Executive Summary:
This document outlines amendments to the Pharm. D. Regulations of 2008, as approved by the Central Government and issued by the Pharmacy Council of India. These amendments, known as the Pharm. D. Amendment Regulations, 2019, address hospital requirements for Pharm.D. institutions, particularly in North Eastern states and hilly regions. The regulations take effect upon publication in the Official Gazette.
Key Points / Main Content:
* **Regulation Name and Effective Date:**
* These regulations are called the Pharm. D. Amendment Regulations, 2019.
* They come into force on the date of their publication in the Official Gazette.
* **Amendment to Hospital Requirements:**
* For institutions seeking Pharm.D. approval in North Eastern states and hilly regions of India, where 300-bed hospitals are unavailable, a Memorandum of Understanding with a district headquarter hospital (with available bed strength) is permitted for providing clinical training to students.
* **Amendment Regarding Location of Hospital and Institution:**
* Where the hospital and institution are located in different Corporation or Municipality or Campus, the distance between the two shall not be more than 30 kms by road.
Impact Analysis:
* **Pharmacy Council of India:**
* Impact: Responsible for implementing and enforcing the amended regulations.
* Action Required: Ensure the amended regulations are properly integrated into the Pharm. D. program approval process.
* **Pharm.D. Institutions (Especially in North Eastern States and Hilly Regions):**
* Impact: Institutions in these regions benefit from relaxed hospital requirements for clinical training agreements.
* Action Required: Assess current hospital affiliations and, if necessary, establish Memorandums of Understanding with district headquarter hospitals.
* **Students of Pharm.D. Programs:**
* Impact: Access to clinical training opportunities in regions with limited hospital infrastructure.
* Action Required: Participate in clinical training programs as per the established agreements between institutions and hospitals.
Key Entities Referenced
Pharmacy Act, 1948: An Indian legislation that empowers the Pharmacy Council of India to make regulations.
Pharmacy Council of India: The regulatory body in India responsible for pharmacy education and profession, empowered to make regulations with the approval of the Central Government.
Central Government: The Union Government of India, whose approval is required for the Pharmacy Council of India's regulations.
Pharm. D. Regulations, 2008: The original regulations pertaining to the Doctor of Pharmacy (Pharm. D.) program in India, which are being amended by this notification.
Pharm.D. Amendment Regulations, 2019: The new regulations amending the Pharm. D. Regulations, 2008.
North Eastern States of India: A group of states in the northeast region of India, specifically mentioned in the context of hospital bed requirements for Pharm. D. program approvals.
New Delhi: The location of the Ministry of Health and Family Welfare and the place of publication for the notification.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy and regulations, under which the Pharmacy Council of India operates.
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MINISTRY OF HEALTH AND FAMILY WELFARE
(PHARMACY COUNCIL OF INDIA)
NOTIFICATION
New Delhi, the 6th December, 2019
No. 14-126/2019-PCI.—In exercise of the powers conferred by section 10 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 further to amend the Pharm. D. Regulations, 2008, namely:-
1. (1) These regulations may be called the Pharm.D. (Amendment) Regulations, 2019.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Pharm. D. Regulations, 2008, in APPENDIX-B, in paragraph 2), in clause b) -
(i) in the opening portion, after the words “hospital attached to it”, the following words shall be added, namely:-
“ except in the case of North Eastern States and hilly regions of India where hospitals with 300 beds strength are
not available, the institutions desiring to seek approval of Pharm.D. course are permitted to sign a Memorandum
of Understanding with district headquarter hospital with available bed strength for providing clinical training to
students”;
(ii) in sub-clause (iii), after the words “involvement as adjunct faculty”, the words “and where the hospital and
institution are located in different Corporation or Municipality or Campus, the distance between the two shall not be
more than 30 kms. by road” shall be added at the end.
ARCHNA MUDGAL, Registrar-cum-Secy.
[ADVT.-III/4/Exty./345/19]
Note: The principal regulations were published in the Gazette of India, vide notification No.14-126/2007-PCI, dated
May10- May 16, 2008 and last amended, vide notification No.10-1/2012-PCI (Pt-I), dated the 28th August,
2014.
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.