The Centre is yet undecided on granting data exclusivity to research oriented pharmaceutical companies with the commencement of the product patent regime from 2005.
According to official sources in the Department of Intellectual Property and Patents (DIPP), Ministry of Commerce & Industry, since the patent and data exclusivity are two different areas and to be handled by two different ministries, there are hardly any coordinated approaches initiated so far to make the data exclusivity provisions compatible with the product patent regime.
However, the companies who are looking for a strong patent regime in the country for ensuring intellectual property protection within the specific framework, believes that the whole exercise of patent protection would prove futile if there is no tight data exclusivity provisions as far as the pharmaceutical research and development is concerned. The industry sources say that unless the government makes clear the mandate to be followed by the Ministry Health for the exclusivity of data submitted for the R&D and clinical trial purposes, the government cannot protect the patent holders' rights as it is expected in TRIPS.
At the same time the other generic manufacturers who oppose the tightening of data exclusivity opines that as the demands for inclusion of data exclusivity in the draft proposal for TRIPS Article 39.3 were opposed and rejected, and the final TRIPS text of Art 39.3 omits the clause for data exclusivity, it is baseless to argue that India should provide for 'data exclusivity' based on the claim that TRIPS, by Art 39.3 obliges the country to do so.
The industry sources representing Indian Drug Manufacturers Association (IDMA) and asserted that Article 39 (3) of TRIPS is very restrictive in scope and implications. It only requires protection against 'disclosure' of 'undisclosed information' and that too only in respect of new drugs containing 'NCEs' - which requires 'considerable effort'. Hence, the IDMA sources alleged, that there is a conscious effort by the multinational companies to mislead the Parliament and the public by claiming that data exclusivity is requirement of Art 39.3 of TRIPS and by not providing for it, India is violating TRIPS.
Moreover, the industry sources added, since there is a provision already existing in the Drugs & Cosmetics Act of India for confidentiality of data for protection against disclosure of undisclosed information, which is to be followed by the Drug Controller General of India (DCGI), an additional provision under the TRIPS need not to be adopted or implemented in the country.