Contaminated with DEG, EG impurities: DRAP restrains pharma industry from using imported material

ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) following the detection of impurities in raw materials contaminated with diethylene glycol (DEG) and ethylene glycol (EG) has directed the pharmaceutical industry to not use the recently imported material till further directions and retailers not to sell the products owing to serious threats to consumers.

Additionally, the industry is directed to recall any finished products that were manufactured using the contaminated lot/batch of propylene glycol, hold the affected batches of finished products and ensure testing of finished products for EG and DEG contamination before releasing them into the supply chain, a DRAP warning issued here on Friday said.

The DRAP warned all the concerned quarters about the use of raw material contaminated with DEG and EG impurities, which can pose serious health risks to consumers. The DRAP also issued directives to nutraceutical and alternative medicine companies to ensure compliance and safeguard public health from contaminated products.

The DRAP said that the Central Drugs Laboratory (CDL), Karachi has declared another sample of raw material i.e. propylene glycol (PG) as substandard sent for test/analysis due to unacceptable levels of ethylene glycol.

Propylene glycol, sorbitol and glycerin are used as solvents in the manufacturing of oral liquid preparations in the pharmaceutical and alternative medicines industry. When used in oral liquid preparations, these solvents can lead to serious health risks due to DEG and EG toxicity. When ingested, DEG and EG are metabolised into toxic metabolites that can affect the central nervous system, heart, and can cause kidney damage, which can be fatal.

The DRAP further said that in the past two years, there have been international reports related to the adulteration of these raw materials with DEG and EG causing kidney damage and death of children in Gambia, Uzbekistan, and Indonesia. Industrial grade DEG and EG are used for various applications (solvents, antifreeze agent) in other industries.

Earlier, several cases of substandard raw materials including PG and finished goods contaminated with DEG and EG have been reported from various part where investigations have suggested that the main problem lies with the integrity of supply chain of raw material which appears to be compromised. Consequently, action has been initiated against the culprits involved.

Despite repeated warnings and instructions, many therapeutic goods manufacturers have neglected to verify the quality and safety of their raw materials from authorized vendors. The CDL Karachi is currently analysing both raw materials and finished products for EG and DEG contamination, following the pharmacopoeial standards and WHO guidelines for testing of EG and DEG in oral liquid preparations. To ensure the quality and safety of their products, manufacturers should test their raw materials for EG and DEG contamination before using them in their production processes to prohibit potential influx of contaminated products in the market.

In view of the criticality of the matter and potential for untold human tragedy, the therapeutic goods industry is once again warned to screen raw materials (propylene glycol, glycerin and sorbitol) for contamination with EG and DEG before using these materials in the manufacturing of oral liquid preparations. Additionally, all finished products must be analysed for EG and DEG contamination before their release into the market.

The DRAP urged pharma industry to take measures to prevent utilisation of contaminated raw material in the manufacturing of liquid preparation including following: (i) Implement a supplier qualification and verify the compliance of the suppliers with the relevant standards and regulations; (ii) Verify traceability and authenticity of the raw material using unique identifiers such as barcodes or RFID tags to track their movement and origin throughout the supply chain; (iii) Conduct regular risk assessments and monitor the performance of the suppliers, and take corrective actions if any issues are detected; (iv) Educate and train the staff and the suppliers on the importance of preventing EG and DEG contamination, and the potential consequences of using contaminated solvents; and (vi) Verify the features that indicate the authenticity of the product, such as holograms, serial numbers, watermarks, or special packaging. The products should also be checked for any signs of poor printing, misspellings, inconsistent logos, tamper-evident seals or sturdy wrapping materials.

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