Even as the NPPA has fixed the ceiling prices of 191 essential drugs as per DPCO-2013 allowing 45 days time to the companies to comply the order, the Kerala Pharmaceutical Manufacturers Association (KPMA) has demanded that the ceiling price notified by the NPPA should not be made applicable on the unsold stocks remaining in the market prior to the date of notification.

However, it could be applicable on the batches of scheduled formulations manufactured after the date of notification, the association in a memorandum to the department of pharmaceuticals (DoP) said. Since there is lack of clarity on several points in the new drug price control order (DPCO), more discussions should be conducted involving representatives of various associations of manufacturers, it said.

The Association’s memorandum says that Para 13 and 24 of the DPCO 2013 state that for the scheduled formulations produced or available in the market before the date of notification of ceiling price, the manufacturers have to ensure the MRP of such formulations is not exceeding the ceiling price. The time given for this price checking/ fixation and recall of the over-priced products is only 45 days from the date of notification which ends on July 28.

KPMA informed the DoP that any product usually takes about a minimum of 45 days to reach the retailer from the date of production/ dispatch from the manufacturers’ plant. The product passes through various distribution channels such as C&F agent, distributor, wholesaler, stockist and finally to the retailer. The medicines do usually have a shelf life of two to three years and they will remain in the market till the expiry period is over.

The association wanted the government to increase the date for recalling by three months from the present 45 days which is not adequate.

KPMA president NP Purushothaman said it is not practically possible to withdraw the formulations from the market within 45 days. In the case of strips and blisters the printing of prices, batch number, manufacturing date, expiry date and maximum retail price (MRP) are on line, therefore opening of strips and blisters may hamper the quality of drugs.  In the case of tubes, the over printing of prices is in the form of crimping which cannot be changed. If changes are made in the prices on labels or any change in the crimping, it will become violation of Drugs and Cosmetics (D&C) Act.

He further said if the stock is recalled the quality of drugs may be adversely affected and products with short expiry date may expire resulting in unnecessary losses. There may be regulatory hurdles and problems with central excise and other taxation authorities.