Pharmaceutical companies that are marketing medicines sourced from contract manufacturers or through marketing tie-ups will soon be equally responsible as the manufacturer for the quality of the drug sold in India.
Union Health Ministry has notified changes in the rule that governs regulation of drug manufacturing and marketing - Drugs and Cosmetics Rules - to treat marketer at par with the manufacturer when it comes to the quality of medicines as well as other regulatory compliances. A government notification on February 11 says that the new rule will come into force from March 1, 2021.
Sourcing of medicines from manufacturers is a common practice followed by big and small companies alike in India. Existence of pharmaceutical manufacturing hubs like Baddi in Himachal Pradesh is primarily because dozens of standalone drug manufacturing facilities in the hill states are able to custom produce the medicines for companies that have pan-India marketing network. The manufacturers also supply medicines to standalone and region-specific marketing firms that sell their own brands by generating local prescriptions. The new rule will make such marketing firms more accountable.
The Drugs and Cosmetics (Amendment) Rules, 2020 defines "Marketer" as a person who as an agent or in any other capacity adopts any drug manufactured by another manufacturer under an agreement for marketing of such drug by labeling or affixing his name on the label of the drug with a view for its sale and distribution.
It says that such marketing firms will not be allowed to label or brand any medicines without an agreement prescribed under the drug laws. It also says that such marketers, who sell or distribute drugs shall be responsible for quality of that drug as well as other regulatory compliances along with the manufacturer under the rules.
While the rule insists for display of the name of the marketer of the drug and its address on the packs, it permits display of just the name of the marketing firm if the drug is contained in an ampoule or a similar small container. The draft notification inviting public comments on the proposed changes was issued in June 2019.