India’s Central Drugs Standard Control Organization (CDSCO) has published advice intended to prevent the contamination of cough syrups with ethylene glycol (EG) and diethylene glycol (DEG).
As CDSCO explained, “it is of paramount importance” that drug formulations are made in compliance with the prescribed standards, “not only in respect of API but also various excipients.” The hundreds of deaths linked to EG and DEG contamination have shown the importance of excipient sourcing and, with India now in one of its cold and flu seasons, use of cough syrup could rise in the coming months.
“Manufacturers are hereby advised that they should purchase and use only pharma grade excipients from their approved sources/vendors which are of quality standards in accordance with the regulatory requirements,” CDSCO wrote. The sourcing recommendations are intended to ensure the quality, safety and efficacy of drugs made and sold in India.
CDSCO posted its notice days before the World Health Organization (WHO) shared another alert about contaminated syrup and suspension medicines. The WHO alert refers to five products initially detected in the Maldives and Pakistan and reported to the public health body last month. Since then, Belize, Fiji and Lao People’s Democratic Republic have found some of the affected products.
In the notice, WHO describes the actions taken to date, explaining that work by the Maldives Food and Drug Authority and Australia’s Therapeutic Goods Administration (TGA) showed five batches of a syrup were contaminated with EG. Officials in Pakistan then inspected Pharmix Laboratories, the stated manufacturer of the products, and found EG and DEG may be present as contaminants in other products and batches made by the company.
WHO’s alert specifically relates to five products. However, the organization is recommending “increased vigilance and testing in respect of oral liquid dosage medicines” made by Pharmix between December 2021 and December 2022 “out of an abundance of caution.”
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