Marketers To Be Held Responsible For Drug Quality

New Delhi, 14 Feb 2020:

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 on Thursday issuing a notification to this effect. 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.

RC Juneja, chairman and managing director at Mankind Pharma, said the new regulation will hurt both small and big companies. “It will discourage small manufacturers which largely depend on big companies for marketing,” he said. “The dependence of big companies on small companies will also reduce. The punishment is too massive.” India’s top drug advisory body had in 2018 approved the proposal to amend the Drugs & Cosmetics Act to make pharmaceutical marketing firms liable for any contraventions of regulations. Economic Times