Drugmakers may be asked to declare whether a drug is gluten-free
New Delhi: Following the move to have labelling identifying the presence of gluten in foods, it is likely that the presence of Gluten in drugs and medicines will also have to be mentioned on the labelling on the packaging.
The move will indeed bring a sigh of relief from thousands of patients suffering from celiac diseases as well as other forms of gluten intolerance, as they would be forwarned before consuming a medicine
According to experts at the AIIMS, celiac disease affects close to six to eight million people in India.
A recent report in Livemint pointed out that issue is on the agenda of the Drug’s Technical Advisory Board that met recently.
Gluten is a mixture of proteins found in wheat, barley, rye and derivatives. Celiac disease is one of the most common chronic, immune-mediated disorders, triggered by its consumption. The body overreacts to the mixture and damages the finger-like structure along the walls of the small intestine.
Besides Drug’s Technical Advisory Board’s decision to label a drug gluten-free, All India Institute of Medical Sciences(AIIMS) has suggested the board after recommendations by the department of physical medicines and rehabilitation to make alterations in the law and instruct drugmakers to avoid usage of agents containing gluten.
In 2017, USFDA also drafted a guidance which intended to convey the drug manufacturers to label drugs containing gluten, a matter of interest to individuals with celiac disease. Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten. Confronted by uncertainty, some patients may forego important medication rather than risk an adverse reaction to gluten. Thus, even if gluten is not present at levels that would harm a typical individual with celiac disease, that individual may be harmed through uncertainty and lack of information.
The matter has also now been taken by the Indian Counterpart. Two people aware of the matter told live mint on condition of anonymity, “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.”