Glaxo's Augmentin banned in Taiwan. Will India follow?

Augmentin, an antibiotic produced by GlaxoSmithKline (GSK), is set for a smooth sail in India notwithstanding the storm raging over it in Taiwan.

Taiwan authorities on Saturday asked GSK to recall the drug — generic amoxicillin clavulanate — after tests by its health department detected the presence of di-isodecyl phthalate (DIDP), a chemical banned in that country.

For the record, DIDP is used in the production of plastics.
Somewhat predictably, a GSK spokesperson chose to play down the Taiwan episode, saying the level of DIDP identified in the samples tested was very low, much lower than what the US and EU authorities deem risky for humans.
But local medical practitioners expressed concern at the presence of such substances in popular antibiotics.

An internal medicine consultant from a hospital in Mumbai said it was all the more worrying because people tend to use antibiotics randomly and irrationally, thereby subjecting themselves to greater exposure to the plasticiser.

Chandra M Gulhati, editor of Monthly Index of Medical Specialties, a reference journal for medical practitioners, said the authorities should take suo motu cognisance of issues related to quality or safety of medicines whenever they came up abroad.
Still, nobody expects any action to be taken against Augmentin in India immediately.

Augmentin is GSK’s largest selling brand in India with annual sales of ¤240 crore, or around 10% of its revenues.
Clearly, any action by the authorities could leave the company’s financials dented, analysts said.
Also, quality issues and recalls impact not just the revenues but also the brand image of a manufacturer, Nitin Bidikar, associate director, KPMG said. 

Drugs controller Surinder Singh and joint controller AB Ramteke could not be reached for comment.

The GSK spokesperson said the company will work closely with Indian regulatory authorities and provide information and clarity as and when required.
Gulhati drew attention to the technical issues involved in detection of such substances in the country, where laws mandate only the active ingredients to be printed on the label by the manufacturer and checked by the authorities.

“In India, an examination would not have picked up the presence of the plasticiser,” he said. This is because the plasticiser is not an active pharmaceutical ingredient but one of the pharmacologically inactive ingredients in the drug. “In Augmentin, amoxicillin and clavulanic acid are the active ingredients. All medicines contain inactive substances like colouring agents, binding agents and flavouring agents. The plasticiser was found in the flavouring agent in Taiwan.”