PATENT PROTECTION AND INDIAN PHARMACEUTICAL INDUSTRY

BY

Chandra Teja U
KVSR Siddhartha college of pharmaceutical sciences, Vijayawada-520010

The status of Pharmacy and medicines in Pre- and early- independence era in INDIA...
Foreign multinational companies made the entire drugs supply in India. They controlled more than 90% of the Indian pharmaceutical industry and hence determined supply, price and availability of drugs. Drugs were manufactured outside India and imported for a higher cost. The cost of drugs in India was amongst the highest in the world.

 Antibiotics like Tetracyclines, Aureomycin, and other commonly used drugs have had very high and inaffordable prices. India was the largest reservoir of epidemic diseases. Around 50% of Indias population were living under poverty and were unable to afford the cost of drugs. Consequently, life expectancy was very low and mortality rate due to diseases was very high.

Stratagies to tackle the situation...

Unable to control the expenditure on drugs, the government of India took two significant steps to remedy the situation. First, the government signed an agreement with UNICEF to set up a factory for manufacturing of penicillin and other antibiotics. This resulted in the establishment of Hindustan Antibiotic Limited (HAL) in 1957 to manufacture drugs at a cheaper rate for the public.

 Second, appointed justice RajagopalaAyyangar Committee in 1957 to recommend revision to the patent law to suit industrial needs. The object of the committee was to ensure India developed a locally sustainable pharmaceutical market.

What happened Finally...?

The report submitted that the patent legislation needed a clear directive. The Ayyanger report argued that a patent policy vesting unrestrained monopoly would deny a vast section of Indias population from access to medicines. The report recommended a compulsory licensing system and process patenting of drugs. Since health care was a major concern, the Drug Price Control Order was also passed in 1970. The order gave control over the price of drugs to the government thus complimenting the compulsory license provisions in the Indian legislation. After the Drug Price Control Order was passed, the government of India placed most drugs under price control.

PATENT ACT 1970

A patent is a government granted exclusive right, or a set of specified rights, to an inventor, or a person who claims to be the true and first inventor (or the discoverer of a new process) to make, use or sell an invention, usually for a specified term. Specifications of patent :
patents shall be available for any inventions, whether product or process, in all fields of technology provided that they are new, involve an inventive 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 on which the application for the patent was filed.

How It Happened...?
Initially, Patents were only given for a period of 7yrs after application. Most of the Indian patents, in pharmaceutical interest, were PROCESS PATENTS and not PRODUCT PATENTS... Thus, the country started to develop new processes for production of same final output and claim patent for the process. This has drastically reduced the expenses of PRODUCTION and so, the final COST in the market also came down. The government of India encouraged indigenous Pharmaceutical Industries like Ranbaxy, Dr Reddys and Cipla to produce the existing and new drugs, which will cost much less than import of drugs from Other Countries.

Currently,
24,000 pharmaceutical companies are licensed in India. Of the 465 bulk drugs used in India, approximately 425 are manufactured within the country. Indian industry has emerged as a world leader in the production of several bulk drugs. Indian production accounts for nearly 50% of the world production. Other than developing indigenous pharmaceuticals, India has grown as a major 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.

Amendments
In the PATENT ACT 1970, The patent term has been increased from 7yrs to 20yrs in all areas like PRODUCT PATENT, PROCESS PATENT & USE PATENT.. This act facilitates free conduction of drug trails on the people of this country making them guinea pigs for experiments. 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 has led to a reduced control over the Generic products.

Where do all this lead to?

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

Since the patent term has been raised to 20yrs, the competition among the companies decrease and the prices of drugs are seeing 5% to 500% rise. Recently, there are many cases where the masses of India are being exploited in the name of CLINICAL TRAILS for new drugs. Just like a small fish gets eaten by a big one, all these Multi nationals are trying to merge Indian companies into themselves and thereby establish their DICTATORSHIP in this aspect

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 is able to access the benefits of the most common drugs, Treatment procedures, available for use in the market There are many spurious, adulterated and non-authentic drugs in Indian market taking the lives of thousands each year Drugs that are banned in other developed countries are still in wide use in India.
Now, Proper intelligentsia from all sections of people should prepare a patent policy that suits our requirements. Otherwise, as the patent rights are claimed by America on Turmeric, Neem, Black pepper which are our Indigenous products for centuries; Some hotel groups applying patents on IDLY! Etc make a mockery of the patent rights

No duty is more urgent than that of returning THANKS

References,

India Today, Times of India, Patent Act, DPCO, State Pharmacy Council's Drug Information Centre.