NPPA fixes ceiling price of 18 scheduled formulations and retail price of 23 formulations

Saturday, June 10, 2023

The National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling price of 18 scheduled formulations and the retail price of 23 new drugs based on applications from the company, through a recent meeting. The price regulator has fixed the price of an ophthalmic drug formulation based on an earlier order to fix the value of formulations where there is high inter brand variation in prices.

The NPPA has issued an order fixing the ceiling prices of thiopentone powder for injection 1 gram at Rs. 55.32 per vial, thiopentone powder for injection 0.5 g at Rs. 45.69 per vial, permethrin gel 5% at Rs. 1.31 per gram, sumatriptan tablet 25 mg (Rs. 32.50 per tablet), 50 mg (55.68 per tablet), clofazimine capsule 100 mg (Rs. 3.98 per capsule), 50 mg (Rs 2.11 per capsule), dapsone tablet 100 mg (0.41 per tablet), isoniazid tablet 300 mg (Rs. 1.29 per tablet), 100 mg (Rs. 0.65 per tablet), warfarin tablet 5 mg (Rs. 2.40 per tablet), 3 mg (Rs. 3.18 per tablet), 1 mg (Rs. 2.46 per tablet), and succinylcholine injection 50 mg/mL at Rs. 5.21 per ML. The prices are exclusive of Good Sena Services Tax (GST), said the Authority in an order issued on June 8, 2023.

It has also fixed the ceiling price of framycetin cream 1% at Rs. 1.66 per gram and fludrocortisone tablet 0.1 mg at Rs. 13.20 per tablet, through another order, issued on the same day.

Besides, the Authority fixed the ceiling price of latanoprost drops 0.005%, an ophthalmic drug used to treat glaucoma, at Rs. 232.57 per ML, through another order. The Authority said that an inter brand price variation it has identified following the addition of certain new formulations in revised Schedule I of the Drugs (Prices Control) Order, 2013, has been observed in the case of latanoprost drops 0.005% also and the matter was deliberated in a recent Authority meeting. The meeting approved the ceiling price of this formulation based on the reasons detailed in a similar order issued on March 31, 2023.

In its order on March 31, 2023, the NPPA observed that the same formulation of one company having multiple prices for different brands and brands having inbuilt margins and high profits coupled with information asymmetry in the pharmaceutical sector, make many drugs beyond the reach of common man and also lead to financial burden/impoverishment.

“This is an extra-ordinary situation leading to market failure and working against public welfare. Therefore, it is essential to undertake an exercise to reduce the inter-brand price difference in the public interest in respect of schedule formulations since these formulations are considered to be essential medicines and have been included in the NLEM, 2022 for the first time and therefore, should not fall out of price control,” it said.

As per Para 20 of DPCO, 2013, no manufacturer can increase the prices of non-scheduled formulation by more than 10% during preceding twelve months, where the increase in the prices of non-scheduled formulations is beyond 10% of MRP, the manufacturer shall reduce the same to the level of 10% of MRP for next twelve months. Thus, Para 20 does not recognise the brand, and monitoring under Para 20 is done at the formulation level. Also, Para 20 does not differentiate the price increase of the same formulation based on the situation under which such price increase has occurred. In all situations, the manufacturer is bound to reduce the price to the level of 10%, it said.

Such anomalies in variation in price to retailer of same formulations sold by same companies under different brand names is considered to be extraordinary circumstance leading to market failure and against public welfare.

“Thus, the Authority after due deliberation decided that it becomes essential to undertake such exercise to remove huge inter brand/pack size price variation by capping the PTR of various brands/pack sizes of a formulation of a particular company at price of the lowest brand/ pack size plus 10%in the cases where non-scheduled formulations have come in the purview of NLEM, 2022 for the first time,” said the order.

Violation of the provisions of DPCO including Para 20 is not acceptable and should not form a basis for fixation of ceiling prices under NLEM, 2022. Hence, in the cases where non-scheduled formulations have come in the purview of NLEM, 2022 for the first time, if the inter-brand variation in the price of same formulation is more than 10%, the manufacturer is bound to reduce the price to the level of 10% as per the provisions of DPCO, 2013, it added.

The authority has also fixed the retail price of 23 formulations based on the applications from the individual manufacturers and marketers including Mankind Pharma Ltd, Eris Lifesciences Ltd, German Remedies Pharmaceuticals Pvt Ltd, Abbott Healthcare Pvt Ltd, Zydus Healthcare Ltd, Emcure Pharmaceuticals, Alembic Pharmaceuticals, Torrent Pharmaceuticals, Healing Pharma India Pvt Ltd, Aristo Pharmaceuticals and Alkem Laboratories Ltd.

PHARMABIZ.com