|
NPPA fixes ceiling prices of over 160 scheduled formulations under revised Schedule I of DPCO, 2013
|
|
Gireesh Babu, New Delhi
April 04 , 2023
|
|
|
The National Pharmaceutical Pricing Authority (NPPA) has revised or fixed ceiling price of over 160 scheduled formulations in its latest meeting, in line with its efforts to revise the ceiling price of formulations under the revised Schedule I of the Drugs (Prices Control) Order, 2013, which was amended last year with the National List of Essential Medicines (NLEM), 2022. The new ceiling prices for all the formulations may be notified after applying the Wholesale Price Index (WPI) increase of 12.128 per cent in line with the Authority’s order on March 27, 2023.
The Authority, which has uploaded the revised or newly fixed ceiling price calculation sheet for around 659 formulations till March 20, and approved 481 of them in earlier meetings, has picked up matters for finalising the ceiling prices of 171 formulations in its meeting held on March 29, 2023.
It has received a total of 1065 representations from companies within the prescribed time period of 10 working days till March 21, 2023, related to data in worksheets and those related to methodology.
After deliberation, the Authority approved ceiling prices of 80 scheduled formulations under the Para 4 of the DPCO, 2013, which is related to calculation of ceiling price of a scheduled formulation of specified strengths and dosages based on the calculation methods mentioned in the Paragraph.
This include certain strengths and dosage forms of ivermectin, diltiazem, clotrimazole, amoxicillin, cholecalciferol, bupivacaine, azithromycin, pheniramine, esmolol, permethrin, iohexol, caffeine, tetanus toxoid, vitamin A, vitamin C, dexamethasone, acetylsalicylic acid, haloperidol, doxorubicin, methotrexate, ifosfamide, loperamide, metoprolol, among others.
For the formulations dexamethasone injection 4mg/ml (pack of 20 ml) and gentamicin injection 40 mg/ml (pack of 2ml), the price fixation has been deferred, as the Authority directed to revise the worksheet for these two formulations since the ceiling prices may be fixed on per ml basis for different pack sizes existing in the market instead of making the range for pack sizes as proposed.
For certain formulations such as enoxaparin injection of certain strengths, paclitaxel injection of certain strengths, and budesonide respirator solution, the Authority deliberated the price fixation and fixed prices based on the prices of the other strengths of the same formulation.
It has also fixed the ceiling price of 54 scheduled formulations including certain strengths of ethambutol tablet, tramadol capsule, omeprazole capsule, cyclophosphamide tablet, haloperidol tablet, nitrofurantoin oral liquid, azathioprine tablet, lorazepam injection, amoxicillin powder for injection, mannitol injection, diltiazem injection, oxytocin injection, sodium bicarbonate injection, among others , under paragraph 6 of the DPCO, 2013, which is related to fixing ceiling price of a scheduled formulation in case of no reduction in price due to absence of competition.
The Authority also refuted the contention made by some representations that two different methodologies have been applied for common formulations and newly included formulations under NLEM, 2022, stating that it is “not tenable.” The comment is in connection to the fixation of ceiling price of newly added formulations in NLEM 2022, where inter-brand variation is observed more than 10 per cent.
The NPPA, observing high inter-brand variations of the same formulation of a company, has earlier decided to reduce the price difference while fixing the ceiling prices of the formulations by capping the price of the lowest brand or pack size plus 10 per cent.
“As per Para 20(1) of DPCO, 2013, where the increase in the prices of non-scheduled formulations is beyond 10 percent of MRP (Maximum Retail Price), the manufacturer shall reduce the same to the level of 10 percent of MRP for next twelve months. Hence, in cases where non-scheduled formulations have come within the purview of NLEM, 2022 for the first time, if the inter-brand variation in the price of same formulation of a company is more than 10 per cent, the manufacturers is bound to reduce the price to the level of 10%,” said the Authority.
“In view of this, for the formulations that have been included under NLEM 2022 for the first time, the PTR of various brands/pack sizes of a formulation of a particular company have been capped at price of the lowest brand/pack size plus 10 percent, an existing reference under DPCO, 2013 and the ceiling prices have been calculated as per the methodology prescribed as per Para 4 or Para 6 of DPCO, 2013, as the case may be. Further, monitoring under Para 20 is done at the formulation level and not a brand level. Any violation of Para 20 should not form a basis for fixation to ceiling prices under NLEM, 2022. Hence the present methodology is as per the provisions of DPCO, 2013. Therefore, the contention made in the representations that two different methodologies have been applied for Common Formulations and Newly included formulations under NLEM 2022 is not tenable,” further added the Authority.
Following this deliberation, the Authority decided to notify the prices of 27 newly added formulations. It has also fixed the ceiling price of atracurium injection 10mg/ml and dobutamine injection 50 mg/ml among others.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|