Sunday, September 23, 2018
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Do We Need to Prepare Ourselves for Generic Medicines in India?


– Dr. R. B. Smarta
All over the world in an era of aging population and rising healthcare costs, generics medicines
allow patients to access safe, effective, high quality generic medicines at 20% – 80% of the
price of branded originator medicines. In this way, generics medicines support the sustainability
of healthcare provision and contribute to controlling pharma expenditure. It also generates
additional savings for patients. This is true for almost all those countries where patents regime
is followed and when the patents expire, patent originators allow generics medicines to sell.
Recent scenario of world shows that there is a steep decline in new patented molecule and
Health care cost has increased so much that they need management urgent attention to
manage. Indian ‘Generics medicines’ is the answer to the world.
However in India, the situation is quite different, upto 2005, India was not under patent regime.
As a result, Indian companies created “second brands” in India. After patents are applicable in
India these medicines are called as branded generics or generics.
One of the studies conducted by Simons, S. In current Medical research, opin 2007, 23, 2647
where prices of generics medicines of 15 molecules / strengths in 9 European countries and
India and found out that on an average generic medicines of these molecules / strengths were
63% cheaper in India!
Generics policy of Europe is influenced by price competition from Indian generics medicines
manufacturers!! That’s the power of Indian generics!! Will it be limited to export Indian
generics to the world to provide a cost-effective alternative and satisfy the need of Indian
generics in India!
Indian market is an important market for the world due to its demographic dividend and rural
and urban potential. Penetration with Indian generics will increase unit wise sales and add
value to the total Indian domestic market.
Cost effective and safe medicines is the need of all Indians. Initiative of promoting Jan Aushadhi
Bandar is an encouraging move from Indian Government! Recently, Satyameva jayate has
further made it urgent for everybody by focusing a need of Generic Medicines.
Have we really examined what needs to be done in order to succeed in Generic Medicines in
Market Dynamics:
Today, Indian market is fully of branded generics. Thousands branded generics are competing
with each other. Upto 2005, we did not have a patent regime! Indian market is dominated by
more than 60,000 branded generics. Each generic molecule has more than 50 to 100 alternates
available from National, Multinational, Regional and local companies. It is too difficult to stock,
Prescribe and sale! Large national companies have also launched so called generic – generics
portfolio and made the distribution system effective!
Critical Concerns:
Although generics are established to the good for the patients in India, we have critical
concerns which need to be addressed before we need to implement initiatives for generic
medicines. They are as follows:
a. Regulatory –
1. Availability of counterfeit, spurious generic medicines
2. Painfully inadequate structure of FDA
3. No entry barriers to manufacturer, launch any generics
4. Variable prices for few available combinations or single ingredient generic
b. Safety and Quality – Patients would not be able to judge whether the generic
product given to him at generic medicine outlet is safe or with quality?
c. Margins – Pharmacists will push generics where they get higher margins
d. Combinations – Indian market is fully of complexity of strengths and combination.
Hence, patient may not be able to decide which combination to take. Doctors also
would not be able to prescribe many combinations in generics
Suggest actions:
Hence, government has to take following actions before we make ourselves ready for Generic
Medicines or simultaneously work for them:
 Enforce strict governance through legislation for safe and effective medicines
 Create and carry out deferral punishments for counterfeits or spurious medicines
 Educate patients, physicians for the use of generics
 Incentivize pharma companies to prepare for new patents and new generics
 Avoid dominos effect leading to downsizing and cost cutting due to stiff competition
Unless and until these concerns are addressed, this will be a very temporary measure. Safety
needs to be ensured before it harms patient’s health.
In fact, Generic is what is required for India and Government must consider strengthening
                                                                                                     – Published in Pharmabiz