The pharmaceutical industry in the country is up in arms against the recent notification of the National Pharmaceutical Pricing Authority (NPPA) in which the national drug price regulator has brought prices of 108 non-scheduled formulation packs involving the anti-diabetic and cardiovascular drugs under government control under Paragraph 19 of DPCO, 2013.
Paragraph 19 of DPCO, 2013, authorises the NPPA in extraordinary circumstances, if it considers necessary so to do in public interest, to fix the ceiling price or retail price of any drug for such period as it deems fit.
“It is a retrograde move by the NPPA which will adversely affect the growth of the pharma industry. We will soon approach the NPPA chairman and senior officials of DoP to discuss the issue and convince them the need to withdraw the notification”, said S. V. Veerramani, chairman IDMA, which commands a membership of more than 700 Indian drug manufacturers.
After fixing the prices of a large number of drugs under the national list of essential medicines (NLEM), the government appears to have decided to bring even the non-scheduled drugs under price control, which will have a devastating effect on the growth of the pharma industry in the country, Veerramani further said.
In a notification dated 10.7.2014, the NPPA had fixed prices of anti-diabetic and cardiovascular drugs in respect of 108 non-scheduled formulation packs based on bulk drugs like Gliclazide, Glimepiride, Miglitol, Repaglinide, Pioglitazone, Sitagliptin, Voglibose, Acarbose, Metformin hcl, Ambrisentan, Amlodipine, Atenolol, Atorvastatin, Bisoprolol, Bosentan, Carvedilol, Clopidogrel, Coumarin, Diltiazem, Dobutamine, Enalapril, Enoxaparin, Eplerenone, Esatenolol, Fenofibrate, Heparin, Indapamide, Irbesartan, Isosorbide, Ivabradine, Labetalol, Levocarnitine, Lisinopril, Metolazone, Metoprolol, Nebivolol, Nicorandil, Nitroglycerin, Olmesartan, Prasugrel, Prazosin, Propranolol, Ramipril, Rosuvastatin, Simvastatin, Telmisartan, Terazosin, Torasemide, Trimetazidine and Valsartan.
While bringing these drugs under price control, the NPPA noted that it is of the considered view that there exist huge inter-brand price differences in branded-generics/ off patent drugs, which is indicative of a severe market failure, as different brands of the same drug formulation, including the off patent drug, which are identical to each other in terms of active ingredient(s), strength, dosage, route of administration, quality, product characteristics, and intended use, vary disproportionately in terms of price.
It is observed that, the different brands of the drug formulation may sometimes differ in terms of binders, fillers, dyes, preservatives, coating agents, and dissolution agents, but these differences are not significant in terms of therapeutic value. The market failure in respect of pharmaceuticals in the context of India can be attributed to several factors, but the main reason is that the demand for medicines is largely prescription driven and the patient has very little choice in this regard, the NPPA noted.
Market failure alone may not constitute sufficient grounds for government intervention, but when such failure is considered in the context of the essential role of pharmaceuticals play in the area of public health, which is a social right, such intervention becomes necessary, especially when exploitative pricing makes medicines unaffordable and beyond the reach of most and also puts huge financial burden in terms of out-of-pocket expenditure on healthcare.
The NPPA considered this matter in detail at its 147th meeting held on 16.05.2014 and approved objective guidelines for fixation/ revision of price of non-scheduled drugs showing extreme inter-brand price differences, under paragraph 19 of DPCO 2013. It has decided that, to start with inter-brand price variation will be examined in respect of single ingredient formulations in eight therapeutic groups, namely, anti-cancer, HIV/ AIDS, anti-TB, anti-malaria, cardiovascular, anti-diabetics, anti-asthmatic, and immunological (sera/ vaccines); and wherever the maximum retail price (MRP) of the brand(s) of medicine of a particular formulation exceeds 25 per cent of the simple average price the same will be capped at the 25 per cent level, the NPPA further noted.