Schedule M

SCHEDULE M

GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES,

PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS

GAZETTE OF INDIA EXTRAORDINARY, PART II-SECTION 3, SUB-SECTION (i)]

MINISTRY OF HEALTH AND FAMILY WELFARE (DEPARTMENT OF HEALTH)

New Delhi, the 11 December, 2001.

N O T I F I C A T I O N

G.S.R 894(E). Where as 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 page 42, with the Notification of the Government of India in the Ministry of Health and family Welfare (Department of Health), No. GSR 8(E) dated the 4th January, 2001 in the Gazette of India, Extraordinary, Part II, Section 3, Sub Section (i) dated the 4th January, 2001 inviting objections and suggestions from all persons likely to be affected thereby before the expiry of period of forty-five days from the date on which the copies of the Official Gazette containing the said Notification were made available to the public; And whereas copies of the said Gazette were made available to the public on 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 Government, after consultation with Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely:-