NPPA panel rejects Cadila Healthcare retail price fixation application for Tacrolimus PR capsules

This came in line with the clarification received from the CDSCO that it has not given approval to drug maker Cadila Healthcare to import/ manufacture the formulation Tacrolimus Prolonged Release hard gelatine capsule 3 mg.

At the 41st meeting of the Multidisciplinary Committee of Experts held on 08.04.2022, the expert panel thoroughly reviewed Cadila Healthcare's application for retail price fixation of Tacrolimus Prolonged Release hard gelatine capsules 3 mg.

Tacrolimus is an immunosuppressive drug whose main use is after organ transplant to reduce the activity of the patient's immune system and thus the risk of organ rejection. It is also used in a topical preparation in the treatment of severe atopic dermatitis, severe refractory uveitis after bone marrow transplants, and the skin condition vitiligo.

At the recent authority meeting, the panel noted that the clarification dated 07/04/2022 received from the Office of the Central Drugs Standard Control Organisation (CDSCO) that they have not received any application from Cadila Healthcare for the manufacture or import of Tacrolimus Prolonged Release hard gelatine capsules 3 mg.

Further, the committee also observed Para 2(w) (iv) and the Explanation to Para 2 (w) of the New Drugs and Clinical Trials Rules, 2019, which state as follows:

"Para 2(w)(iv) - a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licensing Authority, or

Explanation: The drugs, other than drugs referred to in sub-clauses (iv) and (v}, shall continue to be new drugs for a period of four years from the date of their permissions granted by Central Licensing Authority "

After detailed deliberation, the committee is of the opinion that since Tacrolimus Prolonged Release hard gelatine capsule 3 mg would continue to be a new drug after the promulgation of the New Drugs and Clinical Trials Rules, 2019, Cadila Healthcare would require specific approval from COSCO to import or manufacture the formulation Tacrolimus Prolonged Release hard gelatine capsule 3 mg in India.

Accordingly, the Committee decided to reject the application of Cadila Healthcare for retail price fixation of Tacrolimus Prolonged Release hard gelatine capsules 3 mg since CDSCO has not given approval to Cadila Healthcare to import or manufacture the formulation of Tacrolimus Prolonged Release hard gelatine capsules 3 mg.