This slide contains what is generic drug, what is advantages & disadvantages,reason behind unpopularity of generic drug in India, why generic drugs are important in India, why there is a need of generic drug policy, who are the regulatory authority, what are the act & laws, what policy existing in India for generic drug then Conclusion.
Part I - Anticipatory Grief: Experiencing grief before the loss has happened
Generic drug
1. School of Public Health
20-02-2018
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SEMINAR
GENERIC DRUG
Name: Shubha Ranjan Jena
Course : MPH
Roll No: 1736005
2. CONTENT:
1. What is Generic drug?
2. Why Generic Drug was needed?
3. What is the Advantages of Generic Drug?
4. What is the Disadvantages of Generic Drug?
5. Reason behind unpopularity of generic drugs
in India?
6. Why Generic Drugs are important in India?
7. Why there is a need Generic drug policy?
8. Regulatory Authority?
9. What are the act & laws?
10. What policy existing in India for generic
medicine?
11. Conclusion
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Generic Drug
A generic drug is a medication that has exactly the same
active ingredient as the brand-name drug and yields the
same therapeutic effect. It is the same in dosing, safety,
strength, quality, the way it works, the way it is taken, and
the way it should be used. Generic drugs do not need to
contain the same inactive ingredients as the brand name
product.
However, a generic drug can only be marketed after the
brand-name drug's patent has expired, which may take up
to 20 years after the patent holder’s drug is first filed with
the U.S. Food and Drug Administration (FDA).
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Generic drugs are usually much less expensive than
brand name drugs once they reach the market.
A drug company develops new drugs as brand-name
drugs under patent protection. This protects their
investment in drug research by giving the drug company
the sole right to manufacture and sell the brand-name
drug while the patent is in effect.
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Why Generic Drug was needed?
As we shall see, very often the cost
difference is so much that even well to do
people cannot afford a branded drug while
the generic version can be afforded. India
is a Developing country so people can’t
afford branded drug.
6. What is the Advantages of Generic Drug?
•These drugs are comparatively cheaper.
•They save out of pocket expenditure on the part of the patie
•Generic Drugs also break the nexus between the
pharmaceutical companies and the doctors, in which the
doctors are given incentives, gifts etc to promote a specific
brand of medicine. Often, it causes the doctors to
prescribe expensive medicines (although, the cheaper
versions are available) which increase the burden on the
patient.
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The generic medicines have also found an attractive
market overseas. A number of Indian pharmaceutical
companies have taken advantage of this and have been
exporting these drugs to both developed and developing
nations. This earns the pharmaceutical companies a
considerable volume of foreign exchange. It not only
helps the pharmaceutical sector, but it also makes Indian
pharmaceutical industry recognized on a global scale.
•Such profits also increase the capacity of the
pharmaceutical companies to invest in research and
development.
•Increase access to health care for the majority.
Peoples are not facing any financial hardship. Patient
can easily access and afford the cost of generic drug. So
it’s help to achieve Universal Health Coverage.
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What is the Disadvantages of Generic Drug?
Generic Drugs are not possible in all cases. Because its
takes long time to expire any patent.
Reason behind unpopularity of generic drugs in
India?
In India people are influenced by the “brand name” of a product
whether it may be clothes, cosmetics, accessories, including
grocery, durables or medicines. Even in the case of the
medicines market, the brand names are more popular. Certain
names of medicines have a powerful impact on people’s minds
that both the medicine and the brand have become
synonymous.
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Another reason is lack of awareness about generic drugs.
Even there is a certain section of the population who feels that
since these are comparatively cheaper, they may be of inferior
quality. Chemists give medicines that are written on the
prescription and in most cases, the doctors don’t prescribe
generic drugs.
Reason behind unpopularity of generic drugs in
India?
One has to understand that several branded drugs for treating
lifestyle diseases like diabetes, cancer, hypertension, etc. are
highly expensive and physicians usually prescribe these branded
products.
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Therefore to promote the use of cheaper generic substitutes
popular in the country, physicians support is the most critical
factor. It is only now the health ministry decided to make it
mandatory for all the physicians in the country to prescribe
drugs with generic names. This is going to be a great challenge.
Reason behind unpopularity of generic drugs in India?
Several countries including those in the developed world
are seriously trying to promote the use of generic drugs for
their citizens today. In India with huge poor and sick
population, the government should have seriously
attempted popularizing the use of generics nationwide long
back. The Government is also to blame for the lack of
awareness. The Department of Pharmaceuticals has failed
to do enough promotion of generic drugs and the proper
implementation of the Jan Ausadhi scheme. Launching of
Jan Aushadhi stores by the Central government in 2008 to
promote the use of generic drugs was a well intended
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Why Generic Drugs are important in India?
Poverty is a significant issue in India. The World Bank
reviewed and proposed revisions in May 2014, to its poverty
calculation methodology and purchasing power parity basis for
measuring poverty worldwide, including India. According to this
revised methodology, the world had 872.3 million people below
the new poverty line, of which 179.6 million people lived in
India. In other words, India with 17.5% of total world's
population, had 20.6% share of world's poorest in 2011.
So the main important is that the generic drugs are
comparatively cheaper than their branded counterparts. It
will allow the drugs to be more accessible and will reduce
the out of pocket expenditure on the parts of the patient
family.
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Why there is a need Generic drug policy?
Lack of access to essential medicines for non communicable
diseases is a major challenge for the health systems in many
low-resource countries, potentially contributing to increased
mortality and morbidity in these countries. The World Health
Organization (WHO) has recommended that every country
should have a national drug policy that ensures access, quality
and rational use of medicines as an integral part of its broader
strategic health-care policy. It has also recommended that non
communicable diseases be incorporated into the strategic plans
of national drug policies. The WHO Model list of essential
medicines contains 95 basic medicines for most non
communicable diseases, including 16 new medicines for cancer
that were added in May 2015. Despite the wide adoption of
national drug policies in low- and middle-income countries, the
majority of these do not include essential medicines for non
communicable diseases.
