India: NPPA Updates For The Month Of February 2018

Last Updated: 16 March 2018
Article by Singh & Associates

Most Read Contributor in India, December 2018

The National Pharmaceutical Pricing Authority (NPPA), is an executive body under the Drugs (Prices Control) Order (DPCO), 2013 under Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. NPPA regulates drug prices and availability of the medicines in the country by fixing/revising the prices of controlled bulk drugs and formulations. The NPPA's key announcements/notices of February 2018 are apprised and described below:

  1. NPPA fixed/revised ceiling/retail prices of 30 formulations under DPCO 2013,
  2. NPPA releases clarification regarding partially revised format of Form – I for applications of new drug under Para 2(u) of DPCO 2013
  3. Analysis of Trade margin in Cardiac guide wire/Balloon catheter/ Guiding catheter,
  4. Revision of coronary stents price
  5. NPPA fixed/revised ceiling/retail prices of 09 formulations under DPCO 2013
  6. Price analysis based on the complaints received in NPPA regarding overcharging in bills by four hospitals,
  7. NPPA fixed/revised ceiling/retail prices of 14 formulations under DPCO 2013.

1. NPPA has fixed/revised ceiling prices/retail prices of 30 formulations: On February 06, 2018, NPPA has fixed ceiling prices/retail prices of 30 formulations under DPCO, 2013. Amongst the 30 formulation included in this price fixation notice, included drugs are used for treatment of conditions like Pain, Infections, Hypertension, Epilepsy, Diabetes, Cancer etc. as described below -

