Section 139 in The Drugs and Cosmetics Rules, 1945
139. Condition for the grant [***] [Omitted 'or renewal' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).] of a license in Form 32.
- Before a license in Form 32 is granted [***] [Omitted 'or renewed' by Notification No. G.S.R. 1337(E), dated 27.10.2017 (w.e.f. 21.12.1945).], the following conditions shall be complied with by the applicant:-(1)The manufacture shall be conducted under the direction and personal supervision of a competent technical staff consisting of at least one person who is a whole-time employee and who possesses any one of the following qualifications:-(a)holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (8 of 1948), or(b)is registered under the Pharmacy Act, 1948 (8 of 1948), or(c)has passed the Intermediate Examination with Chemistry as one of the subjects or an examination recognized by the licensing authority as equivalent to it.[* * *] [Proviso to Clause (c) and Clause (d) omitted by G.S.R. 331(E), dated 8.5.1984 (w.e.f. 8.5.1984).](2)[ The factory premises shall comply with the requirements and conditions specified in Schedule M-II.] [Substituted by G.S.R. 723(E), dated 11.8.1992 (w.e.f. 11.8.1992).][* * *] [Conditions (3) and (4) omitted by G.S.R. 723(E), dated 11.8.1992 (w.e.f. 11.8.1992).](5)The applicant shall either-(i)provide and maintain adequate staff, premises and laboratory equipment for testing the cosmetic manufacture, and the raw materials used in the manufacture, 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 such tests to be regularly carried out in this behalf by the institution.
