Patent Protection and Pharmacy in India

8/3/2019 Patent Protection and Pharmacy in India

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PATENT PROTECTION

ANDINDIAN PHARMACEUTICAL INDUSTRY

Chandra Teja U

KVSR Siddhartha college of pharmaceutical sciences,

Vijayawada-520010

BY


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Foreign multinational companies made the entire drugs

supply in India.

They controlled more than 90% of the Indianpharmaceutical industry and hence determined supply,price and availability of drugs.

Drugs were manufactured outside India and imported fora higher cost. The cost of drugs in India was amongst thehighest in the world.

The status of Pharmacy and medicines in Pre- and

early- independence era in INDIA...


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Antibiotics like Tetracyclines,Aureomycin, and othercommonly used drugs havehad very high and inaffordableprices.

India was the largest

reservoir of epidemic diseases.

Around 50% of Indiaspopulation were living underpoverty and were unable to

afford the cost of drugs.Consequently, life expectancywas very low and mortality ratedue to diseases was very high.


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Unable to control the expenditure on drugs, thegovernment of India took two significant steps to remedythe situation.

Stratagies to tackle the situation...

First, the government

signed an agreement withUNICEF to set up a factoryfor manufacturing ofpenicillin and otherantibiotics. This resulted in

the establishment ofHindustan Antibiotic Limited(HAL) in 1957 tomanufacture drugs at acheaper rate for the public.


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Second, appointed

justice Rajagopala-Ayyangar Committeein 1957 torecommend revisionto the patent law to

suit industrial needs.The object of thecommittee was toensure Indiadeveloped a locallysustainablepharmaceuticalmarket.


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The report submitted that the patent legislation needed aclear directive. The Ayyanger report argued that a patentpolicy vesting unrestrained monopoly would deny a vastsection of Indias population from access to medicines.

The report recommended a compulsory licensing systemand process patenting of drugs.

Since health care was a major concern, the Drug PriceControl Order was also passed in 1970. The order gavecontrol over the price of drugs to the government thuscomplimenting the compulsory license provisions in the Indianlegislation.After the Drug Price Control Order was passed, thegovernment of India placed most drugs under price control.

What happened Finally...?


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PATENT ACT 1970

A patent is a government granted exclusive right, or a set of specifiedrights, to an inventor, or a person who claims to be the true and firstinventor (or the discoverer of a new process) to make, use or sell aninvention, usually for a specified term.

Specifications of patent :

patents shall be available for any inventions, whether product orprocess, in all fields of technology provided that they are new, involve aninventive step, and are capable of industrial application.

Patents are registrable nationally.

Registration provides a patentee the right to prevent anyone making,using, selling, or importing the invention for 7 years from the date onwhich the application for the patent was filed.


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How It Happened...?

Initially, Patents were only given for a period of 7yrs afterapplication.

Most of the Indian patents, in pharmaceutical interest, werePROCESS PATENTS and not PRODUCT PATENTS...

Thus, the country started to develop new processes for production ofsame final output and claim patent for the process. This has drasticallyreduced the expenses of PRODUCTION and so, the final COST in themarket also came down.

The government of India encouraged indigenous PharmaceuticalIndustries like Ranbaxy, Dr Reddys and Cipla to produce the existingand new drugs, which will cost much less than import of drugs fromOther Countries.


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Currently,

24,000 pharmaceutical companies are licensed in India.

Of the 465 bulk drugs used in India, approximately 425 are manufacturedwithin the country.

Indian industry has emerged as a world leader in the production of severalbulk drugs.

Indian production accounts for nearly 50% of the world production.

Other than developing indigenous pharmaceuticals, India has grown as amajor player in the international generic drugs market.

Indian drug-makers export the generic version of various drugs to Russia,USA, Brazil, Southeast Asia and Middle East at highly competitive prices.


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Amendments

The patent term has been increased from 7yrs to 20yrs in allareas like PRODUCT PATENT, PROCESS PATENT & USEPATENT..

This act facilitates free conduction of drug trails on the people

of this country making them guinea pigs for experiments.

In the PATENT ACT 1970,

In other Acts,

The number of drugs that were under the specifications of

DPCO has been decreased from 354 to 74.

The amendments in other acts like D&C act, DPCO, etc hasled to a reduced control over the Generic products.


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Where do all this lead to?

Since the patent term has been raised to 20yrs, thecompetition among the companies decrease and the prices

of drugs are seeing 5% to 500% rise.

Recently, there are many cases where the masses ofIndia are being exploited in the name of CLINICALTRAILS for new drugs.

Just like a small fish gets eaten by a big one, all theseMulti nationals are trying to merge Indian companies intothemselves and thereby establish their DICTATORSHIP inthis aspect

These latest changes in the Patent act, DPCO, etc has given theMulti national companies a new chance to loot our country onceagain


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Conclusions

Just like they say World Goes Round, the present scenario of

Pharmacy in India is reminding us of that in per-independence time

According to a survey conducted, only 30% of the Indian population isable to access the benefits of the most common drugs, Treatmentprocedures, available for use in the market

There are many spurious, adulterated and non-authentic drugs inIndian market taking the lives of thousands each year

Drugs that are banned in otherdeveloped countries are still in wide usein India.

Now, Proper intelligentsia from all sections of people should prepare a patent policythat suits our requirements. Otherwise, as the patent rights are claimed by Americaon Turmeric, Neem, Black pepper which are our Indigenous products for centuries;Some hotel groups applying patents on IDLY! Etc make a mockery of the patentrights


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No duty is more urgent than that of returning THANKS


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References,

India Today,

Times of India,

Patent Act,

DPCO,

State Pharmacy Council's Drug Information Centre.

Patent Protection and Pharmacy in India

Documents

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