Sl. No. Name of the Formulation / Brand Name Strength Unit
(1) (2) (3) (4)
1. Paracetamol + Dicyclomine Tablet (Pacimol Spas) Each Uncoated tablet contains: Paracetamol IP 500mg, Dicyclomine Hydrochloride IP 20 mg 1 Tablet
2. Amoxicillin Potassium Clavulanate Tablet (Clavam Forte DT) Each uncoated dispersible tablet containing: Amoxi- cillin Trihydrate IP eq. to Amoxicillin 400mg, Potassium Clavulanate diluted IP eq. To Clavulanic acid 57 mg 1 Tablet
3. Telmisartan + Chlorthalidone Tab- let (Tigatel CH40) Each film coated Tablet contains: Telmisartan IP 40mg, Chlorthalidone IP 12.5mg 1 Tablet
4. Cilnidipine + Telmisartan tablet (Telvacil 80mg) Each Tablet contains: Cilnidipine 10mg , Telmisartan IP 80mg 1 Tablet
5. Metoprolol ER Tablet Each film coated extended release Tablet contains: Metoprolol Succinate IP 71.25mg eq. to Metoprolol Tartrate 75mg. 1 Tablet
6. Paracetamol + Caffeine Tablate (Pacimol Active) Each film coated Tablet contains: Paracetamol IP 650mg, Caffeine Anhydrous IP 50mg 1 Tablet
7. Doxycyclilne + Lactic Acid Bacillus capsules Each hard Gelatin capsule contains: Doxycycline Hyclate eq. to Doxycycline 100mg, Lactic Acid Bacillus 5 Billion Spores 1 Capsule
8. Doxycyclilne + Lactic Acid Bacillus capsules Each hard Gelatin capsule contains: Doxycycline Hyclate eq. to Doxycycline (Pellets) 100mg, Lactic Acid Bacillus (enteric coated Pellets) 5 Billion Spores 1 Capsule
9. Cilnidipine + Telmisartan Tablet Each film coated tablet contains: Cilnidipine 10mg, Telmisartan IP 40mg 1 Tablet
10. Cilnidipine + Telmisartan Tablet Each film coated tablet contains: Cilnidipine 10mg, Telmisartan IP 40mg 1 Tablet
11. Levetiracetam Tablet Each film coated tablet contains: Levetiracetam IP 1000mg 1 Tablet
12. Levetiracetam Tablet Each film coated prolonged release tablet contains: Levetiracetam IP 1000mg 1 Tablet
13. Phenylephrine + Chlorphenira- mine Syrup Each 5 ml Contains: Phenylephrine Hydrochloride IP 5mg, Chlorpheniramine Maleate IP 2mg 1 ML
14. Sumatriptan + Naproxen Tablet (NAXCOM) Each uncoated bilayer tablet contains: Sumatriptan Succinate IP eq. to Sumatriptan 85mg, Naproxen Sodium USP 500mg 1 Tablet
15. Cilnidipine + Telmisartan + Chlorthalidone Tablet Each film coated tablet contains: Cilnidipine 10mg, Telmisartan IP 40mg, Chlorthalidone IP 6.25mg 1 Tablet
16. Telmisartan + Amlodipine + Chlorthalidone Tablet Each film coated tablet contains: Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, Chlorthalidone IP 12.5mg 1 Tablet
17. Telmisartan + Amlodipine + Chlorthalidone Tablet (Tigatel ACH 40) Each film coated tablet contains: Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, Chlorthalidone IP 12.5mg 1 Tablet
18. Telmisartan + Amlodipine + Chlorthalidone Tablet (Tigatel ACH 80) Each uncoated tablet contains: Telmisartan IP 80mg, Amlodipine Besylate IP Eq. to Amlodipine 5mg & Chlorthalidone IP 12.5mg 1 Tablet
19. Human Insulin Injection Insulin Biophasic Isophane Ph. Eur./ USP (30% as soluble Insulin Injection and 70% as Isophane Insulin Injection) Each ml contains: r-human Insulin (Regu- lar) 100 IU/vial, m-Cresol USP – 0.16% w/v, Phenol IP 0.065% w/v 1 ML
20. Human Insulin Injection Insulin Biophasic Isophane Ph. Eur./ USP (50% as soluble Insulin Injection and 50% as Isophane Insulin Injection) Each ml contains: r-human Insulin (Regu- lar) 100 IU/vial, m-Cresol USP – 0.16% w/v, Phenol IP 0.065% w/v 1 ML
21. Human Insulin Injection Soluble Insulin Ph. Eur./USP Each ml contains: r-hu- man Insulin (Regular) 100IU/vial 1 ML
22. Docetaxel Injection (Docetaxel IP 120mg/3ml) Each ml of concentrate contains: Docetaxel (as anhydrous) 40mg, Polysorbate 80 – 566mg, Ethanol Anhydrous 326mg, Citric Acid Monohydrate 2mg (for PH adjustment), water for injection Each Pack (120mg/3ml)
23. Escitalopram + Clonazepam Tablet (Szetalo Plus 5) Each film coated tablet contains: Escitalopram Oxalate IP eq. to Escitalopram 5mg, Clonazepam IP 0.5mg 1 Tablet
24. Telmisartan + Amlodipine Tablet (Telmiduce AM) Each uncoated tablet contains: Telmisartan IP 40mg, Amlodipine Besylate IP eq. to Amlodipine 5mg 1 Tablet
25. Telmisartan + Hydrocholrothiazide (Telmiduce H 40) Each uncoated tablet contains: Telmisartan USP 40mg, Hydrocholrothiazide USP 12.50mg 1 Tablet
26. Rosuvastatin + Aspirin + Clopidogrel Capsule (Rozucor Gold 10) Each Hard Gelatine Capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastation 10mg (As pellets), Aspirin IP 75mg (As Gastro - resistant pellets), Clopido- grel Bisulphate IP eq. to Clopidogrel 75mg (As pellets) 1 Capsule
27. Rosuvastatin + Aspirin + Clopidogrel Capsule (Rozucor Gold 20) Each Hard Gelatine Capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastation 20mg (As pellets), Aspirin IP 75mg (As Gastro - resistant pellets), Clopido- grel Bisulphate IP eq. to Clopidogrel 75mg (As pellets) 1 Capsule
28. Amoxycillin + Clavulante Suspen- sion Each combipack contains: (a) One bottle of Amoxycil- lin & Potassium Clavunate Oral Suspension I.P. Each 5ml of reconstituted suspension contains: Amoxycil- lin Trihydrate IP eq. to Amoxycillin 400mg, Potassium Clavulante Diluted IP eq. to Clavulnic Acid 57mg 1 ML
29. Paracetamol + Mafenamic Suspen- sion (Pacimol MF 125) Each 5ml contains: Paracetamol IP 125mg, Mafenamic acid IP 50mg Flavoured Syrup base 1 ML
30. Etoricoxib + Paracetamol Tablet (Etomax P) Each film coated tablet contains: Etoricoxib IP 60mg, Paracetamol IP 325mg 1 Tablet

