Legal Guide on setting up a Herbal Cosmetic Business in India

By

Sakshi Shairwal

Avnip Sharma

Now there are two types of Cosmetic Registration present in India, that are explained below:

i.) Manufacturing in India

ii.) Importing to India for Re-sale purpose

A manufacturing license is required wherein you intend to manufacture the cosmetics in India. As a result, according to the D & C Act, 1940, the following license is necessary for cosmetic product manufacturing and marketing in India.

i.) The application is filed in Form 31 and the license is issued in Form 32 for producing cosmetics for sale or distribution.

ii.) The loan license is issued in Form 32-A, and the application is made in Form 31-A for producing cosmetics for sale and distribution.

iii.) The Form 37 license is provided for the purpose of granting or renewing clearance for conducting tests on pharmaceuticals, cosmetics, or raw materials used in their manufacture on behalf of a license for the manufacture and sale of drugs and cosmetics.

When we do not manufacture the cosmetic but rather import and resell it in India, we need an importer cosmetic registration in India.

Now, the registration and granting of license also depend on the technical staff the said company have and the factory conditions, as there shall also be an inspection be held by the licensing authority prior to granting of license. It is the duty and sole responsibility of the manufacturer to ensure that there is just and proper conditions in the manufacturing plant, as there is no scope for any negligent actions.

Technical Staff

It is the manufacturer's duty to make sure that a qualified and committed technical team is available to review the manufacturing process. There ought to be one person on staff who has the necessary academic background.

i.) The personnel must have either a Diploma in Pharmacy, which must be authorized by the Pharmacy Council of India under the Pharmacy Act, 1948, or a bachelor’s degree in Pharmacy.

ii.) The items might be registered under the Pharmacy Act of 1948, or they can be sold.

iii.) The material must pass an intermediate examination that includes Chemistry as one of the subjects, or any other examination recognized by the Licensing Authority as comparable.

Inspection

The Licensing Authority is supposed to order an inspection of the entire process of the activities before awarding or refusing the license. Inspectors should be appointed in accordance with the Act. The inspectors are then expected to provide the Licensing Authority with a thorough report on the operations. The Licensing Authority will then decide whether or not to award the license.

Factory Requirements

Now as per the Drug and Cosmetics Act, there also are certain requirements that are supposed to be met for the factory premises under which the products will be manufactured. Under Schedule M-II[1], the essential conditions of the factory premises for starting a cosmetic organization have been outlined. The following prerequisites must be met:

Location & Surroundings: It is expected that the location will have all of the necessary amenities for establishing a cosmetic manufacturing company. Before beginning building, the issue of location should be carefully considered. The surrounding area should be kept clean and sanitary. The surgery cannot be carried out in or near a residential area.

Building: The structure should be free of rodents, insects, and other pests that could disrupt the entire operation or product. The rooms in the structure must meet a number of requirements. The room's ceiling height should not be less than 6 feet from the ground. The surfaces of the rooms should be smooth, watertight, and easy to clean. The floor shall also be smooth, dust free and washable.

Recycling of used water: The workers should make suitable plans and be cautious about proper wastewater emission or disposal.

Staff: All manufacturing employees should be free of any communicable or contagious diseases. The personnel must employ the essential equipment, such as hand gloves, masks, and uniforms. It's also a good idea to have a first-aid station on the premises of the factory.[2]

Labelling of the Products

The Drugs and Cosmetics Rules of 1945 outlined how cosmetics should be labelled. The following are indeed the regulations:

i.) The product's name and manufacturing address can be seen on both the inner and outside labels. If the container is tiny, the principal site of manufacture and the pin code are sufficient, according to cosmetic labelling guidelines.

ii.) The list of ingredients used in the product's manufacturing should be included on the outside label and clearly stated.

iii.) To avoid any risk, the inner label must include the ‘Directions for use,' as well as any warnings or cautions. The names and quantities of the ingredients must also be mentioned by the manufacturer.

iv.) Cosmetic labelling instructions, according to the Drugs and Cosmetics Rules, state that a distinguishing batch number preceded by the letter "B" and manufacturing batch preceded by the letter "M," Manufacturing Date, Best Before, and manufacturing license number (if applicable) must be listed on the label.

v.) The Indian government imposed some restrictions on all imported cosmetics in January 2001. All of the following features, as well as the maximum retail sales price, must be included in pre-packaged items (MRP). The MRP should include all taxes, total transportation charges, dealer commissions, and all charges for advertising, delivery, and packing.

vi.) This labeling requirement does not apply to the import of pre-packaged commodities such as raw materials, bulk imports, and other items that require additional processing before being supplied to end customers.

In the case of the aforementioned categories of items, quality requirements must adhere to Indian standards established and revised by the Bureau of Indian Standards (BIS) on a regular basis.

Cosmetics Sample Testing: Guidelines and Requirements

Cosmetic products should be tested in accordance with the Bureau of Indian Standards (BIS) regulations. It must meet all of the requirements for the registration of imported cosmetic products, as well as satisfy the maker, buyer, and customer. The following items are included in the sample testing:

i.) Raw materials and active substances are subjected to physical and chemical investigation.

ii.) Heavy metals in cosmetics, as well as forbidden colors and compounds, are subjected to safety examinations.

iii.) Microbiological quality control to guarantee that microbiological numbers and diseases are not present;

iv.) Estimation of active substances in both qualitative and quantitative terms;

v.) Viscosity, spreadability, scratch test, and pay-off test are examples of physical testing parameters.

vi.) Calculation of the UVA/UVB protection factor;

vii.) Studies on skin irritability and sensitivity;

viii.) Testing for stability, determining shelf life, and so on.

Documentation Requirements

In order to get your cosmetics company to get a license, there are numerous documents required as per the law for granting of the license and need to be submitted at the time of the registration.

1.) In the case of an importer, an original copy of the Power of Attorney is required.

2.) Letter of marketing authorization, certificate of free sale

3.) Form 42, which has been fully signed and filed, as well as the list of products that need to be renewed,

4.) Fees, as previously stated

5.) A self-declaration that previous shred information has not changed,

6.) Pollution Control Board's No-Objection Certificate

7.) Plan out the layout of the space.

8.) If you're renting a space, you'll need to sign a lease agreement.

9.) Laboratory equipment list,

10.) Applicant's Affidavit,

11.) A list of the manufacturing machinery that has been installed,

By the deadline, the importer must apply for cosmetic registration.

1.) A manufacturer's authorized representative,

2.) The manufacturer's subsidiary,

3.) A company with a registered office in India.

4.) Any other importer

Penalties

The 1940 Drugs and Cosmetics Act is punitive legislation. On a first conviction, imprisonment of up to one year or a fine of up to Rs. 1000 or both can be imposed if any of the Act's requirements or norms relating to cosmetics are not followed, and on successive convictions, imprisonment of up to two years and a fine of up to Rs. 2000 can be imposed.

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