New pharma policy to streamline branding of drugs
Joseph Alexander, New Delhi

Branding of drugs and therapeutics may soon be under the purview of a central regulatory system, instead state-level authorities, to avoid `misbranding' and other duplications, as per the proposed pharmaceutical policy awaiting the nod from the Cabinet.

Necessary amendments in the existing legislations have been mooted in the new policy, which is going to the Cabinet soon along with the note from the Chemicals and Fertilisers Ministry. Drug manufacturers looking to get approved a new brand will have to approach a Central regulatory system that is going to be in place under the new policy. The change in the procedure is being made after the present practice of state-level approval was viewed as `inappropriate.'

The drug regulator will maintain a database on brands and their compositions, and all brand registration of drugs must compulsorily be approved by the drug regulator. In particular, no change should be permitted in the composition of a given brand, sources said.

It is felt that the present system of brand approvals in the country was not appropriate for the pharmaceutical sector. The new move is made since a number of pharma products had the same brand name or names, which were similar phonetically, or written.

Besides, there are a number of recorded instances where the composition of a particular brand has been changed without any change in the brand name - a phenomenon termed as 'misbranding'.

Both these have the potential to cause immense harm through mis-prescription and/or wrong dispensing, it is felt. At present, brand names of drug products are approved while granting manufacturing licenses by the State authorities, which is not a desirable practice when marketing is done at the national level.

As the new pharma policy is cleared, the nature and format of the new regulatory mechanism for branding would be finalized by bringing in necessary amendments in the Drugs and Cosmetics Act. The comments of the Health Ministry have also been included in the proposed policy.

The public interest groups have been demanding the streamlining of branding mechanism for sometime now as similar brand names available in the pharma market confused the customers and scrupulous vendors took the naïve customers for a ride, by pushing the sales of products of their interest. It was also found that several occasions, companies did not change their brand name though the compositions of drugs were modified.

Source: www.pharmabiz.com
8th January 2007

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