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Prices of 21 New Drugs fixed by NPPA; Details


Prices of 21 New Drugs fixed by NPPA; Details

The NPPA order is likely to affect drug majors including Torrent Pharma, Alkem Laboratories, Zydus Pharmaceuticals, Cadila Healthcare, Mylan, Cipla, Hetero Labs, Emcure, Sun Pharma, Natco Pharma, Dr Reddy’s and others.

New Delhi: Through a recent notification, the government regulatory agency, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 21 drug formulations. These formulations include medicines used to treat viral infection, anti-diabetic medicine which lower the blood sugar level, certain injections which help in treating different infections and meningitis.

The NPPA order is likely to affect drug majors including Torrent Pharma, Alkem Laboratories, Zydus Pharmaceuticals, Cadila Healthcare, Mylan, Cipla, Hetero Labs, Emcure, Sun Pharma, Natco Pharma, Dr Reddy’s and others.

Some of the formulations whose price has been fixed by the NPPA are Tenofovir Alafenamide Tablet manufactured by Dr Reddy’s, Metformin + Glimepiride Tablet (Azulix 0.5 MF) manufactured by Torrent Pharma, Cadila Pharma’s Atorvastatin +  Fenofibrate Tablet and so on. The notice detail reads;

Sl. No. Name of the Formulation / Brand Name Strength Unit Manufacturer & Marketing Company Retail Price (Rs.)
(1) (2) (3) (4) (5) (6)
1. Sodium Fusidate +
Halobetasole  Cream
Cream contains:
Sodium Fusidate IP eq. to Fusidic Acid 2% w/w,
Halobetasole Propionate USP 0.05% w/w
 

 

1 gm

M/s Apex Laboratories Private Limited 12.92
2. Metformin + Glimepiride Tablet (Azulix 0.5 MF) Each Uncoated Bilayered Tablet contains:
Glimepiride IP 0.5mg,
Metformin Hydrochloride IP 500mg (As Prolonged Release Form)
1 Tablet M/s Pure and Cure Healthcare Pvt. Ltd. / M/s Torrent Pharmaceuticals Limited 3.58
3. Escitalopram + Clonazepam Tablet  (Newcita Mini) Each film coated tablet contains:
Escitalopram Oxalate IP eq. to Escitalopram 5mg,
Clonazepam IP 0.5mg
1 Tablet M/s Ravian Life Science Pvt. Ltd. / M/s Alkem Laboratories Ltd. 6.10
4. Ceftriaxone +
Sulbactum Injection (Taxone SB 1000mg )
Each vial contains:
Ceftriaxone Sodium IP eq. to Ceftriaxone 1gm
Sulbactum Sodium USP eq. to Sulbactum 500mg
1 vial M/s Mapra Laboratories Pvt. Ltd. 110.95
5. Ceftriaxone +
Sulbactum Injection (Taxone SB 250mg )
Each vial contains:
Ceftriaxone Sodium IP eq. to Ceftriaxone 250gm
Sulbactum Sodium USP eq. to Sulbactum 125mg
1 vial M/s Mapra Laboratories Pvt. Ltd. 43.21
6. Ceftriaxone +
Sulbactum Injection (Taxone SB 500mg )
Each vial contains:
Ceftriaxone Sodium IP eq. to Ceftriaxone 500gm
Sulbactum Sodium USP eq. to Sulbactum 250mg
1 vial M/s Mapra Laboratories Pvt. Ltd. 71.60
7. Atorvastatin +  Fenofibrate Tablet Each film coated Tablet contains:
Atorvastatin 10mg,
Fenofibrate 160mg
1 Tablet M/s Rivpra Formulations Pvt. Ltd. / M/s Cadila Pharmaceuticals Limited 11.52
8. Hyaluronic Acid + Lidocain Hydrochloride Injection Each ml contains:
Hyaluronic Acid BP 24.0mg
Lidocain Hydrochloride IP 3.00mg
Per Pack having 2 prefilled syringe of 1 ML Each M/s Virchow Biotech Limited. / M/s Zydus Healthcare Limited 26987.40
9. Emtricitabine + Tenofovir Alafenamide tablet (Tafmune – EM) Each film coated tablet contains:

