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MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Indian Systems of Medicines and Homoeopathy)

NOTIFICATION

New Delhi, ihe 20th August, 2002

G.S.R. 607(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, which

the Central Government after consultation with the Ayurvcdic, Siddha and Unani Drugs Technical Advisory Board "

proposes lo make, in exercise of the powers conferred by clause (a) of Sub-section (l).of Section 33 -N read with Sub-section

(I), clause (d) and (f) of Sub-section (2) of Section 6 oi the Dmgs and Cosmetics Act, 1940 (23 of 1940), is hereby published

as required by the said sections for the information of all persons likely to.be affected thereby and notice is hereby given

that the said draft rules will be taken into consideration alter the expiry of a period of 4 5 days from the date on which copies

of ihe Official Gazette in which this notification is published, are made available to the public;

Objections or suggestions, if any, maybe addressed to the Secretary, Department of Indian System of Medicine

and Homoeopathy, Ministry of Health and Family Welfare, Indian Red Cross Society Building, New Dclhi-JlOOOl;

Any objection or suggestions, which may be received from any person with respect to the said draft rules within

the period specified above will be taken into consideration by the Central Government

DRAFT RULES

1 (1) These rales maybe called the Drugs and Cosmetics (

Amendment) Rules, 2002.

(2) They shall come into force on-the date of final publication in the Official Gazette.

2. In the Drugs and Cosmetics Rules, 1945,—

(a) after rule 162, the following shall be inserted, namely :-

"rule 162A—Qualifications for State Drug Licensing Authority for licensing of Ayurveda, Siddha and

Unani drugs

(a) The Ayurvedic/Siddlia/Unani qualifications as per Schedule II of CCIM Act 1970/B Pharma (Ayurveda) of

a lecogni/.ed University.

(b) At least 5 years experience in the Ayurveda/Siddha/Unam drug manufacturing or testing of Ayurvedic,

Siddha and Unani drugs or enforcement of provisions of Chapter IV A of the Drugs and Cosmetics Act arid

Rules therounder or teaching/research of clinical practice of Ayurvcda/SiddhaAJnani System"

|F. No. K-11024/3/2()02-DCC(ISM)]

L. PRASAD, J.t.Secy. (ISM &H)

Foot Note :—The Drugs and Cosmetics Rules, 1945 as amended upto 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) and the Rules (PDGHS-61) and last amended videGS.R No. 504(E) dated 18-7-2002.

I'rmied l>> Ihe Munngei. Govt, of India

IYIM, Rin^ Road, Maytipuri, Now Dolhi-110064

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ot Pnhlicitiiins, Delhi-I 10054