Section 92A – Compulsory License for Export of Patented Pharmaceutical Products in Certain Exceptional Circumstances.

  • Compulsory Licence shall be given for manufacturing and exporting certain pharmaceutical products to any country that has no or less manufacturing capacity to produce and address the public health problem of that country, if the other country has also granted a compulsory license for the patent or has allowed the import of those patented pharmaceutical products from India.
  • After receiving an application for Compulsory License from any manufacturer under such situations, the Controller may grant a license to only manufacture and export the pharmaceutical product to such Country based on the terms and conditions that he thinks right.
  • Such grant of Compulsory licenses are subject to a limit or extent as defined under this law or / and by the terms and conditions which shall be applicable to the pharmaceutical products produced under a Compulsory License for Export.
  • Pharmaceutical product includes ingredients to manufacture a drug, diagnostic kits used for the purpose, patented product or process through which a product is manufactured.

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