Laws and Legal Compliances applicable upon Foreign Companies for Selling Baby Care Products in India: Lawyers Advice

India is a market for some of the most extensively known global brands as well as popular domestic brands in baby products segment. While a leading player like Nestle has a number of brands under its belt like Cerelac, Nan Pro1 and Pro2, Lactogen, Nestum, there is growing commitment from other companies to introduce more products in this category.

Laws Governing Baby Products in India
Policies related to Baby Care Market in India include Infant Milk Substitutes Act (1992 and 2003), Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 and 2003 and Bureau of Indian Standards Act, 1986.
Apart from these laws, government entities supervising the baby care market in India include Breast-Feeding Promotion Network of India (BPNI), Food Safety and Standards Authority of India (FSSAI), Indian Council for Child Welfare (ICCW), Association of Consumer Action on Safety and Health (ACASH), Indian Academy of Paediatrics and Indian Medical Association.

Section 6 of the IMS Act has clear and unambiguous directions for “information on containers and labels of infant milk substitutes or infant foods.”

Section 11 of the IMS Act also states that no infant product can be either sold or distributed unless it follows the standards set in the Prevention of Food Adulteration Act, 1954 and the product container should also have the relevant Standard Mark as decided by the Bureau of India Standards as per Section 3 of the Bureau of Indian Standards Act, 1986.

In the case of Nestle India Limited and Anr vs Union Of India and Ors (W.P.(C) 4832 of 1995), the High Court of Delhi stated that since inconsistencies existed between the provisions of the PFA Act and the IMS Act, it is impossible to adhere to the provisions of both the enactments simultaneously and this case, compliance to just the PFA Act will also be sufficient.

The Food Safety and Standard Regulations also has the following conditions set for compliance: –
• Highlight that proper germ-free preparation of infant foods/infant milk substitute is vital for good health.
• Give an estimated configuration of nutrients per 100 grams of the product as well as its energy value in Kilo Calories/Joules.
• The appropriate storage conditions explicitly stating storage to be done in a cool and dry area inside an air tight container.
• Directions for use as well as feeding chart and instructions for use of measuring scoop and the quantity per scoop as well as instructions for discarding leftover feed.
The prohibitions in FSSR for infant food alongside those specified in IMS Act are as follows:
• The packaging and/or any other labelling of the infant milk substitute or infant food shall not showcase the words, “Full Protein Food”, “energy food”, “complete food” or “Health Food” or any other related expression.
It is relevant to note at this point, that the FSSAI has approved exemptions for Foods for Special Medical Purposes (FSMP) and in that case the label should clearly convey the warning that the product is neither an infant milk substitute nor is it an infant food.”

Important legal points to consider: –
• According to the IMS Act, 1992, the words “IMPORTANT NOTICE” in capital letters is a requisite for every label on infant food or infant milk substitute containers. This label is followed by the message “MOTHER’S MILK IS BEST FOR YOUR BABY” also in capital letters.
• A declaration that infant food or infant milk substitutes should be consumed only under the guidance of a health worker who can dictate the proper method of its use and the need for its use. A further warning to clearly convey that infant food or infant milk substitutes are not the only source of nourishment for an infant.
• Labels present on infant food or infant milk substitutes are prohibited to have pictures of a woman or an infant or both, and it cannot not have any kind of pictures or graphic material or phrases intended to increase the sale of the infant food or infant milk substitute.
• The infant food and infant milk substitute manufacturers should also conform with provisions with regards to packaging as specified in the Legal Metrology (Packaged Commodities) Rules, 2011 since pre-packaged commodities are obligated to fulfil certain compulsory labelling requirements involving labels that must show MRP, net quantity and customer care information.
• Infant products meant for lactose or lactose and sucrose intolerant infants shall indicate clearly that the product is lactose-free or sucrose-free or lactose and sucrose-free in capital letters along with a warning that it has to be taken under medical advice.
• Infant milk substitute designed for infants allergic to soy protein or buffalo or cow milk protein shall indicate clearly that the product contains a “hypoallergenic formula” in capital letters and with a warning that it has to be taken under medical advice.

In conclusion, the baby and infant products segment is also monitored closely by child rights organisations as well as other welfare organisations and any contraventions to necessary labelling requirements can quickly attract negative press coverage and social media outrage. Thus, the manufacturers have to continuously be wary in order to guarantee safety standards so as to avoid litigations and protect brand integrity.
Authored By: Adv. Anant Sharma & Parinay Gupta