The National Pharmaceutical Pricing Authority (NPPA) has signed an MoU with Indian Institute of Science (IISc), Bangalore, for identifying derivatives, salts, esters and stereo-isomers of 74 scheduled bulk drugs.

NPPA requires IISc's expert opinion to detect manufacturers' claims about new chemical entities (NCEs) while fixing or revising prices of scheduled formulations in accordance with the Drug Price Control Order (DPCO) 1995. Further, the expertise is expected to help NPPA to weed out the dubious claims made by pharmaceutical companies.

The pricing authority has to track or monitor over 500 drugs that enter the market in different crystalline forms, diverse polymorphisms or with varied solubility and dissimilar bio-availability. As there have been very few innovations in the pharmaceutical industry, pharma companies have been trying to cash in on new salts and show them as new chemical entities to evade pricing control.

The scientists with institute are well-versed with chemical compounds and NPPA wants to tap this expertise whenever it needs to sort out the derivatives of the new drug compounds. IISc's role would be purely technical and advisory, according to Prof S Chandrasekaran, chairman, division of chemical sciences, and professor, department of chemistry, IISc.

Certain difficulties it met in the past have led NPPA to take our assistance," Prof Chandrasekaran told Pharmabiz. "This is the first time IISc is undertaking such a service. There is neither remuneration nor any time-frame for the project. We may take 3 to 4 days to complete each NPPA query".

The MoU signed last month says there is a tendency among companies to circumvent the provision of price control by using different salts like trihydrates, anhydrous, benzoate, propionate etc. equivalent to the dose of the basic drug for which a ceiling price does not exist under the DPCO. "Overages on labeled bulk drug quantity and equivalent technical conversion ratio in terms of base activity wherever applicable in pricing of formulations based on 74 bulk drugs may need to be re-examined," according to the terms of the MoU.

Prof Chandrasekaran said, "Our service is relatively minor in nature but technically important. NPPA will take our assistance when it is suspicious about the camouflage of a chemical and will ask us to verify the product against the submissions made by the pharma company".

The drug samples sent by NPPA will be analyzed by a 10-member team comprising of entists from the departments of organic chemistry, inorganic chemistry, chemical engineering and biological sciences who are already working on drug design, discovery and manufacture of bulk drugs and fine chemicals. They already deal with drug chemistry, drug synthesis and structure of molecules and are familiar with the compounds and can detect the subtle differences, informed Prof Chandrasekaran.

IISc may extend this arrangement to a short-term training programme for the NPPA staff and also make them familiar with the protocols used in drug R&D, he added.