[Ip-health] Indian ministries move to include data protection clause in pharma law

[Sarah Rimmington]

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Business Standard (India)

Data safety likely in drug, agrochem laws
Joe C Mathew / New Delhi August 22, 2007
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 =93trade secret=94 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 =93data protection=94
they are looking for is unlikely to be in place.

=93The Satwant Reddy Committee does not even touch the basic issue of
protection to the innovator=92s data,=94 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.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/