2. NPPA releases clarification regarding partially revised format of Form – I: On February 05, 2018, NPPA released clarification regarding partially revised format of Form – I for applications of new drug under Para 2(u) of DPCO, 2013. NPPA clarified that in order to expedite the retail price of new drug applications, the applicant company has been asked to indicate drug category as per the report of Kokate committee and Drug Technical Advisory Board (DTAB) to save time spent by NPPA on seeking this information from Drug Controller General of India (DCGI)17.

3. Analysis of Trade margin in Cardiac guide wire/Balloon catheter/ guiding catheter: On February 12, 2018, NPPA analyzed the trade margins in the Cardiac Guidewire/Balloon Catheter and Guiding wire based on available data from the official sources and manufacturer/importer as described below –

SI No Particulars Average Margin %
(MRP – import price)
Average Margin %
(MRP – PTD)
1 Cardiac Balloon Catheter 405% 234%
2 Cardiac Guidewire 158% 112%
3 Cardiac Guiding Catheter 295% 93%
4 Cardiac Drug Eluting Balloon or Cutting Balloon 292% 140%
5 Cardiac Guiding Catheter — Special feature 172% 62%

*MRP: Maximum Retail Price, PTD: Price to Distributor/Stockist.18

4. Revision of coronary stents price: On February 12, 2018,19 NPPA fixed and notified the revised ceiling prices of drug eluting stents (DES) from Rs. 29,600 to Rs 27,890, while marginally raising the cap on bare metal stents from Rs 7,260 to Rs 7,660, exclusive of goods and services tax applicable, if any. Whereas, any manufacturer intending to discontinue production or import of any Coronary Stent shall furnish information to the NPPA, in respect of discontinuation of production and / or import in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation as prescribed under paragraph 21(2) of the DPCO, 2013 and follow the ceiling price in such manner and till such a time prescribed by the Government. The revised ceiling price hereinabove shall be applicable till March 31, 2019 unless revised by another notification20.

5. NPPA has fixed/revised ceiling/retail prices of 09 formulations: On February 13, 2018, NPPA revised the ceiling prices of nine scheduled formulations under DPCO, 2013. The said formulations are used to treat a range of ailments from infertility in women to arthritis to seizures. The formulations included in this price revision are Clomiphene tablets, Adenosine injection 3mg/ml, Povidone Iodine Solution 10 percent(1 ml), Methylprednisolone injection 40mg/ml (1 ML), Sodium Valproate CR tablets 300 mg,& 500mg, Isosorbide 5 Mononitrate tablet 20 mg, and Lignocaine Topical Forms 2-5 per cent (1 gm or 1 ml)21.

6. Price analysis based on the complaints received by NPPA regarding overcharging in bills by four hospitals: On February 20, 2018, NPPA released Price analysis report after receiving complaints of overpricing and inflated bills from the relatives of deceased patients. NPPA, within its jurisdiction under Drug Prices Control Order, 2013 had asked for details of billing from these hospitals and analyzed the same in great detail.

The report suggests that the total expenditure on drugs and devices and diagnostics is substantially high (46%) and does not make part of the publicized 'estimate' or 'package'. This is a clear case of market distortion where manufacturers after accounting for their profits print inflated MRPs to meet the demands of a distorted trade channel without getting any benefits from this 'artificial inflation' and patients have to incur huge out-of-pocket expenditure in hospitalization cases. The major beneficiaries of profits in all these cases because of inflated MRPs have been hospitals rather than drugs and devices manufacturers. The violation of ceiling price and corresponding MRPs is detected only in very few cases which shall be pursued further by NPPA for recovering the overcharging amounts from defaulters22.