Emtricitabine IP 200 mg

Tenofovir Alafenamide Hemifumarate eq. to Tenofovir Alafenamide 25 mg

1 Tablet M/s Hetero Labs Ltd. / M/s Cipla Ltd. 55.33
10. Tenofovir Alafenamide + Emtricitabine Tablet (TAFICITA) Each film coated contains:
Tenofovir Alafenamide fumarate eq. to Tenofovir Alafenamide 25 mg
Emtricitabine 200mg
1 Tablet M/s Mylan Laboratories Ltd.  / M/s Mylan Pharmaceuticals Pvt. Ltd. 55.33
11. Tenofovir Alafenamide Tablet Each film coated tablet contains:

Tenofovir Alafenamide fumarate eq. to Tenofovir Alafenamide 25 mg

1 Tablet M/s Mylan Laboratories Ltd./ M/s Mylan Pharmaceuticals Pvt. Ltd. 44.29
12. Tenofovir Alafenamide Tablet Each film coated tablet contains:

Tenofovir Alafenamide Hemifumarate eq. to Tenofovir Alafenamide 25 mg

1 Tablet M/s Hetero Labs Ltd./ M/s Cipla Ltd. 44.29
13. Tenofovir Alafenamide Tablet Each film coated tablet contains:

Tenofovir Alafenamide Hemifumarate eq. to Tenofovir Alafenamide 25 mg

1 Tablet M/s Hetero Labs Ltd./ M/s Cadila Healthcare Ltd. 44.29
14. Tenofovir Alafenamide Tablet Each film coated tablet contains:

Tenofovir Alafenamide Hemifumarate eq. to Tenofovir Alafenamide 25 mg

1 Tablet M/s Hetero Labs Ltd./ M/s Emcure Pharmaceuticals Ltd. 44.29
15. Tenofovir Alafenamide Tablet Each film coated tablet contains:

Tenofovir Alafenamide fumarate eq. to Tenofovir Alafenamide 25 mg

1 Tablet M/ Natco Pharma Ltd. / M/s  Sun Pharma Laboratories Ltd. 44.29
16. Tenofovir Alafenamide Tablet Each film coated tablet contains:

Tenofovir Alafenamide fumarate eq. to Tenofovir Alafenamide 25 mg

1 Tablet M/ Natco Pharma Ltd. / M/s Abbott India Ltd. 44.29
17. Tenofovir Alafenamide Tablet Each film coated tablet contains:

Tenofovir Alafenamide fumarate eq. to Tenofovir Alafenamide 25 mg

1 Tablet M/ Natco Pharma Ltd. 44.29
18. Tenofovir Alafenamide Tablet Each film coated tablet contains:

Tenofovir Alafenamide fumarate eq. to Tenofovir Alafenamide 25 mg

1 Tablet M/ Natco Pharma Ltd. / M/s Cadila Healthcare Ltd. 44.29
19. Tenofovir Alafenamide Tablet Each film coated tablet contains:

Tenofovir Alafenamide fumarate eq. to Tenofovir Alafenamide 25 mg

1 Tablet M/ Natco Pharma Ltd. / M/s  Dr. Reddy’s Laboratories Ltd. 44.29
20. Tenofovir Alafenamide Tablet Each film coated tablet contains:

Tenofovir Alafenamide fumarate eq. to Tenofovir Alafenamide 25 mg

1 Tablet M/ Natco Pharma Ltd. / M/s  Aprazer Healthcare Pvt. Ltd. 44.29
21. Emtricitabine + Tenofovir Alafenamide Tablet Each film coated tablet contains:
Emtricitabine IP 200mg,
Tenofovir Alafenamide Hemifumarate eq. to Tenofovir Alafenamide 10mg
1 Tablet M/s Hetero Labs Limited / M/s Cipla Limited 31.17

The notice further adds;

  • The manufacturer of above mentioned formulations i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (6) of the table hereinabove.
  • The manufacturer may add goods and services tax only if they have paid actually or it is payable to the Government on the retail price mentioned in column (6) of the above said table.
  • The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in accordance with the retail price specified in column (6) of the above table as per provisions contained in paragraph 11 of the DPCO, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers.
  • As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.
  • The above mentioned retail price is applicable only to the individual manufacturer / marketer as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013 and subject to fulfilment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies.
  • In case the retail price of any of the aforesaid formulations is not complied with, as per instant price notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO, 2013 read with the Essential Commodities Act, 1955.
  • Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded.

Also Read: NPPA fixes retail price of 29 drug formulations including BP, Cholesterol, pain medications; Details


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