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Based on the WHO essential medicines concept, the
national drug policy identified 150 essential drugs for
controlled pricing. The policy was instrumental in
improving the supply and accessibility of quality essential
drugs at an affordable price.
Why there is a need Generic drug policy?
Most non communicable diseases can be treated or
managed with a small range of low-cost generic medicines
such as anti-hypertensives, statins and other
cardiovascular drugs, analgesics, anti-asthmatics and
some common anti-cancer drugs.
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Regulatory Authority?
1-The Central Drug Standards and Control Organization
(CDSCO)
•CDSCO functions under the Ministry of Health and Family
Welfare
•Prescribes standards and measures for ensuring the
safety, efficacy, and quality of drugs, cosmetics,
diagnostics and devices in the country;
•Regulates the market authorization of new drugs and
clinical trials standards;
•Supervises drug imports and approves licenses to
manufacture the above-mentioned products;
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2--The National Pharmaceutical Pricing Authority (NPPA),
1997
Regulatory Authority?
•The NPPA functions under the Department of Chemicals
and Petrochemicals.
•Fixes or revises the prices of decontrolled bulk drugs and
formulations periodically
•Updates the list under price control through inclusion and
exclusion of drugs in line with prescribed guidelines
priodically
•Maintains data on production, exports and imports and
market share of pharmaceutical firms;
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The Ministry of Health and Family Welfare examines
pharmaceutical issues within the larger context of public health
while the focus of the Ministry of Chemicals and Fertilizers is on
industrial policy. In July 2008,the cabinet Secretariat, created a
new department under Ministry of Chemicals and Fertilisers –
the Department of Pharmaceuticals, with the objective of giving
greater focus and thrust on the development of Pharmaceutical
Sector in India and to regulate various complex issues related to
pricing and availability of affordable medicines, research &
development, protection of intellectual property rights and
international commitments related to pharmaceutical sector
which require integration of work with other ministries.
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What are the act & laws?
•The Drugs (Amendment) Act, 1955 (11 of 1955)
•The Drugs (Amendment) Act, 1960 (35 of 1960)
•The Drugs (Amendment) Act, 1962 (21 of 1962)
•The Drugs and Cosmetics (Amendment) Act, 1964 (13 0f
1964)
•The Drugs and Cosmetics (Amendment) Act, 1955 19 of
1972)
•The Drugs and Cosmetics (Amendment) Act, 1982 (68 of
1982)
•The Drugs and Cosmetics (Amendment) Act, 1986
•The Drugs and Cosmetics (Amendment) Act, 1995 (71 of
1995)
•Narcotic Drugs And Psychotropic Substances Act
•The Patents Act
•Right To Information (RTI) Act
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What policy existing in India for generic medicine?
Making quality medicines available at affordable prices for
all, particularly the poor and disadvantaged, through exclusive
outlets "Jan Aushadhi Medical Store", so as to reduce out of
pocket expenses in healthcare.
In September 2015, the 'Jan Aushadhi Scheme' was
revamped as 'Pradhan Mantri Jan Aushadhi Yojana' (PMJAY). In
November, 2016, to give further impetus to the scheme, it
was again renamed as "Pradhan Mantri Bhartiya Janaushadhi
Pariyojana" (PMBJP).
•I--Pradhan Mantri Bhartiya Janaushadhi Pariyojana"
(PMBJP)
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Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) is
a campaign launched by the Department of Pharmaceuticals
to provide quality medicines at affordable prices to the
masses. PMBJP stores have been set up to provide generic
drugs, which are available at lesser prices but are equivalent in
quality and efficacy as expensive branded drugs.
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II—NATIONAL HEALTH POLICY:
Drug Regulation: Prices and availability of drugs are regulated by the
Department of
Pharmaceuticals. However, with regard to other areas of
drugs and pharmaceuticals, this policy encourages the
streamlining of the system of procurement of drugs; a
strong and transparent drug purchase policy for bulk
procurement of drugs; and facilitating spread of low cost
pharmacy chain such as Jan Aushadhi stores linked with
ensuring prescription of generic medicines. It further
recommends education of public with regard to branded
and non-branded generic drugs. The setting up of
common infrastructure for development of the
pharmaceutical industry will also be promoted. The policy
advocates strengthening and rationalizing the drug
regulatory system, promotion of research and
development in the pharmaceutical sector and building
synergy and evolving a convergent approach
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Pricing- Drugs, Medical Devices and Equipment:
The regulatory environment around pricing requires a
balance between the patients concern for affordability and
industry‟s concern for adequate returns on investment for
growth and sustainability. Timely revision of National List of
Essential Medicines (NLEM) along with appropriate price
control mechanisms for generic drugs shall remain a key
strategy for decreasing costs of care for all those patients
seeking care in the private sector. An approach on the
same lines but suiting specific requirements of the sectors
would be considered for price control with regard to a list
of essential diagnostics and equipment.
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Availability of Drugs and Medical Devices:
The policy accords special focus on production of Active
Pharmaceutical Ingredient (API) which is the back-bone of
the generic formulations industry. Recognizing that over
70% of the medical devices and equipments are imported
in India, the policy advocates the need to incentivize local
manufacturing to provide customized indigenous products
for Indian population in the long run. The goal with respect
to medical devices shall be to encourage domestic
production in consonance with the “Make in India” national
agenda. Medical technology and medical devices have a
multiplier effect in the costing of healthcare delivery. The
policy recognizes the need to regulate the use of medical
devices so as to ensure safety and quality compliance as
per the standard norms.
