Skip to main content

Do I need any license or approvals for cosmetics brand?

Query: I have read your blog on how to start a cosmetics brands I have one doubt As I want to start my cosmetics brand and get products manufactured by some third party manufacturer . Do I need any license or approvals for same ?.kindly let me know Response: For only marketing and selling of cosmetic brands , you will not be required to have a drug license. If we talk about approval, then before manufacturing of your products, the manufacturer will take product approval from the drug department if needed. That's the manufacturer's responsibility. Hope this information is helpful to you...

Drug Manufacturing License

For manufacturing of drugs and pharmaceutical products, drug authority issued a license which is known as Drug manufacturing License. Manufacturing unit that want to indulge into manufacturing of drugs and other pharmaceutical products has to take a manufacturing license.

Every Drug manufacturing License has a unique number which is known as drug manufacturing license number.

Types of Drug Manufacturing Licenses:
  • Form 24: Application for the grant of or renewal of a licence to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (1) and X
  • Form 24A: Application for grant or renewal of a loan license to manufacture for sale or for distribution of drugs other than those specified in Schedules C and C (I) and X
  • Form 24B: Application for grant or renewal of licence to repack for sale or distribution of drugs, being drugs other than those specified in Schedules C and C (1) excluding those specified in Schedule X
  • Form 24C: Application for the grant or renewal of a licence to manufacture for sale or for distribution of Homoeopathic medicines or a licence to manufacture potentised preparations from back potencies by licensees holding licence in Form 20C
  • Form 24F: Application for the grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedules C and C(1)
  • Form 25: Licence to manufacture for sale or for distribution of] drugs other than those specified in Schedules C and C(1) and X
  • Form 25A: Loan licence to manufacture for sale or for distribution of] drugs other than those specified In Schedules C and C (1) and X
  • Form 25B: Licence to repack for sale or distribution of drugs being drugs other than those specified in Schedules C and C (1) excluding those specified in Schedule X
  • Form 25C: Licence to manufacture for sale or for distribution of Homoeopathic medicines
  • Form 25F: Licence to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedules C and C(I)
  • Form 26: Certificate of renewal of licence to manufacture for sale of drugs other than those specified in Schedule X
  • Form 26A: Certificate of renewal of loan licence to manufacture for sale of drugs other than those specified in Schedule X
  • Form 26B: Certificate of renewal of licence to repack for sale or distribution of drugs being drugs other than those specified in Schedules C and C (1) excluding those specified in Schedule X
  • Form 26C: Certificate of renewal of licence to manufacture for sale of Homoeopathic medicines
  • Form 26F: Certificate of renewal of licence to manufacture for sale of drugs specified in Schedule X
  • Form 26H: Certificate of renewal of licence to manufacture for sale of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs specified in Schedules C and C(I) excluding those specified in Schedule X
  • Form 26J: Certificate of renewal of loan licence to manufacture for sale of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs specified in Schedules C and C(I) excluding those specified in Schedule X
  • Form 27: Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Part XB and Schedule X
  • Form 27A: Application for grant or renewal of a loan licence to manufacture for sale or for distribution of drugs specified in Schedules C and C(1) excluding those specified in Part XB and Schedule X
  • Form 27B: Application for grant or renewal of a licence to manufacture for sale or for distribution of drugs specified in Schedules C, C(I) and X
  • Form 27D: Application for grant or renewal of a licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X
  • Form 27DA: Application for grant or renewal of a loan licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X
  • Form 28: Licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Schedule X
  • Form 28A: Loan Licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) excluding those specified in Schedule X
  • Form 28B: Licence to manufacture for sale or for distribution of drugs specified in Schedules C, C(I) and X
  • Form 28D: Licence to manufacture for saleor for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs specified in Schedules C and C(I) excluding those specified in Schedule X
  • Form 28DA: Loan licence to manufacture for sale or for distribution of Large Volume Parenterals/Sera and Vaccines/recombinant DNA (r-DNA) derived drugs excluding those specified in Schedule X
  • Form 29: Licence to manufacture drugs for purposes of examination, test or analysis
  • Form 30: Application for licence to manufacture drugs for purposes of examination, test or analysis
  • Form 31: Application for grant or renewal of a licence to manufacture cosmetics for sale or for Distribution
  • Form 31A: Application for grant or renewal of loan licence to manufacture cosmetics for sale or for distribution
  • Form 32: Licence to manufacture cosmetics for sale or for distribution
  • Form 32A: Loan licence to manufacture cosmetics for sale or for distribution
  • Form 33: Certificate of renewal of licence to manufacture cosmetics for sale
  • Form 33A: Certificate of renewal of loan licence to manufacture cosmetic for sale
  • Form 44: Application for grant of permission to import or manufacture a New Drug or to undertake clinical trial.
  • Form 46: Permission / Approval for manufacture of new drug formulation
  • Form 46A: Permission/ Approval for manufacture of raw material (new bulk drug substance)

