Press Note
Subject: A brief on the decisions taken in the 117th meeting of the Authority held on 13.12.2010 and 16.12.2010 regarding fixation/revision of prices of scheduled bulk drug, CC, PC, PL & PM Norms and Formulation and other items.
The National Pharmaceutical Pricing Authority (NPPA), an independent body of experts in the Ministry of Chemicals and Fertilizer was formed by the Govt. of India vide Resolution published in the Gazette of India No. 159 dated 29.08.97. The functions of NPPA inter-alia include fixation and revision of prices of 74 scheduled bulk drugs and formulations containing any of the scheduled bulk drugs under the Drugs (Prices Control) Order, 1995 (DPCO’95), as well as monitoring and enforcement of prices. NPPA also provides inputs to Government for policy formulation and other specific issues concerning affordable medicines to the consumers.
- The NPPA in its meeting held on 13th and 16th December, 2010 fixed/revised the price of three bulk drugs and also revised the norms of Conversion Cost, Packing Charges, Process Loss and Packing Materials. The details are given below:
A. Bulk Drugs:-
Cefotaxime Sodium (sterile)
Human Insulin
Aspirin
- The price of Cefotaxime Sodium (sterile) has been revised based on a comprehensive cost price study undertaken by NPPA under para 3 of DPCO 1995. The revised price of this bulk drug is higher by 3.23% in comparison to the existing price. The impact of increase on the formulations of this bulk drug will be less than 1%. The previous study of this bulk drug was conducted in July, 2008. This bulk drug is used as an antibiotic.
- The price of Human Insulin has been revised based on a comprehensive cost price study undertaken by NPPA under para 3 of DPCO 1995. The previous study of this drug was done in August 2008. The revised price of this bulk drug has been worked out to Rs. 3950134 per kg as compared to the previous price of Rs. 3396087 per kg. The increase in the price of human insulin is due to increase in the cost of raw materials. The increase will provide level playing field to the indigenous manufacturers in relation to the imports.
- Price of Aspirin has been increased by 5.46% considering the increase in market prices of major raw materials, namely phenol and acetic anhydride under para 3(5) of DPCO 1995 in comparison to the existing price. The impact of increase on the formulations of this bulk drug will be around 2%.
b. Conversion Cost (CC), Packing Charges (PC), Process Loss (PL) and Packing Materials (PM).
The norms for conversion cost, packing charges, process loss and packing materials are required to be notified each year. Accordingly, these have been revised based on a study conducted by NPPA. The norms for CC and PC have increased by 5.76%. In respect of process loss, the current norms have been retained. However in cases where lower process losses were noticed as per study, such lower norms have been adopted. The impact of the increase in the norms of conversion cost and packing charges on the formulations will be about 1.5%. The packing material cost norms have increased by 0.8 to 3.36%. The impact of this increase on the formulations will be about 1%. Last year, no increase was given in these norms by re-notifying the previous norms.
1. Formulation Pricing
The Authority considered and approved the price revision of internal ceilings rates followed in respect of certain excepients (Pharmaceutical aids) commonly used in the manufacturing of formulations.
The Authority approved the prices in respect of 59 cases of formulation pricing. In addition, the prices of 37 formulation packs based on pro-rata pricing related to these 4 cases out of 59 cases have been fixed. This included 24 cases of formulations imported in finished form by different companies. In these cases the price reduction was from 10 % to 34.5% from their claimed prices. In most of the cases, the price were remained at the existing level and the price got reduced in 2 cases by 1.49% and 3.71% of Diavobet Ointment of M/s. Win Medicare and Vitalux Plus TR Tablet of M/s. Novartis respectively. All these imported cases included Insulin based formulation, Vitamin formulation, Methyl Predisolone formulation and Calcipotriol+Betamethasone Skin Ointment.
As regards the indigenously manufactured formulation pricing, there was one new case of Naproxen Gel for treating inflammation and pain and its price was reduced by 9.7% as compared to prices claimed by the company. In respect of the cases of price revision, the prices were reduced ranging 5.3% to 36.5% from the prices claimed by the respective company. However, in certain cases, prices have been increased considering increase in raw material cost and other input cost and revision in the norms of CC, PC & PM notified on 16.12.2010, particularly in respect of Analgin Injection by 23.5% and in 3 cases of Chlorpromazine based tablets increased ranging 10.9% to 36.8%. Prices of these formulations have been increased mainly due to bulk drug rates as applicable. The price of Chlorpromazine tablets of 200mg will be about Rs.1 per tablet. The Authority also reduced the prices of 7 Ibuprofen derivative formulations and 16 Ranitidine derivative formulations on suo-motu basis in order to pass on the effect of reduced notified price of these two drugs. Besides, the prices of 4 cases were fixed for the first time on suo-motu basis. A statement is enclosed for ready reference. For specific notifications, the NPPA’s website www.nppaindia.nic.in may be referred.
The formulations for which NPPA has fixed/revised the price are used for Diabetes, Pain killer, Anti- ulcer, Diahoerraial, Allergy, Asthma, Anti-Anxiety, Vitamins etc.
The manufacturers/importer affected by these price changes include Eli-Lilly, Pfizer, Novartis, Sanofi Aventis, Win Medicare, GSK, Abbott, Cadila, J. B. Chemicals, Torrent etc.
Summary of cases approved is as under.
Particulars | No. of Cases | Increased over Existing | Decreased over Existing | No change |
---|---|---|---|---|
Imported cases | 24 | -- |
2 1.49% & 3.71% |
22 |
New Cases | 1 | – | – | – |
Revision Cases | 7 (plus 33 Pro-rata packs) |
6 10% to 36.84%
|
1 3.71% |
-- |
Suo-Moto Cases Based on Ibuprofen
Based on Ranitidine |
7
16 |
—
— |
7 0.3% to 6.5% 15 1.23% to 16.9% & 33.3% & 59.8% |
–
1 |
Other Suo-moto cases Based on NPPA examination |
4 | – |
4 45.23% to 89.38% |
– |
Total | 59 (plus 33 cases of Pro-rata) | 6 | 29 | 23 (plus 1 new case) |
Last Page Updated: 07-02-2019
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