New Delhi: Pharmaceutical companies that market medicines made by third parties in the country will now be held responsible for drug product quality with the health and family welfare ministry issuing a notification to this effect.
To download the notification, click here
The move will impact many big domestic and multinational pharmaceutical companies that get their medicines manufactured by smaller companies.
At present, there is no liability on them for any defect in a drug. Under the Drugs and Cosmetics Rules, only the manufacturer is held responsible for spurious or substandard drug. The marketing companies just require a license to sell their drugs.
Once the new rules come into effect from March 2021, the drug regulator can also penalise the marketing companies in case of spurious or substandard medicines.
“Any marketer who sells or distributes any drug shall be responsible for quality of that drug as well as other regulatory compliances along with the manufacturer under these rules,” the health ministry notification said.
Contraventions to the rules can attract penal punishment of 3-5 years of imprisonment in case the drug is not of standard quality, or life imprisonment in cases where they are found to be spurious.
Experts said the proposed move to make marketers accountable for drug quality will help check spurious drugs while some industry executives said it would hurt companies.