Review Article CODEN: IJPRNK ISSN: 2277-8713 Bhupender Singh, IJPRBS, 2015; Volume 4(5): 26-38 IJPRBS
Available Online at www.ijprbs.com 26
AN UPDATE ON INITIATIVES TAKEN BY INDIAN GOVERNMENT TO PROMOTE GENERIC MEDICINES.
BHUPENDER SINGH, ARUN NANDA, VIKAAS BUDHWAR
Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, Haryana.
Accepted Date: 14/08/2015; Published Date: 27/10/2015
Abstract: The Indian pharmaceutical sector is highly knowledge based and its substantial growth is positively affecting the Indian economy. Pharmaceutical companies manufactured 20-22 percent of the world's generic drugs in volume terms and offered 600 finished medicines and nearly 400 bulk drugs in formulations. However affordability and availability of cheap drugs to country’s own population is still challenging and crucial. In our country a large number of people are living below poverty line. They are not able to afford costly branded drugs because many a times these drugs are too expensive; therefore, cheaper generic drugs are a preferred option. Promotion of generic medicine can effectively cut down the ‘out of pocket’ expenses. The central as well as state governments through numerous schemes have been promoting generic medicines and providing affordable generic medicine to masses. However, the pace at which promotion is done needs catalyst to ensure the public health through availability and affordability of generics in our country. The review discuss the current scenario of generic medicine; mindset of patient, doctor and the pharmacist and the measures through which the promotion and awareness about generic medicine can be done. This review critically analyzes the various governmental initiatives to promote generics in India, and attempts to highlight the various shortfalls in the same. Authors have suggested some changes in the statutes amongst other initiatives to promote generics in India.
Keywords: Jan Aushadhi, generic schemes, branded medicines, generic promotion
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Review Article CODEN: IJPRNK ISSN: 2277-8713 Bhupender Singh, IJPRBS, 2015; Volume 4(5): 26-38 IJPRBS
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INTRODUCTION
Globally, the Indian pharmaceutical industry is ranked 3rd largest in volume terms and 10th
largest in value terms. The Indian pharmaceutical Industry has witnessed a robust growth and is
expected to grow at a compound annual growth rate (CAGR) of 14% to reach a turnover of Rs
2.91 trillion (US$ 47.06 billion) by 2018 which is valued at Rs1.6 trillion (US$25.87billion) at
present as reported by Ministry of External Affairs, Government of India 2014 [1].
However affordability and availability of drugs to country’s own population is still challenging
and crucial. The situation as in developing countries is quite more serious than in developed
countries the patient has to bear the total cost of medicine by himself for almost all medicines.
At least 80% of the population has to indulge “out of pocket” expenditure in the absence of
nationwide health insurance coverage [2]. Securing access to 348 essential drugs covered under
National List of Essential Medicine, (NLEM) 2011 still remains an enormous challenge.
According to World Health Organization (W.H.O.) one-third of the world's population, mainly in
low-and middle-income countries continues to lack regular access to essential drugs. In the
poorest parts of Africa and Asia, this figure rises to over 50%. The reasons are well known and
comprise insufficient financing, deprived health care and delivery lack of awareness [3].
In India, unapproach ability to essential medicines challenges most patients seeking treatment
of acute and chronic diseases. Approximately 40% of Indians live on less than US $1 per day and
most of them pay out of pocket for using healthcare. Out-of-pocket spending in India is over
four times higher than public spending on healthcare. Unexpected illness can have a disastrous
effect on the family of the ill person; direct out-of-pocket payments could push 2.2% of all
healthcare users and one-fourth of all hospitalized patients, into poverty in a year. Large and
unpredictable health payments can expose households to significant monetary risk and, at their
most extreme, can result in impoverishment [4].
One of the major components of the increased cost of healthcare related expenses is cost of
medicines. Medicines consume a major portion of total money spent on healthcare. The use of
generic drugs has been steadily increasing internationally as a result of economic pressure on
healthcare budgets. Generic drugs provide the prospect for major savings in healthcare
expenditure since they are significantly lower in price than the equivalent branded
counterparts. Prescribing drugs by their generic name or International Non- proprietary Name
(INN) by doctors and requesting pharmacists to dispense generic drugs are often suggested
means for lowering the costs of health care [5]. Generic drugs are a proven cost-effective
strategy for dropping drug expenditure. The cost of health insurance premium will also be
reduced if generic medicine will be commonly prescribed by physician/doctors. Only 17 per
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cent of the total population was found covered by health insurance at the end of March 2014
as per the Insurance Regulatory and Development Authority (IRDA) [6].
What are generic medicines?
According to W.H.O. a generic medicine is “A pharmaceutical product usually intended to be
interchangeable with an innovator product that is manufactured without a license from the
innovator company and marketed after the expiry date of the patent or exclusive right” [7].
