Torrent Pharma to get NPPA notice for failing to apply for price fixation of FDCs despite expiry of exemption

The drugmaker was granted an exemption under para 32 of DPCO 2013 for Fixed-Dose Combination (FDC) of Prasugrel Hydrochloride 10 mg (as film-coated) plus Aspirin 75 mg (as enteric-coated) and for Olanzapine Pamoate Prolong Release Powder for suspension for IM Injection (Olanzapine Pamoate Monohydrate eq. to Olanzapine 210mg/ vial, 300 mg/vial, and 405 mg/vial).

Para. 32 of DPCO 2013 creates an exemption from price control for new drugs patented under the India Patents Act, 1970, thereby creating an unprecedented link between the Patents Act and drug prices. However, the drug watchdog observed that the pharma firm continued with the formulations despite the expiry of the exemption granted.

It was further noted that Acetylsalicylic (Aspirin) 75mg tablet is a scheduled formulation, included in revised schedule I of DPCO'13. Accordingly, FDC of Prasugrel Hydrochloride 10 mg (as film-coated) plus Aspirin 75 mg is a new drug for the existing companies as per the provisions of DPCO 2013. Further, Olanzapine Pamoate Prolong Release Powder for suspension for IM Injection (Olanzapine Pamoate Monohydrate eq. to Olanzapine 210mg/ vial, 300 mg/vial, and 405 mg/vial) is a non-scheduled formulation under DPCO 2013.

The matter was referred to the Multidisciplinary Committee of Experts in its meeting held in January 2021 in which the Committee noted that for the formulation "Fixed-Dose Combination (FDC) of Prasugrel Hydrochloride 10 mg (as film-coated) plus Aspirin 75 mg (as enteric-coated)" Torrent Pharma is an existing manufacturer or marketer and needs to have price approval for marketing or manufacturing of the formulation after the expiry of the exemption granted under para 32(iii) of DPCO 2013.

However, the company did not seek any price approval. Accordingly, the Committee directed that explanation may be sought from the company for non-compliance and that the reply received from the company may be examined and placed in its next meeting.

Examining the matter in detail, NPPA observed that Torrent Pharmac, being an existing manufacturer or marketer is required to apply for retail price fixation of "Fixed-Dose Combination (FDC) of Prasugrel Hydrochloride 10 mg (as film-coated) plus Aspirin 75 mg (as enteric-coated)" after the expiry of the exemption granted under para 32(iii) of DPCO 2013.

Accordingly, the Authority decided that;

"The retail price for the new drug "Fixed-Dose Combination (FDC) of Prasugrel Hydrochloride 10 mg (as film-coated) plus Aspirin 75 mg (as enteric-coated)" is to be fixed for Torrent Pharma and overcharging notice, as applicable, is to be issued for the noncompliance.

In this regard, the Authority directed that the matter regarding retail price fixation of "Fixed-Dose Combination (FDC) of Prasugrel Hydrochloride 10 mg (as film-coated) plus Aspirin 75 mg (as enteric-coated)" for Torrent Pharmaceuticals Ltd be placed before the Multidisciplinary Committee of Experts for its recommendation and place in the next Authority meeting.

NPPA further observed that the formulation Olanzapine Pamoate Prolong Release Powder for suspension for IM Injection (Olanzapine Pamoate Monohydrate eq to Olanzapine 210mg/ vial, 300 mg/vial and 405 mg/vial) is a non-scheduled formulation under DPCO 2013 and accordingly directed that the formulation be monitored as per the applicable provisions of DPCO 2013.