of Chemicals and Fertilizers issued a recent notification in this regard. The retail price of the formulation of Abacavir +Dolutegravir + Lamivudine tablet has been fixed exclusive of goods and services tax(GST).
Abacavir/dolutegravir/lamivudine is a fixed-dose combination drug for the treatment of HIV/AIDS. It is a combination of three drugs with different and complementary mechanisms of action: 600 mg abacavir (reverse transcriptase inhibitor), 50 mg dolutegravir (integrase inhibitor) and 300 mg lamivudine (nucleoside analog reverse transcriptase inhibitor).
The drug was developed by ViiV Healthcare and approved by the Food and Drug Administration for use in the United States in August 2014.
The formulation of each film-coated tablet contains Abacavir Sulphate IP eq. to Abacavir Abacavir 600 mg Dolutegravir Sodium eq. to Dolutegravir 50 mg Lamivudine IP 300 mg. The retail price of the formulation has been fixed as Rs 157.69 for the formulation that is made/sold by Emcure Pharmaceuticals
The notice states
|Name of the
Formulation / Brand Name
|Each film coated tablet contains:
Abacavir Sulphate IP eq. to Abacavir 600 mg
Dolutegravir Sodium eq. to Dolutegravir 50 mg
Lamivudine IP 300 mg
The notice further reads,
- The manufacturer of above-mentioned formulation 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 carried 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 formulation 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.