Section 85B in The Drugs and Cosmetics Rules, 1945
85B. Application for license to manufacture Homeopathic medicines.
(1)Application for grant or renewal of licenses to manufacture for sale [or for distribution] [Inserted by G.S.R. 788(E), dated 10.10.1985 (w.e.f. 10.10.1985).] of Homeopathic medicines shall be made to the licensing authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the licensing authority) and shall be made in Form 24-C.(2)[ The application in Form 24-C shall be accompanied-(a)by a fee of [rupees two hundred] for the manufacture of Homeopathic mother tinctures and potentised preparations and an inspection fee of [rupees one hundred] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] for the first inspection or [rupees fifty] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001)] in case of inspection for renewal of license;(b)by a fee of [rupees two hundred] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] for the manufacture of Homeopathic potentised preparations only, and an inspection fee of [rupees one hundred] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] for the first inspection or [rupees fifty] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] in case of inspection for renewal of license;](c)by a fee of [rupees two hundred] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] for the manufacture of potentised preparations from back potencies by pharmacies which are already licensed to sell Homeopathic medicines by retail and an inspection fee of [rupees one hundred] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] for the first inspection or [rupees fifty] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] in case of inspection for renewal of license.(3)If a person applies for renewal of a license after its expiry but within six months of such expiry, the fee payable for the renewal of such a license shall be-(a)[rupees two hundred] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] plus an additional fee at the rate of [rupees one hundred] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] per month or part thereof and an inspection fee of [rupees fifty] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] for the manufacture of Homeopathic mother tinctures and potentised preparations;(b)[ [rupees two hundred] [Substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] [plus an additional fee at the rate of [rupees one hundred] [Substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] [per month or part thereof and an inspection fee of [rupees fifty] [Substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] [for the manufacture of Homeopathic potentised preparations only;] [Substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).](c)[rupees two hundred] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] plus an additional fee at the rate of [rupees one hundred] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] per month or part thereof and an inspection fee of [rupees fifty] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] for the manufacture of potentised preparations from back potencies by pharmacies who are already licensed to sell Homeopathic medicines by retail.(4)A fee of [rupees fifty] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).] shall be paid for a duplicate copy of the license for the manufacture of Homeopathic mother tinctures and potentised preparations issued under sub-rule (1) if the original is defaced, damaged or lost; while the fee to be paid for such a duplicate copy of the license for the manufacture of Homeopathic potentised preparations only shall be [rupees fifty] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001). Earlier it was substituted by G.S.R. 779, dated 18.7.1980 (w.e.f. 26.7.1980).].(5)[ Applications by licensee to manufacture additional items of Homeopathic medicines shall be made to the licensing authority and such applications shall be accompanied by a fee of [rupees fifty] [Inserted by G.S.R. 13(E), dated 7.1.1983 (w.e.f. 7.1.1983) ][for each additional item.] [Inserted by G.S.R. 13(E), dated 7.1.1983 (w.e.f. 7.1.1983).][Substituted by G.S.R. 245, dated 3.2.1976 (w.e.f. 11.2.1976).]
