Launch New Drug in 6 Months or Face Cancellation of License – DCGI

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Drugs Controller General of India (DCGI) has recently issued DCGI Circular F. No. 12-01/12- DC Pt- 127 dated January 10, 2013 by which all manufacturers of ‘new drug’ are required to launch the new drug within six months from the date of the grant of the permission by the DCGI, failing which the permission received from the DCGI will be cancelled. Manufacturing of new drug after cancellation of permission would constitute violation of the Drugs and Cosmetics Act, 1940, and those who deal with new drug produced after cancellation of such permission would be liable to be punished under S. 27 (d) r/ w S. 18 of the Drugs and Cosmetics Act, 1940. the Act.