Definition, Responsibility & Labelling Requirements For The Marketer Of The Drugs.

The Union Health and Family Welfare Ministry has issued a notification on the execution of Drugs and Cosmetics Rules 2020 that states that marketers and manufacturers are responsible for giving assurance about the quality and regulatory compliances of the marketed drugs in the country with regulatory process for import and export of drugs in India.

On February 13, 2020, the Ministry of Union Health and Family Welfare made a declaration for replacing a clause that contains the definition of "Marketer" which implies a person who is an agent or in any other capacity that adopts any drug that is manufactured by any other manufacturer under an agreement for drug marketing by labelling his name on the drug label given its sale and distribution. In addition to this amendment, Rule 83C, Rule 84D and Rule 84E have been inserted in the Drugs and Cosmetics Rules, 1945 for defining agreement for marketing and responsibility of marketer of the drugs.

The rule 84E comprises responsibility of marketer of the drugs that states "any marketer who sells any drug is responsible for the quality of that drug along with other regulatory compliances".

Clauses shall also be included which states that a drug pack must have the marketer name along with the address, in cases where the drug is marketed by a marketer. When a drug is present in an ampoule or such similar container, then it's necessary to show the marketer name only. The amended rule is called Drugs and Cosmetics (Amendment) Rules, 2020 and will come into force on 1st March 2021.

The latest amendment in the Drug and Cosmetic Act will help the pharmaceutical companies with marketing those drugs that have been manufactured by other pharmaceutical companies by labelling their name. This in a way helps in preventing duplication of the drug. This assists in selling an authentic product to the public and will help in the prevention of side effects in association with drug duplication.