Executive Summary:
This notification details amendments to the Minimum Standard Requirements for 100 Admissions Annually Regulations, 1999, under the Indian Medical Council Act, 1956. These amendments, sanctioned by the Central Government, focus on Microbiology departments and hospital waste management, and take effect upon publication in the Official Gazette on June 8, 2020.
Key Points / Main Content:
Microbiology Department Accommodation:
* A Virology Service Laboratory with BSL2 level is required, including specific areas for sample receiving, PPE handling, biosafety cabinet use, pre- and post-PCR activities, and biomedical waste handling.
Hospital Waste Management:
* Medical institutions must comply with the Biomedical Waste Management Handling Rules, 1998, and have a robust policy for biomedical waste management, including segregation and discarding procedures.
Microbiology Department Staffing:
* Additional staff is required for the Virology Service Lab: 1 Medical Microbiologist trained in Virology, 2 Technicians with experience in Molecular Virology, and Multi-Tasking Staff.
Equipment for Microbiology Department:
* Biosafety cabinet BSC class 2A2B calibrated: 4 Nos.
* Additional equipment required: 80°C deep freezer with UPS (1), Real-time PCR machine calibrated for fluorophore dyes with UPS (2), Refrigerated Centrifuge (1). Consumables for Virology Lab as required, including PPE, Viral Transport Medium (VTM), and kits for Virology studies.
Impact Analysis:
Medical Colleges:
Impact: Medical colleges must update their infrastructure, equipment, waste management policies, and staffing to meet the new minimum standard requirements for Microbiology departments and waste disposal.
Action Required: Review and update existing facilities and policies to ensure compliance with the amended regulations, particularly regarding the Virology Service Laboratory and biomedical waste management. Hire additional staff for the Virology Service Lab and procure equipment.
Medical Council of India (now superseded):
Impact: The Board of Governors in Supersession of the Medical Council of India has issued these amended regulations under the powers conferred by the Indian Medical Council Act, 1956.
Action Required: Ensure that inspections and accreditations align with the new standards outlined in the amended regulations.
Central Government:
Impact: The Central Government sanctioned these amendments.
Action Required: Oversee the implementation and enforcement of the updated regulations across medical institutions in India.
Key Entities Referenced
Medical Council of India: An organization related to medical education and standards in India, now superseded by the Board of Governors.
Board of Governors in Supersession of Medical Council of India: The governing body that has superseded the Medical Council of India.
Indian Medical Council Act, 1956: The legislative act providing the framework for medical education and regulation in India.
Minimum Standard Requirements for 100 Admissions Annually Regulations, 1999: Regulations prescribing the minimum standards for medical institutions admitting 100 students annually.
New Delhi: The location where the notification was issued, New Delhi, Delhi.
The Gazette of India: The official government publication in which the notification is published.
Biomedical Waste Management Handing Rules, 1998: Rules concerning the management and handling of biomedical waste.
