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Its All In The Name: State drug regulators told to BAN marketing of new formulations in old brand names


Its All In The Name: State drug regulators told to BAN marketing of new formulations in old brand names

New Delhi: In a major setback to many pharma companies in the country, the ruling Government is reported to have directed state drug controllers to prevent pharma companies to sell new drugs under old brand names.

This comes in response to the practice of pharma companies that have built a particular brand name and go ahead to use the brand name for a different API(active pharmaceutical ingredient)/ altered API.

The Government has come up with the move after the expert panel is of the view that such drugs wherein the ingredients are changed or altered by the companies while retaining the same brand name is misleading. Besides, such practices may result in undesirable pharmacological effects as the consumer would take the formulation considering it as the earlier composition.

A recent report in TOI states about the new policy move of the Government, adding that the Government order will also hit the sale of widely used household drugs. It is learnt that certain drugs are marketed with modified formulations which are marketed without changing the brand name.

This is done in order to take the advantage associated with the brand. TOI reports that these include Corex as Corex DZ, Zifi AZ under the new brand name Zifi OZ, Panderm Plus as Panderm NM, Zeet syrup retains the brand name ZEET, Zedex plus as Zedex, Macbery syrup as MACBERY.

Establishing brand name certainly helps a company relaunch its product but may create confusion regarding the ingredient inside a product, for example, Pfizer changed the cough syrup preparation and relaunched it while retaining the old brand name Corex after its composition Codeine was banned.

Presently, in effect, certain companies will be restricted to retain the brand name in medicines that have undergone alteration in raw material (active pharmaceutical ingredient). It could not be ascertained whether this would apply with retrospective effect, reports the daily.

The Government is of the strong opinion that carrying a brand name in a new or changed formulation wherein the ingredients of the same have been modified is misleading and detrimental for the patients.

On the other hand, companies continue to argue since they have invested in building a brand and it enjoys loyalty, they should be permitted to benefit from its value, report TOI.

The issue has been deliberated for a decade now in several Drugs Consultative Committee meetings.

Also Read: Glenmark launches SGLT2 Inhibitor Remogliflozin under brand names Remo, Remozen


Source: with inputs
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