Medical nutrition products are becoming increasingly popular in developed markets especially in cases where drug approach has been seen to be ineffective in treating modern chronic diseases.
While a drug attacks one biochemical pathway in the body, chronic health problems like diabetes and heart disease are caused by defects in more than one biochemical pathway. Treating such diseases with drugs is a simplistic approach with not much chances of success in the long term.
Medical nutrition products fall in between traditional nutrition and drugs. Nutritional products, being complex mixtures themselves, have a better chance of affecting multiple pathways in the body.
This field, called medical nutrition or pharma nutrition, is an emerging area with promising results worldwide.
Medical nutrition is increasingly considered as a useful and sometimes essential component in the management of patient health. Medical nutrition is not intended to treat disease, but is widely used by doctors and dieticians as a complement to traditional drug therapies and as a means to support patients to better fight their condition or maintain their strength.
Many medical conditions can be better managed when a patient is receiving a specialised diet adapted to their unique circumstances. Sometimes the constraints to appetite may be physical, as in the case of stroke patients who may find it difficult or impossible to swallow, or of young children with neurological disabilities. Sometimes the problem may simply be insufficient intake, caused by the loss of appetite that is so common among cancer patients or the very elderly. Medical nutrition supports cases across a broad range of care settings - in the hospital, in the care home or in the community.
Whether in combating general malnutrition, or in bringing more specialised support in disease areas as diverse as diabetes, sarcopenia, COPD and decubitus - or even in neurology - Medical nutrition brings doctors more options in the management of those in their care, and offers the opportunity of a better quality of life for patients everywhere.
In the meanwhile therapeutic proteins are a fast growing segment of the pharmaceutical industry. These include native proteins, recombinant and fusion proteins, peptides and antibody fragments, many of which are manufactured through microbial fermentation.
India’s bio-pharmaceutical companies reveals a dichotomy in their view on the recently issued draft USFDA guidelines on ‘ Immunogenicity Assessment for Therapeutic Protein Products.’
While a section of the industry is upbeat and viewed the guidelines as a set of systematic norms which would in every way keep poor quality companies at bay, the Association of Biotechnology Led Entrepreneurs(ABLE) Biosimilars Committee have called for better clarity and understanding on the interpretation of norms with regards to biosimilars.
Therapeutic proteins are manufactured using microbial fermentation route. Indian companies engaged in the development of therapeutic protein products include Biocon, Panacea Biotech, Serum Institute of India, Reliance Life Sciences, Shantha Biotechniques, Indian Immunologicals, Bharat Biotech, Cadila Health Care, Intervet India, Intas Biopharma, Eli Lilly, Hafkine Biopharmaceuticals, Glaxo Smith Kline and Novo Nordisk .
"USFDA draft guidelines for immunogenicity of therapeutic proteins are quite comprehensive and by and large consistent with the approach followed by most advanced biotech companies like Biocon. We are committed to developing high quality, safe and efficacious therapeutic proteins for global markets and comprehensive assessment of immunogenicity is an integral part of that commitment. These guidelines are a welcome addition to clarify the expectations from regulators like FDA", said Abhijit Barve, President R&D, Biocon Ltd.
But Dr. Cyrus Karkaria, President – Biotech Division, Lupin Ltd and member of ABLE's Committee for Biosimilar, Clinical Research and Advocacy said that the guideline did not mention anything about biosimilars, which will comprise a major portion of the approved biologics on the market in the coming decade.