What is meant by
generic drug? A
generic drug is a copy of a brand name drug. To be sold, a generic drug must be
“bioidentical” to the brand name drug. This means that the generic drug must be
proven to be the same as the original brand name drug in the following
ways:
Why majority of medical fraternity are apphrensive about usage of generic
drugs?
There is no proper monitoring and quality control mechanism
at retail and stockist level. even if the doctor prescribes generics, usually
it has been supplemented by higher profitable branded drugs or another
substandard generic drug.
The quality of generics of many players in
In the
In the
In
Because, there is surety of quality and efficacy with branded
drugs and having no confidence on generics , because the government's
regulatory mechanism to check sale of spurious drugs in the name of generic
drugs is simply not efficient, unlike in the US.The problem in
Because,Now
govt.wants to promote and sell generics country wide by establishing
"generic drug stores-jana oushadhi". It’s just a reminder from MCI to
our fraternity.
As per Section 1.5 code
of medical ethics - 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.
What is the present status
of generics in
India Japan and Australia
A
Person who runs the Jan Aushadhi store comments,
that Generics we sell are 20% the price of branded drugs. Popular brands
of paracetamol cost Rs 10 a strip of 10 tabs, whereas its non-branded, generic
equivalent costs only Rs 2.45 per strip. Still, patients tend to go for the
former."
Advise to doctors:
1.Complying with IMC regulations(regulation 1.5) & section 33(m) of the Indian Medical Council Act, 1956 (102 of 1956) & section 6 of the Consumer Protection Act, 1986,- prescribe medicines by their chemical name and counsel the patients about drug's side effects and probable interaction with other medicines&food.
2.The doctors need not worry about the quality of the medicine purchased by the patient from a pharmacy. No such responsibility lies upon the doctor. The responsibility for selling a spurious drug lies upon the seller.
3. when a doctor wants to dispense medicines to his / her own patients ,then the doctor has to bother about quality of the drugs procured .
• dosage form (tablet,
capsule, liquid, etc.)
• strength (same amount of drug in both)
• safety
• how it is taken (by mouth, injection, etc.)
• quality
• how the medicine gets into the bloodstream and works in the body .
• strength (same amount of drug in both)
• safety
• how it is taken (by mouth, injection, etc.)
• quality
• how the medicine gets into the bloodstream and works in the body .
Why generic drugs
produced?
Because they are
cheap and affordable to millions of patients.
What
are the benefits of generic prescription, especially for our country?
Benefits are huge for patients
suffering from prolonged illnesses such as cancer, HIV and diabetes. ''Most
cancer drugs are costly. For example, Nexavar (a pioneer drug), used for
treatment of liver and kidney cancer costs Rs 3 lakh per month for 120 tabs.
The generic version costs Rs 7,000 per month. Another branded drug for lung
cancer and head and neck cancer earlier cost Rs 80,000 per month for 100 tabs
but with generic medicines available, it has come down to Rs 7,500. So, even
original manufacturers are forced to reduce prices to remain competitive.
What is the recent
policy shift of Indian govt.?
"India
a decision that could change the lives
of hundreds of millions, but a ban
on branded drugs stands to cut Big
Pharma out of the windfall".
When
a patent for a brand name drug expires, there are usually a number of companies
that begin to make a generic version of the drug. Since there is more than one
company making the drug, the price is lowered even farther due to competition between
all of the different generic drug makers.
Why majority of medical fraternity are apphrensive about usage of generic
drugs?
There is no proper monitoring and quality control mechanism
at retail and stockist level. even if the doctor prescribes generics, usually
it has been supplemented by higher profitable branded drugs or another
substandard generic drug.
The quality of generics of many players in India
In the US
In the UK
In india
Because, there is surety of quality and efficacy with branded
drugs and having no confidence on generics , because the government's
regulatory mechanism to check sale of spurious drugs in the name of generic
drugs is simply not efficient, unlike in the US.The problem in India
Generic medicines have a
few inherent disadvantages.
Several generic drugs were
still not available in the market."Sunitinib, a medicine for kidney cancer, for
instance, is not available in a generic form.
More importantly,
combination drugs can't be prescribed without a brand name.
A wider range of
drugs is needed to effectively replace brands.
Big pharmaceuticals often
sell both branded and generic medicines and the price difference is marginal.
The idea is to maintain a monopoly, so the governement needs to be careful about
this.
Retail medical shops
could influence the ignorant consumers by promoting
a particular generic drug .
why
this renewed direction from MCI?
Because,Now
govt.wants to promote and sell generics country wide by establishing
"generic drug stores-jana oushadhi". It’s just a reminder from MCI to
our fraternity.
As per Section 1.5 code
of medical ethics - 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.
What is the present status
of generics in india
but,still
the patients /consumers are not convinced and doubted the quality and they
don't
want to take chances with their life.
How
to deal with MNC company's strategy of “ever-greening of patent rights”?
India India
A ruling by India
Advise to doctors:
1.Complying with IMC regulations(regulation 1.5) & section 33(m) of the Indian Medical Council Act, 1956 (102 of 1956) & section 6 of the Consumer Protection Act, 1986,- prescribe medicines by their chemical name and counsel the patients about drug's side effects and probable interaction with other medicines&food.
2.The doctors need not worry about the quality of the medicine purchased by the patient from a pharmacy. No such responsibility lies upon the doctor. The responsibility for selling a spurious drug lies upon the seller.
3. when a doctor wants to dispense medicines to his / her own patients ,then the doctor has to bother about quality of the drugs procured .
IMA-HBI AP's submission to MCI& MOH:
1. The Drug industry needs monitoring at all levels.
The
Central Drugs Standard Control Organisation, the country's top drug
regulatory
body,
is woefully understaffed — only 124 out of 327 sanctioned posts are
filled.
It
also lacks sufficient lab facilities to check quality of medicines.
Health
ministry officials point out that while tests are conducted to check chemical
composition of a generic drug, there are none to ensure 'bioequivalence' or its
efficacy compared to the pioneer drug.
2. IMA HB definitely
supports the greater common cause- "generic drug usage", if the
govt gives assurance to the medical fraternity about the quality of said
generics.
IMA HBI observed, Out-of
pocket spend accounts for 78% of health expenditure in India
3. Union and state
govts must Publish essential drug list and initiate this generic revolution at all public hospitals and educate
the masses by clearing their valid doubts regarding quality of generics. The govt should organize sensitization programs for doctors through
IMA as ppm project.
4.Regulators should allow limited branded generics of a particular compound
and ensure quality".
5. Govt.must take all stake holders especially IMAHBI ,in to confidence and chalk-out further action plan to popularise and implement the "quality generic" drug usage.
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