New Delhi : The drug price regulator has clarified that while complying with the prices fixed or revised recently as part of the amended Schedule I of the Drugs (Prices Control) Order, 2013, recalling, re-labelling or re-stickering on the label of the container or pack of released drug stocks in the market prior to the date of notifications is not mandatory, if the manufacturers are able to ensure price compliance at the retailer level through issuance of a revised price list.
The clarification comes after the National Pharmaceutical Pricing Authority (NPPA) received some queries from the manufacturers, drug distributors and dealers associations regarding the implementation of notified revised ceiling prices consequent to revision in Schedule I of DPCO, 2013 on the basis of the National List of Essential Medicines (NLEM), 2022. The NPPA has recently notified 119 formulations with the revised or newly fixed prices, based on the market data for the month of July, 2022.
Referring to two official memoranda issued by the NPPA in April and May, 2016 related to the same mater, the Authority reiterated that recalling or re-labelling or re-stickering on the label of container or pack of released stocks in the market prior to date of notification is not mandatory, if manufacturers are submitting revised price list and are able to ensure price compliance at the retailer level.
“However, the manufacturers, if they so desire in order to comply with notified prices, may re-label or re-sticker or recall the stocks, as the case may be. Putting the stickers of revised prices is being practiced by many manufacturers which is the preferred option by retailers as intimated to NPPA by their associations,” it added.
If the manufacturers are recalling the stock, they may ensure that recall is done in a phased manner so that it does not cause acute shortage of medicines in the market.
The dealers including stockists and retailers may not return any stocks in case current price list as per revised notified price has been made available, reiterated the Authority. However, no manufacturer or distributor shall withhold from sale or refuse to sell to a dealer any drug without good and sufficient reasons, it added quoting the Paragraph 28 of the DPCO, 2013.
All the manufacturers and retailers are required to comply with the prices of revised NPPA in line with the provisions of DPCO, 2013.
“It is again reiterated that recalling or re-labelling or re-stickering on the label of container or pack of released stocks in the market prior to date of notifications, is not mandatory, if manufacturers are able to ensure price compliance at the retailer level through issuance of a revised price list,” said the latest Office Memorandum.
In December, the NPPA has approved the ceiling prices of 119 formulations as part of fixing the ceiling price of formulations in the National List of Essential Medicine (NLEM), 2022, which was recently amended into the Schedule I of the DPCO, 2013. The formulations for which the ceiling prices has been approved include specific strengths of paracetamol, allopurinol, hydroxychloroquine, carbamazepine, clobazam, levetiracetam, lorazepam, mebendazole, cefadroxil, artemether and lumefantrine combination, cefixime, ethionamide, among others.
The Authority, in an earlier meeting said that it is planning to fix the ceiling prices of around 954 formulations, comprising 388 medicines, based on the database from market research firm Pharmatrac for the month of July, 2022. While the total unique formulations for which ceiling prices are to be fixed through the exercise are around 819, in view of the expansions to the revised Schedule 1 and others, the number of formulations may increase beyond 954 formulations to around 1,000 formulations, said the Authority. The NLEM 2022 has 56 formulations of newly added drugs, while around 763 are continued from NLEM, 2015. The ceiling price revision is following the revision of Schedule 1 of the Drugs (Price Control) Order, 2013 replacing NLEM 2015 with NLEM 2022, notified by the Department of Pharmaceuticals (DoP) on November 11, 2022.
As per the provisions of the DPCO, 2013, the ceiling prices for the medicines in the Schedule I has to be fixed within 60 days from the notification of the Schedule.
While the general practice is that the ceiling prices are fixed considering the market-based data for fixing the ceiling price of schedule formulation due to revision in the First Schedule shall be the data available for the month ending immediately before six months of notification of revision in the first schedule, the Authority used the data from July, 2022, paying heed to the representations of the industry associations.