Drug Prices fixed under DPCO 1995 have to be Mandatorily Implemented

New Delhi, PIB: Under the provisions of the Drugs (Prices Control) Order 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. The manufacturing/marketing companies are required to obtain the prescribed statutory approvals in respect of 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.

It is 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 DPCO’1995 have to be mandatorily implemented by the manufacturing/marketing companies.

The prices fixed and notified under the 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.

Source: PIB
13th December 2007

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