The question for exclusivity of clinical trial data of drugs has been debated for quite some time. Soon after India implemented the product patent regime, the multinational pharmaceutical companies have been demanding exclusivity upon the data released during the clinical trial phases, which, currently can be used by the generic companies. Data exclusivity is in originator of a drug when let to protect the data submitted by him to the regulatory authority against unfair commercial use. During the period of data exclusivity the data can be protected from being cited by the subsequent applicant for requiring marketing approval. The 15 member Satwant Reddy Committee constituted in 2007, also recommended data exclusivity provisions under the Indian patent regime, in accordance with Art. 39.3 of TRIPS. However, at the same time, the committee suggested that only after further studies and keeping in mind the interests of the Indian pharma industry, the provisions be introduced.

According to news reports, the government is mulling over introducing data exclusivity provisions and is seeking the opinion of the industry in this regard. The Indian drug industry is reported to be upset over this study conducted jointly by the Ministry of Health and WHO, to examine the impact of a legal provision on the domestic industry and public health. Some studies had also been conducted earlier, when the committee was formed.

There has been a drawn out debate on the likely impact of such provisions on the growth of industry and on availability of low cost generic medicines. The WTO mandates that each member country is free to formulate its laws keeping its domestic interests in mind, while interpreting TRIPS. Again, it has to be noted that in a country like India, a balance has to be struck between the need of the public to have access to medicines and the need of the pharma industry to generate revenues for research and development.