The health ministry has proposed changes in regulations to hold marketing companies accountable for drug product quality. The move will impact both domestic and multi national pharmaceutical companies which also outsource production to third-party units. This is chiefly done due to capacity constraints at plants or to use facilities for export purposes.
Under the Drugs and Cosmetics Rules, the manufacturer of drug is held responsible for product quality and is liable for action in case of defects. Currently there is no liability on the marketing company for drug quality under these rules. The ministry plans to amend the rules to