The manufacturers of scheduled formulations, whose prices are being revised by the National Pharmaceutical Pricing Authority (NPPA) in accordance with the new National Pharmaceutical Pricing Policy, will be allowed to re-label their already manufactured drugs as per the new prices and be sold in the market as the new prices come into effect.

The Drugs Controller General of India (DCGI) has made it clear that his office had no objection in re-labelling the products. “The office of DCG (I) does not have any objection for re-labelling/sticking of the drugs concerned under Rule 104A of Drugs and Cosmetics Rules for this purpose. Since the activity involved is large, it is necessary to take the practical approach to expedite re-printing of price, so that benefits of price reduction can be passed on to the consumers,” a letter from the DCGI said.

The NPPA has already revised the prices of nearly 250 formulation packs based on the new Drugs Price Control Order (DPCO) 2013, notified in accordance with the new pharmaceutical pricing policy which sought to control the prices of 348 bulk drugs, sold as 650 formulations.

As per the new DPCO, the new prices should be made effective within 45 days of the notification. The first batch of formulations under revised prices was announced on June 14 by the NPPA and the new prices should be effective by the end of this month accordingly. The drugs thus fixed should have new maximum retail price of such scheduled formulations (ceiling price and local taxes as applicable) by the deadline.

“Consequent to the fixing of ceiling prices of the scheduled formulations by the NPPA, the manufacturers may be required to re-print/relabel the revised prices of formulations,” the order of the DCGI said, clearing confusion the sale of already manufactured drugs.

“Provided, that in case of scheduled formulations produced or available in the market before the date of notification of ceiling price, the manufacturers shall ensure within a period of forty-five days of the date of such notification that the maximum retail price of such scheduled formulation does not exceed the ceiling price (plus local taxes as applicable),” according to the DPCO.