Drug prices fixed under DPCO 1995 have to be compulsorily implemented: Government
11 Dec 2007
The ministry of chemicals and fertilizers has clarified that the prices fixed and notified under the Drugs (Prices Control) Order 1995 (DPCO 1995) do not grant or provide any exemption or immunity whatsoever from compliance of the provisions of the Drugs & Cosmetics Act, 1940 and / or the provisions of DPCO, 1995.
Under the provisions of DPCO 1995, the National Pharmaceuticals Pricing Authority (NPPA), notifies the prices of scheduled bulk drugs and formulations. These bulk drugs and formulations have been defined under Para 2(a) and Para 2(h) respectively of DPCO 1995.
Manufacturing and marketing companies are required to obtain the prescribed statutory approvals for bulk drugs and formulations under the provisions of DPCO 1995 and also obtain the prescribed statutory approvals under the Drug and Cosmetics Act, 1940 as well.
The ministry has reiterated that DPCO 1995 and the Drug and Cosmetics Act, 1940 are independent of each other. The DPCO 1995 primarily relates to price(s) of scheduled bulk drugs and related formulations. Accordingly, prices fixed / notified under DPCO1995 have to be mandatorily implemented by the manufacturing/marketing companies.