Laws & Legal Compliances for Selling Baby Care Products in India: Lawyers Advice

With the Indian population increasing at a rapid pace, the market for baby care products in the country has also increased exponentially. Baby care products include baby oils, creams, soaps, body washes, diapers, baby foods, wipes, etc. If an entrepreneur aspires to get involved in the sale of baby care products in India, the follow compliance requirements ought to be borne in mind to avoid running into unnecessary hassles.

Baby care products come under the broader umbrella of cosmetics in India. The statute that regulates the manufacture/ import and sale of baby care products in India is the Drugs and Cosmetics Act, 1940 (the ‘Act’). Section 3(aaa) of the Act defines a cosmetic as “any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of a cosmetic.”

The Drugs and Cosmetic Rules, 1945 (the “Rules”) lays down the procedure that ought to be followed for the manufacturing of cosmetics. In order to carry out the manufacturing of a cosmetic, a licence for the same has to be obtained from a licensing authority who is appointed by the concerned State Government.

The rules further stipulate that the application for a manufacturing license has to be submitted in Form 31 with a Rs. 2500 license fee and a Rs. 1000 inspection fee. Further, manufacturing activities have to be carried out by competent and qualified technical staff who are registered under the Pharmacy Act, 1948.

Compliance Requirements under the Food Safety and Standards Act, 2006 (FSSA)
The provisions of this statute will be attracted in the case where the product in question is a food item. The market for baby food products is vast and products need to be conceived keeping the safety and nutritional requirements of babies in mind.
The Food Safety and Standards Authority of India and the food authorities of the respective states are responsible for the implementation and enforcement of the FSSA. In order to manufacture baby food products in the country, a FSSAI Food License has to be obtained. The following are the documents required for the same –
• Duly completed and signed Form – B;
• Layout of the manufacturing location;
• Details of the machinery to be used for manufacture;
• Photo ID and address proof of the entrepreneur.
• FSSAI declaration form;
• Source of milk; and
• IE Code issued by DGFT for importers;

Penalties for non – compliance with the FSSA
Sections 49 – 67 provide for penalties under the Act. In order to avoid penalties, the entrepreneur should ensure that
• The product is of the quality that is demanded by the purchaser;
• Is not sub – standard;
• Is not misbranded;
• Is not advertised in a misleading manner;
• Does not bear a false description;
• Does not contain extraneous matter; and
• The manufacturing process is not unhygienic/ unsanitary.
The Supreme Court held in the case of Indian Soaps & Toiletries Makers v. Ozair Husain & Ors. (Civil Appeal No. 5644 of 2003) held that the consumer of food products should know the contents of the food that they are consuming by virtue of the provision of the Prevention of Food Adulteration Act, 1954.

Compliance requirements pertaining to packaging under The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Amendment Act, 2003 (IMS Act)
If the entrepreneur wishes to sell a baby product which intends to act as a substitute to infant milk, the provisions of the abovementioned Act will be attracted. The Act provides that the container in which the product is sold should indicate the following –
• A statement “mother’s milk is best for your baby” in capitals;
• A warning that infant food is not the sole mode of nourishment for the infant;
• The ingredients used;
• The composition of the product;
• The requisite storage conditions; and
• The date of manufacture, batch number and expiry date.
Baby food product manufactures should also ensure that they are in compliance with packaging requirements under The Legal Metrology (Packaged Commodities) Rules, 2011. There requirements pertain to indications of the net quantity of the product, the maximum retail price and customer care information.

The Hon’ble Delhi High Court held in the case of Nestle India Limited & Anr v. Union of India & Ors (W.P. (C) 4832 of 1995) that the provisions of the IMS Act are in addition to and not in derogation of the Prevention of Food Adulteration Act. In case same violation is termed as an offence under two different enactments and a person follows one of the enactment which results in violation of the other, then Section 26 of the General Clauses Act, 1897, would come into play which protects a person/entity from double jeopardy.

Compliance requirements under the Food Safety and Standards Regulation, 2017 (FSSR)
These regulations apply in addition to the provisions of the IMS Act. The compliance requirements are as follows –
• There has to be a warning which states that there should not be any diluted or concentrated feeding;
• The composition of the nutrients per 100g of the product and its energy value;
• The ideal storage conditions;
• A feeding chart along with the directions for use and instructions on how to discard the leftovers;
• Instructions on how to use a measuring scoop; and
• If the product does not contain any milk or milk derivatives, then the words “contains no milk or milk products” should be mentioned in a conspicuous manner;
• The regulations also provide that the package shall not contain the words “Full Protein Food”, “Energy Food”, “Complete Food” or Health Food” or any other expression that is similar.

Compliance requirements for baby care products which are not meant to be ingested
If the product in question is not to be ingested by the infant, the compliance requirements for such a product is similar to any other cosmetics in India.
It is mandatory for all cosmetic products that are imported into/ manufactured in India for sale to be registered with the licensing authority as provided for under Rule 21 of the Rules The application for registration has to be made in Form – 42 to the Drugs Controller General. In order to obtain a registration certificate, the following documents need to be provided –
• A cover letter from the applicant;
• Form 42;
• Treasury Challan;
• Power of Attorney;
• Schedule D III;
• Original or a copy of the Label;
• Free Sale Certificate (FSC) or a Marketing Authorisation Letter and the Manufacturing License if any;
• Product specification and testing protocol;
• A list of all the countries where Market Authorisation/ import permission/ registration was granted;
• Samples; and
• Information pertaining to the brand, manufacturer and product.

Advertising Compliances
The Advertising Standards Council of India (ASCI) is a non – statutory tribunal, established to promote ethical advertising practices. The ASCI came out with a code that mandates that
• Truthful and honest representations are made in advertising;
• No offensive material is broadcast;
• Harmful products to individuals, minors and/or society are not promoted; and
• Fair competition and consumer interests are given paramount importance.
The Government of India made it mandatory that the ASCI code be followed in August 2006. If an entrepreneur who wishes to sell cosmetics in India is aware of and follows the abovementioned compliance requirements, they can be rest assured that business will run smoothly and that they will not run into any sort of roadblocks with the regulatory authorities.
Authored By: Adv. Anant Sharma & Vismay G.R.N.