Last Updated on December 31, 2023 by The Health Master
Download NPPA’s OM dated 29-12-0222, the link is given below: The National Pharmaceutical Pricing Authority (NPPA) has clarified in its office memorandum dated 29-12-0222, 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 NPPA received questions from manufacturers, drug distributors, and dealers’ associations about the implementation of notifications of revised ceiling prices as a result of revisions in Schedule I of the DPCO, 2013, based on the National List of Essential Medicines (NLEM), 2022.
Referring to two official memoranda issued by the NPPA dated 13-04-2016 and 10-05-2016 (download links given below) related to the same matter, the authority reiterated as follows:
- That recalling, re-labelling, or re-stickering on the label of a container or pack of released stocks in the market prior to the date of notification is not mandatory, if manufacturers are submitting revised price lists 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, 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.
- 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 authority reiterated that dealers, including stockists and retailers, may not return any stocks if the current price list with the revised notified price is available.
- However, no manufacturer or distributor shall withhold from sale or refuse to sell to a dealer any drug without good and sufficient reasons (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, re-labelling, or re-stickering on the label of a container or pack of released stocks in the market prior to the date of notifications, is not mandatory, if manufacturers are able to ensure price compliance at the retailer level through the issuance of a revised price list,” said the latest Office Memorandum.
As per the provisions of the DPCO, 2013, the ceiling prices for the medicines in Schedule I have to be fixed within 60 days of the notification of the schedule.
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