NPPA fixes retail prices of 30 formulations, rejects four applications

The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices of 30 formulations under the provision of the Drugs (Prices Control) Order (DPCO) 2013.

Although the authority received applications for 34 new drug pricing, it approved only 30 new drugs. Two applications each from Micro Laboratories and Sun Pharma have been deferred by the authority i.e. dapagliflozin + metformin hydrochloride ER tablet, dapagliflozin + metformin hydrochloride tablet, Metformin SR + glimepiride + voglibose tablet respectively.

There are a total of 11 manufacturers whose prices for 30 different formulations have been capped under the DPCO 2013. Mylan Pharmaceuticals leads the list with its five formulations included in the price control list. It is followed by Intas Pharmaceuticals, Aristo Pharmaceuticals, Lupin and Stedman Pharmaceuticals with four formulations each. The list also consists of Sun Pharma’s two formulations, and one formulation each from Zydus Healthcare, Alkem Laboratories, Glenmark Laboratories and Unison Pharmaceuticals.

In the recently held 77th meeting of DPCO 2013, the authority discussed the received applications by pharma companies pertaining to the new drug application price fixation under the para 5 and para 15 of DPCO, 2013.

The Economic Adviser under the Department of Economic Affairs presented an analysis after examining the present procedure of calculating the retail price. The data comprised companies that have one per cent or more market share and illustrated the changes in prices by altering the threshold of the market share.

And based on the presented report by the Economic Adviser, the authority noted that the present practice of taking data of companies having one per cent and more market share is as per the provisions of DPCO 2013. It is based on the National Pharmaceutical Pricing Policy, 2012 (NPPP 2012) and also approved by the Cabinet. However, any alteration of the market share threshold requires a change in the policy, hence, the retail price calculation has to be as per the applicable provisions of DPCO 2013.

Therefore, under para 5 and 15 of the DPCO 2013, it has approved the retail prices of 30 new drugs.

Dr Amit Rangnekar, Chairman, Pricing Committee, IDMA, said, “The NPPA has fixed the retail prices for 30 formulations in its 77th authority meeting. These formulations are used to treat diabetes, hypertension, Alzheimer’s, cancer, mental health disorders, as well as formulations in the categories of steroids, anti-infectives, vitamin supplements and hand sanitisers. This notification will ensure affordable medicines in important chronic and acute therapies.”

During the meeting, the DCGI also confirmed that it has already given permission for phase IV trials of the subject formulations, which indicated that that the competent authority has allowed pharma companies to manufacture and market. However, the authority has directed them to get written confirmations from the DCGI.

Names of the fixed retail price formulations under DPCO 2013 by NPPA

1) Memantine hydrochloride + Donepezil hydrochloride tablet – Intas Pharmaceuticals: Rs 16.55

2) Rosuvastatin+ Clopidogrel capsule (Cardiology CV 10mg) – Aristo Pharmaceuticals: Rs 14.09

3) Rosuvastatin+ Clopidogrel capsule (Cardipill CV 20mg)- Aristo Pharmaceuticals: Rs 18.70

4) Rosuvastatin+ Aspirin + Clopidogrel capsule (Cardipill Gold 10mg) –Aristo Pharmaceuticals: Rs 11.89

5) Rosuvastatin+ Aspirin + Clopidogrel capsule (Cardipill Gold 20mg) — Aristo Pharmaceuticals: Rs 18.34

6) Metronidazole ER tablet– Abbott Healthcare: Rs 4.47

7) Desvenlafaxine ER + Clonazepam tablet (MDD-XR Plus 50) — Abbott Healthcare: Rs 12.42

8) Desvenlafaxine ER + Clonazepam tablet (MDD-XR Plus 100) — Abbott Healthcare: Rs 20.38

9) Glimepiride + Metformin tablet (MyGainPro 2)– Mylan Laboratories: Rs 8.00

10) Amlodipine +Atenolol tablet (MyAdol)– Mylan Pharmaceuticals: Rs 5.03

11) Amlodipine + losartan potassium tablet (MyLosdro A)– Mylan Pharmaceuticals: Rs 7.30

12) Calcium carbonate +Vitamin D3 tablet (MyVitacillin)– Mylan Pharmaceuticals: Rs 4.81

13) Metoprolol + cilnidipine tablet– Lupin Rs 9.25

14) Tolperisone SR+ diclofenac tablet–Intas Pharmaceuticals: Rs 27.05

15) Dexamethasone tablet– Zydus Healthcare: Rs 3.69

16) Metoprolol PR + cilnidipine tablet– Lupin: Rs 7.22

17) Paracetamol + mefenamic acid suspension (Sumo-L PlusDS)– Alkem Laboratories: Rs 0.67

18) Bisoprolol + amlodipine tablet– Lupin: Rs 5.89

19) Bisoprolol + amlodipine tablet– Lupin: Rs 7.69

20) Mesalazine suppository– Sun Pharma Laboratories: Rs 97.88

21)  Glimepiride + voglibose + metformin hydrochloride tablet (Gemer V2)– Sun Pharma Laboratories: Rs 12.35

22)  Vildagliptin + metformin HCL tablet–Glenmark Pharmaceuticals: Rs 6.17

23) Capecitabine + cyclophosphamide tablet– Intas Pharmaceuticals: Rs 168.53

24) Capecitabine + cyclophosphamide tablet– Intas Pharmaceuticals: Rs 107.53

25) Methylcobalamin + Alpha Lipoic acid + pyridoxine + folic acid capsule (MyFocoly)–Mylan Pharmaceuticals: Rs 12.37

26) Folic Acid+ methylcobalamin +pyridoxine hydrochloride tablet– Unison Pharmaceuticals: Rs 3.87

27)Chlorhexidine gluconate + Isopropyl alcohol topical solution (100 ml) –Stedman Pharmaceuticals: Rs 42.37

28) Chlorhexidine gluconate + Isopropyl alcohol topical solution (200 ml)–Stedman Pharmaceuticals: Rs 84.75

29) Chlorhexidine gluconate + Isopropyl alcohol topical solution (500 ml)–Stedman Pharmaceuticals: Rs 211.87

30) Chlorhexidine gluconate + Isopropyl alcohol topical solution (5000 ml)–Stedman Pharmaceuticals: Rs 21118.64