The pharmaceutical industry in the country has urged the Department of Pharmaceuticals (DoP) to stay the two internal guidelines dated 4.10.2012 and 9.10.2012 issued by the National Pharmaceutical Pricing Authority (NPPA) on overcharging and on referring cases for prosecution under DPCO '95 as these guidelines will work against the interests of the industry in the country.

Seeking the intervention of the DoP secretary in the matter, the industry has said that these guidelines will have far-reaching consequences on the entire Indian pharma industry and may even impede its growth.

Earlier the NPPA had issued internal guidelines for dealing with overcharging and without price approval (WPA) cases. The guidelines are based on the recommendations of an expert committee constituted by the government to examine the issues relating to the practice followed in the NPPA based on the existing internal guidelines in regard to overcharging and WPA cases.

As per the recommendations of the committee, any scheduled formulation manufactured and sold by a company either at a price higher than the notified price or without price approval shall be liable for appropriate action as provided for in the DPCO'95. All price violation cases shall necessarily fall under 'Overcharging case' or 'WPA category' or both.

Besides, the NPPA had issued revised internal Guidelines for referring the case for prosecution under para 8 of DPCO, 1995.

As per the revised guidelines, penal action for violations of para 8 of the DPCO, 1995 shall be initiated against all pharma units without any distinction between the organised sector and SSI units who have not been specifically exempted by the NPPA in terms of S.O. No. 134(E} dated 02.03.1995. Penal action for violation of para 8 of the DPCO,1995 shall be initiated against concerned pharma companies in the uniform manner.

In such cases wherein the manufacturer has been found to have failed to take prior price approval in sale of scheduled formulation packs then the penal action will be initiated against both companies.

Such pharma units which are found to have prima-facie violated the provisions of para 8 of the DPCO,1995, with a view to afford them with an opportunity to state their case before taking a final view to proceed further, will be issued with a "show cause notice".