Section 85E in The Drugs and Cosmetics Rules, 1945
85E. Conditions for the grant or renewal of a license in Form 25-C.
- Before a license in Form 25-C is granted or renewed the following conditions shall be complied with by the applicant:-(1)The manufacture of Homeopathic medicines shall be conducted under the direction and supervision of competent technical staff consisting at least of one person who is a whole-time employee [and who is-(a)a graduate in Science with Chemistry as one of the subjects with three years' experience in the manufacture of Homeopathic medicines; or(b)a graduate in Pharmacy with 18 months of experience in the manufacture of Homeopathic medicines; or(c)holds qualification as defined under sub-clause (g) of clause (1) of section 2 of the Homeopathic Central Council Act, 1973 (59 of 1973) with 18 months of experience in the manufacture of Homeopathic medicines:Provided that the persons who are already in employment with five years' experience in the manufacture of Homeopathic medicines and whose name was accordingly entered in any license granted in Form 25-C for manufacture of different classes of Homeopathic medicines included in them shall be deemed to be qualified for the purpose of this rule.] [Substituted by G.S.R. 812(E), dated 14.11.1994 (w.e.f. 14.11.1994) as corrected by G.S.R. 517(E), dated 26.6.1995.](2)[ The factory premises shall comply with the requirements and conditions specified in Schedule M-I:Provided that where the licensing authority considers it necessary or expedient so to do, it may having regard to the nature and extent of manufacturing operations, relax or suitably alter the said requirements or conditions in any particular case for reasons to be recorded in writing.] [Substituted by G.S.R. 570(E), dated 12.6.1987 (w.e.f. 12.6.1987).](3)The applicant for manufacture of Homeopathic mother tinctures shall either (i) provide and maintain adequate staff, premises and laboratory equipment for identifying the raw materials and for testing the mother tinctures wherever possible, or (ii) make arrangements with some institution approved by the licensing authority [under Part XV(A) of these rules] [Inserted by G.S.R. 1172, dated 23.8.1977 (w.e.f. 10.9.1977).] for some tests, wherever possible, to be regularly carried out on his behalf by that institution.(4)The premises where Homeopathic medicines are manufactured shall be distinct and separate from the premises used for residential purposes.(5)Homeopathic medicines shall not be manufactured simultaneously with drugs pertaining to other systems of medicine.(6)The applicant shall make arrangements for proper storage of Homeopathic medicines manufactured by him:[Provided that in case potentised preparations are made in a Pharmacy holding license in Form 20-C, the conditions (2) and (3) shall not apply. The licensee shall ensure to the satisfaction of the licensing authority that the products manufactured by it, conform to the claims made on the label.] [Inserted by S.O. 4816, dated 19.11.1969 (w.e.f. 6.12.1969).]
