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Core Purpose

The Pharmacy Council of India, with the approval of the Central Government, has made the Pharmacy Council of India (Manner of Holding Inquiry and Imposition of Penalty) Regulations, 2025.

Detailed Summary

The Pharmacy Council of India, exercising powers conferred by clause (i) of sub-section (2) read with sub-section (1) of section 18 of the Pharmacy Act, 1948 (8 of 1948), and with the Central Government's approval, has enacted the Pharmacy Council of India (Manner of Holding Inquiry and Imposition of Penalty) Regulations, 2025. These regulations define terms such as 'Act' (Pharmacy Act, 1948), 'adjudicating officer' (authorized under section 43A of the Act), 'appellant', and 'appellate authority' (President, Central Council, under section 43A). They outline a process for filing complaints in Form-I regarding contraventions of the Act, initiating inquiries by an adjudicating officer with a show cause notice in Form-II (minimum seven days response time), and conducting hearings where the adjudicating officer is not bound by the Bharatiya Sakshya Adhiniyam, 2023 (47 of 2023). Proceedings must be completed within six months from notice issuance. Aggrieved persons may appeal to the appellate authority in Form-IV within forty-five days (with provisions for extension) and the appeal must be disposed of within ninety days. All orders are to be dated, signed, communicated, and penalties realized will be credited to the respective state pharmacy council. The regulations came into force on June 13, 2025, the date of their publication in the Official Gazette.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-18062025-263943 EXTRAORDINARY PART III—Section 4 PUBLISHED BY AUTHORITY NEW DELHI, FRIDAY, JUNE 13, 2025/JYAISTHA 23, 1947 No. 426] 3813 GI/2025 (1) PHARMACY COUNCIL OF INDIA NOTIFICATION New Delhi, the 10th June, 2025 No. F. 19-1/2025-PCI.—In exercise of the powers conferred by clause (i) of sub-section (2) read with sub- section (1) of section 18 of the Pharmacy Act, 1948 (8 of 1948), the Pharmacy Council of India, with the approval of the Central Government, hereby makes the following regulations, namely:— 1. Short title and commencement. – (1) These regulations may be called the Pharmacy Council of India (Manner of Holding Inquiry and Imposition of Penalty) Regulations, 2025. (2) They shall come into force on the date of their publication in the Official Gazette. 2. Definitions. – (1) In these regulations, unless the context otherwise requires,— (a) "Act" means the the Pharmacy Act, 1948 (8 of 1948); (b) "adjudicating officer" means an officer authorised under section 43A of the Act; (c) "appellant" means a person aggrieved with an order of adjudicating officer who prefers an appeal before the appellate authority under sub-section section (2) of section 43A of the Act; (d) "appellate authority" means the President, Central Council referred to in sub-section (2) of section 43A of the Act; (e) "Form" means a form appended to these regulations. (2) The words and expressions used in these regulations and not defined, but defined in the Act, shall have the same meanings respectively assigned to them in the Act. 3. Complaint.— Any person may file a complaint in Form-I through electronic means or speed post or in person, to the adjudicating officer regarding any contravention of the provisions of the Act . 4. Holding of inquiry. — (1) On receipt of a complaint under regulation 3, the adjudicating officer shall issue a notice in Form-II to the person against whom such complaint has been filed, requiring him to show cause within such period as may be specified in the notice (being not less than seven days from the date of service thereof), why an inquiry should not be held against him. (2) Every notice under sub-regulation (1) shall indicate the nature of contravention alleged to have been committed. (3) After considering the cause, if any, shown by such person, the adjudicating officer is of the opinion that an inquiry should be held, he shall issue a notice requiring the appearance of that person personally or through a representative duly authorised by him on such date as may be fixed in the notice. (4) On the date fixed, the adjudicating officer shall explain to the person proceeded against or his authorised representative, of the alleged contravention and the provisions of the Act, in respect of such contravention. (5) The adjudicating officer shall, then, give an opportunity to such person to produce such documents or evidence in Form-III as he may consider relevant to the inquiry and if necessary, the hearing may be adjourned to a future date: Provided that in taking any evidence under these regulations, the adjudicating officer shall not be bound to observe the provisions of the Bharatiya Sakshya Adhiniyam, 2023 (47 of 2023). (6) While holding an inquiry under these regulations, the adjudicating officer may require and enforce the attendance of any person acquainted with the facts and circumstances of the case to give evidence or to produce any document which in the opinion of the adjudicating officer may be useful for or relevant to the subject matter of the inquiry. (7) If any person fails, neglects or refuses to appear as required under sub-regulation (3) before the adjudicating officer, the adjudicating officer may proceed with the inquiry in the absence of such person after recording the reasons for doing so. (8) If, upon consideration of the evidence produced before the adjudicating officer, the adjudicating officer is satisfied that the person has committed the contravention, he may by order in writing, impose such penalty under the Act, as he considers reasonable. (9) Every order made under sub-regulation (8) shall specify the provision of the Act in respect of which contravention has been committed and shall contain the reasons for imposing the penalty. (10) Every order made under sub-regulation (8) shall be dated and signed by the adjudicating officer. (11) A copy of the order made under this regulation and all other copies of proceedings shall be supplied free of cost to the complainant and the person against whom the inquiry was held. (12) The adjudicating officer shall complete the proceedings within six months from the issuance of the notice to the opposite party under sub-regulation (1). (13) A notice or an order issued under these regulations shall be served on the person against whom an inquiry is held, in any of the following manner, namely:— (a) by delivering or tendering it to that person or his authorised representative; or (b) by sending it to the person through electronic means or by registered post or speed post to the address of his place of residence or his last known place of residence or the