Approval Granted U/S 12(1) Pharmacy Act Applies To Entire Course Of Study; But M. Pharm Couse Requires Renewal Every 5 Years: Delhi HC

The Delhi High Court held that the approval granted to colleges under Section 12(1) of the Pharmacy Act, 1948 applies to the entire course of study, except for the M. Pharm course, which requires renewal every five years as per M. Pharm Regulations.

In that context, the Bench of Justice C Hari Shankar observed that, "It is hereby declared that the approval granted to the course of study conducted by an institution under Section 12(1) is to the entire course of study and not to any one year thereof. Such approval, once granted, is to apply, subject it is being liable to be withdrawn in accordance with Section 13. The PCI has no power or authority to call on any institution to obtain continuation of the approval granted under Section 12(1) every year, nor can the PCI require the Institution to pay PERC on an yearly basis to obtain continuation of the approval granted to the courses under Section 12(1). The only exception is in the case of the M. Pharm course, for which the approval would have to be renewed after 5 years, as required by the M. Pharm Regulations."

The petitioner-institution ran programs resulting in B. Pharm, M. Pharm, D. Pharm, and Pharm. D degrees, with approval granted and governed by Section 12 of the Pharmacy Act, 1948. The petitioner challenged specific clauses of a communication issued by the Pharmacy Council of India (PCI) on 14 December 2023, which required institutions already approved under Section 12 of the Act to apply yearly for continuation of approval. The petitioner argued that the concept of "continuation of approval" was foreign and opposed to the Act, asserting that once approval was granted to a course, it did not need yearly renewal. The petitioner also challenged the Approval Process Handbook 2024-2025 and the charging of Pharmacy Education Regulatory Charges (PERC) for obtaining "continuation of approval," contending that these requirements were contrary to the Act and Article 265 of the Constitution of India.

The issues in controversy were limited to whether the PCI could require yearly applications for continuation of approval for B. Pharm and D. Pharm courses and whether it could charge PERC for this purpose. The petitioner had previously submitted an application on 5 August 2022 in response to a PCI circular, seeking approval for B. Pharm and D. Pharm courses with an intake of 60 students each. Despite delays in processing, the PCI eventually granted approval on 29 November 2023, but only for the 2023-2024 academic year. The petitioner, therefore, sought to challenge the PCI's circular issued on 14 December 2023, which required existing approved institutions to apply for continuation of approval and pay PERC.

The petitioner argued that Section 12 of the Act envisioned approval for a course rather than a specific time frame and that the requirement for yearly renewal was not supported by the Act or any related regulations. The petitioner also highlighted that the B. Pharm and D. Pharm course regulations did not contemplate periodic renewal of approval, unlike the M. Pharm course regulations. Therefore, the petitioner contended that the PCI's requirement for yearly continuation of approval and the associated charges were illegal and should be set aside.

The High Court resolved the controversy by referring to Section 12 of the Pharmacy Act, 1948, supported by the Education Regulations. Section 12 was found to be clear and categorical, referring to the "course of study" conducted by an institution. The Court rejected the PCI's submission that the terms "course of study" and "course" should have different interpretations, emphasizing that both terms refer to the same thing as per Section 12(1).

Given this understanding, the Court concluded that the decision of the PCI to require institutions with existing approvals under Section 12(1) to apply yearly for continuation of approval was illegal. It was noted that Section 12(1) mandates institutions to apply for approval of the course of study and, once granted, this approval is for the entire course, not for individual years. The Court stated, "Section 12(1) requires the institution which conducts the course of study to apply to the PCI for approval of that course of study... The approval is therefore to the course of study, whether one refers to it as a ‘course’ or as a ‘course of study’". 

The Court further explained that Regulation 2 of the B. Pharm Regulations, which is similar to the corresponding provisions in the M. Pharm and D. Pharm Regulations, supports this interpretation by referring to the complete course of study and the examinations as prescribed in the regulations. Consequently, the approval is for the entire B. Pharm/M. Pharm/D. Pharm course, not for any particular year.

Additionally, the Court rejected the contention that the word "course" refers to each individual year of the B. Pharm/D. Pharm courses, finding it contrary to Section 12(1), the Regulations, and the PCI’s own written submissions. The Court highlighted that, according to PCI’s written submissions, the approval is for the entire course of study, not for each year individually.

Moreover, the Court addressed the consequence of failing to obtain yearly renewal of approval, clarifying that withdrawal of approval is governed by Section 13 of the Act. It was emphasized that approval, once granted, continues until it is withdrawn according to the provisions of Section 13 and cannot be discontinued by an administrative decision.

No merit was found in the PCI's plea for a purposive interpretation to justify the PCI’s yearly continuation requirement, as the Act already contains provisions, such as Section 12(3) and Section 16, for monitoring institutions. The Court stated, "Adequate and sufficient provisions, to subserve the purpose for which the PCI has resorted to the practice of seeking yearly continuation of approvals already finding place in the Act, the practice cannot be sought to be sustained on the principle of purposive interpretation".

Cause Title: SLS College of Pharmacy vs Pharmacy Council of India

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