India: National Pharmaceutical Pricing Authority (NPPA) Updates For Month Of December 2017

National Pharmaceutical Pricing Authority (NPPA) is an organization of the Government of India which is an executive body under the Drugs (Prices Control) Order (DPCO), 2013 established to fix/ revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country. There are some key announcements/notice released by NPPA for the month of December 2017 as described below -

  1. National List of Essential Medicines (NLEM), 2015 formulations under provisions of DPCO, 2013 (Consolidated list as on 30.11.2017)
  2. NPPA fixed/revised ceiling prices/Retail Prices of 65 scheduled formulations under DPCO, 2013
  3. Form -I application for price fixation of new drug under Para 2(u) of DPCO, 2013
  4. NPPA fixed/revised ceiling prices/Retail Prices of 27 scheduled formulations under DPCO, 2013
  5. NPPA's consideration of Medtronic's request for discontinuation of Endeavour Sprint RX Zotarolimus Eluting Coronary Stent System

National List of Essential Medicines (NLEM), 2015 formulations pending for price fixation

On December 06, 2017, NPPA released the list of formulations pending for ceiling price fixations as on November 2017 under NLEM 2015, as the All Indian Origin Chemists & Distributors (AIOCD) association's Pharmatrac is not capturing the Price to Retailer (PTR) and Moving Annual Turnover (MAT) of said formulations. Therefore, NPPA requested all the concerned manufacturers / marketing companies to furnish the PTR & MAT in terms of value, duly self-attested with proper authorized signature & seal of the authorized officer of the company, for the formulations listed in NLEM, 2015 (revised Schedule - I of DPCO, 2013) i.e. Annexure -I for the month of August 2015 by December 22, 2017 for enabling NPPA to take appropriate action for ceiling price fixation under provisions of DPCO, 201327.

NPPA has fixed/revised ceiling prices/Retail Prices of 65 scheduled formulations under DPCO, 2013

On December 18, 2017, the NPPA has fixed/revised the ceiling /retail prices of 65 scheduled formulations under DPCO. The 65 scheduled formulations under price cap are mostly from anti-cancer, anti-HIV, anti-diabetics, lipid lowering drugs and other antibiotics categories as described below under various provisions -

Table1-Notified Retail price of 63 formulations under Drugs (Prices Control) Order, 2013

