Question : Violation of IMS Act

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether certain types of baby foods are exempted from the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 and its regulations, if so, the details thereof and the reasons therefor;

(b) whether the Government has allowed the Food Safety and Standards Authority of India (FSSAI) to undertake any project in relation to infant milk substitutes in partnership with certain NGOs of Indian or foreign origin and if so, the details thereof;

(c) whether the Government has received any complaints regarding violations of IMS Act by certain baby food companies in the healthcare system, if so, the details thereof and the actions taken therein;

(d) whether it is true that Government is considering any proposal by FSSAI to add more product to the exemption list, if so, the details thereof and the reasons therefor; and

(e) whether there are medical conditions where breastfeeding is absolutely contraindicated, if so, the details and the reasons thereof?

ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SHRI ASHWINI KUMAR CHOUBEY)
(a): The draft regulations of Foods for Infant Nutrition under development has-been harmonized with Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 except the labelling provision ‘MOTHER’S MILK IS BEST FOR YOUR BABY’ in case of infant food for special medical purposes where breastfeeding is contraindicated on medical grounds for disease(s), disorder(s) or medical condition(s).

In the absence of standards on food for Inborn Errors of Metabolism(IEM) and hypoallergenic conditions and considering the critical shortage of specialised diets for children with IEM known as Food For Special Medical Purposes (FSMP), FSSAI at the request of medical community and the parent support groups has permitted as an interim measure, the import and domestic production of identified FSMPs vide direction dated 2.11.2016 under Section 16(5) of Food Safety and Standards Act, 2006 to ensure that this critical medical requirement for children with these conditions could be met. Process of developing standards for such products has also been expedited. All imported foods including infant foods have to comply with the provisions of the Food Safety and Standards (Import) Regulations including due examination of composition, label and claims.
(b): No.

(c): Yes. In the complaints, the violation of IMS Act is alleged stating, inter-alia, that it goes against the direction of the Government and discourages breast feeding. The same has been examined and addressed by harmonizing the provisions of Food for Medical Purposes (FSMPs) which are being developed by FSSAI under draft regulations on Foods for Infant Nutrition with IMS Act except the labelling provision ‘MOTHER’S MILK IS BEST FOR YOUR BABY’ where breastfeeding is contraindicated on medical grounds for disease(s), disorder(s) or medical condition(s).

(d): No such proposal has been received from FSSAI.

(e): Yes. In case of some IEM conditions such as galactosemia, an infant cannot digest mother’s milk. Hence, breastfeeding is contraindicated on medical grounds.