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Data protection proposed through D&C, Insecticides Acts amendment
Jayashree Padmini - New Delhi
In a view to become TRIPs compliant, the Consultative Committee on Data Exclusivity
under the chairmanship of secretary Department of Chemicals & Petrochemicals
in its report will recommend for providing data protection for drugs and agro-chemicals.
The Committee is keen not to give TRIPs plus provisions but
adhere to TRIPs Article 39.3 is understood to have outlined the provisions for
trade protection. Based on the suggestions from legal experts, the Committee
will recommend changes in the Drugs & Cosmetics Act and Rules as well as
The Insecticides Act to bring in data protection.
It is proposed to add new Section 18A for prohibition and liability for disclosure
of information and to amend Drugs & Cosmetics Rules 1945. The amendment
to Rule 122 A and 122 B seek to ensure that for drugs approved/marketed in other
countries importer will submit to the local authority, only data from local
clinical trials and not data approved abroad. In the Insecticides Act 1968,
it is proposed to provide additional provisions for data protection under the
Section 9 and by way of amendments to Form I.
The introduction of Section 18A will see that no person shall be entitled to
the license under sub section (c) of Section 10 or under section (c) of section
18 for a drug unless approved by the licensing authorities in accordance with
the Rules prescribed under the D&C Act. For approval under subsection (1),
the licensing authorities may ask for submission of undisclosed information
by the applicant. The licensing authority will have to keep undisclosed such
information submitted under sub-clause (2) for new drugs, unless the government
by notification seek disclosure of such information in public interest. The
applicant shall be entitled to injunction, compensation, or account of profit
from any person using the information submitted under subsection 93) in violation
of breach of confidence. Such violations is liable for prosecution under Official
Secrets Act, 1923.
It is suggested that India should adopt the model of such countries with manufacturing
capabilities, but weak development capabilities which provide trade secret form
of protection for undisclosed data submitted for approval.
This will adequately satisfy the obligations under TRIPs Article 39.3. This
is aimed at ensuring availability of drugs at affordable cost. Developed countries,
with advanced pharmaceutical research and manufacturing base, follow the model
of data exclusivity for a fixed period of time for data submitted for approval.
The US MNCs have been strongly lobbying and campaigning that India should provide
data exclusivity.
The proposed amendments are in the light that the Consultative Committee observed
that the existing law in the country does not satisfy the obligation under Article
39.3 of TRIPs.
There is no express provision in the Drugs & Cosmetics Act of Insecticides
Act providing for any form of protection for the data submitted to the authorities
for approval of drugs/insecticides.
— jayashreep@expressindia.com
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