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Drug packs not to mention gluten content for now, DTAB defers proposal to amend rules
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Arun Sreenivasan, New Delhi
December 19 , 2018
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Drug manufacturers in India are not required to redesign their product packagings for now to incorporate a declaration about a medication’s gluten content. An expert group’s proposal to amend the Drugs and Cosmetics Rules of 1945 to make the declaration on packagings mandatory has been deferred by the country’s apex drug advisory body, it is learnt.
The proposal was put forward by the Department of Physical Medicine and Rehabilitation at All India Institute of Medical Science (AIIMS) in New Delhi to provide relief to millions of celiac disease sufferers in India. The proposition was to amend the D&C Rules so that drug manufacturers declare on their packing, whether any of the contents of the product do or do not contain any gluten ingredient. The AIIMS experts also wanted to enforce a law to avoid using gluten-containing bulk-forming agents in medicines as a general principle.
The proposal was prompted by data from recent studies conducted by the country’s premier medical institute that showed that around 8 million Indians suffer from celiac disease, an autoimmune genetic disorder where gluten-filled foods such as wheat, rye and barley can cause serious damage to the patient’s small intestine. Celiac disease, also termed gluten-sensitive enteropathy, is different from allergy to gluten, a protein, as the damaged small intestine does not absorb the food consumed. The patients fail to gain height or weight and develop chronic diarrhoea, anemia and skeletal fragility.
At its recent meeting, the Drug Technical Advisory Body (DTAB) deliberated the matter at great length, where experts observed that starch from corn and potato was more commonly used in pharmaceutical products in India and wheat starch might be used only rarely. The minutes of the meeting have been reviewed by Pharmabiz.
Though there is a possibility that very small amount of wheat gluten is present in starch derived ingredients if wheat starch is used as the starting material, the board has arrived at the conclusion that an amendment to the D&C Rules is not necessary.
Celiac disease advocates in the country have been expecting a favourable move from the DTAB, following a similar decision by the US Food and Drug Administration (FDA). The US regulator issued a guidance document for drug manufacturers on the labelling of medications for gluten content in 2017, though the measure remains voluntary. According to medical professionals, a considerable percentage of individuals with celiac disease reported having gluten-related symptoms to prescription medication, which frequently leads to anxiety and non-compliance in taking drugs.
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