Provisions Pertaining to Cosmetics

Provisions Pertaining to Cosmetics

Import Cosmetics

Import of cosmetics of following categories is prohibited into our country.

1.        Misbranded, spurious, adulterated and substandard cosmetics.

2.        Cosmetics containing any ingredient which may render it unsafe for use.

3.        Cosmetics whose import is prohibited under the provisions ofthe Act and Rules.

4.        Cosmetic containing coal-tar colour, other than one mentioned in Schedule.

5.        Cosmetic containing more than 2 ppm of arsenic, 20 ppm of lead or 100 ppm of any metal.

6.        Cosmetic intended for use on eye brows or eye lashes whic}l contains coal-tar dye colour, or intermediate or a base.

7.        Cosmetics containing hexachlorophene.

8.        Cosmetics containing mercury compounds.

Manufacturing of Cosmetics

Application for grant or renewal of a licence to manufacture cosmetic is made in Form 31 and the licence to manufacture is issued in Form 32. Schedule M and GMP, competent staff, hygienic conditions of working, adequate space, plant structure and good testing facilities should be in accordance with the provisions of the Act and Rules. The licence should be displayed in the manufacturing premises. Any change in staff should be informed to Licensing Authority.

The loan licence for manufacture of cosmetics is issued in Form 32-A for which application is made in Form 31-A. For loan licence, all the conditions of space, plant structure, testing facilities, maintenance of production and analytical records should be fulfilled. The Licences are valid till 31 't, december every year and are required to be renewed.

Labelling of Cosmetics

It should be both on inner and outer label and should contain name of cosmetic, name of manufacturer and place of manufacture. The outer label should contain net content ofcosmetic i.e., weight for solids, measure for liquids and weight for semisolids. On inner label of cosmetic with hazardous ingredient, adequate direction should be printed in the form of warning. The statement of quantity of hazardous ingredients, Mfg. Lic. No., Batch No. and other particulars should be depicted on the label.

For hair dyes containing coal tars

On inner and outer labels, the words printed should be "Caution - the product contains ingredients which may cause skin irritation in certain cases, and a preliminary test according to accompanying direction should be carried out. This product should not be used for dyeing eye-lashes or eye-brows as such use may cause blindness". This statutory warning should be printed both in English and local language.

The cosmetic should conform to the standards laid down by Indian Standards Institute.

Sale of Cosmetics

The cosmetics which do not contravene to the Provisions of Rules can be sold without licence. It is prohibited to stock misbranded, spurious, substandard and· adulterated cosmetics. The dealer and shop keeper should reveal the particulars of the stock of cosmetic, if asked by the Licensing Authority or Controlling Authority.

Sale of Drugs

The ultimate objective of pharmaceutical manufacture is to sell quality drug formulations to the consumers or patients. Pharmaceutical marketing today, is a glittering and challenging professional activity. The distribution channel in pharmaceutical marketing is -

(i) Manufacturer → Distributor → Wholesaler → Retailer → Consumer

(ii) Manufacturer → Wholesaler → Retailer → Consumer