An essential medicines list is a list of minimum medicines that a country should have, so as to be able to take care of the health needs of a majority of its population. If you were short of resources, you could at least stock these in sufficient quantities and at affordable rates.
Like the WHO, India too has been coming out with essential medicine lists, the latest being the National List of Essential Medicines, 2011 (NLEM 2011).
The previous list of 2003 was a response to a directive by the Supreme Court, in a PIL filed by civil society organisations against the draft pharma policy 2002.
The Supreme Court PIL however has been dragging on since then. This was partly due to UPA-1 and -2 governments not being able to arrive at a consensus, and partly due to hectic footwork by pharma lobbies.
The period also saw several meetings between stakeholders, the Government and with a Group of Ministers (GOM) headed by Mr Sharad Pawar. In March 2011, the Government of India told the Supreme Court that it no longer considers the 2002 draft policy appropriate, and promised the Court to come out with a new policy.
Escaping Price Regulation
The draft policy now circulating for public discussion is the draft National Pharmaceutical Policy (NPPP) 2011.
An earlier piece by the author in this paper (“Pharma industry gets away lightly”, Business Line , November 8) showed how the ceiling prices proposed by the NPPP 2011 — arrived at by the so-called weighted average of the prices (WAP) of the top 3 brands — were still way too high. A more recent ceiling price formula by the Economic Advisory Council set ceiling prices even higher than the WAP top 3 formula. Both these ceiling price formulas deserve to be junked.
A new GOM chaired by Mr Sharad Pawar again met various stakeholders to discuss the NPPP 2011 on May 14 and May 18. The GOM will place its recommendations to the Cabinet which will then make a final decision on pharma pricing policy, and the Supreme Court will take a call in the matter thereafter.
What is at stake for ordinary patients is affordable health care, as medicine costs can go up to about 80 per cent of health care costs (NSS 66th Round).
The proposal of NPPP 2011 to regulate prices of all the 348 drugs in the NLEM 2011, though paved with good intentions, has inbuilt ways to escape from price regulation.
As a manufacturer, if I find that a particular drug, say enalapril maleate (brand Envas), used in high blood pressure and cardiac failure, is under price control, I will do a couple of things to escape price regulation: I make a combination of enalapril with a medicine outside the NLEM 2011 list. Or I shift to a useful drug of the same therapeutic class but not in the NLEM list.
Or most likely, I make a drug which is a “me too”, drug of the same chemical class — easily done by tweaking a molecule. Thus if I am making enalapril, I can now manufacture instead ramipril, captopril, lisopril or any of the “me-too prils”.
Enalapril is in NLEM 2011 and therefore would be under price regulation, and the others of the enalapril class of medicines called ‘ace-inhibitors', are not in NLEM 2011, and therefore will not be under price regulation.
There is hardly any therapeutic difference amongst these four medicines but there is a huge price-difference between enalapril and others. The generic version of enalapril 5 mg costs less than Rs 5 for a strip of 10 tablets; its branded version costs around Rs 25.
In contrast, the branded versions of lisinopril, ramipril and perindopril for equivalent dose are priced at Rs 38, Rs 67 and Rs 79 respectively per strip!
Hence, a sensible price regulation policy would bring not only enalapril but all ace-inhibitors under price-control. All “me-too” drugs should have the same price ceiling, namely, the ceiling price of the original drug.
This has also been suggested by the Pronab Sen Task Force Report in September 2005. Similarly in the class of angiotensin II receptor antagonists (also used in high blood pressure), we have losartan potassium in the NLEM 2011 list but not candesartan, irbesartan, telmisartan, valsartan and olmesartan.
Therefore the latter drugs will not be regulated and losartan will become relatively scarce in the market.
Among drugs used in asthma we have salbutamol and the rarely used ipratropium, whereas other frequently used drugs in asthma such as terbutaline, salmeterol, formeterol, bambuterol, theophylline, doxofylline, montelukast and zafirlukast will be out of price regulation.
Policy Measures Needed
The number of useful molecules in use in India is probably somewhere between 800 and 1000.
A list that is the basis for price regulation needs to cover all these 800-1,000 molecules. Therefore the NLEM 2011 with 348 molecules will defeat the purpose of price regulation. Alternatively, me-too drugs need to have the same price ceiling. And all drugs useful for a particular disorder like say asthma or diabetes — need to be under price regulation.
And if the government is really serious about price regulation and affordable health care, it needs to get rid of all the other drugs (including irrational combinations) in the market — these include medicines of little or no therapeutic value and a host of harmful drugs.
Combinations of useful drugs with inessential or useless drugs should also have the same price ceiling, if they are not to be totally withdrawn from the market.
All medicines out of patent would need to be de-branded — again a recommendation of the Pronab Sen Task Force Report. That is, they should be selling only under their generic names.
Paracetamol should sell only as paracetamol and not as Crocin or Calpol. India is the only country with a developed pharmaceutical industry, where prescription drugs out of patent are sold under brand names.
Bangladesh de-branded essential drugs in 1982 and was threatened with “sanctions” from Governments where MNCs reside. But there has been no flight of pharma MNCs from Bangladesh.
Only with these measures can we hope to call ourselves ready for a relevant health care system that cares for its people – where pharma companies do not indulge in overpricing, or market irrational medicines and drugs of doubtful or no value, not found in any standard pharmacology text book.
(The author is associated with LOCOST, All India Drug Action Network and Medico Friend Circle.)