The Drugs and Cosmetic Rules, 1945 has been amended by Drugs and Cosmetics (Eleventh Amendment) Rules, 2019 dated 17th July 2019.
The newly revised rules now require manufacturers and distributors of drugs specified in Schedule C and C (1) to pay a “licence retention fee” for a valid licence. In case of failure to pay the licence retention fee on or before the due date i.e. before the expiry period of 5 years from the date of issue, the licensee will be required to pay the same along with a late fee calculated at the rate of 2 percent of the licence fee for every month or part thereof up to six months. In case of non-payment, the licence will be cancelled.
The same shall also apply to holders of a loan licence. Further, certain rules under Part XV (A) dealing with approval of institutions for carrying out tests on drugs, cosmetics and raw materials on behalf of licensees for manufacture for sale of drugs /cosmetics were also altered.
Further, Rule 150J that dealt with renewal process in the previous set of rules has been omitted. Provision for renewal has also been removed from Rule 150E relating to conditions of approval of this licence. Lastly, in Schedule A, in Form 24C relating to application for the grant of a licence to manufactures or distributors of Homoeopathic medicines for sale, the option of renewal has been included and accordingly, changes have been made. Form 26J relating to certificate of renewal of loan licence to manufacture for sale of large volume parenteral or sera and vaccine or recombinant DNA (r-DNA) derived drugs specified in Schedule C and C-1 excluding those specified in schedule X has been omitted. In Form 37, under the sub-heading “Conditions of Approval”, the word ‘renewal’ has been omitted.
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