Retail prices be calculated based on market data: NPPA Panel on Hetero Healthcare Lidocaine Patches

This recommendation came during the 46th meeting of the Multidisciplinary Committee of Experts held on October 19, 2022, where the issue of the retail price fixation of each adhesive patch containing lidocaine 700 mg in an aqueous base (50 mg per gramme of adhesive) manufactured and marketed by Hetero Healthcare Limited under Para 5 of the DPCO, 2013 was deliberated.

Lidocaine is a local anaesthetic of the amide type. It is used to provide local anaesthesia by blocking nerves at various sites in the body. It does so by stabilising the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby affecting local anaesthetic action. In particular, the lidocaine agent acts on sodium ion channels located on the internal surface of nerve cell membranes.

The panel noted at a recent Multidisciplinary Committee of Experts meeting that the matter was discussed at the 45th meeting of the Multidisciplinary Committee of Experts, which was held on September 13, 2022, and that the retail price of Lidocaine 700 mg patch was calculated by applying the ratio of Fentanyl injection to patches on Lidocaine Injection to patches.

Furthermore, at the same meeting, the Committee recommended the retail price of each Adhesive Patch containing "Lidocaine 700mg in an aqueous base (50mg per gm adhesive) for Hetero Healthcare Limited (Manufacturer and Marketer) at Rs 9.94 per patch excluding GST (being lower than the price claimed by the company at Rs. 44.64 per patch excluding GST).

In response to the above recommendation, the drug maker Hetero Healthcare Ltd. made a representation to the committee stating that patches cannot be considered at par injections as both have different drug delivery systems.

The company further submitted the list of prices of fentanyl patches with MRP and the list of Lidocaine patches available in the market.

In continuation, the matter was also placed before the Authority in its 102nd meeting held on September 27, 2022, at which the Authority noted the representation of Hetero Healthcare Ltd. and decided that the matter be referred to the Committee for examination of the representation.

Furthermore, Hetero Healthcare Ltd made a personal presentation to the committee and provided a sample of Lidocaine Patch 350 mg from another manufacturer that is currently on the market.

In addition to this, company also stated that Lidocaine Patches are available in the market as claimed for other manufacturers also, but the same are not reflected in AWACS database due to low demand of the patches.

In light of the presentation made by Hetero Healthcare, the committee after deliberation decided that the claim of the company may be verified and the retail price may be calculated based on the market data of other manufacturer and marketer companies.