In a move towards fixing the much anticipated ceiling price of the 348 formulations falling under the new Drug Price Control Order (DPCO) 2013, the NPPA last week directed all the state licensing authorities (SLAs) to submit the details of all the manufacturers in their respective states, manufacturing these formulations.
Through this initiative, the National Pharmaceutical Pricing Authority (NPPA) is finally understood to have started the long pending process of collecting the updated market data on the total sale and turnover of the select formulations included in the DPCO, for the effective enforcement of the new order across the country. NPPA has requested all the SLAs to submit, at the earliest, detailed information on the number of manufacturing units manufacturing these formulations along with their market share, etc. along with other important marketing details so as to start fixing the ceiling prices.
Dr H G Koshia, commissioner, Gujarat Food and Drug Control Administration (FDCA) informed that his office has already intimated all the manufacturers in the state to provide all the required information on this as directed by the NPPA to speed up this matter. He stressed that considering the importance of this issue with respect to fixing the ceiling price of the formulations all the steps are being taken to ensure speedy and timely deliverance of this matter from Gujarat.
The new DPCO which came into effect from May 15, 2013 replacing the 1995 Order puts the mechanism for regulating the prices of 348 drugs, instead of 74 drugs, based on the simple average of market price of a product. This move comes in the wake of long standing confusion prevailing in the industry, over the enforcement of the new DPCO in the absence of any government notification so far on the ceiling prices of medicines.
Industry insiders believe this is one of the first initiatives taken by the NPPA for fixing the ceiling price of the 348 formulations based on market based pricing after the notification. However, there is lot of fear and uncertainty among the industry over the impending enforcement of the new order, as many cite that 45 days is a short period to adopt this new order once the ceiling price is notified.
In a further development, it is understood that government is likely to come out with gazette notification on June 30, postponing and extending the deadline for the enforcement of the new DPCO from its designated July 1 deadline to further six months, as they have not yet fixed the ceiling prices of medicines.