Hypoallergenic Products in India: Making difference in Younger Ones - PowerPoint PPT Presentation

Hypoallergenic Products in India: Making difference in Younger One’s Lives. Dr. Nandan Joshi

What is Hypoallergenic? What is Hypoallergenic Infant Formula? According to the American Academy of Pediatrics (AAP) . According to the AAP, a hypoallergenic infant formula must: • Be studied in a clinical trial • Be studied in patients with documented cow milk allergy • Have been shown to be tolerated by at least 90% of the patients

What is special about this date? 2 nd November 2016

November 2, 2016 will always be remembered as a landmark date

There has been a dramatic increase in the prevalence of food allergy in the last 10 - 15 years Adapted from Prescott SL. WAO

What is food allergy? The top 8 food allergens in children • Food allergy is an adverse response to an accounting for approximately 90% of ingested food or to one of its components that involves the immune all allergic reactions system • Food allergens are almost always proteins, but not all food proteins are allergens • Food allergies are a rapidly emerging public health issue

How do food allergies develop?

Cow’s Milk Protein Allergy peaks in the first year of life with a prevalence of up to 3% • CMPA is defined as a reproducible adverse reaction to one or more milk proteins (usually caseins or Acquisition of tolerance to whey beta-lactoglobulin) mediated by IgE and / or cow's milk during the first two non-IgE-mechanisms years of age • CMPA peaks in the first year of life with a prevalence of up to 3% • In rare cases, exclusively breastfed infants may also develop clinically significant CMPA via dairy protein transferred into human breast milk 9 – The remission rate of CMPA is good with most children (up to 80%) developing a tolerance to cow’s milk by 2 years of age

CMPA in India Journal of Gastroenterology and Hepatology 2009

Patient Pathway – Financial & Emotional Burden Seek help in days to wks of Symptoms – blood in Triggers – BM to CM, Home remedies, stools, excessive crying, IF, igE Mediated, few medication that weight loss, resp symptoms days worked in the past Initial symptoms Final trigger to stage Self management seek medical help BF, elimination diet Further Referral + Soy milk, organic eHF & aAFs if Soy ~1 month or Intolerance more Final Diagnosis & Referral to Initial Diagnosis & management Paed/Paed gastro management Peds – iGE tests – further referal. Elimination diets, Antibiotics, Antihistamines, Diarrhoea management Patient follow Outcome of CMPA ups/drop out management dynamics Primary Outcome – Monthly follow ups cessation of diarrhoea, uptil 1 yr vomiting Drop out rates are Secondary Outcome – frequent Respiratory, Skin, growth & Development

Symptoms of Cow’s Milk Protein Allergy fall into 3 general categories • CMPA can induce a diverse range of symptoms of variable intensity in infants • The majority of infants and children with CMPA have ≥ 2 symptoms and symptoms from ≥ 2 organ systems Respiratory Skin Digestive 50-60% 20-30% 50-70%

ISSAC Study – 2.4% - 6% [n - 37000] [3] > 9% [Kerala ] - Rising trend in AD in last 4 decades - commonest dermatosis registered to pediatric dermatology clinic - Urban > Rural [1] - Mean age of Onset – 3.3 months – 4.2 months [1] - Mean Duration of Disease – variable – 3 months to 6 years

Types of Hypoallergenic formulas Amino Acid Extensively Hydrolysed formulas formulas Increased Allergenicity

Unique Manufacturing – Only 1 location in the world Raw materials are free No Milk protein Finished product is from allergenic protein. allowed in the facility, immunology tested Careful evaluation and not even tea or coffee testing.

If not Milk then where do these Amino Acids come from

What has changed after the notification • The label submission and approval process completed • Products are now available in India • It is available at 90+ institutes across India • And 500+ chemists retailers • Education and awareness programs are being conducted on how to diagnose and manage CMPA

What’s Next • Maintaining patient registry • Documenting case studies • Developing consensus guidelines specific to India for diagnosis and management of CMPA • Evolving regulations as new innovations keep coming in this category