In India generic version of medicine has been first described in DPCO 2013, as ‘A formulation
sold in Pharmacopoeial name or the name of active pharmaceutical ingredient without any
brand name’ [8]. According to Department of Pharmaceuticals, Government of India, generic
medicines are unbranded medicines which are equally safe and having the same efficacy as that
of branded medicines in terms of their therapeutic value. The prices of generic medicines are
much cheaper than their branded equivalent (Table (a)) without compromising the quality,
safety and efficacy of generic version of medicine [9].
Table (a) Price comparison of few Branded/Branded-generic medicines with their generic
counterparts available at Jan Aushadhi Stores
Why generics cost less?
A brand name drug has to go through 10-15 years of research and cost over $1 billion. The
success rate is 5 out of 10,000; further the sale promotion cost is also involved. As patent for a
brand name drug expires, any other company can manufacture the drug and sell a generic
Drug /Strength Manufacturer Trade Name Price/Tablet or Capsule (Rupees)
Tramadol- 50mg Intas Tramatas 6.36 Zydus Tramazac 9.15
Win Medicare Urgendol 8.3 Jan Aushadhi Tramadol 0.39
Azithromycin- 500 mg
Venus Remedies Actimycin 205
Epitome Azitome 27 Cipla Azimax 20.2
Jan Aushadhi Azithromycin 10.5 Clopidogrel- 75mg Cipla Clopivas 3.72
USV Clopigrel 21.5 Sanofi Synth Plavix 115.35
Jan Aushadhi Clopidogrel 0.67
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version. These companies must only prove bio-equivalence studies .This means that generic
drug companies do not have to spend as much time and money. This is why generic drugs cost
less [10].
In India one more class of drug exists ‘Branded Generics’ which is a generic product but
manufactured under a brand name and is not promoted by its manufacturing company. Thus,
these branded generics are “generics” as far as the trade is concerned, but are branded, as far
as the patient is concerned [11]. These drug products have given the pharma trade huge
margins at different levels. But the patient, who is the ultimate consumer, feels cheated and is
not benefited by this practice. The variation between the maximum retail price (MRP) and
price-to-retailer (PTR) speaks a lot about the profitability shared by the pharmaceutical traders
[12].
Promotion of Generics by State and Central Governments
In India, the central government as well as several state governments took several steps in
promoting a generic medicine through regulations and schemes. In 2008 Jan Aushadhi was
scheme launched by the Department of Pharmaceuticals in association with Central Pharma
Public Sector Undertakings, to provide quality medicines at affordable prices to the common
people. Jan Aushadhi stores were proposed to be set up all over the country (at least one per
district) to provide generic drugs, which would be available at lesser prices but are equivalent in
quality and efficacy as expensive branded drugs. In November 2008 first generic drug store was
opened at the public sector civil hospital in Amritsar, Punjab state, and the second store in
February 2009 at Shastri Bhawan, New Delhi. Eighteen more such stores have been opened as
of September 2009 in the states of Punjab, Haryana, and Rajasthan [13]. Out of 164 Jan
Aushadhi Stores opened so far, 87 are presently functional as provided by official website of Jan
Aushadhi. The government has proposed that each of the 660 districts in India will have at least
one Jan Aushadhi store. In spite of the fact that these stores are being established by the
government of India in the larger public interest, reports from few of these stores suggests that
sales are minimal [14-15]. A patient appears to be reluctant to purchase medicines from these
stores of public facilities because of their apprehensions about the quality of medicines and
even doctors and pharmacists are not exception to this misconception [16]. Further a reason of
limited availability of drugs at these stores reduced the pace of growth of the government Jan
Aushadhi stores, a study found the mean availability of drugs at these stores stood at only 33
per cent. In 2013, a government commissioned consultancy tasked with preparing a new viable
business plan for the project estimated that 84 such shops are functional of the 149 and despite
to mandate to store 319 drugs, only 85 drugs across 11 therapeutic groups was available [17].
This limited portfolio of medicines coupled with chronic stock-outs has seriously eroded the
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credibility of these stores as customers desire a one-stop shop for all prescribed drugs. The
status of functional Jan Aushadhi stores till December 2014 is depicted in Figure 1 [18]
Figure: 1. Status of Jan Aushadi (December, 2014)
In February 2012, partly as a response to the persistent demands of civil society and the
recommendations of the High Level Expert Group of the Planning Commission, the government
announced plans to increase the outlay for health to 2.1% of the gross domestic product by the
end of the 12th Five Year Plan (2012-17) which was 1% in the previous five year plan [19].
