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 a

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 .—

(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.

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

"29. Morphine Tablets

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.

Extent and conditions of Exemption

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:-

(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 monograph

THE GAZETTE OF INDIA : EXTRAORDINARY

[PART II—SEC 3 (i)]

"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).

Fruited by the Manager, Govt. of India Press, Ring Road, Mayapuri, New Delhi-110064

and Published by the Controller of Publications, Delhi-1100?4