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With reference to the re-stickering of price controlled scheduled drugs and National List of Essential Medicines (NLEM), the Drugs Controller General of India (DCGI) has issued a circular to the state drug controllers (SDCs) stating that it has no objection for relabeling and stickering of the drugs under Rule 104A of Drugs and Cosmetics (D&C) Rules and directed them not to intervene on the same.
Pharma industry has welcomed this move as a timely gesture from the DCGI as the manufacturers can save a lot of time and energy involved in the value chain towards timely accessibility and affordability of medicines to the patients and consumers.
“Since the activity involved is large, it is necessary to take the practical approach to expedite reprinting of price by the manufacturer at its premises so that benefits of price reduction can be passed on to the consumers in a timely manner. In this context, it is stated that labeling and restickering of the formulations is not in the purview of the National Pharmaceutical Pricing Authority (NPPA). It forms part of the manufacturing process and is regulated by the Central Drugs Standard Control Organisation (CDSCO). The DCGI had also issued a letter dated June 26, 2013 to the SDCs in this respect,” informed DCGI Dr V G Somani.
According to industry sources, the NPPA had shared an email with the DCGI concerning the matter which read, “An email dated January 20, 2023 was received from Torrent Pharmaceuticals Pvt Ltd, wherein they have stated that the local Food and Drug Administration (FDA) authority of Cochin and Chennai had visited their stockist’s premises and informed them to discontinue re-stickering of revised maximum retail price (MRP) for NLEM products as notified by the NPPA. The state FDA authority further informed them that in case they continue the re-stickering process then their license would be cancelled. In view of the same, the request of Torrent Pharmaceuticals Pvt Ltd is hereby forwarded to the DCGI office for necessary action and issue for further instructions.”
Further the email stated, “Our stockist representative had met in person P V Vijayalakshmi in Chennai and the local drug inspector of Cochin. Further, we have also shared the enclosed circular date June 26, 2013 and office memorandum (OM) dated April 13, 2016 according to which restickering/relabelling of existing stock at other any location is permitted and the DCGI has no objections to such restickering/relabeling under Rule 104 A of D&C rules. However, both FDA took a view that restickering of NLEM products is to be done at manufacturing location only. Hence, all NLEM products should be returned to the manufacturing location only.”
“The guidance given by the local FDA is ultra vires and is completely against the guidance given by the DCGI and the NPPA. We request you to kindly intervene and allow us to do restickering of revised maximum retail price (MRP) of NLEM products at stockist location as we intend to be fully compliant with reference to revised prices as notified by the NPPA,” the email from Torrent Pharmaceuticals Pvt Ltd read.
In pursuance to the NPPA order or notification no 1542 (E) to 1692 (E) dated June 14, 2013 and subsequent notifications in this regard which will follow for revising the ceiling price of the scheduled formulations, the NPPA is fixing the ceiling prices of scheduled formulations produced or available in the market. Accordingly, the manufacturers are required to ensure within a period of 45 days of the date of the notification that the MRP of such scheduled formulation does not exceed the ceiling price (plus local taxes as applicable).
Consequent to the fixing of ceiling prices of the scheduled formulations by the NPPA, the manufacturers may be required to re-print/re-label the revised prices of scheduled formulations produced or available in the market.
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