With the announcement of Drug Policy
implementation from April this year, made by the Minister for Health, hornet’s
nest has been stirred up again and a series of seminars, press conferences and related
articles have yet again started surfacing in the local media. People associated
with pharmaceutical trade seem to be bracing up for yet another round of
agitation against the drug policy. Previous phase of agitation last year witnessed
information being propagated in the newspaper columns that was, more often than
not, factually incorrect. Before another bout of such misinformation campaign
is unleashed, this article attempts to look at the actual facts and dwell into
the pros and cons of state drug policy with a view to subside certain
misgivings about the same.
First question that needs to be
addressed is: what is the need for a state level drug policy? Need for a drug
policy arises out of the fact that as per World Health Organization (WHO),
one-third of global population comprising 1.3-2.1 billion people does not have
access to medicines. At national level, an estimated 50-65% population within
India does not have access to medicines as per the World Medicines Situation
Report published by WHO. When we look at our own state of J&K, we find that
21% population in our state comprising of 24 lac people are living below the
poverty line and it is these people who are deprived of an equitable access to
essential and life-saving medicines. Furthermore irrational prescribing and
irrational dispensing practices are also rampant in our state. Therefore there
is need for a state level drug policy that addresses the issue of accessibility
(including availability and affordability) of essential medicines and also devises
discrete policy provisions for ensuring quality, safety and efficacy of
medicines besides enforcing rational prescribing and dispensing practices and
streamlining the procurement and supply chain management of medicines. Since
75%-80% of total expenditure on healthcare in India goes on medicines alone,
need to have a drug policy even in absence of a comprehensive health policy in
the state is therefore justified.
Next question that needs to be addressed
is whether the state drug policy will render lakhs of people associated with
pharmaceutical trade jobless. Answer is in negative because generic drug
prescribing clause of the drug policy covers only 348 drugs listed in the
essential drugs list which comprise only 30% of all the drugs approved in India
that are at present available in the market whereas 70% of drugs will still be
outside the purview of generic drug dispensing clause of the approved drug
policy. Moreover generic drug prescribing applies only to govt. hospitals and
not to the private sector pharmacies. It applies only to GMC and its associated
hospitals besides hospitals and health centers in various districts. It does
not apply to SKIMS and JVC hospitals either. Total budgetary allocations on
Drugs and Instruments of all government hospitals of the J&K state does not
exceed Rs 25 cores whileas the total worth of drug market in our state has been
claimed to be more than 1000 crores per annum. By that measure, entire
government drug supply constitutes only 2.5% of the total drug market. Given
these facts, it is difficult to conclude how 80% of our pharmaceutical trade is
dependent on drug supply in govt. hospitals.
Drug policy that govt. is going to
implement is not wholly and solely about prescribing and dispensing generic
drugs in govt. hospitals but generic drug prescribing is just one of the many
clauses of the drug policy. There are almost a dozen more clauses that concern
patients at large that deal with adverse drug reaction monitoring of medicines
in govt. hospitals, establishing drug information centres, strengthening drug
control department and drug testing laboratories, streamlining drug storage and
inventory control mechanisms, promoting human resource, research and
development in pharma sector and much more. Nobody seems to have any problems
with any of these provisions of the drug policy. All controversies and
conflicts of interest surround only one clause of the drug policy i.e., generic
drug prescribing in govt. hospitals. Therefore it is grossly inappropriate to
outrightly reject the entire drug policy just because one particular clause
does not suit the interests of a particular section of the pharma trade.
Even the generic drug prescribing is a
policy that has not only been advocated by WHO, National Human Rights
Commission in 1999 and Supreme Court of India in 2003, 2012 but also by various
committees of experts including Hathi Committee (1975), Standing Parliamentary
Committee on Petroleum and Chemicals (2001), Mashelkar Committee (2003) and
National Commission on Macroeconomics and Health (2005). Worldwide generic
drugs comprise 30% of the total drug sales including branded medicines and
constitute a market of 80 billion USD. A total of 75% prescriptions in USA and
a total of 83% prescriptions in UK contain generic medicines. Therefore when
such affluent and rich nations prefer to use generic drugs there is no reason
why poor people of India and other developing nations should be force-fed with
costly branded medicines. Some people are apprehensive about the quality of
generic drugs but that is only a misconception, far from reality since India
supplies quality generics to the global market to the tune of 22% and is known
as the “Pharmacy of the developing world”. Highest number of USFDA approved
generic drug manufacturers outside USA exist in India. India is a world leader
in pharmaceutical sector ranking third in value and thirteenth in volume
worldwide. Therefore when India can supply quality generics at affordable
prices to the entire world why should 50-65% of its population still lack
access to essential medicines. Generic prescribing is the remedy to overcome
this dismal scenario.
Some people argue that drug markets
within India are poorly regulated leading to manufacture of inferior quality
drugs in small shacks that mostly find their way into our shops and hospitals.
They fear that introduction of generic drugs will further worsen the situation
and deteriorate the quality of drugs. However the degree of market regulation
is same for generic as well as branded medicines. Therefore quality will also
be the same. If low quality generics can sneak into our hospital supplies so
can low quality branded medicines. Therefore with existing drug regulatory and
quality assurance mechanisms, situation and degree of quality standards are invariably
the same for both generic and branded drugs. Moreover in several other states
within India where generic drug prescribing has been implemented, savings to
the extent of 30-40% have been recorded in their drug budgets, whose benefits
gets eventually transmitted to the patients. Tamil Nadu Medical Services
Corporation and Rajasthan Medical Services Corporation have provided role
models in ensuring quality as well as low price of generic medicines in govt.
hospitals. These models have been duly appreciated and recommended not only by
the government of India but by WHO too.
Lastly it is pertinent to mention that Govt.
of India has formulated a scheme at the central level that envisages to make
generic drugs available free of cost for poor patients in govt. hospitals
across India. A sum of Rs 1200 crores have been earmarked during the twelfth
five year plan for this scheme and the scheme will take off irrespective of
whether a state has its own generic drug policy or not. Therefore generic drug
policy will anyhow be implemented in the state through the central scheme.
Further there is a provision for the review of the state drug policy every five
years. Whatever flaws and loopholes are there in the present policy can be
rectified during the subsequent review. However for a successful implementation
of the policy it shall be incumbent upon the state government to keep generic
drugs available within the hospitals throughout the year without leaving scope
for any stockouts at any point of time. Any stockouts within the hospital will
lead to substitution of prescribed generics with other generic or branded
medicines by private pharmacies. Therefore success or failure of this policy
entirely depends on the efficiency of procurement mechanism and inventory
control. Govt. has to streamline its procurement mechanism as soon as possible
on the pattern of TNMSC so that all apprehensions in this regard are addressed
well in time. Further it has been observed that majority of the people
associated with pharmaceutical trade are still not aware about the nuances of
the drug policy. Therefore there is need to generate awareness among common
masses and address genuine grievances of all stake-holders simultaneously. Drug
policy implementation should not affect the livelihood of any sizeable section
of the society on a large scale. However the slogan should be to fully
implement the policy rather than not implementing the policy.
(Article is based on the excerpts from a talk delivered by the author during the seminar on State Drug Policy organized by the Chemists and Druggists Association Kashmir on March 24)