Condition of Drug Manufacturing License:
  • Factory premises should compile with the standards lay down in Schedule M
  • Premises should have adequate space, plant, machinery/equipment for manufacturing unit as recommended under schedule M.
  • Manufacture and testing of drugs to be conducted under supervision of fulltime competent technical staff i.e. drug manufacturing chemist and drug analytical chemist
  • Maintain adequate staff, premises and laboratory equipment for carrying out tests of the strength, quality and purity of the substances at a testing unit. Refer: Drug testing Laboratory
  • Adequate arrangements for the storage of drugs
  • Comply with the requirements of Good Manufacturing Practice as laid down under Schedule M

Qualification of Competent Technical Staff for Drug manufacturing License:
Manufacture of drugs to be conducted under the active direction and supervision of full time competent technical staff that possess either of following qualifications:
  • A graduate in Pharmacy or Pharmaceutical Chemistry with 18 months practical experience in manufacture of drugs after graduation
  • A graduate in Science with at least three years of practical experience in manufacture of drugs after graduation
  • A graduate in Chemical Engineering or Chemical Technology or Medicine with at least three years of practical experience in manufacture of drugs after graduation
  • holding any foreign qualification equivalent to above educations and practical experience

Related Articles:

Keywords: how to start a pharmaceutical manufacturing plant, how to start a generic pharmaceutical company in india, small scale pharmaceutical manufacturing in india, medicine manufacturing plant cost in india, how to start pharma company in India, licenses required for pharmaceutical company in india, pharmaceutical marketing companies, pharma manufacturer company

Comments

Send Distribution/Franchise Query

Name

Email *

Message *

Register your business at

Find pharmaceutical, cosmetics, nutraceutical, ayurveda and alternative medicine's distributors, franchise, suppliers query for free.

If you want to take distribution, franchise or associates with any pharmaceutical, cosmetic or ayush company then you can find it here...

Popular posts from this blog

How to Register as a Pharmacist in India?

Who is a Pharmacist: Pharmacist is a person having educational qualification in pharmacy profession i.e. Diploma in Pharmacy or Bachelor in pharmacy or Pharma D etc. Who is a Registered Pharmacist: Registered Pharmacist is a person having educational qualification in pharmacy and his/her name is registered under state pharmacy council  of state in which person reside or want to conduct his/her profession or business . How to become a Registered Pharmacist? For becoming pharmacist in India, a person has to fulfill criteria as per Pharmacy Act. A person want to register himself/herself as a pharmacist should have at least minimum of Diploma in Pharmacy or Bachelor in Pharmacy or Pharma D. After completing above mentioned qualifications, you become eligible for registering as a pharmacist. If you have only Diploma in pharmacy, then 500 hours practical training spread over a period of not less than 3 months is also required to become eligible. download pdf After registering your name in s

State Pharmacy Council, Its Constitution and Composition and Functions

State Pharmacy Council: State Pharmacy Council is constituted as per the Pharmacy Act, 1948 & State Pharmacy Rules, 1951. State Pharmacy Council is an authoritative council to regulate Pharmacy Act, 1948 & State Pharmacy Rules, 1951. What is state pharmacy council? State Pharmacy Council means a State Council of Pharmacy constituted under section 19, and includes a Joint State Council of Pharmacy constituted in accordance with an agreement under section 20 under the Pharmacy Act, 1948 & State Pharmacy Rules, 1951. State Pharmacy Council constituted and work under  Pharmacy council of India . Composition of State Pharmacy Council: The State Pharmacy Council consists of the following: i) Six members, elected from amongst themselves by registered pharmacists of the State; ii) Five members, of whom at least three shall be persons possessing a prescribed degree or diploma in pharmacy or pharmaceutical chemistry or registered pharmacists nominated by the State Governme

What are the Schedules under Drug and Cosmetic Act, 1940 & Rules 1945?

Schedules are the set of provisions for classifications of drugs, forms, fees, standards, requirements and regulations related to pharmaceutical, Ayurvedic (including siddha), unani and tibb system of medicines, homeopathy, blood and realted products etc under Drug and Cosmetic Act, 1940 and Rules, 1945. The schedule to the drugs and cosmetics act are Schedule A, B, C, D, E, F, G, H, I, J, K, L, M, N, O, P, Q, R, S, T, U, V, W, X, Y. Drug and cosmetic rules are divided into schedules alphabetically and named also alphabetically like Schedule A, Schedule B etc till Schedule Y. The schedules to the drugs and cosmetics act are important part. Every schedule contains specific information as discussed below. Schedule A:  Schedule A  describes application forms and licenses types. Download Schedule A Pdf Schedule B:  Schedule B  describes Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories. Download Schedule B Pdf Schedule B1: Schedule B1 describes