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2 THE GAZETTE OF fNDlA : EXTRAORDINARY [PART II—SEC. 3(i)] T< HRf ^TTRq H ^ l f d ^ ' ^ Tnszn} ^ , ^ f erf ^raW^^t I T<arf?fk T ^ l , H*pRT sfem MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) NOTIFICATION New Delhi, the 15th September, 2009 G.S.R. 677(E).—Whereas, the Central Government is satisfied that the drugs 'Oseltamivir Phosphate' and 'Zanamivir' are essential to meet the requirements of emergency arising due to epidemic and in public interest.
and it is necessary and expedient to regulate and restrict the manufacture, sale and distribution of the drugs 'Oseltamivir Phosphate' and 'Zanamivir' and preparations based tiiereon and for preventing their misuse;
Now, therefore, in exercise of the powers conferred by Section 26B of the Drugs and Cosmetics Act, !940 (23 of 1940). the Central Government here by directs (lint no persons shall manufacture for sale or for distribution, or sell or stock, or exhibit or offer for sale, or distribute any preparation containing the drug :Oseltamivir Phosphate' or 'Zanamivir1 except in the manner specified below, namely:—
(a) no person shall himsel for by any other person on his behalf manufacture for sale or for distribution without the prior approval in writing from the Drugs Controller (India);
(b) the conditions specified in the Drugs and Cosmetics Rules, 1945 in respect of the drugs specified under Schedule X to that rules shall apply to the drugs 'Oseltamivir Phosphate' and 'Zanamivir' or any preparation based thereon;
(c) no manufacturer, distributor, stockist, dealer or any other person licensed to sell the drugs shall sell or supply in India any preparation containing the drug'Oseltamivir Phosphate' and'Zanamivir' except to the Centra! Government or a State Government or Union Territory Administration or hospitals or nursing homes or such other agency or agencies as the Government may, by order in writing, designate :
Provided that the export of the drug 'Oseltamivir Phosphate' and 'Zanamivir' or any preparation based thereon may be allowed by the Drugs Controller (India) in consultation with the Central Government:
Provided further that any dealer who has the licence to sell, stock or distribute drugs specified under Schedule X to the Drugs and Cosmetics Rules, 1945 may sell the said drugs and shall maintain records for such sales;
(d) every manufacturer of the drug 'Oseltamivir Phosphate' and 'Zzmamivir or any preparation based thereon shall submit to the Drugs Controller (India) a monthly statement, containing therein the quantity of such drugs supplied by them to distributors, stockists, dealers by the end of every month;
(e) every distributor, stockist and dealer holding stocks of'Oseltamivir Phosphate' and 'Zanamivir' or any preparation based thereon shall submit to the concerned licensing authority in the State or Union territory, as the case may be, a monthly statement, containing therein the quantity of such drugs available with them, by the end of every month;
(f) the Central Government, State Governments or the Union Territory administrations shall make arrangements for the distribution of'Oseltamivir Phosphate' and 'Zanamivir' and preparations based thereon through the public health systems, as it may consider appropriate.
2. Ill is order shall come into force on the dale of its publication in the Official Gazette, [F. No. X-11014/5/2009-DFQC | DEBASISH PANDA, Jt. Secy.
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