Data safety likely in drug, agrochem laws

The ministries of health and agriculture are expected to soon initiate action to include data protection clauses in the Drugs and Cosmetics Act, 1940, and Insecticide Act, 1968.

At present, there is no separate legislation to protect the undisclosed test data submitted to the regulatory authorities by the pharmaceuticals and agro-chemicals industry. The decision was taken at a recent meeting of the ministries.

The amendments to these Acts have been suggested by an inter-ministerial committee on data protection headed by former chemicals secretary Satwant Reddy in its report submitted on May 31.

The committee was constituted in February 2004 to identify the steps to be taken by the government to comply with the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement of the World Trade Organisation (WTO) on protection of undisclosed information.

For agro-chemicals, the committee has recommended a fixed-term data protection for three years from the date of registration in India. In other words, the regulator will not rely on the data submitted by the originator of the data while granting market approval for the same products of second and subsequent applicants during the three-year period.

However, in the case of new pesticides which are patented in India, data protection will not exceed the term of the patent granted. In the case of pharmaceuticals, the committee recommended certain modifications in the Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945, to ensure the applicants are asked to declare "trade secret" data that require protection in their applications.

Though the committee wanted to make drug regulatory officials responsible for the protection of the trade data, it is learnt the health ministry may not proceed in the matter.

In both cases, multinational firms are not very enthused. While agro-chemical firms are looking for protection for all its products and not just the post-1995 molecules as required under the WTO, multinational pharmaceutical firms say the kind of "data protection" they are looking for is unlikely to be in place.

"The Satwant Reddy Committee does not even touch the basic issue of protection to the innovator's data," said Ranjit Shahani, president, Organisation of Pharmaceutical Producers of India (OPPI), which represents multinational research-based pharmaceutical companies.

Meanwhile, the department of commerce, which constituted the committee, has excused itself from the implementation part by requesting the administrative ministries to go ahead with their plan of action.