S l . No. Name of the Scheduled Formulation / Brand Name Strength Unit
1. Ferrous Ascorbate + Folic Acid + Cyanocobalamin +Zinc Sulphate Monohydrate tablet (Autrin - XT) Ferrous Ascorbate eq. to Elemental Iron 100mg, Folic Acid IP 1.5mg, Cyanocobalamin IP 15 mcg, Zinc Sulphate Monohydrate IP eq. to Elemental Zinc 22.5mg 1 Tablet
2. Rosuvastatin + Clopidogrel Capsule (Roseday CV 10) Rosuvastatin Calcium IP eq. to Rosuvastatin (As granules) 10mg, Clopidogrel Bisulphate IP eq. to Clopidogrel (As a film coated tablet) 75mg 1 Capsule
3. Rosuvastatin + Clopidogrel Capsule (Roseday CV 10) Rosuvastatin Calcium IP eq. to Rosuvastatin (As granules) 10mg, Clopidogrel Bisulphate IP eq. to Clopidogrel (As a film coated tablet) 75mg 1 Capsule
4. Teneligliptin + Metformin tablet (Ten20 M 1000) Teneligliptin Hydrobromide hydrate eq. to Teneligliptin 20mg, Metformin HCL 1000mg (as extended release) 1 Tablet
5. Clobetasol + Clotrimazole + Neomycin Sulphate Cream Clobetasol Propionate IP 0.05%w/w, Clotrimazole IP 1.00% w/w, Neomycin Sulphate IP 0.50%w/w 1 GM
6. Moxifloxacin + Cefixime Tablets (Moximac Plus) Moxifloxacin Hydrochloride BP eq. to Moxifloxacin 400mg, Cefixime IP (as trihydrate) eq. to Ahydrous Cefixime 400mg 1 Tablet
7. Tramadol + Paracetamol Tablet Tramadol Hydrochloride IP 37.5mg, Paracetamol IP 325mg 1 Tablet
8. Rosuvastatin + Aspirin + lopidogrel Tablet Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg, Aspirin IP 75mg, Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg 1 Tablet
9. Teneligliptin + Metformin Tablet Teneligliptin Hydrobromide hydrate eq. to Teneligliptin 20mg, Metformin HCL 500mg (as extended release) 1 Tablet
10. Teneligliptin + Metformin Tablet Teneligliptin Hydrobromide hydrate eq. to Teneligliptin 20mg, Metformin HCL 1000mg (as extended release) 1 Tablet
11. Paracetamol + Caffeine + Phenylephrine + Diphenhydramine Tablet Paracetamol IP 500mg, Caffeine (Anhydrous) IP 30mg, Phenylephrine Hydrochloride IP 5mg, Diphenhydramine Hydrochloride IP 25mg 1 Tablet
12. Ramipril + Amlodipine Tablet Ramipril IP 5mg, Amlodipine Besilate IP eq. to Amlodipine 5mg 1 Tablet
13. Teneliglitptin + Metformin Tablet Teneliglitptin Hydrobromide Hydrate 20mg eq. to Tenegliptin 20mg, Metformin Hydrochloride IP 1000mg (In Sustained Release form) 1 tablet
14. Teneliglitptin + Metformin Tablet Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg, Metformin Hydrochloride IP 500mg 1 Tablet
15. Rosuvastatin + Clopidogrel Capsule (Roistar CV 10/75) Rosuvastatin Calcium IP eq. to Rosuvastatin 10mg (As Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (as Pellets) 1 Capsule
16. Rosuvastatin + Clopidogrel Capsule (Roistar CV 20/75) Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (as Pellets) 1 Capsule
17. Diclofenac Injection Diclofenac Sodium IP 75mg Injection 1 ML
18 Teneligliptin + Metformin Tablet (EFIGLIN M) Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg, Metformin HCl 500mg 1 Tablet
19. Rosuvastatin + Clopidogrel Capsule Rosuvastatin Calcium IP eq. to Rosuvastatin 20mg (As granules), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (as to film coated tablets) 1 Capsule
20. Rosuvastatin + Clopidogrel Capsule (Roseday CV 20) Rosuvastatin Calcium IP eq. to Rosuvastatin (As Pellets) 20mg, Clopidogrel Bisulphate IP eq. to Clopidogrel (As Pellets ) 75mg 1 Capsule
21. Teneligliptin + Metformin Tablet Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg, Metformin HCL 500mg (as sustained release) 1 Tablet
22. Teneligliptin + Metformin Tablet Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg, Metformin HCL 1000mg (as sustained release) 1 Tablet
23. Metformin + Glimepiride + Voglibose Tablet Metformin HCL 500mg (as sustained release form), Glimepiride 2mg, Voglibose 0.3mg 1 Tablet
24. Paracetamol Tablet Paracetamol IP (as Immediate Release) 300mg, Paracetamol IP (as Sustained Release) 700mg 1 Tablet
25. Aceclofenac + Paracetamol Tablet Aceclofenac IP 100mg, Paracetamol IP 325mg 1 Tablet
26. Rosuvastatin + Clopidogrel Capsule Rosuvastatin 10mg, Clopidogrel 75mg 1 Capsule
27. Teneligliptin + Metformin Tablet (EFIGLIN M 1000) Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg, Metformin Hydrochloride IP 1000mg (as Sustained Release form) 1 Tablet
28. Olmesartan + Amlodipine Tablet Olmesartan Medoxomil IP 20mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, 1 Tablet
29. Telmisartan + Metoprolol Tablet (Xstan- Beta 25mg) Telmisartan IP 40mg, Metoprolol Tartrate IP 25mg (ER) 1 Tablet
