Date: 2015-08-06Category: Extra OrdinaryState: Union GovernmentCountry: India
In exercise of the powers conferred by clause (3) of article 77 of the Constitution, the President hereby makes the following rules further to amend the Govt., of India (Allocation of Business) Rules, 1961, namely.
This notification, S.O. 2130(E), dated August 5, 2015, amends the Government of India Allocation of Business Rules, 1961. These amendments, called the Government of India Allocation of Business Three Hundred and Fifteenth Amendment Rules, 2015, came into force immediately.
The key changes involve the allocation of responsibilities related to the medical devices industry. Specifically, within the SECOND SCHEDULE of the 1961 rules:
* Under the MINISTRY OF CHEMICALS AND FERTILIZERS (RASAYAN AUR URVARAK MANTRALAYA), DEPARTMENT OF PHARMACEUTICALS (AUSHADH VIBHAG), a new entry "1A" is inserted, assigning responsibility for "Medical Devices Industry issues relating to promotion, production and manufacture; excluding those specifically allotted to other Departments."
* Under the MINISTRY OF HEALTH AND FAMILY WELFARE (SWASTHYA AUR PARIVAR KALYAN MANTRALAYA), DEPARTMENT OF HEALTH AND FAMILY WELFARE (SWASTHYA AUR PARIVAR KALYAN VIBHAG), in entry 12, a new item "j" is inserted, assigning responsibility for "Regulatory aspects namely quality, safety, labelling and performance of medical devices."
The notification is issued by order of the President, Pranab Mukherjee, and signed by Deepti Umashankar, Joint Secretary. The file number is F. No. 1215/2012-Cab.
Key Entities Referenced
Constitution: Refers to the Constitution of India, specifically article 77, clause 3, which grants powers to the President to make rules for the allocation of government business.
President: The President of India, who exercises powers conferred by the Constitution to amend the Government of India Allocation of Business Rules.
Government of India Allocation of Business Rules, 1961: A set of rules that govern the allocation of business among various ministries and departments of the Government of India.
Ministry of Chemicals and Fertilizers: A ministry in the Government of India, specifically its Department of Pharmaceuticals (Aushadh Vibhag), which has been assigned responsibilities related to the Medical Devices Industry.
Department of Pharmaceuticals: A department under the Ministry of Chemicals and Fertilizers responsible for issues related to the Medical Devices Industry.
Medical Devices Industry: A sector now under the purview of the Department of Pharmaceuticals, concerning promotion, production, and manufacture of medical devices.
Ministry of Health and Family Welfare: A ministry in the Government of India, specifically its Department of Health and Family Welfare, which has been assigned regulatory aspects of medical devices.
Department of Health and Family Welfare: A department under the Ministry of Health and Family Welfare responsible for regulatory aspects of medical devices, including quality, safety, labelling, and performance.
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3365 GI/2015 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
CABINET SECRETARIAT
NOTIFICATION
New Delhi, the 5th August, 2015
S.O. 2130(E).—In exercise of the powers conferred by clause (3) of article 77 of the Constitution, the President
hereby makes the following rules further to amend the Government of India (Allocation of Business) Rules, 1961,
namely:—
1. (1) These rules may be called the Government of India (Allocation of Business) Three Hundred and
Fifteenth Amendment Rules, 2015.
(2) They shall come into force at once.
2. In the Government of India (Allocation of Business) Rules, 1961, in THE SECOND SCHEDULE,-
(a) under the heading “MINISTRY OF CHEMICALS AND FERTILIZERS (RASAYAN AUR URVARAK
MANTRALAYA)”, under the sub-heading “C. DEPARTMENT OF PHARMACEUTICALS (AUSHADH VIBHAG)”,
after entry 1, the following entry shall be inserted, namely:—
“1A. Medical Devices – Industry issues relating to promotion, production and manufacture; excluding those
specifically allotted to other Departments.”;
(b) under the heading “MINISTRY OF HEALTH AND FAMILY WELFARE (SWASTHYA AUR PARIVAR
KALYAN MANTRALAYA)”, under the sub-heading “A. DEPARTMENT OF HEALTH AND FAMILY WELFARE
(SWASTHYA AUR PARIVAR KALYAN VIBHAG)”, in entry 12, after item (i), the following item shall be inserted,
namely:—
“(j). Regulatory aspects namely quality, safety, labelling and performance of medical devices.”.
PRANAB MUKHERJEE
President
[F. No. 1/21/5/2012-Cab.]
DEEPTI UMASHANKAR, Jt. Secy.
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.