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New Regulatory Focus: Mandatory expert committee review for all FDC approvals Stronger requirements for clinical safety and efficacy data Periodic re-evaluation of existing FDCs Strict enforcement against irrational drug combinations This step reinforces Indias commitment to patient safety, rational pharmacotherapy, and public health protection

High acquisition cost, need for prior authorization, injectable or infusible formulation, and requirement for clinical oversight typically trigger specialty classification

Gosselin C, Haman F (2012) Effects of green tea extracts on non-shivering thermogenesis during mild cold exposure in young men

Whilst once-weekly preparations such as semaglutide and dulaglutide can be administered at any time of day, other formulations have more specific timing requirements

Empty stomach or with food

Polygenic risk score for predicting weight loss after bariatric surgery