CDSCO move towards smarter, risk-based regulation to ease doing business for Indian pharma: iPHEX…
The Central Drugs Standard Control Organisation (CDSCO) is moving towards a smarter, risk-based regulatory approach that reduces…
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Browsing Tag
CDSCO
The double burden of tighter enforcement, slower implementation
India’s pharma MSMEs are facing a tough transition to revised GMP norms, hampered by slow implementation of the very schemes that…
CDSCO directs action against unapproved Enclomiphene drug products
State and UT Drugs Controllers asked to identify manufacturers, marketers, distributors and retailers dealing with Enclomiphene…
India to build future-ready drug regulatory framework to accelerate healthcare innovation, Says J P…
India is building a future-ready drug regulatory framework to accelerate healthcare innovation while maintaining the highest…
CDSCO proposes to ban “Same Brand, Different Drug” practice
Regulator introduces “One Brand – One Formulation” policy to improve patient safety and reduce medication errors
In a landmark…
Emcure to expand use of Poviztra for MASH indication after CDSCO nod
Poviztra® is manufactured and imported from Novo Nordisk's European manufacturing facility and contains innovator rDNA-origin…
Takeda gets DCGI approval for its dengue vaccine QDENGA (TAK-003)
QDENGA, now approved in 43 countries, including India, is designed to protect against all four dengue virus serotypes
Leiutis marks global milestone with CDSCO approval for Synthetic Cannabidiol Oral Solution for mild…
Leiutis Pharmaceuticals LLP has announced that the Central Drugs Standard Control Organisation (CDSCO) has granted regulatory…
FOPE seeks CDSCO clarification on pharmacovigilance obligations under revised Schedule M
The Federation of Pharma Entrepreneurs (FOPE) has sought clarifications from the Central Drugs Standard Control Organization…
Lilly launches Tanstrive (Selpercatinib), a RET inhibitor to treat advanced cancers with RET gene…
Available in India in 40 mg, 80 mg, 120 mg and 160 mg tablet strengths; administered orally twice daily