7. NPPA fixed/revised ceiling/retail prices of 14 formulations under DPCO 2013: On February 27, 2018, NPPA fixed/revised the retail/ceiling prices of 14 scheduled formulations under DPCO, 2013. The revised formulations are used for the treatment of diabetes, hypertension, cancer and Hyperlipidemia etc. as described below-

SI. No. Name of the Formulation / Brand Name Strength Unit
1. Amlodipine +, Valsartan Tablet (Valembic 80 AM) Each film coated tablet contains: Amlodipine Besylate eq. to Amlodip- ine USP 5mg, Valsartan USP 80mg Tablet 1 Tablet
2. Amlodipine +, Valsartan Tablet (Valembic 160 AM) Each film coated tablet contains: Amlodipine Besylate eq. to Amlodip- ine USP 5mg, Valsartan USP 160mg Tablet 1 Tablet
3. Paclitaxel (Protein Bound Particles) for Injectable Suspension (Nabtoxol) Each vial contains: Paclitaxel 100mg Human albumin 1 Vial
4. Telmisartan + Chlorthali- done Tablet Each uncoated bilayered tablet contains: Telmisartan IP 40mg, Chlorthalidone IP 6.25mg 1 Tablet
5. Glimepiride + Metformin + Voglibose Tablet (TRIVO- GO 2/0.3 Mg) Each uncoated bilayered tablet contains: Glimepiride IP 2mg, Metformin Hydrochloride IP 500mg (As SR form) Voglibose IP 0.3mg 1 Tablet
6. Etoricoxib + Paracetamol Tablet Each film coated tablet contains: Etoricoxib IP 60mg , Paracetamol IP 325mg 1 Tablet
7. Sofosbuvir + Velpatasvir Tablets Each film coated tablet contains: Sofosbuvir IH 400mg, Velpatasvir IH 100mg 1 Tablets
8. Atorvastatin + Clopidogrel Capsule Each hard gelatin capsule contains: Atorvastatin Calcium IP eq. to Atorvastatin 10mg (As Pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) 1 Capsule
9. Atorvastatin + Clopidogrel Capsule Each hard gelatin capsule contains: Atorvastatin Calcium IP eq. to Atorvastatin 20mg (As Pellets) Clopidogrel Bisulphate IP eq. to Clopi- dogrel 75mg (As Pellets) 1 Capsule
10. Rosuvastatin + Aspirin + Clopidogrel Capsule Each hard gelatin capsule contains: Rosuvastatin Calcium IP eq. to Rosuvastation 20mg (As pellets) Aspirin IP 75mg (As enteric coated pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As pellets) 1 Capsule
11. Ferrous Ascorbate + Folic Acid Suspension Each 5ml of suspension contains: Ferrous Ascorbate eq. to elemental Iron 30mg, Folic Acid IP 550mcg In a flavoured Syrupy base. 1 ML
12. Bortezomib Injection Each vial contains: Bortezomib IP 3.5mg Injection 1 Vial
13. Teneligliptin + Metformin HCl Tablet Each uncoated bilayered tablet contains: Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg Metformin HCl 500mg (SR) 1 Tablet
14. Teneligliptin + Metformin HCl Tablet Each uncoated bilayered tablet contains: Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg Metformin HCl 1000mg (SR) 1 Tablet2

Footnotes

17. http://www.nppaindia.nic.in/order/om_revisedformat(09022018).pdf

18. http://www.nppaindia.nic.in/order/trade_margin(Catheters).pdf

19. http://www.nppaindia.nic.in/order/revised_prices(coronary-stents).pdf

20. http://www.nppaindia.nic.in/minutes/minutes-2017-18/Authority_minutes.pdf

21. http://www.nppaindia.nic.in/ceiling/press13feb18/Formulation_Prices(09).pdf

22. http://www.nppaindia.nic.in/order/overcharging_details(20022018).pdf

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