Issue Date: May 1, 2017 | Web Date: June 27, 2017
India amends law to make generic drugs safer
India has made bioequivalence studies mandatory for certain classes of generic drugs before they are launched. The move is to ensure that generic medicines have the same quality and efficacy as their branded counterparts. Bioequivalence studies are conducted to establish that two medicines, normally the original patented drug and a generic version, work in the same way, to the same extent, and for the same purpose. India’s Drugs & Cosmetics Rules, 2017, have been formally amended to require bioequivalence studies on generic drugs with low solubility. The move follows the government’s recent effort to ensure that doctors prescribe generic medicines that are priced far lower than branded ones. Currently, drugs that have been in India for less than four years are required to undergo bioequivalence studies if they are in use in developed markets such as the U.S. and Europe. Generics entering the market after four years require permission from state licensing authorities, who are not required to demand bioequivalence studies.
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