Virology Service Laboratory: A specialized laboratory for virology services, including sample handling, RNA extraction, and PCR analysis.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एलxx.x-GअI.D-E0x8x0x 62020-219824
CG-DL-E-08062020-219824
असाधारण
EXTRAORDINARY
भाग III—खण्ड 4
PART III—Section 4
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 186] नई ददल्ली, सोमिार, िनू 8, 2020/ज्य ष्े ठ 18, 1942
No. 186] NEW DELHI, MONDAY, JUNE 8, 2020/JYAISTHA 18, 1942
भारतीय आयर्वु िज्ञान पररषद ्के अजधक्रमण म ेंिासी बोड ड
अजधसचू ना
नई ददल्ली, 3 िून, 2020
स.ं भा.आ.प.-34(41)/2020-मजे ड./103234.—भारतीय आयुर्विज्ञान पररषद ् अजधजनयम, 1956 (1956 का
102) की धारा 33 द्वारा प्रदत्त िजियों का इस्ट्तेमाल करते हुए, “प्रजतिषड एम.बी.बी.एस. म ें 100 दाजखलों के जलए
न्यूनतम ितें जिजनयमािली, 1999” म ें पुन: संिोधन करने हते ु भारतीय आयुर्विज्ञान पररषद,् केंद्रीय सरकार के पिू ड
अनुमोदन स े एतदद्वारा जनम्नजलजखत जिजनयम बनाती ह,ै नामत:-
1. (i) इन जिजनयमों को “प्रजतिषड एम.बी.बी.एस. म ें 100 दाजखलों के जलए न्यूनतम ितें जिजनयमािली, (संिोधन)
2020” कहा िाएगा।
(ii) य,े सरकारी रािपत्र म ें उनके प्रकािन की तारीख स ेप्रिृत्त होंग।े
2. “100 दाजखले प्रजतिष ड के जलए न्यूनतम मानक ित ें जिजनयमािली, 1999” म ें अनुसूची I म ें : “क.2 जिभाग” के अंतगडत
“मेजडकल कालेिों और उनके सबं द्ध अस्ट्पतालों म ें आिास” िीषडक के अंतगडत “सूक्ष्मिीि जिज्ञान जिभाग” म ें प्रजिजि संख्या 5
म ें जनम्नजलजखत िोडा िाएगा :
घ क) जिषाणु-जिज्ञान सेिा प्रयोगिाला, बीएसएल-2 स्ट्तरीय प्रयोगिाला होगी। इस प्रयोगिाला म ें जनम्नजलजखत क्षत्रे
िाजमल होंग:े
i. नमूना प्राजि क्षेत्र
ii. हस्ट्त प्रक्षालन एि ं पी पी ई पहनना / उतारना क्षत्रे
2455 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
iii. िीि सुरक्षा केजबनेट और नमूना हडैं ललग के जलए नाजमत क्षत्रे
iv. नाजमत दकया गया जप्र-पी सी आर (आर एन ए जनष्कषडण एि ं सांचा अजभिधडन), पी सी आर (िााँच करने के जलए)
और पोस्ट्ट पी सी आर (पररणाम व्याख्या और जिश्लेषण के जलए) कक्ष
v. बायोमेजडकल अपजिि संबंधी कारडिाई करने के जलए स्ट्थान
3. “100 दाजखले प्रजतिष ड के जलए न्यूनतम मानक ितें जिजनयमािली, 1999” म ें अनुसूची I म ें : “ख अध्यापन
अस्ट्पताल” िीषडक के अंतगडत “मेजडकल कालेिों और उनके अध्यापन अस्ट्पतालों म ें आिास” के अंतगतड “ख.8 अस्ट्पताल
अपजिि प्रबंधन” जनम्नजलजखत रूप म ेंप्रजतस्ट्थाजपत दकया िाएगा :
“जचदकत्सा संस्ट्थान को िीि-जचदकत्सा अपजिि (प्रबंध और हस्ट्तन) जनयम, 1998 का अनुपालन सुजनजित करना
चाजहए और उसके पास बायो मेजडकल अपजिि के पथृ क्करण और फेंकन े के जलए एक सुपररभाजषत व्यिस्ट्था के साथ
मानि उत्पजत्त िाले बायोमेजडकल अपजिि प्रबंधन पर एक मिबूत संस्ट्थागत नीजत भी होनी चाजहए। अस्ट्पताल
अपजिि प्रबंधन के जलए सुजिधाए,ं केन्द्र / राज्य सरकारों के जिधानों के अनुरूप होगी।
4. “100 दाजखले प्रजतिषड के जलए न्यूनतम मानक ित ें जिजनयमािली, 1999” म ें अनुसूची II म ें : “सूक्ष्मिीि-जिज्ञान
जिभाग” म ें “स्ट्टाफ की आिश्यकता” के पिात जनम्नजलजखत रटप्पणी िोडी िाएगी :
