REGD NO. D. L.-33004/99 The Gazette of India
EXTRAORDINARY
PART II~Section 3—Sub-section (1)
PUBLISHED BY AUTHORITY
No. 6] NEW DELHI, THURSDAY, JANUARY 4,2001/PAUSA 14,19222 THE GAZETTE OF INDIA : EXTRAORDINARY PART II—SW 3 (i)J
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health)
NOTIFICATION
New Delhi, the 4th January, 2001
G.S.R. 6 (E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945. was published as required by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), at pages 3 to 5 in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), dated the 10th July, 2000 in the notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health), No GSR 596 (E), dated the 10th July, 2000 inviting objections and suggestions from all persons likely to be affected thereby before the expiry of a1 period of forty five da?' trom the date on w *iich the copies of the Official Gazette in which the said notification were made available to the public;
And whereas copies of the said Gazette vure made available to the public on 11 -7-2000.
And whereas objections and suggestions received from the public on the said draft rules have been considered by the Central Government;
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Govern- ment after consultation with Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely .—
1, (i) These rules may be called the Drugs and Cosmetics (First Amendment) Rules, 2001 (ii) They shall come into force on the date of their publication in the Official Gazette.
2. In SCHEDULE K to the Drugs and Cosmetics Rules, 1945 after item number 28 and the entries relating thereto, the following shall be inserted, namely :—
Class of Drugs
Extent and conditions of Exemption
1
2
"29. Morphine Tablets
The provisions of Chapter IV of the Act and the rules made there- under which require them to be covered by a sale licence, subject to the following conditions, namely;-
(i) The drug shall be supplied by the Palliative Care Centres approved by the State Government to terminally ill cancer patients.
(ii) The drug shall be kept under the custody of the Medical
Officer-in-charge of the said Centre.
(iii) The drug shall be purchased from a dealer or a manufac- turer who holds licence under these rules, and records of such purchases showing the names and quantities together with their batch numbers, and names and addresses of the manufacturers or dealers and the names and addresses of the patients to whom supplies have been made shall be main- tained. Such records shall be open to inspection by an In- spector appointed under the Act, who may also take samples for test.
All the provisions of Chapter IV of the Act and rules made there- under which require them to be covered by a licence to operate a Blood Bank for collection, storage and processing of whole human blood for sale or distribution subject to the following conditions:-
30. Whole Human Blood collected and transfused by Centres run by Armed Forces Medical Services in border areas, small mid-zonal hospitals including peripheral hospitals. Field Ambulances, Mobile medical units and other field medical units including blood supply units in border, sensitive and field areas.
(i) These Centres shall collect, process and transfuse blood in emergent situations which require life saving emergency surgeries/or transfusion.
(ii) These Centres shall be under the active direction and personal supervision of a qualified Medical Officer, possessing the qualifications and experiences specified in condition (i) of rule 122-G.
(iii) Each blood unit shall be tested before use for freedom from HIV I and II antibodies, Hepatitis B surface antigen, malarial parasites and other tests specified under the monograph4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC 3 (i)] 1 2 "Whole Human Blood" in current edition of Indian Pharmacopoeia.
(iv) These Centres shall have adequate infrastructure facilities
for storage and transportation of blood.
(v) The blood collected and tested by such Centres shall be transiused by the Centre itself and may be made available for use of other peripheral Armed Forces hospitals or centres during operational circumstances."
[F.No.X. 11014/7/99-DMS&PFA]
DEEPAK GUPTA, Jt. Secy.
Foot Note:—The Principal Rules were published in the Official Gazette vide notification No. F.28-10/45-H(l) dated 21st December, 1945 and last amended vide GSR 904(E), dated 1-12-2000. The Drugs and Cosmetics Rules, 1945 as amended up to 1-5-1979 is contained in the publication of the Ministry of Health and Family Welfare (Department of Health) containing the Drugs and Cosmetics Act, 1940 (PDGHS-61).
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