NPPA fixes retail price of 14 drug formulations; Details
New Delhi: Through a recent notification, the apex drug price regulatory agency, the National Pharmaceutical Pricing Authority (NPPA) has fixed the retail price of 14 drug formulations under the Drugs Prices Control Order (DPCO), 2013, exclusive of goods and services tax (GST).
The formulations whose prices have been fixed by NPPA include combination drug Emtricitabine and Tenofovir (Tafmune-EM), Tenofovir Alafenamide tablet, Tenofovir + Emtricitabine Tablet (TAFICITA), Tenofovir Alafenamide Tablet (Tenocruz
AF) and so on.
Various drugmakers including Sun Pharma, Natco Pharma, Mylan, Hetero Labs, Cadila Healthcare, Cipla, Emcure Pharma, Abbott, Dr Reddy's Labs, Torrent Pharma are involved in manufacturing the said formulations under different brand names.
The formulations mentioned in the list are indicated for the treatment of HIV-1 infection in adults and chronic hepatitis B infection, a viral infection of the liver,
The details of the list of all 14 formulations released by NPPA read;
Sl. No. | Name of the Formulation | Dosage form & Strength | Unit | Retail Price (Rs.) | Review Order number and date | Existing SO number & date | Manufacturer & Marketing Company respectively |
(1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) |
1. | Emtricitabine + Tenofovir tablet | Each film-coated tablet contains: | 1 Tablet | 57.69 | 31015/10/2019- Pricing dated 30.08.2019 | 1489(E) dated 29.03.2019 | M/s Hetero Labs Ltd. / M/s Cipla Ltd. |
(Tafmune – EM) | Emtricitabine IP 200 mg | (at Sl. No. 9) | |||||
Tenofovir Alafenamide | |||||||
Hemifumarate eq to Tenofovir | |||||||
Alafenamide 25 mg | |||||||
2. | Emtricitabine + | Each film-coated tablet | 1 | 32.49 | 1489(E) dated | M/s Hetero Labs Ltd. / | |
Tenofovir | contains: | Tablet | 29.03.2019 | M/s Cipla Ltd. | |||
Alafenamide tablet | Emtricitabine IP 200 mg + | (at Sl. No. 21) | |||||
Tenofovir Alafenamide | |||||||
Hemifumarate eq to Tenofovir | |||||||
Alafenamide 10mg tablet | |||||||
3. | Tenofovir | Each film-coated tablet | 1 | 46.18 | 1489(E) dated | M/s Hetero Labs Ltd. / | |
Alafenamide tablet | contains: | Tablet | 29.03.2019 | M/s Cipla Ltd. | |||
Tenofovir Alafenamide | (at Sl. No. 12) | ||||||
Hemifumarate eq to Tenofovir | |||||||
Alafenamide 25 mg tablet | |||||||
4. | Tenofovir + | Each film-coated tablet | 1489(E) dated | M/s Mylan Laboratories Ltd. / M/s Mylan Pharmaceuticals Pvt. Ltd. | |||
Emtricitabine | contains: | 29.03.2019 | |||||
Tablet (TAFICITA) | Tenofovir Alafenamide fumarate eq. to Tenofovir | 1 Tablet | 57.69 | (at Sl. No. 10) | |||
Alafenamide 25mg, | |||||||
Emtricitabine 200mg , | |||||||
5. | Tenofovir | Each film-coated tablet | 1 | 1489(E) dated | M/s Mylan Laboratories Ltd./ M/s Mylan Pharmaceuticals Pvt. Ltd. | ||
Alafenamide | contains: | Tablet | 29.03.2019 | ||||
Tablet | Tenofovir Alafenamide | 46.18 | (at Sl. No. 11) | ||||
fumarate eq. to Tenofovir | |||||||
Alafenamide 25 mg | |||||||
6. | Tenofovir | Each film-coated tablet | 1 | 46.18 | 1489(E) dated | M/s Hetero Labs Ltd./ | |