place where he carried on or last carried on, business or personally works or last worked for gain; or (c) if it cannot be served in the manner specified under clauses (a) or (b), by affixing it on the outer door or some other conspicuous part of the premises in which that person resides or is known to have last resided or carried on business or personally works or has worked for gain. (14) For the purposes of conducting inquiry under these regulations, the adjudicating officer may take assistance of the Registrars or Inspectors appointed under the Act. 5. Appeal. (1) Any person aggrieved by an order of the adjudicating officer under these regulations, may prefer an appeal to the appellate authority in Form-IV. (2) The appeal shall be filed with the appellate authority within a period of forty-five days from the date of receipt of the order: Provided that the appeal may be admitted after the expiry of the period of forty-five days, if the appellant satisfies the appellate authority that he had sufficient cause for not preferring the appeal within such period. (3) The appeal shall be accompanied by a copy of order of the adjudicating officer issued under sub-regulation (8) of regulation 4 and a clear statement of facts appealed against, the grounds for appeal and contraventions under the relevant sections of the Act. (4) The appeal shall be filed in triplicate by the appellant or by his authorised representative duly appointed in writing in this behalf, in person or by registered post or speed post or through electronic means. (5) The appeal sent by post shall be deemed to have been filed before the appellate authority on the day it is received. (6) If, on scrutiny, the appeal is found to be in order, it shall be admitted. (7) If the appeal is found to be defective, the same shall, after notice to the party, be returned for compliance and if within twenty-one days of receipt of such notice or within such extended time as may be granted, the defect is not rectified, the appellate authority, may, for reasons to be recorded in writing, reject the appeal. (8) A copy of the appeal shall be served by the appellate authority on the respondent by hand or by registered post or speed post or through electronic means. (9) The respondent may, within thirty days of service of notice of appeal, file reply to the appellate authority. (10) The appellate authority may call for the records relating to the proceedings from the adjudicating officer. (11) The appellate authority may, after giving the parties to the appeal an opportunity of being heard, pass such orders as he may consider reasonable. (12) The appellate authority shall dispose of the appeal within ninety days from the date of filing of the appeal. 6. Order and penalties. — (1) Every order under these regulations, shall be dated, signed and communicated to all the parties. (2) All sums realised by way of penalties under these regulations shall be credited to the account of the respective state pharmacy council. ANIL MITTAL, Registrar-cum-Secy. [ADVT.-III/4/Exty./159/2025-26] FORM I (see regulation 3) To, The Adjudicating Officer .................................................. .................................................. .................................................. 1. Particular of complainant:- (a) Name: (b) Address for service: (c) Contact No: (d) Email (for service): 2. Particulars of complaint:- (a) Date, time and instance of commission of the alleged contravention or default: (b) Statement of contravention or default setting out all relevant material particulars: (c) Evidence in support of the statement: (d) Tentative claimed amount (in pecuniary terms) with break-up: I/We.........., the complainant. ..herein declare that the facts stated herein are correct to the best of my/our knowledge. 3. Name and Signature of the Complainant: Note. - Strike out whichever is not applicable. Form-II [See sub-regulation (1) of regulation 4] To .................................................. .................................................. .................................................. .................................................. SHOW CAUSE NOTICE Sub: Contravention of the provisions of the Pharmacy Act, 1948 (8 of 1948). Sir/Madam, As per the complaint received in Form-I dated ____________ (copy enclosed), contravention has been committed under section ________________ of the Pharmacy Act, 1948 at ____________________. 2. The above contravention is liable for penalty. Therefore, you are required to show cause within a period of ---- days of service of this notice, why an inquiry should not be initiated against you under section 43A of the Pharmacy Act, 1948 for imposition of penalty. In case, no reply is received within the given period, further action shall be taken under the Act. Adjudicating officer Date and place..……………………………… In case, no reply is received within the given period, the further action shall be taken under the Act. ____________________________________ ____________________________________ Date and place...……………………………… Adjudicating officer FORM-III Furnishing of document or evidence [See sub-regulation (5) of regulation 4] To .................................................. .................................................. .................................................. 1. I/We, ___________________________________ hereby give a counter statement to the complaint made in Form-I The grounds in which the counter statement is made are as follows:- ____________________________________ ____________________________________ ____________________________________ ____________________________________ 2. Complete address including postal index number/code and state along with mobile number and e-mail: 3. Signature of the alleged contravener or his authorised representative: 4. Name of the person along with mobile number who has signed: FORM-IV Appeal [See sub-regulation (1) of regulation 5] To Appellate Authority, .................................................. .................................................. .................................................. 1. Particulars of appellant: (i) Name: (ii) Address for correspondence: (iii) Contact No: (iv) Email: 2. Grounds of appeal: (A copy of order of adjudicating officer to be enclosed) 3. Date of order of the adjudicating officer: 4. Statement of facts: I/We............, the appellant hereby declare that the facts stated herein above are correct to the best of my/our knowledge, information and belief. 5. Signature of appellant and date: 6. Name of appellant: Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054. GORAKHA NATH YADAVA Digitally signed by GORAKHA NATH YADAVA Date: 2025.06.18 14:26:46 +05'30'

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