UNION OF INDIA Vs. SWISS GARNIER LIFE SCIENCES

JUDGEMENT

(1.) THESE appeals arise out of the common judgment dated 19.05.2010 passed by a learned Single Judge of this Court in W.P.(C) Nos. 10277/2009 and 12958/2009. The said writ petitions had been filed challenging the price fixation notifications dated 30.04.2009 and 17.11.2009 whereby the government had fixed the prices of Doxofylline formulations. By virtue of the impugned judgment it has been held that Doxofylline is not a bulk drug within the meaning ascribed to it under paragraph 2(a) of the Drugs (Prices Control) Order 1995 (hereinafter referred to as the DPCO, 1995). The contention of the appellant before us and the respondent before the learned Single Judge was that Doxofylline was a bulk drug under the said paragraph 2(a) and, therefore, the government was entitled to fix the price of its formulations under paragraph 9 of the DPCO, 1995 and it is pursuant to that power that the said notifications dated 30.04.2009 and 17.11.2009 were issued, fixing the prices of Doxofylline formulations.

(2.) ON the other hand, it was contended on behalf of the respondents herein and the petitioners before the learned Single Judge that Doxofylline was not a bulk drug within the meaning of paragraph 2(a) of the DPCO, 1995. Mr Ganesh, the learned Senior Counsel appearing on behalf of the respondents further submitted that even if it were to be assumed, without admitting, that Doxofylline was a bulk drug, as defined in paragraph 2(a) of the DPCO, 1995, the prices of Doxofylline formulations could not be fixed under paragraph 9 or 11 of the DPCO, 1995 because paragraph 9 and consequently paragraph 11 only relates to scheduled formulations. He submitted that Doxofylline formulations in respect of which the said notifications were issued were not scheduled formulations and, therefore, on this ground also the notifications were liable to be struck down. It was further contended by Mr Ganesh that even if we ignore the first two points, the issue of satisfaction of the criteria specified under paragraph 22.7-2 of the new drugs policy would still have to be considered. He submitted that the criteria which are set out in the said paragraph are not at all satisfied in the present cases. He further submitted that though this point was noted by the learned Single Judge in paragraphs 12 and 13 of the impugned judgment, he did not think it necessary to deal with the same because of the view, that he took, that Doxofylline was not a bulk drug.

(3.) WE shall take up the first point and that is whether Doxofylline is a bulk drug within the meaning of paragraph 2(a) of the DPCO, 1995. Bulk drug has been defined in the said paragraph as under: