Drug data set for 5-year cover

In a major win for multinational pharmaceutical companies in India, the government is on the verge of giving five-year protection to data submitted by an innovator to the Drug Controller General of India (DCGI). However, a slew of riders will be added to ensure availability of the drug.

The drug controller will not accept mere bioequivalence data from subsequent applicants, which would have to generate data from scratch, involving a considerable cost and money.

The Satwant Reddy committee, which is going into the issue, is also looking at including herbal, unani, ayurvedic, siddhi and homeopathic drugs under data protection, a move that has the support of Department of Ayush and the domestic industry.

The multinational segment of the pharmaceutical industry in India has been demanding such protection under Article 39 (3) of the TRIPS agreement, while the domestic lobby sees it as a ploy to restrict market access to cheaper generic versions.

Article 39 (3) prohibits "unfair commercial use" of drug data submitted to the regulator but doesn't mention either the drugs that need protection or the form and duration of the protection, leaving a large grey area.

To address the concerns of the domestic industry, the department of chemicals and petrochemicals has inserted riders like price checks on drugs enjoying data protection. Also, the period of protection will begin on the first date of publication of the data worldwide and only drugs that came after 1995 will be eligible.

The department also plans to allow generic applicants to put in bioequivalence data with the DCGI two years before the expiry of the protection term. This will enable them to have a series of drug launches the day the drug loses protection.

"As Article 39 (3) doesn't specify which drugs qualify for data protection, the government will provide it to any drug that is being introduced in India for the first time. However, it will keep out derivatives that have been mentioned in Para 3 (d) of the Patents Act," said a ministry source.

This means that the definition will not coincide with that of the patentability of a drug. Para 3 (d) of the Patents Act says that derivatives like salts, esters and polymorphs of a known drug are not patentable.

The committee initially considered a compensated liability model under which the subsequent applicants could pay royalty to the innovator for commercial use of the data.

The suggestion was dropped as calculating an acceptable percentage of royalty was difficult.