New Delhi: Drugmakers may be asked to declare on their packagings whether a medicine contains gluten, a step that health officials say would provide immediate relief to millions of Indians suffering from celiac disease, an autoimmune disorder in which the body mistakenly reacts to gluten. India’s chief advisory body on drugs will discuss the issue at its meeting scheduled on Thursday, two people aware of the matter said on condition of anonymity.
Gluten, a composite of proteins present in wheat, barley and rye, can trigger the production of antibodies that damage the lining of the small intestine when consumed by people with celiac disease.
The Drug Technical Advisory Board’s decision to consider labelling a product gluten-free follows a recommendation by the department of physical medicine and rehabilitation at the All India Institute of Medical Sciences (AIIMS).
Apart from the declaration on the packaging, experts at AIIMS have suggested changes in the law to force drug makers to avoid gluten-containing agents. Celiac disease affects as many as eight million people in India.
The proposal is also in line with the instructions issued by the US Food and Drug Administration (FDA) in 2017. FDA issued draft guidance for drug makers on the labelling of medications for gluten content.
The regulator also recommended that drug manufacturers include a voluntary statement in the description section of a medication—that it “contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)”.
As per FDA, around 1% of the US population has celiac disease. “For people with celiac disease, every single thing that enters the digestive tract of the body is a concern and needs to be evaluated,” FDA commissioner Scott Gottlieb said in a statement.
In the US, the decision was taken after a 2011 study on 5,623 people with celiac disease and gluten sensitivity, with 25% of respondents reporting that they suspected an adverse reaction caused by gluten in their medication. “Patients reported a wide range of symptoms associated with their suspected gluten exposure, including: constipation, nausea, diarrhea, abdominal pain, bloating, headache, fatigue, irritability, muscle tremors/cramps, failure to thrive and skin rash,” it said.
Patients and healthcare providers find it difficult to ascertain whether a medication is gluten-free, causing anxiety, according to the people cited earlier.
“We have to consider the potential impact on those individuals with celiac disease, who take multiple oral medications each day. Patients sensitive to gluten would want to eliminate all sources of ingested gluten and hence minimise exposure. The Drug Technical Advisory Board will take up the matter and if approved, drug firms will be encouraged to revise their labelling to use the statement,” said the first of the two people cited earlier.
Sunil Attavar, president of Karnataka Drugs and Pharmaceuticals Manufacturers’ Association, said that making label changes were not necessary. “Corn starch and its derivatives are commonly used in almost all oral solid dosage forms as a diluent, binder and disintegrant. Corn starch is considered gluten-free and safe for those who have celiac disease, he said. “Instead of once again making changes in the labelling requirements, it could be made a part of the pharmacopoeia requirements for use of starch and its derivatives.”