Fresh Licenses are issued with perpetual validity . Each Licensee should have to submit a declaration of the compliance of Schedule T of Drugs & cosmetic Act at their premises , in every year for the retention of Drug License.
The declaration of compliance of Schedule T of Drugs & cosmetic Act shall be made within 3 months of completion of 1 year from the date of issue of license in form 25D/25E or from the date of submission of last self declaration. In the event of non submission of self declaration within the time mentioned the license shall be suspended temporarily and if the licensee fails to submit the self declaration within a further period of three months, the license of the said product shall be deemed to have been cancelled.
One time retention for existing Drug Licenses
License obtained under From 25D prior to the date of commencement of the Drugs
( 4th amendment) Rules 2011( before 01/10/2021) and such license holders having a GMP certificate on the date of its renewal have to apply for one time license retention and GMP retention
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