Although India had already taken a stand against introduction of data exclusivity in pharmaceutical industry, some of the public interest groups are now concerned that the same may be introduced in the country if adequate caution is not taken in the current negotiations between India and European Union for a Free Trade Agreement. EU with the intention of protecting interests of drug MNCs of its member countries seems to be pushing for incorporation of a suitable clause in the Indian laws to introduce data exclusivity so as to extend the market exclusivity of a drug beyond its patent life. Currently, patents on drugs are granted in most countries for 20 years from the date of filing. The trade pact is likely to be signed by the end of this year during the India-EU summit of 2010. After initiating the process in 2007, eight rounds of talks have been completed between the two sides and they have claimed considerable progress on several issues. The concern expressed by the public interest groups is in the background of the fact that India is a major producer and exporter of generic drugs to the global market especially to the developing countries. Any restriction on the export of generic drugs by India with a possible introduction of data exclusivity clause can affect the availability of these cheap but quality drugs to a huge number of poor patients in developing world.
A generic drug can be currently registered with a regulatory authority if the manufacturer shows that the drug is therapeutically equivalent to an existing drug. There is no need for the generic company, therefore, to conduct lengthy three phase clinical trials to establish that it is safe and effective. Relying on the original product data is sufficient for the drug authorities to grant marketing approval. The requirement to re-test a drug which is already proven to be safe and effective is rather unethical as it needs to engage a number of patients to take part in clinical trials. India emerged as a leading producer of most of the life saving generic drugs during the last ten years is on account of the non existence of data exclusivity condition. Satwant Reddy committee in its report submitted on May 31, 2007 had also made it clear that Article 39.3 of the TRIPS Agreement does not require data exclusivity and that it may not be in the national interest to grant data exclusivity to pharmaceutical drug data. Such exclusivity period even for a short period can create a new patent-like monopoly by blocking the registration of generic medicines. The drug companies would be required to generate their own test data to register any generic medicine imposing huge costs on them. In fact, data exclusivity undermines genuine innovation as it encourages originator companies to focus their activities in changes in existing products rather than focus on developing new, innovative and beneficial products. And data exclusivity period is granted some times without the originator having to demonstrate any of the basic principles of novelty or inventiveness.