Marketing Companies is equally responsible for Quality and Other Regulatory Compliance of drugs!
Ministry of Health and Family Welfare (Department of health and Family Welfare) have issued notification dated: 24th June, 2019 regarding draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, Heading: Definition Responsibility labeling requirements for marketer of the drugs.
The said draft rules will be taken into consideration on or after the expiry of a period of thirty days from the date on which copies of the Gazette of India containing these draft rules are made available to the public.
The Draft Rules States that:
“Responsibility of marketer of the drugs: Any marketer who sells or distributes any drug shall be responsible for quality of that drug as well as other regulatory compliance’s along with the manufacturer under these rules.”
Draft Rules also states the definition of Marketer:
‘Marketer’ means a person who as an agent or in any other capacity adopts any drug manufactured by another manufacturer 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.”
Labeling Requirements states:
The name of the marketer of the drug and its address, in
case the drug is marketed by a marketer:
Provided that if the drug is contained in an ampoule or a similar small
container, it shall be enough if only the name of the marketer is shown.”
Conclusion: There are two aspect of this draft. One is good for marketing companies and second is unpleasant one.
First one is: Before proposition of this draft, Drug and Cosmetic Act & Rules, doesn’t explain anything about marketer, marketing companies, there legality or not. After implantation of this draft, officially government will provide legality to marketing companies and marketed by addresses.
Second: At present, marketing companies have benefits of not having responsibility of quality and regularity compliance. If a drug is found to be not of standard quality, a marketing company has to show only purchase invoices received by manufacturing company if asked by Drug Department. They aren’t responsible for drugs not fulfilled quality standards. But after implementation of this draft, they will also be equally responsible for quality of drugs as of manufacturer.
What can marketing companies do now?
- Manufacturing is done only through renowned manufacturers
- Update about packaging, labeling standards and other quality compliance’s notified by Drug Authority
- Take Certificate of Analysis (COA) of every batch from manufacturer
- Possibly conduct Assay for every batch from independent laboratory randomly or for every batch or Set-up own laboratory for testing of drugs
Complete Draft Check: 2019.06.24 Draft G.S.R. 447(E)