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NPPA refuses Cipla’s application for discontinuation of four HIV drugs

Gireesh Babu, New Delhi
Wednesday, September 15, 2021, 08:00 Hrs  [IST]

The drug price regulator has refused pharma major Cipla Ltd’s application to discontinue four of its formulations to treat Human Immunodeficiency Virus (HIV), noting that it may affect availability of the drugs under the National Aids Control Programme.

However, it has allowed discontinuation of Hepcvir 28 tablets, consisting of sofosbuvir 400 mg, for treatment of hepatitis C.

The National Pharmaceutical Pricing Authority (NPPA) has said that Cipla has submitted a Form-IV intimation for discontinuation of five scheduled formulations - Abamune L tablets, Abamune tablets, Efavir 200 capsules, Tenvir L tablets and Hepcvir 28 tablets under the provisions of Drugs (Prices Control) Order, 2013.

The Authority referred the matter to the Standing Committee related to discontinuation of scheduled formulations, which in turn recommended it to obtain the view of the National Aids Control Organisation (NACO) with respect to the formulations except Hepcvir 28. As for Hepcvir 28, the Standing Committee recommended the discontinuation of the formulation subject to other conditions of the DPCO, 2013.

Based on the reply of NACO, the Standing Committee in a meeting held on September 2, recommended that the discontinuation of four formulations is not acceptable since it may affect the availability of the drugs since these drugs are required under National Aids Control Programme.

Accordingly, the NPPA accepted the recommendation of the Committee to allow discontinuation of Hepcvir 28 tablets, subject to other conditions of the DPCO 2013. However, it decided not to allow Cipla to discontinue the other four formulations.

Abamune L tablets, a fixed dose combination of abacavir 600 mg + lamivudine 300 mg, is indicated for the treatment of HIV-1 infection in adults, with recommendations to take the tablet orally once daily, in combination with other antiretroviral agents with or without food.

Abamune tablets comprise abacavir sulfate 300 mg, is a carbocyclic synthetic nucleoside analogue, which is used in the treatment of HIV-1 infection. Efavir 200 has Efavirenz 200 mg in its composition, is an non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1. Its activity is mediated predominantly by non competitive inhibition of HIV-1 reverse transcriptase (RT).

Tenvir L tablets is a fixed dose combination of lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, indicated for the treatment of adult patients with HIV infection. The dose of Tenvir-L is a once daily tablet to be taken orally with or without food. Hepcvir 28, Sofosbuvir 400 mg, is a direct-acting antiviral agent against the hepatitis C virus and it is essential for viral replication.

NPPA, in the guidelines for discontinuation of a scheduled formulation under the Paragraph 21 (2) of DPCO, 2013, has said that while there are provisions for companies to discontinue their scheduled drugs by taking an application to the Authority, whenever concerns regarding shortage is apprehended or a formulation is found to be critical for public health, based on circumstances and also in cases where it is established that the company is intending to discontinue production/import and sale of a scheduled formulation and has already launched or intends to launch ‘a new drug’ to evade price control; cases requiring continuance of production/import and sale beyond 12 on this or any other cases; with the approval of the Chairman, NPPA will be referred to a Standing Committee. The recommendations of the Committee will be put up to the authority. The Standing Committee will comprise Advisor (Cost), NPPA and representatives from CDSCO and DGHS as members.

Cipla introduced the first ever recommended 3-in-1 fixed dose combination of stavudine+lamivudine+nevirapine to fight acquired immunodeficiency syndrome, priced at less than $1 per day resulting in a cost of around $300 a year per patient, as compared to over $12,000 per patient per year for the then prevailing medications.The company currently has a range of 25 antiretrovirals approved under the PEPFAR and pre-qualified by WHO. It’s antiretrovirals are supplied to more than 115 countries and various ministries of health worldwide, according to the NPPA.

 

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