30. Telmisartan + Metoprolol Tablet (Xstan- Beta 50mg) Telmisartan IP 40mg, Metoprolol Tartrate IP 50mg (ER) 1 Tablet
31. Voglibose + Glimepride + Metformin Tablet Voglibose IP 0.2mg, Glimepride IP 1mg, Metformin HCL IP 500mg (SR) 10 Tablets
32. Atorvastatin + Clopidogrel Capsules (Atchol CV 10mg) Atorvastatin Calcium eq. to Atorvastatin (as pellets) 10mg, Clopidogrel (as pellets) 75mg. 10 Capsule
33. Voglibose + Glimepride + Metformin Tablet Voglibose IP 0.2mg, Glimepride IP 2mg, Metformin Hydrochloride IP 500mg (SR) 1 Tablet
34. Teneligliptin + Metformin Tablet (Tenephron M) Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg, Metformin Hydrochloride 500mg (SR) 1 Tablet
35. Teneligliptin + Metformin Tablet (Tenephron M Forte) Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg, Metformin HCl 1000mg (SR) 1 Tablet
36. Teneligliptin + Metformin Tablet (TYTIN M) Teneligliptin Hydrobromide hydrate eq. to Teneligliptin 20mg, Metformin Hydrochloride 500mg (as extended release) 1 Tablet
37. Tacrolimus Capsule Tacrolimus IP 0.25mg 1 Capsule
38. Telmisartan + Amlodipine Tablet Telmisartan IP 80mg, Amlodipine Besilate IP 5mg 10 Tablet
39. Telmisartan + Amlodipine Tablet (Tigatel AM 40) Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg 1 Tablet
40. Cefixime + Ofloxacin Tablet (Ranixime Plus) Cefixime Trihydrate eq. to Cefixime Anhydrous IP 200mg, Ofloxacin IP 200mg 1 Tablet
41. Teneligliptin + Metformin Tablet (Glypte M) Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg, Metformin Hydrochloride 500mg 1 Tablet
42. Teneligliptin + Metformin Tablet (Glypte M Forte) Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg, Metformin Hydrochloride 1000mg 1 Tablet
43. Glemipiride + Metformin Tablet (Ziglim – M1 Forte) GlemipirideIP1mg,MetforminHydrochlorde IP 1000mg (as SR form) 1 Tablet
44. Glemipiride + Metformin Tablet (Ziglim – M2 Forte) GlimepirideIP2mg,MetforminHydrochlorde IP 1000mg (as SR form) 1 tablet
45. Diclofenac Injection Diclofenac Sodium IP 75mg/ml 1 ml
46. Doxorubicin (Pegylated Liposomal) Injection Doxorubicin HCL 2mg(Pegylated Liposomal) water for Injection 1 ml
47. Telmisartan + Indapamide Tablet Telmisartan IP 40mg Indapamide IP 1.5mg 1 Tablet
48. Paracetamol + Mefenamic Acid Injection (Zydol- P DS) Paracetamol 250mg Mefenamic Acid 100mg 1 ml
49. Paracetamol + Phenylephrine + Chlorpheniramine + Sodium Citrate + Menthol Injection Each 5ml contains: Paracetamol 125mg Phenylephrine Hydrochloride IP 5mg, Chlorpheniramine Maleate IP 0.5mg, Sodium Citrate IP 60mg, Menthol IP 1mg 1 ml
50. Atorvastatin + Clopidogrel Capsule (Atocor CV) Atorvastatin Calcium IP eq. to Atorvastatin 10mg (As film coated tablet), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As 2 film coated 37.5mg each tablet) 10 Capsule
51. Tacrolimus Capsule Tacrolimus premix (20%) eq. to Tacrolimus IP 0.25mg 1 capsule
52. Atorvastatin + Clopidogrel Capsule (Avas 10 Gold) Atorvastatin Calcium IP eq. to Atorvastatin 10mg (As film coated tablet) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As 2 film coated 37.5mg each tablet) 10 Capsule
53. Atorvastatin + Clopidogrel Capsule (Astin 10 Gold) Atorvastatin Calcium IP eq. to Atorvastatin 10mg (As film coated tablet), Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As 2 film coated 37.5mg each tablet) 10 Capsule
54. Glimepiride + Metformin Tablet (DIAPRIDE M 0.5) Glimepiride IP 0.5mg, Metformin Hydrochloride IP 500mg (SR) 1 Tablet
55. Telmisartan + Hydrochlorothiazide Tablet (Tigatel H 40) Telmisartan IP 40mg, Hydrochlorothiazide IP 12.5mg 1 Tablet
56. Telmisartan + Hydrochlorothiazide Tablet (Tigatel H 80) Telmisartan IP 80mg, Hydrochlorothiazide IP 12.5mg 1 Tablet
57. Telmisartan + Amlodipine Tablet (Tigatel AMH 40) Telmisartan IP 40mg, Amlodipine Besylate IP Eq. to Amlodipine 5mg, Hydrochlorothiazide IP 12.5mg 1 Tablet
58. Telmisartan + Amlodipine Tablet (Tigatel AMH 80) Telmisartan IP 80mg, Amlodipine Besylate IP Eq. to Amlodipine 5mg, Hydrochlorothiazide IP 12.5mg 10 Tablet
59. Sofosbuvir + Velpatasvir Tablet Sofosbuvir 400mg, Velpatasvir 100mg 28 tablets
60. Methylprednisolone Injection Methylprednisolone Sodium Succinate USP. Eq. to Methylprednisolone 125mg 1 Vial
61. Methylprednisolone Injection Methylprednisolone Sodium Succinate USP. Eq. to ethylprednisolone 500mg 1 Vial
62. Methylprednisolone Injection Methylprednisolone Sodium Succinate USP. Eq. to Methylprednisolone 1000mg 1 Vial
63. Bortezomib Injection (BortiRel) Bortezomib IP 3.5mg Injection 1 Vial1

