Hyderabad: The last two times the US Food and Drug Administration has weighed in on safety of products—Johnson & Johnson’s medicated stents and Glaxosmithkline Plc.’s Avandia diabetes drug—the ripples have been felt in India where both products were being used.
So, this week’s decision by FDA to block imports of toothpastes into the US from China because of the discovery of a potentially toxic chemical in Chinese toothpaste exports has also raised questions among some about the safety of toothpaste in India.
But experts from various industries say the same diethylene glycol, the chemical that has been linked to deaths in China and Central America, is unlikely to be present in products manufactured in India.
In both these countries, patients had died after consuming cough syrup preparations in which diethylene glycol was used to adulterate glycerin. Glycerin is used as a sweetener in medicinal syrups, toothpastes and confectionaries.
Officials at the Andhra Pradesh Drug Control Administration said the chemical has been banned from use in drugs and cosmetics, including toothpastes, following deaths in India during the mid-1980s. Andhra Pradesh has a large number of contract manufacturing facilities where products are manufactured for major pharmaceutical and consumer product players. Companies also played down any safety fears.
Even though glycerin is used in large quantities in India, both in consumer products and pharmaceuticals, it has to adhere to standards set by the government’s Indian Pharmacopoeia, which sets standards for almost all active ingredients as well as other ingredients such as flavours and colours.
These standards also include an impurity profile, which all these ingredients have to adhere to. So, no ingredient can have more than the maximum permissible level of any impurity.
“Even glycerin has to adhere to the IP standards,” said a former manufacturing head with a major domestic pharmaceutical company who did not wish to be named.
According to C. Gulati, editor of MIMS India, a drug reference index, there is very little scope for adulteration with diethylene glycol.
“Most of the raw materials in India are inexpensive, so there is no incentive to add anything to bring down costs further,” said Dr Gulati.
But deaths due to diethylene glycol poisoning have happened in India as well. In 1998 too, the consumption of paracetamol cough syrup prepared with diethylene glycol led to 30 infant deaths in India.
Sagar Malviya contributed to this story.