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Union of India - Section
Section 138A in The Drugs and Cosmetics Rules, 1945
138A. [ Application for loan license to manufacture cosmetics. [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).]
(1)Application for grant [***] of a loan license for the manufacture for sale of cosmetics [shall be made up to ten items of each category of cosmetics categorized in Schedule M-II in Form 31-A to the licensing authority and shall be accompanied by a license fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection thereof.] [Substituted by G.S.R. 601(E), dated 24.8.2001 (w.e.f. 24.8.2001).][ Explanation. - For the purpose of this rule a "loan license" means a license which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 32.[***] [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).](3)[ The licensing authority shall, before the grant of a loan license, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities to undertake the manufacture on behalf of the applicant for a loan license.(4)The loan license shall be granted by the licensing authority to only such applicants who propose to avail of the facilities of manufacture of cosmetics in the premises of a manufacturer located in the same State where the applicant is located. In case the manufacture of cosmetics involves any special process of manufacture or use of equipment which are not available in the State where the applicant is located, the licensing authority, after consulting the licensing authority where the manufacturing unit is located, may grant the loan license.(5)Subject to the provisions of sub-rule (2), application for manufacture of additional items on a loan license shall be accompanied by a fee of [rupees one hundred for each item subject to a maximum of rupees three thousand per application] [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).].(6)[ A [fee of rupees two hundred and fifty] [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).][shall be paid for a duplicate copy of a license issued under sub-rule (1) if the original is defaced, damaged or lost.] [Added by G.S.R. 444, dated 31.3.1973 (w.e.f. 28.4.1973).]
In case the manufacture of cosmetics involves any special process of manufacture or use of equipment which are not available in the State where the applicant is located, the licensing authority, after consulting the licensing authority where the manufacturing unit is located, may grant the loan license.
As per Rule 122-E of Drugs & Cosmetics Rule, a fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with ...
On 28th December 2023, the Union Ministry of Health and Family Welfare implemented the Drugs (Amendment) Rules, 2023. Their objectives are to reinforce Good Manufacturing Practices (GMP) and establish requirements for premises, plant, and equipment in pharmaceutical products.
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