Compulsory licence for export of patented pharmaceutical products in certain exceptional circumstances
—(1) Compulsory licence shall be available for manufacture and export of
patented pharmaceutical products to any country having insufficient or no manufacturing
capacity in the pharmaceutical sector for the concerned product to address public health
problems, provided compulsory licence has been granted by such country or such country
has, by notification or otherwise, allowed importation of the patented pharmaceutical
products from India.
(2) The Controller shall, on receipt of an application in the prescribed manner, grant a
compulsory licence solely for manufacture and export of the concerned pharmaceutical
product to such country under such terms and conditions as may be specified and
published by him.
(3) The provisions of sub-sections (1) and (2) shall be without prejudice to the extent to
which pharmaceutical products produced under a compulsory license can be exported
under any other provision of this Act.
Explanation.—For the purposes of this section, ‘pharmaceutical products’ means any
patented product, or product manufactured through a patented process, of the
pharmaceutical sector needed to address public health problems and shall be inclusive of
ingredients necessary for their manufacture and diagnostic kits required for their use.
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