Table 2 - Notified Retail price of 1 scheduled formulation of Schedule-I under Drugs (Prices Control) Order, 2013.

Sl. No. Name of the Scheduled Formulation Dosage form & Strength Unit
1. Anti-D Immunoglobulin Injection 150mcg Each Vial2

Table 3 - Notified ceiling price of 1 scheduled formulation of Schedule-I under para 19 of Drugs (Prices Control) Order, 2013.

Sl. No. Name of the Scheduled Formulation Dosage form & Strength Unit
1. Phenylephrine Drops 5% 1 ML3

Form -I application for price fixation of new drug under Para 2(u) of DPCO, 2013

On December 19, 2017, the NPPA has decided to de-link the price approval of new drugs with its internal guidelines. Earlier, in September 2014, the drug pricing regulator had asked all pharmaceutical firms to register themselves under its Integrated Pharmaceutical Database Management System (IPDMS), making this a requirement for fixing and revising drug prices. Now, NPPA in an office memorandum, has said that"price approval not be linked to IPDMS and any other conditionality"28.

NPPA has fixed/revised ceiling prices/Retail Prices of 27 scheduled formulations under DPCO, 2013

On December 20, 2017, the NPPA has fixed/revised the retail prices of 27 scheduled formulations under DPCO, 2013; the formulations with price caps are mostly from anti-diabetics, anti-hypertensive including other antibiotics categories as described below under various provisions –

Table 4 - Notified Retail price of 12 formulations under Drugs (Prices Control) Order, 2013

S l . No. Name of the Scheduled Formulation / Brand Name Strength Unit
1. Voglibose + Metformin Voglibose 0.2mg Metformin 500mg 1 Tablet
2. Voglibose + Metformin Voglibose 0.3mg Metformin 500mg 1 Tablet
3. Voglibose + Metformin + Glimepirid Voglibose 0.2mg Metformin 500mg Glimepirid 1mg 1 Tablet
4. Voglibose + Metformin + Glimepirid Voglibose 0.2mg Metformin 500mg Glimepirid 1mg 1 Tablet
5. Voglibose + Metformin + Glimepirid Voglibose 0.2mg Metformin 500mg Glimepirid 1mg 1 Tablet
6. Voglibose + Metformin + Glimepirid Voglibose 0.2mg Metformin 500mg Glimepirid 2mg 1 Tablet
7. Voglibose + Metformin + Glimepirid Voglibose 0.2mg Metformin 500mg Glimepirid 2mg 1 Tablet
8. Voglibose + Metformin + Glimepirid Voglibose 0.2mg Metformin 500mg Glimepirid 2mg 1 Tablet
9. Voglibose + Metformin + Glimepirid Voglibose 0.3mg Metformin 500mg Glimepirid 1mg 1 Tablet
10. Voglibose + Metformin + Glimepirid Voglibose 0.3mg Metformin 500mg Glimepirid 1mg 1 Tablet
11. Voglibose + Metformin + Glimepirid Voglibose 0.3mg Metformin 500mg Glimepirid 2mg 1 Tablet
12. Diclofenac + Tramadol Diclofenac 75mg Tramadol 50mg 1 Tablet4

