Regulation - India

A France based brand is looking to import bulk into India and wanted to understand the feasibility of retaining formulation IP but appoint a manufacturer in India to convert the semi-finished bulk into a finished product.

The project comprised of evaluating the loan licensing model with a manufacturer in order to secure the IP.

The project consisted of liaising with multiple manufacturers, finding the right one and communicating on behalf of the client.
It also comprised of updating the client about the progress and to communicate with them the process and compliance for this model with utmost clarity.

The project mentioned review of following ingredients as per Indian Cosmetics Regulations.
- Salicylic Acid
- Niacinamide
- Polydextrose
- Amylopectin
- Polygonum Cuspidatum Root Extract
- Sodium Hyluronate Butyrate
- Urea Peroxide

The ingredient review was conducted and a detailed report on restrictions, permissions and warnings to be mentioned on the pack was submitted to the client. This enabled the client to take an informed decision about reformulation and launch of their products in India.

based on its type of packaging (Cosmetic? Medical Device? Drug?)
Client has a single-use vial has a capacity of more or less 2 ml. It is made of plastic, and it has a double-chamber system that keeps the liquid and powder phases separate.
To be applied by a professional
Mechanism : Releases the powder directly into the vial using mechanical movements. The vial is only opened when the product is applied on the skin.
Additional info: The product is EU registered.

A report on conclusion of product classification as per Indian Cosmetics Regulation was submitted to the client along with the detailed reasoning and references of similar products in the market.

A French brand wanted to check Formulation Compliance of a exfoliating peel which was to be sold in a vial and applied by a professional.
I carefully checked all the attributes of the formula and submitted an in-depth report about ingredient positioning under the Indian Cosmetics Regulation remit.
One ingredient stood out to be used in chemical peels and hence the advice on changing the functioning and positioning was provided with detailed explanation on why this product falls under a Drug category in India.
Measures taken to position this as a cosmetic were also suggested a s the client was keen on marketing the product as a cosmetic.

All products entering into India must Comply with the requirements of the Indian Cosmetics Regulation. Whether it is imported as a semi-finished product of a finished product.
This project was about
- Doing thorough due diligence about 2 cases in which the client was interested in shipping the product.
- Advicing on how one option is better than the other
- Advicing on the immediate next steps to be performed.

From Oct 2020, I have proofread and adviced on numerous labels and packaging checks.
Each market demands the labels to look different.
All labels are checked for
- Mandatory Labelling requirements
- Claims and their acceptability.
- Font sizes and legibility
Claims corrections are adviced so as to keep the messaging intact within the language of cosmetics remit.