Sunday, December 16, 2018


FSMPs harmonise with IMS Act provisions to save lives of babies with IEM
Thursday, 01 March, 2018, 08 : 00 AM [IST]
Our Bureau, New Delhi
Foods for special medical purpose (FSMPs) is a category of foods that has been harmonised with the IMS Act to save the lives of babies suffering from inborn errors of metabolism (IEM), a life-threatening medical condition affecting thousands of infants in the country.

One of the main treatments for IEM is specialised diets, which fall under the category of FSMP. Without these, children suffering from IEM would not only face cognitive and physical difficulties, but in fact would not even survive.

These disorders are increasingly being diagnosed in India due to the advances in medical technology and improved facilities for testing. However, while being respectful of the IMS Act and its intent, placing FSMPs in the category of IMS Foods poses some genuine challenges.

For instance, all infant milk substitutes and infant food labels have to carry a statement, saying, “Mother’s milk is best for your baby” in capital letters. In case of some IEM conditions, an infant cannot digest mother’s milk, hence such a label is medically contraindicated and cannot be affixed.

Other issues could also arise. For instance, while products under the IMS Act can be taken under the advice of health workers, this cannot be done in the case of IEM diets, which need to be taken only under medical supervision. Hence it would not be feasible to apply the IMS Act to infant FSMPs.

However, in order to ensure that there is no potential misuse by any food manufacturer or distributor, the Food Safety and Standards Authority of India (FSSAI) has placed the following statement in the public domain - “While IEM diets are a separate category of foods for special medical purposes as clarified earlier, the specific provisions of the IMS Act relating to marketing, promotion, sponsorship, etc. would henceforth apply to IEM diets also, to prevent any potential misuse of this platform to promote normal infant foods or infant milk substitutes as defined under the IMS Act.”

Further, to avoid any perceived conflict of interest with the Infant and Young Child Nutrition Council of India (IYNCI), the IEM steering committee, comprising members from the ministry of health and family welfare, Niti Aayog, representatives of the medical fraternity such as the All India Institute of Medical Sciences (AIIMS), Maulana Azad Medical College (MAMC), the Indian Society of Inborn Errors of Metabolism (ISIEM),  etc. and parent support groups, has decided that as a measure of abundant precaution and in the interest of this meaningful initiative, the IYNCI and industry representatives would not constitute a part of the committee, and a modified order to this effect has already been issued by the country’s apex food regulator.

FSSAI has opined that this is a noble cause and as a measure of abundant precaution and to prevent derailment of a meaningful initiative on such grounds, it is taking several steps to improve the life expectancy of infants suffering from this medical condition, and expects that both legislations (IMS and FSMP) would be harmonised to the extent feasible and all concerns regarding potential conflicts of interest would be addressed.

While these actions are taken as an interim measure, further as a long-term measure, the emended proviso in the Regulations of Foods for Infant Nutrition which covers FSMPs intended for infants would be reviewed suitably.
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