De-licensing of bulk drugs permits manufacture without industrial licence, requires IEM filing; recombinant DNA products remain licenced. De-licensing removes industrial licensing and public-sector reservation for Vitamin B1, Vitamin B2, Tetracycline, Oxytetracycline and Folic Acid, while products made by re-combinant DNA technology, in vivo nucleic acid active principles, and specific cell- or tissue-targeted formulations remain under compulsory licensing. Entrepreneurs must file an Industrial Entrepreneurs' Memorandum with the Secretariat for Industrial Assistance; LOI holders need only file Part B of the IEM at commencement of commercial production but may file an initial IEM if variations to LOI or licence conditions are contemplated.
Cases where this provision is explicitly mentioned in the judgment/order text; may not be exhaustive. To view the complete list of cases mentioning this section, Click here.
Provisions expressly mentioned in the judgment/order text.
De-licensing of bulk drugs permits manufacture without industrial licence, requires IEM filing; recombinant DNA products remain licenced.
De-licensing removes industrial licensing and public-sector reservation for Vitamin B1, Vitamin B2, Tetracycline, Oxytetracycline and Folic Acid, while products made by re-combinant DNA technology, in vivo nucleic acid active principles, and specific cell- or tissue-targeted formulations remain under compulsory licensing. Entrepreneurs must file an Industrial Entrepreneurs' Memorandum with the Secretariat for Industrial Assistance; LOI holders need only file Part B of the IEM at commencement of commercial production but may file an initial IEM if variations to LOI or licence conditions are contemplated.
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