Toxins in Benadryl, other drugs due to plastic bottling: Govt study

Companies say they adhere to all quality norms

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A recent health ministry study has found dangerous amounts of toxins - lead, antimony, Di-(2-ethylhexyl) phthalate (known as DEHP) and chromium - in cough syrup brands such as Benadryl and Alex.

It found these four heavy metals leached into the cough syrups packaged in plastic or PET (polyethylene terephthalate) bottles. The study found this leaching happening at room temperature.

Apart from these two cough syrups, German manufacturer Merck Biopharma's Polybion Multivitamin Syrup, and Alkem Labs' Hemfer syrup were also found with the toxins due to leaching from their respective plastic bottles. Popular antacid Mucaine Gel, manufactured by Pfizer's subsidiary Wyeth Laboratories, was also found laced with the heavy metals as well as cadmium.

The study, undertaken on the instructions of the health ministry, was conducted by the government's All India Institute of Hygiene and Public Health (AIIH&PH). In the five brands it tested, the institute found that the leaching of antimony, DEHP and chromium increased with a rise in room temperature. The leaching of lead increased in the cough syrups as the room temperature rose. On lead, the World Health Organisation (WHO) had concluded that there was no known level of safe exposure.

A spokesperson for Benadryl-maker Johnson & Johnson said: "All Johnson & Johnson products, including Benadryl Cough Formula, undergo elaborate stability testing programmes to ensure no abnormal chemicals are generated or migrated into the product. This is done with validated test methodologies at development stage as well as through our post-marketing surveillance programme. The PET (plastic) bottles themselves are selected after rigorous evaluation to confirm to international pharmacopeia standards, wherein it is verified that no hazardous chemical is extracted (migrated) into the bottle through prescribed methods."

Alkem Labs, which manufactures Hemfer cough syrup, said it conducted real-time stability study with the syrup and the results were found satisfactory and within desired specifications. "We use a third-party vendor for getting the PET bottles to package our products. The vendor selected is verified to use FDA-approved raw materials for manufacturing PET bottles. We also get a declaration from the vendor on the potential of leachability from these bottles," it added.

Alex cough syrup is manufactured and marketed in India by Glenmark Pharma. A Glenmark statement said: "Our products conform to the highest quality standards and all our manufacturing facilities are fully compliant with the CGMP regulations. We also conduct rigorous stability studies to ensure compliance with quality, safety and efficacy as per prescribed storage conditions and through the shelf life of the products. Further, we comply with laws and regulations relating to use of pet bottles." Merck Biopharma did not respond to this newspaper's queries."

According to IMS Health, a global information and technology services company, Alex and Benadryl syrups had sales of Rs 50 crore and Rs 35 crore, respectively, in the last one year. Pfizer's Mucaine Gel, the leading player in the antacid category with 50 per cent market share, had annual sales of approximately Rs 100 crore.

A Pfizer spokesperson said: "We are not aware of this study nor have we received any communication from the regulatory agencies on this matter. All Pfizer products released in the market are in compliance with the prescribed pharmacopoeia testing specifications and regulations. Our product Mucaine Gel has a proven record of safety, quality and efficacy and remains the product of choice in its therapeutic area."

The government's top pharmaceutical committee, the Drugs Technical Advisory Board (DTAB), had accepted the institute's test results in May and recommended to the health ministry to prohibit the use of plastic-bottle packaging for any liquid oral formulations having "pediatric use, geriatric use, use by pregnant women and use by any women of the reproductive age group."

The research institute refused to demarcate safe levels of toxin intake in its report to the health ministry. "To consider a level as safe level amounts to playing with fire," the institute said. It added that instead of debating the safe intake levels, the government should focus on minimising the exposure to these "presuming no level is safe level".