Alafenamide | contains: | Tablet | 29.03.2019 | M/s Cadila Healthcare | |||
Tablet | Tenofovir Alafenamide | (at Sl. No. 13) | Ltd. | ||||
Hemifumarate eq. to Tenofovir | |||||||
Alafenamide 25 mg | |||||||
7. | Tenofovir | Each film-coated tablet | 1 | 46.18 | 1489(E) dated | M/s Hetero Labs Ltd./ | |
Alafenamide | contains: | Tablet | 29.03.2019 | M/s Emcure | |||
Tablet | Tenofovir Alafenamide | (at Sl. No. 14) | Pharmaceuticals Ltd. | ||||
Hemifumarate eq. to Tenofovir | |||||||
Alafenamide 25 mg | |||||||
8. | Tenofovir | Each film-coated tablet | 1 | 46.18 | 1489(E) dated | M/s Natco Pharma Ltd. | |
Alafenamide | contains: | Tablet | 29.03.2019 | / M/s Sun Pharma | |||
Tablet | Tenofovir Alafenamide | (at Sl. No. 15) | Laboratories Ltd. | ||||
fumarate eq. to Tenofovir | |||||||
Alafenamide 25 mg | |||||||
9. | Tenofovir Alafenamide Tablet | Each film-coated tablet contains: Tenofovir Alafenamide | 1 Tablet | 46.18 | 1489(E) dated 29.03.2019 (at Sl. No. 16) | M/s Natco Pharma Ltd. / M/s Abbott India Ltd. | |
fumarate eq. to Tenofovir | |||||||
Alafenamide 25 mg | |||||||
10. | Tenofovir Alafenamide Tablet | Each film-coated tablet contains: Tenofovir Alafenamide | 1 Tablet | 46.18 | 1489(E) dated 29.03.2019 (at Sl. No. 17) | M/s Natco Pharma Ltd. | |
fumarate eq. to Tenofovir | |||||||
Alafenamide 25 mg | |||||||
11. | Tenofovir Alafenamide Tablet | Each film-coated tablet contains: Tenofovir Alafenamide | 1 Tablet | 46.18 | 1489(E) dated 29.03.2019 (at Sl. No. 18) | M/s Natco Pharma Ltd/ M/s Cadila Healthcare Ltd. | |
fumarate eq. to Tenofovir | |||||||
Alafenamide 25 mg | |||||||
12. | Tenofovir Alafenamide Tablet | Each film-coated tablet contains: Tenofovir Alafenamide | 1 Tablet | 46.18 | 1489(E) dated 29.03.2019 (at Sl. No. 19) | M/s Natco Pharma Ltd./ Dr Reddy's Laboratories Ltd. | |
fumarate eq. to Tenofovir | |||||||
Alafenamide 25 mg | |||||||
13. | Tenofovir Alafenamide Tablet | Each film-coated tablet contains: Tenofovir Alafenamide fumarate eq. to Tenofovir | 1 Tablet | 46.18 | 1489(E) dated 29.03.2019 (at Sl. No. 20) | M/s Natco Pharma Ltd./ M/s Aprazer Healthcare Pvt. Ltd. | |
Alafenamide 25 mg | |||||||
14. | Tenofovir | Each film-coated tablet | 1 | 46.18 | 1690(E) dated | M/s Hetero Labs Ltd./ | |
Alafenamide | contains: | Tablet | 02.05.2019 | M/s Torrent | |||
Tablet (Tenocruz AF) | Tenofovir Alafenamide Hemifumarate eq. to Tenofovir | (at Sl. No. 17) | Pharmaceuticals Limited | ||||
Alafenamide 25 mg |
The NPPA notice further added;
- 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 (5) 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 (5) 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 (5) 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 prices are applicable only to the manufacturer/marketer as mentioned above for generic/any brand of the same composition / strength of the subject formulations, subject to fulfillment 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 manufacturers/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.
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