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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...

Schedule N


Schedule N (Rule 64(I)):

Schedule N includes the list of minimum equipment for the efficient running of a pharmacy.

Download : Schedule N Pdf here

1. Entrance

The front of a pharmacy shall bear an inscription “Pharmacy” in front.

2. Premises

The premises of a pharmacy shall be separated from rooms for private use. The premises shall be well built, dry, well lit and ventilated and, of sufficient dimensions to allow the goods in stock, especially medicaments and poisons to be kept in a clearly visible and appropriate manner. The areas of the section to be used as dispensing department shall be not less than 6 square meters for one pharmacist working therein with additional 2 square meters for each additional pharmacist. The height of the premises shall be at least 2.5 meters.
The floor of the pharmacy shall be smooth and washable. The walls shall be plastered or tiled or oil painted so as to maintain smooth, durable and washable surface devoid of holes, cracks and crevices.
A pharmacy shall be provided with ample supply of good quality water.
The dispensing department shall be separated by a barrier to prevent the admission of the public.

3. Furniture and apparatus

The furniture and apparatus of a pharmacy shall be adapted to the uses for which they are intended and correspond to the size and requirements of the establishment.
Drugs, chemicals, and medicaments shall be kept in a room appropriate to their properties and in such special containers as will prevent any deterioration of the contents or of contents of containers kept near them. Drawers, glasses and other containers used for keeping medicaments shall be of suitable size and capable of being closed tightly to prevent the entry of dust.
Every container shall bear a label of appropriate size, easily readable with names of medicaments as given in the Pharmacopoeias.
A pharmacy shall be provided with a dispensing bench, the top of which shall be covered with washable and impervious material like stainless steel, laminated or plastic, etc.
A pharmacy shall be provided with a cupboard with lock and key for the storage of poisons and shall be clearly marked with the word “POISON” in red letters on a white background.
Containers of all concentrated solution shall bear special label or marked with the words “To be diluted”
A Pharmacy shall be provided with the following minimum apparatus and books necessary for making of official preparations and prescriptions:

Apparatus 

  • Balance, dispensing, sensitivity 30 mg.
  • Balance, counter, capacity 3 Kgm., sensitivity 1 gm.
  • Beakers, lipped, assorted sizes.
  • Bottles, prescription, ungraduated assorted sizes.
  • Corks assorted sizes and tapers.
  • Cork, extracter.
  • Evaporating dishes, porcelain.
  • Filter paper.
  • Funnels, glass.
  • Litmas paper, blue and red.
  • Measure glasses cylindrical 10 ml, 25 ml, 100 ml and 500 ml.
  • Mortars and pestles, glass.
  • Mortars and pestles, wedgwood.
  • Ointment pots with bakelite or suitable caps.
  • Ointment slab, porcelain Pipette graduated, 2 ml, 5 ml and 10 ml.
  • Ring, stand (retort) iron, complete with rings.
  • Rubber stamps and pad
  • Scissors
  • Spatulas, rubber or vulcanite
  • Spatulas, stwainless steel
  • Spirit lamp
  • Glass stirring rods
  • Thermometer, 0oC to 200Oc
  • Tripod stand
  • Watch glasses
  • Water bath
  • Water distillation still in case Eye drops and Eye lotions are prepared
  • Weights, Metric, 1 mg. to 100 gm
  • Wire Gauze
  • Pill finisher, boxwood
  • Pill Machine
  • Pill Boxes.
  • Suppository mould

Books

  • The Indian Pharmacopoeia (Current Edition)
  • National Formulary of Indian (Current Edition)
  • The Drugs and Cosmetics Act, 1940
  • The Drugs and Cosmetics Rules, 1945
  • The Pharmacy Act, 1948
  • The Dangerous Drugs Act, 1930

4. General provisions

A pharmacy shall be conducted under the continuous personal supervision of a Registered Pharmacist whose name shall be displayed conspicuously in the premises.

The Pharmacist shall always put on clean white overalls.

The premises and fittings of the pharmacy shall be properly kept and everything shall be in good order and clean.

All records and registers shall be maintained in accordance with the laws in force.

Any container taken from the poison cupboard shall be replaced therein immediately after use and the cupboard locked. The keys of the poison cupboard shall be kept in the personal custody of the responsible person.

Medicaments when supplied shall have labels conforming to the provisions of laws in force.

Note: - The above requirements are subject to modifications at the discretion of the licensing authority, if he is of opinion that having regard to the nature of drugs dispensed, compounded or prepared by the licensee. It is necessary to relax the above requirements or to impose additional requirements in the circumstances of a particular case. The decision of the licensing authority in that regard shall be final.

For more detail refer Drug and Cosmetic Act

Question and Answer:

Question: Describe the schedule N drugs list?
Answer: Schedule N don't have drug list. It includes the list of minimum equipment for the efficient running of a pharmacy.

Question: List of minimum requirements for running a pharmacy is given in which schedule?
Answer: Schedule N

Question: Which schedule deals with list of equipment to run a pharmacy?
Answer: Schedule N

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