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OPEN FORUM
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)
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