A generic drug is equivalent to its
brand name counterpart, but is usually much less expensive. A generic drug must
have the same active ingredients, route of administration, dosage form,
strength, and indications as the original brand product. The generic drug may
differ from the original in non-essential characteristics such as color, taste
and packaging. Generic drugs are deemed to be as safe and effective as the
brand name product. Generics cannot be sold until after the drug patent expires
on the original brand name product. Patents typically expire 20 years from the
date of filing. During this period of patent protection, only the original
manufacturer can research, develop and sell the brand name drug. When the
patent expires, other manufacturers can submit an abbreviated new drug
application (ANDA) to the FDA for approval to market the generic version.
Generic drugs have lower research costs
and increased market competition and those substantial savings are passed on to
the patient. However, generic drugs still must meet strict FDA requirements
with respect to quality, performance, labeling, manufacturing, and
bioequivalence. By law, generic drugs must have the same active ingredients as
the brand name product, and they can be expected to have the same effect when
used in place of a brand name drug.
India may be famous for its generic
drugs but patients seeking medicines like rifampicin (Tuberculosis or TB,)
lamivudine (HIV/AIDS,) artemisinin (Malaria,) oxytocin (Reproductive Health,)
fluoxetine (Mental Health,) and metformin (Diabetes) may not find generic drugs
(having no brands) easily in shops across the country. The price of branded
ones available is prohibitive, and not affordable to the common man.
This is the gist of a study published in
the latest edition of the Journal of Global Health that looked at the
availability of essential six medicines, in 124 private pharmacies across the
state, including Mumcai. The study done by researchers at Newcastle University
in UK and in Mumbai, found that the policy to open up the market has generated
a large number of medicines, but there are still not enough availability in
pharmacies.
“There has n’t been adequate
governmental intervention with regard to sales practices by pharmaceutical
companies. The Hathi Committee had years back recommended that medicine strips
mention the generic names in big and in bold print and brand names in smaller
print, but this recommendation has not been implememted.” Pure generic versions
of drugs are not available in most cities.
It is the bounden duty of the government
and the medical authorities concerned to focus their attention to see that
Generic Medicines are made available throughout the country at affordable costs
to the common man.
I am really perturbed by the recent
escalation in the prices of Allopathic medicines. This is observed especially
in the life-saving drugs that are imported; the medical lobby is looting the
public. The medical drug authorities concerned should keep a strict vigil on
them and should be penalized heavily. We are proud to know that our scientists
are successful in sending economical missions like “Chandrayan” and “Mangalyan.”
It is much more significant to achieve self-sufficiency in matters of
nutritious food, clothes, shelter and medical drugs for our people. We have
brilliant and dedicated scientists, doctors and pharmacists; the government
should provide funds liberally and encourage them to invent and manufacture the
required medicines at affordable prices to the common man. It is not advisable
to import medicines from abroad and get exploited in the bargain. Try to avoid
middlemen. I am of the opinion that it is the duty of the government to
maintain not only the quality and quantity of a product but also to control the
price of medicines and all other goods sold in market. In any event, the MRP
(Maximum Retail Price) shall not exceed double the cost price of a product and
would ensure that businessmen shall not loot the public.
Excerpts from
MEMOIRS
An autobiography
by
Joseph J. Thayamkeril
Lawyer, Kochi, Kerala, India.
josephjthayamkeril.blogspot.com
josephjthatamkeril@gmail.com
josephjthatamkeril@gmail.com
