WHO may assist preparation of state level database of drug brands
Joe C Mathew, New Delhi

The World Health Organization (WHO) may encourage state level pharmacy associations or competent NGOs to prepare comprehensive database on the drug brand names that have been approved by respective state drug regulatory authorities. The move can lead to the development of a national registry of drug brand names thereby avoiding registration of similar sounding, look-alike drug brands in future. WHO is interested in supporting such state level data compilation, it is learnt.

Stating that the move to have proper documentation of registered drug brands will reduce the chances of misbranding and wrong dispensation, officials wanted pharmacy organizations to come forward to take up this cause.

It should be noted that the Prime Minister's Task Force on Pharmaceuticals headed by Dr Pronab Sen had specifically stated that the drug regulator must maintain a database on brands and their compositions, and all brand registration of drugs must compulsorily be approved by the drug regulator. It wanted the drug regulators to ensure that no change is permitted in the composition of a given brand.

The Part A of Pharmaceutical Policy 2006, announced few months ago, had also felt that the present system of brand approvals in the country was inappropriate for the pharmaceutical sector. According to the policy document, there are two kinds of problems that are commonly encountered. "First, even a casual look at the list of brands existing in the Indian pharmaceutical sector reveals that a number of products have either the same brand name or names which are very similar both phonetically and written. Second, 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 said.

The Pharmaceutical Policy also wants "branding of drugs and other therapeutics to be under the Central drug regulatory system". The drug regulator must be required to 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. Necessary changes would be made in the Drugs & Cosmetics Act, 1940 in this regard, it said.

Courtesy : www.pharmabiz.com
20th April, 2006

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