Can Indian regulator “fix” drug combos?

Come September 30, a new deadline that the Indian drugs regulator, Drugs Controller General of India, has set for state food and drug administrations to produce safety and efficacy data on scores of marketed fixed dose combinations - two or more molecules combined in specific ratios - from manufacturers, will lapse. This is the latest effort by the DCGI to weed out … Continue reading Can Indian regulator “fix” drug combos?

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Mitigating regulatory risk at Indian Pharma

Earlier this month, Mumbai-based brokerage Ambit Capital published an Expert White Paper on pharmaceuticals in which it observed that the US Food & Drug Administration's decision to conduct surprise inspections at Indian manufacturing sites (as opposed to inspections with prior notice) has "raised regulatory risks" at Indian companies. The US FDA has been under pressure … Continue reading Mitigating regulatory risk at Indian Pharma

Does India need a “TripAdvisor” for healthcare?

Early last year, when I finally threw in the towel at my workplace quite a few well-meaning (and possibly alarmed) persons in my circle of family, friends and professional contacts began thinking of ways to keep me gainfully employed. One such person was my other half. My husband is one of those creative geniuses who … Continue reading Does India need a “TripAdvisor” for healthcare?