NPPA takes on Wockhardt over Insulin Human Injection, moves to regulate price

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.

The price exemption was grated in 2015 for three different formulations namely;

(i) Insulin Human Injection, 200IU/ml

(ii) Isophane Insulin Human Suspension 200IU/ml and

(iii) 70% Isophane Insulin Human Suspension and 30% Insulin Human Injection 200IU/ml

However, the same had recently expired. NPPA further noted that Insulin 40IU/ml is a scheduled formulation, included in revised schedule I of DPCO'13. Accordingly, the three formulations are new drugs for the existing companies as per the provisions of DPCO 2013.

The matter was referred to the Multidisciplinary Committee of Experts in its 26th meeting dated 18.01.2021 in which the Committee noted that for the formulations the firm is an existing manufacturer or marketer and need 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 pharma firm did not seek any price approval, it noted.

Accordingly, the Committee directed that explanation may be sought from the companies for the non-compliance and that the reply received from the company may be examined and placed in its next meeting.

The Authority deliberated upon the matter in detail and observed;

"Wockhardt, being as existing manufacturer or marketer is required to apply for retail price fixation of (i) Insulin Human Injection, 200IU/ml (ii) Isophane Insulin Human Suspension 200IU/ml and (iii) 70% Isophane Insulin Human Suspension and 30% Insulin Human Injection 200IU/ml, after the expiry of the exemption granted under para 32(iii) of DPCO 2013."

Accordingly, the NPPA decided that the retail price for the new drug (i) Insulin Human Injection, 200IU/ml (ii) Isophane Insulin Human Suspension 200IU/ml and (iii) 70% Isophane Insulin Human Suspension and 30% Insulin Human Injection 200IU/ml, is to be fixed for Wockhardt and overcharging notice, as applicable, is to be issued for the non-compliance.

In this regard, the Authority directed that the matter regarding retail price fixation of the formulations for Wockhardt be placed before the Multidisciplinary Committee of Experts for its recommendation and place in the next Authority meeting.