In October 2012 Chief Minister of Rajasthan Ashok Ghelot announced for free generic
medicines and diagnosis to everyone. In beginning of this scheme 200 types of generic
medicines have been put for free distribution which was further increased to 400 and currently
the number is 600 types of generic medicines. However the number of medicines available
differs on the nature of hospital. If a hospital is attached to a medical college the number of
medicines available is 500-550, in district hospital 325-400 & community centers 150-250 [20].
As per the study conducted by Mathur and Vyas at Sardar Patel Dispensary, Jaipur it was found
that there was increase in number of outdoor patients in dispensary to avail the benefit of the
scheme of free generic medicines and also found that accountability on distribution needs to be
reinforced [20]. The initiative of this scheme benefited two lakh people every day [21]. The
present Chief Minister Vasundhara Raje has adopted a “targeted approach” in implementing
this scheme which was a “universal” one when launched by the Ashok Ghelot. With targeted
intervention, only beneficiaries of food security scheme will be eligible for the benefits of the
scheme [22].
0
10
20
30
40
50
60 53
24 24 23
10 8 5 5 4 4 3 3
53
3
9
0 0 0 2 5 3
0 3 3
No. of stores opened
No. of functional stores
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In September 2013 UPA Chairperson Sonia Gandhi inaugurated Kerala’s two major health
schemes Arogya Kiranam and Distribution of free generic medicines in all government
hospitals. Under the scheme to distribute generic drugs free of cost, all government hospitals,
up till primary health centers, would be providing 820 drugs to patients in outpatient clinics to
all except government employees and income-tax-payers [23].
In November 2013, at the time when the Union Department of Pharmaceuticals was working on
reviving the 'Jan Aushadhi' project to make generic drugs available to buyers at an affordable
price, Gujarat government says it will stick to its self-developed model of offering free
treatment for segments of the population [24].
The Maharashtra state government in 2013, decided to use generic drugs for all medicine
supplies to public hospitals. Informing this in the state legislative council public health minister
Suresh Shetty said that the government would formulate a module to spread mass awareness
regarding generic drugs and their benefits [25].
The Tamil Nadu Medical Services Corporation (TNMSC) initiated drug procurement system, the
incorporation happened through a government order. The TNMSC does central tendering and
purchasing of the essential drugs for the entire state that are delivered to the district
warehouses by the supplier in stipulated quantities. From here the drugs are distributed to the
facilities based on a value-based passbook system (each facility is allotted a fixed amount and
can requisition for any quantity of drugs in the Essential Drug List (EDL) within that amount [26].
To infuse a fresh lease of life into its fledgling chain of pharmacy outlets, Jan Aushadhi, the
government plans to link drug procurement for some of its stores to Tamil Nadu Medical
Services Corporation (TNMSC), and learn lessons from the much celebrated state-run model.
TNMSC, which functions as an autonomous agency in Tamil Nadu, buys essential drugs in bulk
through a centralized tendering process, which gets delivered to the district warehouses. From
there on, it goes to different government medical facilities . The agency also offers a service for
procuring and testing drugs for other states, which gives it the advantage of scale and better
bargaining power [27].
In June, 2012 Karnataka government has teamed up with State Cooperative Consumer
Federation to set up 20 Janatha Bazar generic drug stores across the state to make available
affordable drugs to the poor patients in the state. Four Pharma companies Cipla Torrent, Sun
Pharma and Intas have consented to supply generic medicines at subsidized costs to these
stores [28]. The initiative is on similar lines of the Department of Pharmaceuticals (DoP)'s Jan
Aushadhi generic stores which was launched in 2008 to make available affordable drugs to the
poor patients.
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In 2012 an order was sent to all state health secretaries by Drug Controller General of India G N
Singh asking them to instruct their drug license issuing authorities to issue licenses only on
generic names and not on branded or trade names, which is the usual practice now. The
parliamentary standing committee in its scathing report had also expressed strong objection to
the practice of issuing licenses on brand names [29].
These activities in 2012 suggest that scenario might change regarding the promotion of generics
but present condition of affordability and availability of cost effective medicine is still a big
challenge.
A study by World Health Organization in India revealed that generic medicines were available
only in 20%-40% of public health clinics surveyed; WHO said, “More than half of public fac ilities
lack essential medicines”. Around 78% of healthcare expenditure in India is out-of- pocket of
which 72% is spent on medicines [29].
National Sample Survey Organization (NSSO) records show that the highest out-of- pocket
expenditure on drugs is in Himachal Pradesh (87.95%), followed by Uttarakhand (87.75%), Bihar
(84%), Rajasthan (83%), Uttar Pradesh (81.86%) and Chhattisgarh (81.38%). In larger states like
Maharashtra 60% of out-of-pocket expenses are for buying drugs, Karnataka (65%), Delhi (74%),
Tamil Nadu (66%), Madhya Pradesh (71%) and West Bengal (65.80%) [29]. Low public sector
availability forces patients to purchase medicines from the private sector, where prices are
usually higher.
