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FSSAI Releases Directions For Import Of Speciality Foods For IEM And Hypoallergenic Conditions

There are certain special medical conditions like hypoallergenic conditions and inborn errors of metabolism (IEM) which require speciality foods for their management. Although these speciality foods to help manage such conditions in infants and children are required in hospitals, they are not easily available in India. These speciality foods are available worldwide; however, the absence […]

There are certain special medical conditions like hypoallergenic conditions and inborn errors of metabolism (IEM) which require speciality foods for their management. Although these speciality foods to help manage such conditions in infants and children are required in hospitals, they are not easily available in India.

These speciality foods are available worldwide; however, the absence of standards for such foods makes it difficult to import them into India. The list of permitted foods for special medical purpose, as an annexure, was released by FSSAI on November 2, 2016, to authorise the import of speciality foods in India. Previously, the import was endorsed for two years or until the norms for these products were formulated or notified, whichever occurs first.

FSSAI updated the already existing guidelines regarding the import of speciality foods for hypoallergenic conditions and IEM on August 31, 2018. In the latest guidelines, FSSAI also allowed the import of food for special medical purposes for a further six-month period. It includes the following foods:

  • Foods for inborn errors of metabolism
  • Foods for two hypoallergenic conditions

These foods are listed in the updated Annexure-A of the directions. The extension starts on either November 2, 2018, or until the norms are formulated or notified, whichever occurs first.

Importing these products shall be allowed only from the ports of Delhi and Mumbai for effective control. Refer to Annexure-A below for the list of products that are permitted in this duration.

ANNEXURE-A

Inborn errors of metabolism (IEM) conditions
Sr. No Medical Condition Products
1. Homocystinuria Methionine-free diet powder
2. Maple syrup urine disease Diet powder free from valine, isoleucine and leucine
3. Amino acid metabolic disorders Protein and amino acid–free diet powder (with and without fat)
4. Phenylketonuria Phenylalanine-free diet powder
5. Defects in the intraluminal hydrolysis of fat, inadequate transport of fat in the lymphatic system, defective absorption of fat in the mucosa Milk protein–based powder with medium chain triglycerides for children and adults
6. Synthetase deficiency 1, argininemia, argininosuccinic aciduria, carbamoyl phosphate, urea cycle disorders, citrullinemia Diet powder free from non-essential amino acid
7. Tyrosinemia Tyrosine- and phenylalanine-free diet powder
8. Galactosemia Galactose-free formulation
9. Lysinuric protein intolerance, nonketotic hyperglycinemia Protein-free formulation
10. Glutaric acidemia type I Lysine-free and tryptophan-low/free diet powder
11. 3-hydroxy long chain acyl-CoA dehydrogenase (LCHAD) deficiency Special foods for LCHAD deficiency
12. Methylmalonic acidemias, propionic acidemia Isoleucine-, methionine-, threonine- and valine-free diet powder
13. Disaccharidase deficiencies; disorders of carbohydrate metabolism sucrase/isomaltase deficiency, fructose intolerance Protein hydrolysate formula base powder with iron for use with added carbohydrate
14. Glucose transport defect (Glut1 def), pyruvate dehydrogenase complex deficiency Low carbohydrate like sucrose-, fructose-, sugar-free formula
15. Carboxylase deficiency,
3-methylglutaconyl-CoA, hydratase deficiency, isovaleric acidemia,
3-methylcrotonyl-CoA
Leucine-free diet powder
B. Hypoallergenic Conditions
Sr. No Medical Conditions Descriptions
1. Allergy to cow milk protein As per preference,

(i) Amino acid–based formula

(ii) Extensively hydrolysed formula

(iii) Soy-based formula

2. Severe allergy: Multiple food protein intolerances cause it. It is not possible to efficiently manage it by using highly hydrolysed formula Amino acid–based hypoallergenic formula

Reference

  1. FSSAI Directions regarding Import of Specialty Foods for IEM and Hypoallergenic Conditions [Internet]. Uploaded Nov 02, 2018. Available at: https://fssai.gov.in/dam/jcr:5cf5dad8-b1dc-4e36-ab46-fd715fc412a7/Direction_IEM_Foods_02_11_2018.pdf. Accessed on Dec 11, 2018.
  2. Notice related to Import of Speciality foods for IEM disorders [Internet]. Uploaded Aug 31, 2018. Available at: https://www.fssai.gov.in/dam/jcr:281919b7-40a0-46bf-ae2f-09b8c71f5643/Notice_Import_IEM_Foods_31_08_2018.pdf. Accessed on Dec 11, 2018.

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