नोट: जिज्ञान सेिा प्रयोगिाला के जलए जनम्नजलजखत अजतररि स्ट्टाफ की आिश्यकता होगी-जिषाणु :
(i) जिषाणु-जिज्ञान में संकाय सदस्ट्य / मेजडकल सूक्ष्म-िीि जिज्ञानी प्रजिजक्षत - I
(ii) तकनीजियन (आणजिक जिषाणु-जिज्ञान म ें सुसंगत काय डअनुभि िाले) - 2
(iii) मल्टी-टालस्ट्कग स्ट्टाफ - 1
5. “100 दाजखले प्रजतिषड के जलए न्यूनतम मानक ित ें जिजनयमािली, 1999” म ें अनुसूची III म ें : “सूक्ष्मिीि-जिज्ञान
जिभाग” म ें उपकरण (कालेिों और अस्ट्पतालों म ें जिजभन्न जिभागों के जलए) म ेंसूची म ें जनम्नजलजखत आिोधन दकया िाएगा :
सूची म ें प्रजिजि 4 को जनम्नजलजखत रूप म ेंप्रजतस्ट्थाजपत दकया िाएगा :
क्र.स.ं मदों का नाम अपेजक्षत संख्या
.4 बायोसेफ्टी केजबनेट (बी एस सी) श्रणे ी 2क/2ख (अंििोजधत) 04
ितडमान प्रजिजि 53 के पिात जनम्नजलजखत प्रजिजियां िोडी िाएगी :
क्र.स.ं मदों का नाम अपेजक्षत संख्या
54 -80˚सी डीप फ्रीिर, यूपीएस के साथ 01
55 फ्लओू रोफोरे डाइयों के जलए अिं िोजधत ररयल टाइम पी सी आर मिीन, य ू पी एस के 01
साथ (2, 2 केिीए प्रत्येक, 2 घटं े के बैक अप िाली)
56 माइक्रोसेंरीफ्यूि/रेफ्रीिरेटेड सरें ीफ्यूि 01
57 जिषाणु-जिज्ञान प्रयोगिाला के जलए उपयोज्य िस्ट्तुए ं यथा अपेजक्षत
(क) व्यजिगत संरक्षात्मक उपकरण (पी पी ई)।
(ख) िायरल पररिहन माध्यम (िी टी एम)।
(ग) सभी अन्य उपयोज्य िस्ट्तुए ं और दकटें, िो जिषाणु-जिज्ञान अध्ययनों के जलए
आिश्यक हों।
डॉ .राकेि कुमार ित्स, महासजचि
[जिज्ञापन-III/4/असा./42/2020-21][भाग III—खण् ड 4] भारत का रािपत्र : असाधारण 3
पाद रटप्पणी: प्रधान जिजनयमािली, नामत: “प्रजतिषड एम.बी.बी.एस. म ें 100 दाजखलों के जलए न्यनूं तम ित ें जिजनयमािली,
1999” भारतीय आयुर्विज्ञान पररषद ् की ददनांक 30 माच,ड 1999 की अजधसूचना संख्या 35(1)/1998- मेड.
(ii) के अंतगतड ददनांक 29 अप्रलै 1999 को भारत के रािपत्र के भाग-III खंड (4) म ें प्रकाजित की गई थी और
इस े भारतीय आयुर्विज्ञान पररषद ् की ददनांक 20 अक्टूबर, 2008, 01 ददसम्बर, 2008, 13 निम्बर, 2009,
18 िनिरी, 2010, 30 िनबरी, 2010, 26 फरिरी, 2010, 17 जसतम्बर, 2010, 03 निम्बर, 2010,
18 माच,ड 2014, 01 िलू ाई, 2015, 27 िनिरी, 2017, 09 माच,ड 2017, 23 अगस्ट्त, 2017, 22
िनिरी, 2018, 05 फरिरी, 2019, 29 अप्रलै , 2019 और 27 िून, 2019 की अजधसूचनाओं के अंतगडत
संिोजधत दकया गया था।
BOARD OF GOVERNORS IN SUPER-SESSION OF MEDICAL COUNCIL OF INDIA
NOTIFICATION
New Delhi, the 3rd June, 2020
No. MCI-34(41)/2020-Med./103234.—In exercise of powers conferred by Section 33 of the Indian Medical
Council Act, 1956 (102 of 1956), the Board of Governors in Super-session of Medical Council of India with the
previous sanction of the Central Government hereby makes the following regulations to further amend the ―Minimum
Standard Requirements for 100 Admissions Annually Regulations, 1999‖ namely:-
1. (i) These Regulations may be called the ―Minimum Standard Requirements for 100 Admissions Annually
(Amendment) Regulations, 2020.‖
(ii) They shall come into force from the date of their publication in the Official Gazette.
