NPPA authority rejects Cipla's plea to discontinue four HIV drugs including Abamune, Efavir

However, in the case of the hepatitis drug Hepcvir 28 Tablets, the NPPA authority has allowed Cipla's plea to discontinue the production and/or import of Hepcvir 28 Tablets subject to the other conditions of the Drug Price Control Order 2013 (DPCO 2013).

This came in response to the form-IV intimation received from pharmaceutical major Cipla Limited for discontinuation of 5 scheduled formulations viz., (i) Abamune L Tablets (ii) Abamune Tablets (iii) Efavir 200 Capsules (iv) Hepcvir 28 Tablets and (v) Tenvir L Tablets under para 21 (2) of DPCO, 2013.

According to the DPCO,2013, form IV is a proforma for submission of the details in respect of the discontinuation of the production and/or import of a scheduled formulation.

Para 21(ii) of DPCO 2013 says, " Any manufacturer of scheduled formulation, intending to discontinue any scheduled formulation from the market shall issue a public notice and also intimate the Government in Form-IV of schedule-II of this order in this regard at least six months prior to the intended date of discontinuation and the Government may, in public interest, direct the manufacturer of the scheduled formulation to continue with the required level of production or import for a period not exceeding one year, from the intended date of such discontinuation within a period of sixty days of receipt of such intimation."

The Authority, at its 224th meeting , held on September 8th, 2021, under the Chairmanship of Shri Kamlesh Kumar Pant, Chairman, NPPA, extensively investigated the drug-maker Cipla's form-IV intimation for discontinuation of five scheduled formulations, which are detailed below.

The Authority further noted that the matter was referred to the Standing Committee which in its 4th meeting dated 16.06.2021 recommended obtaining the view of the National Aids Control Organisation (NACO) with respect to the formulation of Abamune L Tablets, Abamune Tablets, Efavir 200 Capsules, and Tenvir L Tablets, and allowing discontinuation of the formulation of Hepcvir 28 Tablets subject to other conditions of DPCO 2013.

Each film-coated Abamune L Tablet contains Abacavir 600 mg and Lamivudine IP 300 mg, and is indicated for the treatment of HIV-1 infection in adults.

Abacavir is a carbocyclic synthetic nucleoside analogue which is converted by cellular enzymes to the active metabolite, carbovir triphosphate (CBV-TP), an analogue of deoxyguanosine-5′-triphosphate (dGTP). CBV-TP inhibits the activity of HIV-1 reverse transcriptase (RT) both by competing with the natural substrate dGTP and by its incorporation into viral DNA.

Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1) and hepatitis B (HBV) to disrupt viral DNA synthesis.

Further, Cipla's Efavir 200 Capsules are also indicated for the treatment of HIV-1infection in combination with other antiretroviral agents. Furthermore, in the case of TENVIR-L Tablet, it contains Lamivudine 300mg and Tenofovir Disoproxil Fumarate 300mg, and it is indicated for the treatment of adult patients with HIV infection.

Lastly, Cipla's Hepcvir 28 Tablets which contain sofosbuvir, a HCV nucleotide analogue NS5B polymerase inhibitor, are indicated in combination with under medicinal products for the treatment of chronic hepatitis C (CHC) in adults.

After detailed assessment, the authority agreed to allow Cipla Ltd to discontinue the hepatitis C medication Hepcvir 28 Tablets, subject to the other conditions of the DPCO 2013.

Furthermore, the Authority declined to allow Cipla to stop producing and/or importing four scheduled human immunodeficiency virus (HIV-1) formulations: Abamune L Tablets, Abamune Tablets, Efavir 200 Capsules, and Tenvir L Tablets.

As a result of the foregoing, the authority concluded,

"The Authority deliberated upon the matter in detail and accepted the recommendation of the Committee and decided to allow discontinuation of the formulation mentioned in SI. No. 5 of the Table above subject to the other conditions of DPCO 2013 to M/s Cipla Ltd. The Authority further decided not to allow M/s Cipla Ltd to discontinue the formulations mentioned in SI. No. 1 to 4 of the Table above."