As defined under the Drugs and Cosmetics Act manufacturing includes many stages like the process of making, altering, ornamenting, finishing, packing, labelling and breaking up or treating or adopting any drug or cosmetic with view of its sale or distribution. But the manufacturing process does not include the compounding or dispensing in ordinary course of retail business. But the foremost thing which is required for manufacturing hand made soap is to get a manufacturing licence, for which the procedure and the grounds for acquiring a licence has been mentioned in part XIV of Drugs and Cosmetics Rule. After acquiring a licence the other thing which has to be determined is the area or place where the manufacturing process should be done.
As per the Drugs and Cosmetics Act and Rule, the Central Government and the State Government makes rule regarding issuance of licence to a person for manufacturing cosmetics. Basically it is the State Drug Authorities of respective States, who are authorized to issue manufacturing licenses.
- Firstly, a person applying for a manufacturing licence for hand made soap needs to fill the application form 31 along with it; the person is required to pay an amount of Rs 3,500 and Rs 2,500 as a government and inspection fee of 2500 respectively.
- Secondly, the cosmetics for which the licence is being acquired should be specified into classes of cosmetics, as has been mentioned under Schedule M-II, where the cosmetics have been classified into 10 categories.
- A person applying for the license of manufacturing hand made soap or any other cosmetics should have passed intermediate exam with Chemistry as one of its subject or any examination which is recognised by the Licensing authority.
- Apart from it to get a license it is required to hold a diploma in Pharmacy which should be certified and approved either under the Pharmacy Council of India under the Pharmacy Act, 1948 or under the Pharmacy Act, 1948
- At the time of applying for the licence it is required to mention other information like the lists of equipment, manufacturing facility details with minimum area required for manufacturing, Technical Competent personnel details, etc.
- Apart from those details the licencing authority also considers before approving the licence that whether the cosmetic is misbranded or is a spurious cosmetic.
- For renewal also the manufacturer is required to categorise the cosmetics as per Schedule M-II, apart from it Rs. 1000 has to be paid as a charge for every inspection for renewal
It is mandatory for the Licensing Authority to direct an inspection of the area where manufacturing will take place, before approving or rejecting the application of license. After the inspection a report is send to the Licensing Authority on the basis of which they either approve the licence application or reject it.