The Delhi High Court has set aside the Pharmacy Council of India's (PCI) decision to reject the application of various pharmacy institutions for approval to run diploma in Pharmacy (D. Pharm) course for the academic session 2022-23 since the Council's decision was completely non-speaking. The Court has directed PCI to point out deficiencies to each institution within 21 days with inspection report, within 21 days from the order and give seven day's time for the institutions to rectify the deficiencies and to submit the explanation. The Court, in another order on petitions filed by a set of pharmacy institutions against PCI's decision to reject applications for approval to run B. Pharm Course, also set aside the PCI's decisions with similar observations. The institutions submitted applications with requisite fees to the PCI for the grant of approval to run D. Pharm course for the academic session 2022-23 and an inspection was conducted by a team of two inspectors at the institutions. Following this, the PCI in its Executive Committee meetings considered the case and rejected the application on the ground that the institution has failed to provide facilities as per statutory regulations. Around 11 institutions approached the Court alleging that the PCI's decisions are completely non-speaking. The reports prepared by the inspectors with respect to each institution have never been furnished to the institutions and without providing or pointing out the specific deficiencies, a decision for rejection of the applications should not have been taken, they argued. They argued that the Supreme Court has fixed dates for filing of applications, carrying out inspection and to take any decision with respect to grant or non-grant of the approval, in an earlier litigation. However, the decisions were taken by the PCI immediately after the inspection was carried out and it did not furnish any inspection report to any of the petitioners. Neither under the Pharmacy Act, 1948, nor under the applicable regulations, there is any mechanism for filing an appeal, they said. PCI, on the other hand, argued that it has itself decided to afford opportunity of hearing in the form of an appeal with respect to the decisions taken in the EC meeting, and the institutions still had the opportunity to file an appeal before the PCI based on the date of the EC meeting in which their applications were considered. Appeal or compliances, if preferred by the petitioners-institutions, their cases would be considered by the PCI in accordance with law and appropriate decision in that respect would be taken, argued the Counsel appeared for the PCI. The institutions stated that they, if at all are entitled to conduct the courses, can only do it from the academic year 2023-24 and all institutions are entitled for inspection reports and sufficient time to rectify the deficiencies to satisfy PCI. Scheme for approval of D. Pharm courses under the Pharmacy Act, 1948, provides for forwarding of inspection reports to a concerned applicant for rectification of deficiencies if any, and submission of compliance report with documentary evidence. After hearing the parties, the Court observed that a perusal of the decision taken in respective meetings nowhere indicated as to which institution is deficient of what requirement. "The decision so taken by the PCI is completely non-speaking, It was incumbent upon the PCI to have informed the institutions, with respect to the specific deficiencies, if any. Had it been done with the opportunity to explain, those institutions could have no grievances," observed Justice Purushaindra Kumar Kaurav in an order issued on January 19, 2023. The Court issued the order setting aside the decisions taken by PCI relating to the petitioners, and directed PCI to point out deficiencies with respect to each institution to the concerned representative of the petitioners, within a period of 21 days from the date of order with inspection report. After receipt of the communication from PCI, each institution would be entitled to rectify the deficiencies if any, and to submit the explanation to the PCI within a period of seven days. Depending upon the submission or explanation made by each institution, the PCI is directed to take a final decision within a period of two weeks thereafter, with respect to approval for the academic session 2023-24. Any compliance or appeal filed by the petitioners following the PCI's circular in December 14, 2022 and January 17, 2023 stands withdrawn as all the petitioners have been directed to take a fresh re-course in terms of the directions given in this order. However, nothing expressed in the order can be construed to be an expression on the merits of the entitlement of the approval of the institutions or on the validity of the said circulars, it added. "It is directed that if in case, the PCI decides not to grant the approval to any petitioner-institutions, the PCI should specifically point out the deficiencies in its decision so that the petitioners would be at liberty to take appropriate recourse in accordance with law," added the Court. In petitions filed by three other institutions regarding B. Pharm course, the Court issued the same directions, setting aside the PCI's decisions regarding the petitioner institutions. These institutions alleged that their applications were rejected by the PCI on the grounds of non-submission of No Objection Certificate (NOC) by the concerned State government. The institutions obtained the NOCs from the State governments through an order from the High Court, and submitted the same to the PCI, but they alleged that the PCI rejected the application again on the ground that the institution has failed to appoint faculty and facilities as per the statutory provision. The counsel for the institutions argued that PCI has only pointed out the deficiency in respect to the NOC initially and once that requirement was fulfilled, it was not permissible for the PCI to again point out some different deficiencies. SOURCE: PHARMABIZ
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