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6. Vide Circular dated 3 July 2022, the PCI invited applications from new institutions seeking approval for starting Pharmacy courses. The application was to be submitted on a Standard Inspection Form (SIF). The petitioner submitted an application, on the SIF, on 5 August 2022, in response to the Circular. Approval was sought for conducting B. Pharm and D. Pharm courses with intake of 60 students in each course. The SIF required the applicant to state the year of "Starting of Course (Academic Session)". The petitioner entered 2022-2023 as the relevant year, under the said column, for each of the courses. The requisite PERC, for running the said courses, was also deposited by the petitioner.

24. Mr. Garg relies on the "Statement of Objects and Reasons" of the Act, which empowers the PCI to "prescribe the minimum standards of education and approve courses of study and examinations" for Pharmacists. He further submits that the PCI is manned by persons of authority and competence, and underscores the constitution and composition of the PCI, as set out in Section 332 of the Act. He also points out that Section 10(2)(c) empowers the PCI to, by Education Regulations, prescribe "the subjects of examination and standards therein to be attained". The requirement of a yearly approval being taken by the institutions running Pharmacy courses, submits Mr. Garg, is only to ensure the maintenance of adequate standards of education by the IGNOU.

Of the perusal of section 12(1) read with Section 12(2) & (3) along with regulation 9 of B. Pharm courses of regulation 2014, It is crystal clear that the Pharmacy institutions conducting pharmacy Courses has to submit a scheme year wise in the prescribed format forgetting approval under Section 12(1) of Pharmacy Act, 1948 from Pharmacy Council of India as the course of study has to be followed by examination.

The scheme is required to be submitted annually as per the decision of Pharmacy Council of India under Section 12 of Pharmacy Act since its inception only to regulate the Pharmacy Education at the annual approval of the course of study of Pharmacy Institutions so as to enable the Pharmacy Council to keep a proper check on the institution regarding running of the courses as to whether they are in conformity with the education regulation and as per section 12 of the Pharmacy Act, otherwise it would be very difficult to regulate it. In other words, the word approval in Section 12 of Pharmacy Act 1948 is approval for the course of study of annual so if the approval of the examination of each year. It enables the Pharmacy Council of India to keep itself on guard with regard to performance of the institution so that the approval is extended on year-to-year basis and to easily intervene on any difficulty in running the institutions and every year the institution has to start a new course of study for the academic year which require prior approval otherwise the institution cannot able to run the new course as prior approval from Pharmacy Council is essentially required before opening of new 'course of study' as per mandate of Section 12 of Pharmacy Act and Regulations made thereunder."