Finally better sense has prevailed and a real game-changer and sensible stand has been taken by the regulators. Now, Phase-II Clinical trials will only be required in some case as evaluated by a panel of experts rather than as a rule. The benefits are obvious: Earlier arrival of new molecules into the country. Cheaper final cost of the new molecules.
Reduce wastage of resources by unnecessary payments to the peripheral "opportunistic" participants in the process. For those of you who "believe & presume" that "Indian data" should be generated before approval of a drug I have only one question: In how many drugs' clinical trials, until now, has there been any meaningful result that has shed "new" light for the Indian patient? Money has been made by multiple participants in the clinical trial process without contributing anything to medial knowledge-base irrespective of the institution…
