Understanding India’s Generic Drug Law
India’s drug laws have become the topic of heated debate since the implementation of the Agreement of Trade Related Aspects of Intellectual Property Rights (TRIPS), which is administered by the World Trade Organization. In 1995, TRIPS introduced legislation favoring the pharmaceutical companies’ right to patent their drugs. This ruling applies to all members of the WTO. Because of the tremendous impact of this legislation on the production of generic drugs, developing countries were permitted a ten-year period in which to comply. This allowed India, a major producer of generic drugs, until 2005 to adjust to the new regulations.
India is known as the “medicine factory of the Third World.” The country is the leading manufacturer and exporter of affordable generic drugs. More than half the medicines currently used for AIDS treatment in the developing countries come from India. India is also a major manufacturer of xanax, valium, phentermine, ambien, propecia, tramadol, viagra, and cialis. All of these prescription drugs are available to buy online.
In an effort to comply with the new laws, India passed its revised Patent Act in 2005. This Act is seen as a step toward offering drugs to the poor at a more reasonable price. Anyone wishing to use a drug patent may obtain a compulsory license if 1) a patent is not developed after three years of granting said patent; 2) if the public’s reasonable need for the drug cannot be satisfied in other ways; and 3) if the drug is not available at an affordable price. At this time in India, there are 10,000 drug patent applications awaiting a decision.
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Unfortunately, the revised Patent Act did not completely westernize India’s Intellectual Property Right laws. Manufacturers of Indian generic drugs are still able to copy Western drug patents. The Act allows for any generic drug manufactured in India prior to 2005 to continue to be sold. The generic manufacturers only pay a small royalty fee, thus enabling them to continue selling their drugs at a cheap price.
The genetic drug industry has benefited from compulsory licensing provisions. Compulsory licensing enables India to manufacture and export patented medicines to any third-world country unable to manufacturer its own drugs. For example, in 2005, India’s generic drug manufacturer Cipla announced it would sell a copy of Roche’s Tamiflu drug. Cipla was relying on compulsory licensing to circumvent infringement laws. The problem is that TRIPS allows countries with inadequate drug manufacturing capabilities to import drug from India at lower cost.
India’s generic drug industry has been successful because drugs manufactured in another country do not require licensing. This permits Indian drug manufacturers to continue selling cheap generic drugs. Enforcement of compulsory licensing for drug pattern would dramatic imperil the country’s generic drug industry.
Compulsory licensing was intended to balance the need for affordable healthcare with the right of corporation to make profits. Much is dependent on the outcome of compulsory licensing in India. India’s generic drug manufacturers and a long list of Third World countries that dependent on those cheap drugs have much at stake in the eventual outcome of India’s compulsory licensing laws.