Home arrow Archives arrow Open Forum arrow Open Forum 2006 arrow Pharma Policy:Will It Help The Rural Poor?,Dhurjati Mukherjee, 19 October 2006
News and Features
INFA Digest
Parliament Spotlight
Journalism Awards
Pharma Policy:Will It Help The Rural Poor?,Dhurjati Mukherjee, 19 October 2006 Print E-mail


New Delhi, 19 October 2006

Pharma Policy

Will It Help The Rural Poor?

By Dhurjati Mukherjee

India has made spectacular progress as a manufacturer of drugs and pharmaceuticals in the last two-three decades and today it stands as the fourth largest producer of medicines though in terms of value it is 16th in the world. There are around 250 large units and 8000 small-scale units producing medicines worth almost $ 8 billion of which $ 1.5 billion is exported.

It is also significant that the country provides medicines to our people at a very low price, which is about 1/6th that of USA, 1/10th of Europe and 1/4th of even China where costs of production are reported to be low. However, the yearly consumption of drugs per person in India is quite low i.e. about $ 0.3 and this is indicative of the various types of diseases affecting a major segment of the population. The inaccessibility and the unavailability of medicines to the poorest segments of society in the remotest corners of the country has been a major cause of concern to check the growth of easily curable diseases.

Despite India’s spectacular growth in the pharmaceutical sector, the burden of communicable diseases, infant mortality, respiratory problems, reproductive diseases is indeed startling as revealed from the following facts (National Commission on Macroeconomics and Health, September 2005):Tuberculosis kills around 500,000 Indians each year; almost 100,000 people in the country died from respiratory infections in 1998; 125,000 Indian women died from complications of pregnancy; 100,000 deaths in 1998 could be attributed to nutritional deficiencies, more than half of which were simple protein-calorie malnutrition; HIV affected 3.5 million people in 1998; and Malaria affects 2.6 million each year and killed 20,000 people in 1999; and India has the largest burden of leprosy patients in the world with a caseload of four million.

Keeping in view the need to tackle the large types of diseases and available basic medicines to the rural masses, the Government as a first step has rightly decided to make them available at non-chemist outlets like grocery shops and general stores. The Union Health Ministry has accordingly issued a draft notification, which proposes changes in Sections 12 and 13 of Schedule K of the Drugs and Cosmetic Rules 1945. After views of parties concerned are considered, it is expected to be converted to a final notification, which would make household over-the-counter drugs used for minor ailments available at the neighbourhood grocery shops.

It is generally believed that the measure would be a boon to people in rural and backward areas of the country where medical help for simple diseases like headache, fever, cold and cough and diarrhea are difficult to come by. The move would also promote responsible self-medication, which helps conserve time and spare the expenses on doctors for diseases that can be cured with drugs. Besides, making drugs accessible to the masses, the proposed changes are also expected to bring the prices of these medicines down as chemist shops usually maintain a trade margin of around 25-39 per cent and the grocery shops just 10 per cent.

This indeed has been a welcome measure as statistics reveal that about 29 per cent of the country’s population has no access to medicines, either owing to lack of money or non-availability or non-accessibility to drugs. Moreover as 60 per cent of the consumers do not normally go to the doctor, the ready availability of medicines for common ailments will help in bringing down diseases.

However, some apprehensions have been raised by chemist associations blaming the government of being a prey to pressure from multinational pharmaceutical companies. Their contention of MNCs capturing the market with big advertising campaigns may be valid not just for rural areas but all over the country. From the safety perspective, it may be mentioned that drugs being considered for sale at general stores are of the commonly used variety and have negligible risk of misuse or overdose.

While this measure no doubt shows the government’s eagerness to make drugs available to the common man, it would be more judicious if these medicines were subsidized in some way or at least exempt from all forms of taxes. This is imperative at this juncture to curb diseases, as low costs of drugs would not deter the people from buying the same even for preventive purposes.

Meanwhile, the Government came out with a draft National Pharmaceutical Policy in August last where the question of making quality essential medicines affordable and accessible to the common man has been stressed. Thus the control on drugs is essential at least for developing countries like India. As Dr. Mira Shiva, a noted health expert of the Voluntary Health Association of India, has rightly pointed out: “Drugs are just not any other commodity where competition can regulate the prices. Besides, medicines are not consumed by patients by choice but are prescribed by doctors and the need is immediate”.     

Control of drug prices is very much needed as 80 per cent of the population spends money out of its pocket on health care. Moreover out of this 80 per cent around 40 per cent belong to the economically weaker sections or are below the poverty line and not in a position to spend on diseases. Experts are of the opinion that there should be a check on prices as even in the USA, there is control. In UK as health care is provided by the government-run National Health Service, it is the only buyer of medicines and thgus the issue of price becomes irrelevant.

It is pertinent here to refer to the case of Brazil where an Industrial Property Code (Law 9279) was passed in 1996. It revised patent protection, ending the non-patentability of food, chemical, pharmaceutical and biotechnology products. The legislation permits patents for transgenic micro-organisms (transformed in laboratories) without restriction of they are products of genetic engineering. The law stipulates that a local company wishing to produce a patented product in Brazil must enter into a licensing agreement with its patent holder and pay a royalty fee equivalent to 2-4 per cent of the net profit from sales.

Article 71 of the law authorizes compulsory licensing to address national health emergencies. Most recently, to tackle complicated diseases like HIV/AIDS, Brazil began by making generic copies of 12 drugs whose patents had expired. With the release of new drugs in recent years, the health authorities announced they would break patents unless drug companies agreed to offer drastic reductions, matching the cost of Brazilian made generics. Rather than lose all the revenue, drug companies agreed to drop their prices, sometimes by as much as 80 per cent. In this way, it has halved the number of AIDS deaths since the Country’s treatment programme started in 1997.

Considering the Brazilian success, there is an urgent need for India to come out with a national compulsory licensing policy to combat diseases and, more importantly, the high prices of medicines, which are affecting a major section of the people. Rather than adopting a case-by-case approach, the Union Government may notify the list of medicines eligible for compulsory licensing in public health cases. The Controller is empowered to grant the CL, fixing a royalty using the royalty guidelines. As of now, the grant of such license is available for drugs that are patented under the Act and India should take advantage of this in the interest of the health needs of the poorer sections of the population.  

Thus, it goes without saying that there is need to keep the prices of medicines under control and before finalizing the pharma policy the Brazilian example as also others have to be seriously considered. Before considering any other thing the growing reports of diseases, especially in the rural areas, have to be taken cognizance of in the final policy and how to tackle the challenge in the coming years.

An action plan of reducing diseases in the short-term should find place in the policy. Simultaneously, one is reminded of the President’s advocacy in 2004 at the inauguration of the Charter for Pharma Vision 2020 to look at indigenous drug development in the form of vaccines, medicines and diagnostics, which will ensure cost effective drug therapy to the masses.---INFA

 (Copyright, India News and Feature Alliance)





< Previous   Next >
  Mambo powered by Best-IT