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Alternatively, the health ministry was told, it would have to establish prevalence of “national emergency, extreme urgency” or a valid case for “public non-commercial use” to make a case for invoking Section 92 under which the government can suo motu issue a compulsory licence, sidestepping a patent.
“If the ministry of health wants to proceed on the grounds of affordability, then it has to comply with provisions of Section 84,” the department of industrial policy and promotion (DIPP) said in a letter to the health ministry. While the health ministry, which has been trying to get a compulsory licence for dasatinib for the last two years, had written to the DIPP on January 17 seeking issuance of compulsory licence under Section 92, it had built its case around (lack of) affordability of the drug. The commerce ministry's remarks are significant as in October last year the Indian Patents Office rejected Mumbai-based BDR Pharmaceuticals' application under Section 84 for a licence to manufacture and market a generic version of dasatinib.
der Section 84 of the Patents Act at the instance of a local firm).
TANU
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