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Gireesh Babu, New Delhi February 03 , 2023
The National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling price of 54 scheduled formulations in its latest meeting, as part of fixation of ceiling price of scheduled formulations under the revised Schedule I of Drugs (Prices Control) Order, 2013. With this, the Authority has fixed or revised the retail price of 398 scheduled formulations, listed in the revised Schedule I which carries the National List of Essential Medicines (NLEM), 2022.

In the 108th meeting of the Authority under the DPCO, 2013, held on January 27, under the Chairmanship of Kamlesh Kumar Pant, Chairman of NPPA, it considered 55 formulations proposed for ceiling price approval, the draft working paper of which has been uploaded by the NPPA from the beginning of December, 2022.

The Authority has published draft working sheets of a total of 409 formulations in eight lots from November 25, 2022, and has approved ceiling price of 344 formulations in the previous meetings.

Of the 55 formulations considered in the latest meeting, the Authority deferred price fixation of antipsychotic drug risperidone long acting injection 25 mg/ml, following a complaint from multinational pharma major Johnson & Johnson.

Johnson & Johnson has submitted a representation on January 13, related to the draft working sheet for the formulation uploaded by the NPPA on January 6, 2023, where two line items - Restonorm by Aleteus Biogenics Ltd and Risperdal Consta by Johnson & Johnson - were considered for calculation.

The company, in its representation, claimed that the brand Restonorm is manufactured by HFA Formulations Pvt Ltd and the Central Drugs Standard Control Organisation (CDSCO) has not received the application from HFA Formulations Pvt Ltd for manufacturing of risperidone long acting injection 25 mg/ml.

The Authority, after deliberating the matter, decided to seek clarification from the Drugs Controller General (India) with respect to approval status of Restonorm, marketed by Aleteus Biogenics Ltd and manufactured by HFA Formulations. Based on this decision, it deferred the fixing of ceiling price for the formulation.

The Authority noted that a total of 792 representations were received from the companies till January 20, 2023, within the prescribed time line of 10 days from the release of the draft working sheets. The representations were broadly related to the data in the working sheet and the methodology, which has already been fixed by the NPPA.

Based on the representations, there were 33 formulations for which prices were revised compared to the ceiling price reflected in the uploaded draft working sheets.

Following this, the Authority approved revised ceiling prices of 54 formulations including omeprazole capsule 20 mg, colchicine tablet 0.5 mg, amoxicillin capsule 500 mg, dexamethasone tablet 0.5 mg, prednisolone tablets 5 mg and 10 mg, azithromycine tablets 250 mg and 500 mg, doxycycline capsule 100 mg, sodium valproate oral liquid 200 mg/5ml, Gefitinib tablet 250 mg, among others.

The Authority also approved separate ceiling prices for Mannitol injection 20% and metronidazole injection 500mg/100 ml from three companies - Otsuka Pharmaceuticals Pvt Ltd, Denis Chem Lab Ltd and Rusoma Laboratories Pvt Ltd, by adding 15 per cent over the ceiling prices refixed under the NLEM 2022 considering the special features of these formulations.

For Mannitol injection 20%, the Authority had fixed separate ceiling prices adding 15 per cent over the normal ceiling prices in a meeting held on August 18, 2021 based on the NLEM, 2015 and the latest decision is to revise the separate ceiling price based on the NLEM, 2022.

The NPPA is in the process of fixing the ceiling prices of the formulations listed in the Schedule I of the DPCO, 2013, after it has revised the Schedule replacing the National List of Essential Medicines (NLEM), 2015 with the latest NLEM, 2022.

The Authority earlier said that the number of formulations covered in revised Schedule I include 954 formulations in 388 medicines, with 56 newly added drug formulations and ceiling price of all these formulations may undergo a revision with the revised Schedule I of DPCO, 2013. The formulations continued from NLEM, 2015, are around 763 and total unique formulations for which ceiling prices are to be fixed are around 819. However, in view of the expansions to the revised Schedule 1 and others, the number of formulations may increase beyond 954 formulations to around 1000 formulations.

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 by 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.

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