The Department of Pharmaceuticals (DoP) has suggested increasing the limit of small scale categorisation of pharma units from the current levels at least by Rs.8 crore, so that the SSI units do not lose the protection and support while investing additionally for upgrading to WHO-GMP standards.


The suggestion will be sent to Planning Commission and the Finance Ministry so that this could be implemented by finalising the schemes for the industry during the next five year plan period, sources indicated.


“It is useful to examine the fact that a large number of SSI units are discouraged in the pharma sector from upgrading to medium level because of the loss of price control freedom. Under the Drug Price Control Order, such SSI pharma units are also exempted from price control. In this context, the SSI units have no incentive to grow themselves into medium level in the price control regime” according to a note prepared by the Department.


“A special provision needs to be made for the SSI pharma units to enable them to have higher level of investment in plant and machinery as mandatorily required for WHO-GMP certification even while claiming the SSI status. Therefore, the limit of SSI categorisation should be increased from Rs.5 crore to at least Rs.8 crore,” said the note.


Many associations in the pharma sector have been pressing for increasing the limit as the installation of new machineries and systems needed for going GMP-complaint often involved huge additional investment.


The DoP is also reportedly working on a detailed project report to help the pharma units in the small and medium sector by giving financial assistance to adopt WHO-GMP norms. Most of the units in the SSI sector have not adopted the norms, due to the high burden and the DoP wants to increase the number in the coming two years.