The pharma companies are finding it increasingly difficult in complying with the Drugs Price Control Order, 2013 as the manufacturers feel the provisions in National Pharmaceuticals Pricing Policy (NPPP) 2012 and DPCO 2013 are being wrongly interpreted by the National Pharmaceutical Pricing Authority.
The industry is upset with NPPA's guideline which has asked the manufacturers representing for correction in their working sheet of price uploaded by NPPA in advance must provide the details of all invoices of August 2015 and details of discounts and free schemes if any given during the month of August 2015.
The manufacturers are finding hard to understand the relevance of discount and schemes if any with respect to price to the retailers (PTR). The NPPP 2012 and the DPCO 2013 do not refer to or seek information on discounts or free schemes being given to the retailers. Hence these additional discounts or free schemes have no relevance to PTR.
Mere direction by NPPA to upload the working sheet before announcing the ceiling price is not a justifiable reason to seek such data which they have not called for so far and which has no relevance to price fixation. By calling for these details, NPPA is deviating from the basic method of ceiling price calculation which may cease to be Fair Price, as envisaged under NPPP and DPCO, according to Indian Drug Manufacturers' Association (IDMA).
The Association has informed the Department of Pharmaceutical (DoP) that NPPA is including all differentiated and innovative formulations developed through R&D such as Sustained Release, Controlled Release etc along with ordinary dosage forms in calculating ceiling prices, and has urged the department that such formulations should be excluded from PTR and considered separately for pricing etc.
The Association has also brought to the notice that the industry members are facing difficulties due to NPPA’s anomaly of clubbing various packs of small volume parenterals like dexamethasone 4mg/ml injection, gentamicin 40mg/ml injection, paracetamol 150mg/ml injection and tetanus toxoid injection while notifying ceiling prices. While NPPA has re-fixed the prices of IV fluids it has not rectified the anomaly by re-fixing the prices in case of dexamethasone 4mg/ml injection, gentamicin 40mg/ml injection, paracetamol 150mg/ml injection and tetanus toxoid injection.
There is an inconsistency in consideration of WPI by NPPA. A different criteria has been adopted for calculation of ceiling price in 2013 & 2016, as NPPA did not consider increase of WPI of 7.42 per cent in ceiling price calculation effective from April 1, 2013. Hence negative WPI of 2.71 per cent effective from April 1 2016 should not be considered when revising/fixing new ceiling prices, said IDMA.