2. In the ―Minimum Standard Requirements for 100 Admissions Annually Regulations, 1999‖ in Schedule I:
―Accommodation in the Medical College and its Associated Teaching Hospitals‖ under ― A.2 Departments‖ in entry
no. 5 in the ―Department of Microbiology‖, following shall be added as under:
DA) The Virology Service Laboratory shall be a BSL-2 level laboratory. The Laboratory shall include the following
areas:-
i. Sample receiving area
ii. Handwashing & PPE donning/doffing zone
iii. Designated area for Biosafety cabinet and sample handling
iv. Designated pre-PCR (RNA extraction & template addition), PCR (for running the assay) and post PCR
(for result interpretation & analysis) rooms.
v. Space for handling biomedical waste
3. In the ―Minimum Standard Requirements for 100 Admissions Annually Regulations, 1999‖ in Schedule I:
―Accommodation in the Medical College and its Associated Teaching Hospitals‖ under heading ―B. Teaching
Hospitals‖ under entry ―B.8 Hospital Waste Management‖, the following shall be substituted:
The Medical Institution must ensure compliance with the Bio-medical Waste (Management & Handing)
Rules, 1998 and also have a robust institutional policy on biomedical waste management of human origin,
with a well-defined arrangement for segregation and discarding of biomedical waste. Facilities for hospital
waste management shall be commensurate with the Central/State legislations.
4. In the ―Minimum Standard Requirements for 100 Admissions Annually Regulations, 1999 in Schedule II:
Staff Requirements‖ in the ―Department of Microbiology‖, after ―Staff Requirement‖ following note shall be added as
under:
Note: The following additional staff shall be required for the Virology Service Lab:
(i) Faculty/Medical Microbiologist trained in Virology -1
(ii) Technicians (with relevant work experience in Molecular Virology) – 2
(iii) Multi-Tasking Staff - 14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC. 4]
5. In the ―Minimum Standard Requirements for 100 Admissions Annually Regulations, 1999‖ in Schedule III:
―Equipment‖(for various departments in College and Hospitals) in the ―Department of Microbiology‖, in the list
following modifications shall be made:-
Entry 4 in the list shall be substituted as under:-
S.No. NAME OF THE ITEMS No. REQUIRED
4. Biosafety cabinet (BSC) class 2A/2B (calibrated) 04
After existing entry 53 following entries shall be added:-
S.No. NAME OF THE ITEMS No. REQUIRED
54. -80°C deep freezer with UPS 01
55. Real-time PCR machine calibrated for the fluorophore dyes with UPS (2 01
nos., 2KVA each, with 2 hours back-up)
56. Microcentrifuge / Refrigerated Centrifuge 01
57. Consumables for Virology Lab As required
(a) Personal protective equipment (PPE)
(b) Viral Transport Medium (VTM)
(c) All other consumables and kits as required for Virology studies.
Dr. RAKESH KUMAR VATS, Secy.-General
[ADVT.-III/4/Exty./42/2020-21]
Foot Note: The Principal Regulations namely, ―Minimum Standard Requirements for 100 MBBS Admissions
Annually Regulations, 1999‖ were published in Part – III, Section (4) of the Gazette of India on the 29th
April 1999, vide Medical Council of India Notification No.35(1)/1998-Med. (ii) dated the 30th March,
1999 and further amended vide MCI notification dated 20 October 2008, 1st December 2008, 13
November 2009, 18 January 2010, 30 January 2010, 26 February 2010, 17 September 2010, 3 November
2010, 18 March 2014, 01 July 2015, 27 January 2017, 9 March 2017, 23 August 2017, 22 January, 2018,
5th February, 2019, 29th April, 2019 and 27th June, 2019.
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.