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 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 17th July, 2019 G.S.R. 499(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945was published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 608(E), dated the 3rd July, 2018, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from persons likely to be affected thereby before the expiry of a period of thirty 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 Official Gazette were made available to the public on the 6th July, 2018; And whereas, objections and suggestions received from the public on the said rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely:- 1.            (1) These rules may be called the Drugs and Cosmetics (Eleventh Amendment) Rules, 2019.                 (2) They shall come into force on the date of their publication in the Official Gazette. 2.            In the Drugs and Cosmetics Rules, 1945 (herein after referred to as the said rules), after rule 76A, the following rule shall be inserted, namely:- “77.Duration of licence.- (1) A licence issued in Form 28, Form 28B and Form 28D shall remain valid, if the licencee deposits a licence retention fee referred to in sub-rule (2) before the expiry of period of every succeeding five years from the date of its issue, unless it is suspended or cancelled by the licensing authority. (2) The licence retention fee referred to in sub-rule (1) shall be equivalent to the respective fee required for the grant of such licence excluding inspection fee paid for grant of licence. (3) If the licencee fails to pay licence retention fee on or before the due date as referred to in sub-rule (1), he shall be liable to pay licence retention fee along with a late fee calculated at the rate of two per cent. of the licence fee for every month or part thereof up to six months, and in the event of non-payment of such fee, the licence shall be deemed to have been cancelled.”. 3. In the said rules, after rule 82, the following rule shall be inserted, namely:- “83.Duration of loan licence.- (1) A loan licence issued in Form 28A and Form 28DA shall remain valid, if the licencee deposits a licence retention fee referred to in sub-rule (2) before the expiry of period of every succeeding five years from the date of its issue, unless it is suspended or cancelled by the licensing authority. (2) The licence retention fee referred to in sub-rule (1) shall be equivalent to the respective fee required for the grant of such licence excluding inspection fee paid for grant of licence. (3) If the licencee fails to pay licence retention fee on or before the due date as referred to in sub-rule (1), he shall be liable to pay licence retention fee along with a late fee calculated at the rate of two per cent. of the licence fee for every month or part thereof up to six months, and in the event of non-payment of such fee, the licence shall be deemed to have been cancelled.”. 4.            In the said rules, in rule 140, in sub-rule (1), for the words, figures and letters “Form 32, Form 32A and Form 33”, the words, figures and letters “Form 32 and Form 32A” shall be substituted. 5.            In the said rules, in rule 143A, in sub-rule (1), the words and figures “or Form 33” shall be omitted. 6.            In the said rules, in rule 150E, in clause (e), the words “or renewal” shall be omitted. 7.            In the said rules, rule 150J shall be omitted. 8.            In the said rules, in Schedule A, (a) In Form 24C, (i)            in the heading, after the words “GRANT”, the words “OR RENEWAL” shall be inserted; (ii)           in paragraph 1, for the words “grant”, the words “grant or renewal” shall be substituted; (b) Form 26J relating to “CERTIFICATE OF RENEWAL OF LOAN LICENCE TO MANUFACTURE FOR SALE OF LARGE VOLUME PARENTERALS OR SERA AND VACCINE OR RECOMBINANT DNA (R-DNA) DERIVED DRUGS SPECIFIED IN SCHEDULE C AND C-1 EXCLUDING THOSE SPECIFIED IN SCHEDULE X” shall be omitted. (c) in Form 37, under the sub-heading “Conditions of Approval”, in paragraph 1, the words and figures “and any certificate of renewal in Form 38” shall be omitted. [F. No. X.11014/9/2018-DR] Dr. MANDEEP K. BHANDARI, Jt. Secy.