Re-labelling for price revision not mandatory if drug makers ensure price compliance: NPPA
New Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA) has clarified that recalling or re-labelling of medicines is not mandatory if the manufacturers are able to ensure price compliance at the retailer level through issuance of a revised price list.
This came in wake of queries, NPPA came across, 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.
“It has been informed to the NPPA that some stockists and trade associations are showing resistance in selling the products without stickering/re-labelling. The dealers including stockist/retailers may not return any stocks in case current price list as per revised notified price has been made available," stated the latest Office Memorandum issued by the NPPA.
Directing manufacturer, distributors and dealers, NPPA said that they cannot refuse the sale of drugs subject to the provisions of the Drugs and Cosmetics Act, 1940. It observed;
“All manufacturers and retails shall make sure that prices fixed/notified by the NPPA for essential medicines are duly implemented and benefit of the price is made available to the consumers."
Referring to two official memoranda issued by the NPPA in April and May, 2016 related to the same matter, 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.
The Authority further stated that if drug manufacturers plan to recall or re-label the stock, it may be done in a phased manner to avoid shortage of the drug in the market. It said,
"The printing of prices on the label of packs was earlier governed by Standard of Weights and Measures Act, 1976 and Rules made thereunder. However, now the said printing of prices is governed by Legal Metrology Act, 2009. Under Rule 26(c) of Legal Metrology (packaged commodity) Rules, 2011, formulations under the DPCO are exempted. However, the manufacturers, if recalling the stock, may ensure that recall is done in a phased manner so that it does not cause acute shortage of medicines in the market."
In view of the above, NPPA subsequently informed the stakeholders as;
"All the manufacturers and retailers are required to comply with the prices fixed or revised by NPPA in line with Para 24 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."
In December, the NPPA had 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 had been approved include specific strengths of paracetamol, allopurinol, hydroxychloroquine, carbamazepine, clobazam, levetiracetam, lorazepam, mebendazole, cefadroxil, artemether and lumefantrine combination, cefixime, ethionamide, among others.