In its existing form, the Jan Aushadhi campaign will able to increase the affordability of very few
medicines for a very small population. Yet, by implementing certain possible changes in the
program, government could improve the access to essential medicines for the poor population
of country [13]. Reports from a few of the new stores suggest that sales are minimal [15].
Patients who visit public facilities generally want free medicines supplied through the public
facility pharmacy or if they can afford them, they purchase branded or branded-generic
medicines from private retail pharmacies. Patients seem to have little or no faith in the quality
of generic medicines available at public facility, but poor patients who cannot afford to
purchase medicines have no choice but to take the available free medicines. Patients appear to
be reluctant to purchase generic medicines at generic drug stores on the premises of public
facilities because of questionable quality.
Promotion of generic medicines by providing generic medicines free of cost cannot sustain as a
solution for long term due to financial constraints in budgets. It is very necessary to make
patient as well as doctors aware about generic medicines and their quality. According to a
report May, 2013 by Indian Express, Health Ministry after mentioning its Rs 6,000 crore a year
scheme to provide free generic drugs at government health centers and hospitals for a year,
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the health ministry has now shelved the plan, due to financial constraints and its inability to get
in place a drug procurement policy [30]. The National List of Essential Medicine (NLEM)
contains 348 drugs, none of which is covered under patent protection which means a generic
copy of these drugs can be made and provided to patients but due to mindset and practice of
physician to prescribe costly branded drugs and further a pharmacist doesn’t has the authority
to substitute generic version of medicine, a patient either has to buy costly drug or just go
without treatment. So, if common public is aware that generic is a true copy of branded drug
and performs the same activity at less cost, and if one can easily identify generic medicine the
health care cost can be reduced to greater extent.
Myths about Generics
Although, the generic drug are a true copy of its branded counterpart with the added
advantage of being cheaper than the branded ones; yet in practice, branded expensive
medicines are used with the widespread belief among the public as well as the trade that the
branded product is better/safer and therapeutically more effective than its generics
counterpart. Some common myths are discussed below:
Doctor’s bias against generics: Largely physicians have a mindset that the branded drugs are
better than generic drugs resultantly most of the doctors prescribe the branded drugs. In a
study reported by Singal & Nanda (2010), on randomly selected 500 doctors in Haryana
state in India, from the public as well as private medical facilities, it was found that there
are more than 40% doctors who never prescribe the generic drugs [31]; there are several
similar surveys were reported, which show the poor generic prescription and the
misconception about the safety and efficacy of the generic drugs [32-33-34]. According to
Medical Council of India (MCI), Code of Ethics Regulations, 2002 “Every physician should, as
far as possible, prescribe drugs with generic names and he / she shall ensure that there is a
rational prescription and use of drugs”.
Pharmacist reluctance to stock generics because of less profit
Legal lacunae - A pharmacist cannot substitute cannot substitute a “brand” with a
“generic”. According to Drug and Cosmetics Rules 1945 “No person dispensing a prescription
containing substances specified in Schedule H or X, may supply any other preparation,
whether containing the same substance or not, in lieu thereof”.
Legal lacunae – no means to identify a branded generic/ generic as opposed to branded
medicines.
No advertisement by government regarding the safety and efficacy of generics
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Conclusion & Recommendations
According to situations prevailing about generics in India, the authors suggest some remedial
measures and recommendations for safeguarding affordable quality medicines to the general
public in the country.
1. It is very important to clear the myths about generic medicine in the mindset of patients as
well as of doctors, and government should take initiative to promote generics by
campaigning about the benefits of choosing generic medicines to cut down out of pocket
health care expenditure without compromising the quality. Much emphasis needs to be laid
upon the teaching/ training of physicians, who need to be informed of the good quality of
generics.
2. The concept of Jan Aushadhi stores launched by the Indian Government is also not picking
up, although the generic medicines with lower MRP as compared to their equivalent
branded counterpart are available at such stores. This scheme needs to be given a strong
push up at all levels. The range of generic products available in such stores is narrow, and
the total number of such stores have fallen short of target.
3. The Drugs and Cosmetics Rules, 1945, should be amended to provide for mandatory
identification mark on generics (to distinguish them from Branded-generic/branded
medicines).
4. Government should sponsor studies on comparison of branded with generics
5. Need to allow generic companies to advertise their quality
6. Active co-ordination and co-operation between the Central & State Governments, is
essential for the running of Jan Aushadhi stores successfully.
7. A pharmacist being a healthcare professional should be allowed to made ‘generic’
substitution with ‘brand’, by suitably amending Drugs & Cosmetics Act & Rules.
8. Government and MCI should strictly monitor that all prescribers prescribe medicines by
generic names (and not by brands). Strict penal action be initiated in all cases of non-
compliance, by prescribers.
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