THE GAZETTE OF INDIA. EXTRAORDINARY

[PART IT—{fee 3{i)]

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health)

NOTIFICATION

New Delhi, the 14th August, 2002

G.S.R 570(E).— Whereas the Central Government is of the opinion that circumstances have arisen which render

it necessary to make rules without consulting the Drugs Technical Advisory Board;

And whereas the Central Government proposes to consult Drugs Technical Advisory Board within six months of

making these rules.

Now, therefore, in exercise of the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23

of 1940), the following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, 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 after the expiry of forty five days from the date on which the copies of

the Official Gazette in which this notification is published arc made available to the public;

Objections or suggestions may be addressed to the Secretary (Health), Ministry of Health and Family Welfare,

Government of India, NirmanBhawan, New Delhi-110011

«,

Any objection or suggestion which may be received from any person with respect to the said rules before the

expiry period so specified will be taken into consideration by the Central Government

DRAFT RULES

(I) These rules may be called the Drugs and Cosmetics (

Amendment) Rules, 2002

(ii) They shall come into force on the date of their final pubhcaiton in the Official Gazette.

In the Drugs and Cosmetics Rules. 194i in Srhcdnle I"), after item <i and entries relating thereto, thefollowing

shall be inserted, namely —

Class of drugs

"ft.

Drugs imported for manufacture and export by units

situated in "Special Economic Zones" as notified by

the Government of 1 ndia from time to time

Extent and conditions of exemptions-

The provisions of Chapter III of the Act and Rules

thereunder which require them to be covered by an

import licence, import registration and import through

Notified Port of Entry, subject to the conditions that

these drugs shall not be diverted for sale in the

country"

[No X-11014/1/2002-DMSandPFA]

DEEPAK GUPTA, Jt. Secy

Foot Note :— The Principal Rules were published in the Official Gazette vide notification No F 28-10/45-H(J)

dated21-12-1945andlastamcndcdvidcGSR504(E)dated 18-7-2002.

Pnntud by the Manager, Oi;Vi. ot India Press, Ring Road, Mayapuri, Now Delhi-110064

and Published by the Controller of Publications, Delhi-110054.