The Hindu Business Line : NPPA leans on IISc’s chemistry advice

The move is expected to prevent drug manufacturers from getting away with minor changes on products and claiming them as new chemical entities for pricing purposes.

Our Bureau

Bangalore, Sept. 18

The National Pharmaceutical Pricing Authority, has roped in the Indian Institute of Science as its technical adviser to identify derivatives of the 74 bulk drugs under its purview.

The idea apparently is to help it detect minor tweaks or “improvements” over the basic drug - on the basis of which a drug manufacturer may seek to increase the product price.

Core team

A core team of around 10 chemical scientists drawn from four departments of the premier institute has been formed to look at cases that NPPA may refer whenever it encounters a drug derivative of doubtful or unjustifiable nature, as per an MoU the two signed on August 17, said Dr S. Chandrasekaran, the key person in the arrangement and Chairman, Division of Chemical Sciences and Professor of organic chemistry.

The move is expected to prevent drug manufacturers from getting away with minor changes on products and claiming them as new chemical entities for pricing purposes.

The NPPA is also keen to have its staff trained in detecting such products and IISc is weighing the option of familiarising them with relevant processes at its labs, Dr Chandrasekaran said.

Service-oriented

The institute’s role is non-commercial, recommendatory and rather a service. The NPPA “will seek our advice whenever they need to sort out a (price dispute) case. Prior to the MoU, the authority has referred 2-3 cases to us in the past six months,” he told Business Line.

Technical expertise

Pharma companies come out with various forms of formulations derived from salts or esters by effecting minor changes in the drug structure and try to project them as new chemical entities (NCEs). This is where NPPA felt the need for technical expertise as its decision on pricing could be challenged, according to Dr Chandrasekaran.

The 10-year-old NPPA governs the prices of only 74 of the 500 commonly used bulk drugs, monitors all formulations that contain these bulk drugs - either in a single or combination form.

IISc’s departments of Organic Chemistry, Inorganic Chemistry besides the Chemical Engineering department and the Biological Sciences Division are being involved to authenticate drugs or detect small changes, he said.

Apart from the “identification of bulk drugs, their derivatives, salts, esters, stereo isomers, fixation and revision of prices of scheduled bulk drugs and derivatives as well as of formulations and monitoring of prices under the Drug Price Control Order 1995,” the MoU says the authority “may also seek technical opinion on the pricing of the bulk drugs regarding the issue of basic stage of production vis-À-vis intermediates stage of products.”

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