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The National Pharmaceutical Pricing Authority (NPPA) has issued show cause notice to all manufacturers (including importers/marketers) of medical devices that are notified as ‘drugs’ under Section 3(b) (iv) of the Drugs and Cosmetics Act,1940 who have failed to submit price list/supplementary price list in Form V of Schedule II to the DPCO 2013.
The NPPA's action in this regard comes in the wake of the fact that majority of the manufacturers, including importers and marketers, are not at all, or not regularly, issuing price list or supplementary price list in Form V to the state drug controllers and to the NPPA. Due to this, monitoring of prices and enforcement of the relevant provisions of the DPCO with regard to prices of medical devices that are notified as ‘drugs’ is becoming difficult in the absence of information to be furnished by manufacturers.
As a result of this lapse on the part of majority of the manufacturers, consumers stand highly vulnerable to being overcharged, which severely undermines public interest, the NPPA said.
Therefore all defaulters in this regard are given a final opportunity to file within two weeks from the date of this show cause notice, necessary information with regard to medical devices notified as drugs, as may be applicable, in Form V of the DPCO 2013 to all state drug controllers and government/NPPA without fail, NPPA chairman Injeti Srinivas in the show cause notice said.
“It may be kindly noted that wherever Price to Retailer (PTR) may not be applicable, i.e., if the supply is made by the wholesaler to the hospital directly, the column related to PTR in the Form V may be left blank and in lieu of it the Price to Wholesaler (including applicable duties) may be mentioned separately as a footnote. Apart from furnishing information in Form V, the year-on-year increase in MRP during the past three years may also be furnished with respect to backlog period. Failure to submit the required information within the stipulated time will attract stringent action under the Essential Commodities Act, 1955”, the NPPA chairman warned the medical device manufacturers in the notice.
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