Congress MP Dr Jyoti Mirdha, a member of the Parliamentary Standing Committee on Health and Family Welfare, has termed the draft national pharmaceutical policy as 'incomplete' and 'a big disappointment'.

“The draft policy does not address the primary concerns of majority of Stakeholders nor is it designed to make drugs affordable, a question that ought to have been its basic surmise. There are serious implications of the proposed policy that would adversely affect the ability of the poor to pay for life saving medicines,” the Lok Sabha member, who is a medical doctor, said in separate letters to the Prime Minister, Union Health Minister, MoS for Chemicals and the DoP.

The policy is incomplete since it covers just off-patent medicines being marketed in the country. Any National Pricing Policy should be comprehensive and consolidated covering all medicines being sold in India irrespective of their patent status or source. Irrespective of mechanism used, the end result should be availability of medicines at affordable and fair prices. Unfortunately, if implemented in its current form, NPPP-2011 will result in the prices of most medicines going up many folds in near future. In addition, foreign pharmaceutical manufacturers will enjoy unfair advantages not available to domestic sector, the letter said.

“The price regulation is supposed to cover only those molecules that are included in the National List of Essential Medicines (NLEM). In a way NLEM is a misnomer because it does not cover all essential medicines. There is a difference between the term “essential” used generically in English and “Essential” used as a proper noun in NLEM. No medicine can be categorized as “unessential.” NLEM has a limited, narrow context. Under severe budgetary constraints, it is simply not possible for the state to buy and distribute all medicines for all disorders to all patients. NLEM is meant to serve as guidance for procurement and distribution of most needed drugs for public health sector,” she said.

Drugs included in the NLEM are generally restricted to reference molecules. For example for the treatment of high blood pressure, just one ACE inhibitor enalapril is included in NLEM. Since the list does not include subsequently launched ACE inhibitors  such as fosinopril, imidapril, lisinopril, perindopril, quinapril, ramipril and trandolapril, their prices will not be regulated. Only one agent losartan belonging to another anti-hypertensives group called Angiotension II Receptor Blockers (ARBS) is  included in NLEM. Therefore prices of widely used other agents including candesartan, irbesartan, telmisartan, valsartan and olmesartan will not be regulated, the MP pointed out.

The state sector currently caters to the medical treatment of less than 20 per cent of the population. Thus more than 80 per cent people of India are dependent on private medical care. Private practitioners do not and cannot be made to prescribe only reference medicines listed in NLEM. Thus about 80 per cent of the people will not benefit from price regulation, the letter said.

“The suggested methodology of price regulation itself is fundamentally flawed and heavily tilted in favour of industry. The price of every consumer item is based on “cost plus expenses plus profits” called Cost Based Pricing (CBP). Departing from this universally accepted, sound economic principle, the new NPPP 2011 suggests an amazing method based on Market Based Pricing (MBP). Under this policy the weighted average of three top selling brands will be the ceiling price. There is no logic in restricting the formula to just three brands. Why not five? Why not 10 to arrive at a more representative and reasonable figure? Besides why base on sales figures? In any pricing policy the parameter should be the price. Why not weighted average of 10 least priced brands?,” she asked.

“In all there are just over 1,700 molecules being used as medicines in various countries.  In India just over 900 are being marketed. NLEM that has 348 drugs is supposed to be updated once every 5 years. The policy is not forward looking in the sense that new drugs will need to wait for 5 years or more before they are considered for inclusion in NLEM and consequently brought under price regulation. The gap between NLEM-2003 and 2011 is eight years. Therefore the review will depend on whether the NLEM is really updated in five years or not. These concerns are illustrative rather than exhaustive. There are many other anomalies in the proposed policies such as pricing of suspension, injections etc.  that need to be addressed,” she said.