The Pharmacy Act and its regulations govern Pharmacy Education, and state guidelines cannot impose additional requirements such as an Essentiality Certificate.

ORDER :

N. Mala, J.

Writ petition is filed challenging the impugned order passed by the first respondent dated 24.02.2025, returning the petitioner's application for non-submission of essentiality certificate as per Government Orders and consequently to grant consent of affiliation to the petitioner college to start additional courses namely M.Pharm (Regulatory Affairs) and Pharm.D (Post Baccalaureate) courses for the academic year 2025-2026.

2. The petitioner college is eligible to start additional courses namely M.Pharm (Regulatory Affairs) and Pharm D (Post Baccalaureate) as per the regulations of the second respondent ie., The Pharmacy Council of India scheme of regulations for M.Pharm and Pharm,D Courses. The pre-requisite mandatory documents to be submitted as per the 2014 regulations is the consent of affiliation of examining authority (the first respondent University) for M.Pharm Course (for each specilization) and as per Pharm.D Regulations the prerequisite mandatory documents to be submitted are consent of affiliation of examining authority (1st respondent University) and MOU with 300 bedded hospital. The petitioner college is conducting M.Pharm(Pharmaceutics) and Pharm D Courses from the academic year 2025-2026 and as such the petitioner college is eligible for applying for the additional courses cited above.

3. The learned counsel for the petitioner submits that the impugned order dated 24.02.2025, returning the application of the petitioner for want of submission of the essentiality certificate as per the guidelines issued in G.O (G.O.Ms.No.228 and 229 dated 04.05.2021) by the Health and Family Welfare Department is unsustainable.

4. The learned counsel for the petitioner further submitted the impugned order is contrary to the scheme of the Pharmacy Act , framed by the Pharmacy Council of India. The learned counsel submitted that the statutory scheme contained in the Pharmacy Act was a code in itself and it occupies the field of Pharmacy Education as held by the Hon'ble Apex Court in Pharmacy Council of India Vs. Dr.SK Toshniwal Educational Trust Vidarbha Institute of Pharmacy and Others . The learned counsel further submitted that the production of Essentiality Certificate/NOC is not obligatory as per the statutory scheme the Pharmacy Act . The learned counsel relied on the Judgements of this Court in W.P.No.14834 of 2020 dated 10.11.2020, W.A.No.3534 of 2019 dated 16.06.2020 W.P.(MD)No.18310 of 2019 dated 31.03.2021 and submitted that the impugned order deserved to be set aside

5. The learned counsel for the first respondent reiterated the reasons stated in the impugned order for rejecting the petitioner's application.

6. I have heard the learned counsel for the petitioner and the learned counsel for the respondents and perused the materials available on record.

7. It is undisputed that the petitioner institution was given approval by the Pharmacy Council of India for B.Pharm. Course under Section 12 of the Pharmacy Act , 1948, for the purpose of registration as Pharmacist. The petitioner therefore as an eligible institution applied to the 1^st respondent,University on 30.01.2025, for grant of certificate of registration /consent of affiliation for starting additional courses namely M.Pharm. (Regulatory Affairs) and Pharm. D. (Post Baccalaurate), for the academic year 2025-2026. The 1^st respondent University vide impugned order dated 24.02.2025, returned the applications for non production of the Essentiality Certificate as per the Government guidelines issued in G.O.Ms.Nos.228 and 229, of the Health and Family Welfare Department, dated 04.05.2021. The said rejection order is challenged in the present writ petition.

8. The core issue to be decided in this writ petition is whether the insistence on the Essentiality Certificate from the Government as per the G.O.Ms.Nos.228 and 229, issued by the Health and Family Welfare Department, dated 04.05.2021, is justified or not.

9. The scheme framed under Regulation 9 of the Pharm.D