Separate licence for marketers of drugs: CIPMMA’s demand

Their argument is that the marketers are neither manufacturers nor distributors

838
Report, Audit, Inspection, Documents , medicine FDA
Picture: Pixabay

In the wake of the recent gazette notification by the Union health ministry on implementation of Drugs and Cosmetics (Amendment) Rules, 2020 which mandates pharma marketers legally responsible for quality aspects of medicines along with manufacturers, the Thanjavur-based marketers’ association, CIPMMA, has reiterated its demand for a special category licence for pharma marketing companies.

The Consortium of Indian Pharmaceutical Marketers and Manufacturers Association (CIPMMA) is the lone trade organization of exclusive pharmaceutical marketers in India.

Their argument is that the marketers are neither manufacturers nor distributors. But as responsible businessmen they welcome the amendment of the drug rules by the government.

Members of CIPMMA do not engage in marketing of other company’s products, but they market their own brands.

So, the association urges the government to consider the marketing companies as a separate segment within the supply-chain and issue separate licence for them.

“As a responsible business man who distributes his products into the public market should be conscious of the quality of his products.

We, members of CIPMMA, are manufacturing our products, which are our own brands, in another company on third party agreement and doing business.

Here, both the parties in the agreement, the manufacturing company and the marketing company, should undertake the responsibility of the quality of the products.

But, our mode of operation is different from loan licencees. We have our own brand and that brand is promoted. That is why we demand for a separate marketing licence,” said Karunai Kadal, president of CIPMMA.

Also read: Drug marketers to be held responsible for quality

The third party marketers do not have manufacturing facilities, but they manufacture their branded products in another facility on certain agreements.

The responsibility of marketing such products is vested on themselves only. The company with indication ‘marketed by’ prints its name and address on the label of the medicine. This is not a loan licensing agreement, said Kadal.

When contacted AK Jain, the drugs controller of Uttar Pradesh where the drugs control department does not permit any marketer or manufacturer to print, ‘marketed by’ indication on the label.

He said his department does not issue third party licences to operate as marketers. The DCA issues manufacturing licences and loan licences. Marketers can avail loan licences and the label of the medicine should be printed on the indication ‘manufactured by’ so-and-so companies, not marketed by, said the DC.

“The amendment of the rules is a welcome decision and it is a good law as far as medicine marketing is concerned. There should be a control over the marketers and distributors.

Lot of marketing companies are mushrooming every day and every person is becoming a marketer. So the new amendment 2020 will control such marketing companies”, said Jain over telephone from Lucknow.

The new amendment of the D&C Rule (2020) will come into force on March 1 next year.