Table 5 - Notified Retail Price of 15 formulations under Drugs (Prices Control) Order, 2013

S l . No. Name of the Scheduled Formulation / Brand Name Strength Unit
1. Glimepiride + Metformin Tablets Glimepiride 1mg & Metformin 500mg. 1 tablet
2. Glimepiride + Metformin Tablets Glimepiride 2mg & Metformin 500mg. 1 Tablet
3. Metoprolol + Chlorthalidone Tablets Metoprolol 25mg & Chlorthalidone 12.5mg. 1 Tablet
4. Metoprolol + Chlorthalidone Tablets Metoprolol 25mg & Chlorthalidone 12.5mg 1 Tablet
5. Metoprolol + Chlorthalidone Tablets Metoprolol 50mg & Chlorthalidone 12.5mg 1 Tablet
6. Metoprolol + Chlorthalidone Tablets Metoprolol 50mg & Chlorthalidone 12.5mg 1 Tablet
7. Moxifloxacin + Cefixime Tablets Moxifloxacin 400mg & Cefixime 400mg 1 Tablet
8. Gliclazide + Pioglitazone + Metformin Tab- lets Gliclazide 60mg, Pioglitazone 7.5mg & Metformin 500mg 1 Tablet
9. Teneligliptin + Metformin Tablets Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg, Metformin HCl 1000mg 1 Tablet
10. Teneligliptin + Metformin Tablets Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg Metformin HCl 500mg 1 Tablet
11. Glimepiride + Metformin Tablets Glimepiride 1mg & Metformin 1000mg 1 Tablet
12. Glimepiride + Metformin Tablets Glimepiride 2mg & Metformin 1000mg. 1 Tablet
13. Glimepiride + Metformin Tablets Glimepiride 3mg & Metformin 1000mg 1 Tablet
14. Metformin + Glimepiride + Pioglitazone Tablets Metformin 500mg, Glimepiride 1mg & Pioglitazone 15mg 1 Tablet
15. Metformin + Glimepiride + Pioglitazone Tablets Metformin 500mg, Glimepiride 2mg & Pioglitazone 15mg 1 Tablet5

NPPA's consideration of Medtronic's request for discontinuation of Endeavour Sprint RX Zotarolimus Eluting Coronary Stent System

On December 27, 2017, the NPPA has considered the request of M/s India Medtronic Pvt. Ltd for discontinuation of Endeavor Sprint RX Zotarolimus Eluting Coronary Stent based on unavailability because of stoppage of its production globally; and noted in the Authority meeting No 51 held on 15/12/2017. The consideration was under para 21(2) of Drugs Prices Control Order (DPCO), 2013 on the ground of stoppage of manufacturing of these stent brands globally.

Para 21 (2) of the DPCO, 2013 reads as follows:

21. Monitoring the availability of scheduled formulations:

(1)...

(2) Any manufacturer of scheduled formulation, intending to discontinue any scheduled formulation from the market shall issue a public notice and also intimate the government in Form- IV of Schedule-ll of this order in this regard at least six months prior to the indented date of discontinuation and the Government may, in public interest, direct the manufacturer of the scheduled formulation to continue with required level of production or import for the period not exceeding one year, from the intended date of such discontinuation within a period of sixty days of receipt of such intimation

NPPA has further advised that, in order to formally 'complete' the process of 'withdrawal' the company will issue a public notice in the prescribed format, in at least two national newspapers (one English and one in Hindi) and also publish the same on their website and send a copy of the same to NPPA29.

Footnotes

27 http://www.nppaindia.nic.in/order/om_07-12-2017.pdf

28 http://www.nppaindia.nic.in/order/om_19-12-2017.pdf

29 http://www.nppaindia.nic.in/order/om_27-12-2017.pdf

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Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

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