India Launches Consultation on Fixed-Dose Combinations Including Investigational Drugs

Sponsors of fixed-drug combinations in which one of the ingredients is an investigational drug must submit Phase I through III clinical trial data to obtain marketing authorization, India’s Central Drugs Standard Control Organization says in a new draft guidance. Companies also must provide a rationale for combining the drugs in the proposed amounts, information about the active ingredients and formulation, animal pharmacology and toxicology data, prescribing information, samples and testing protocols and regulatory status in other countries.
International Pharmaceutical Regulation Monitor