Asia-Pacific Roundup: DRAP advises firms in Pakistan on preventing DEG, EG contamination

The Drug Regulatory Authority of Pakistan (DRAP) has published an advisory to help manufacturers avoid buying excipients that are contaminated with diethylene glycol (DEG) or ethylene glycol (EG).

In recent years, authorities in Pakistan and other countries have found liquid drug formulations such as cough syrup that are contaminated with DEG and EG. The contaminants are toxic substances used as industrial solvents and antifreeze agents. Contamination happens with DEG and EG are used instead of safer, more expensive diluents such as pharmaceutical-grade glycerin.

The contaminants can cause severe health issues, including death, even when consumed in small amounts. Children are particularly vulnerable. Hundreds of children are estimated to have died from DEG and EG poisoning globally.

DRAP published an advisory after its surveillance of raw materials, which it stepped up after finding the contaminants in finished products, revealed the sale of excipients such as glycerin, sorbitol, and propylene glycol via unverified online platforms. The agency said the sale of the excipients on social media platforms and e-commerce sites raises risks related to traceability, authenticity, and adulteration.

The regulator said it has sought to mitigate the risks by inspecting manufacturers and vendors, ordering sampling, investigating supply chains, seizing materials, collaborating with the World Health Organization, and extending testing for DEG and EG at federal and provincial laboratories. Now, DRAP is asking drug companies to address the procurement risks.

“Manufacturers are directed not to purchase excipients from unverified sources, including online platforms, and all therapeutic goods manufacturers must perform vendor qualification for excipients and [active pharmaceutical ingredients],” DRAP said. “Manufacturers must procure these materials from qualified vendors and authorized distributors, adhering to DRAP guidelines that include audits, documentation review and risk assessment.”

The agency said manufacturers must keep testing each batch of glycerin, sorbitol, and propylene glycol for impurities, either at their own facilities or at Pakistan’s federal and provincial laboratories. DEG and EG are detectable using gas chromatography. The regulator added that companies must keep conducting risk assessments of their excipient supply chains.

DRAP said the discovery of adulterated or substandard raw materials or finished products that contain DEG or EG will render the manufacturer liable to regulatory action. Manufacturers must prioritize work to prevent contamination by adhering to the guidelines and ensuring the quality and authenticity of their raw materials, DRAP said. The agency is urging “enhanced vigilance in procurement and quality control.”

The advisory is the latest in a series of DRAP actions intended to prevent contaminated products from reaching patients. DRAP previously offered advice on testing for DEG or EG, using pharmaceutical-grade solvents from qualified vendors, performing identity tests, requiring Certificates of Analysis, reporting analysis results, and carrying out risk-based sampling.

DRAP Notice

Philippine FDA exempts certain cancer, cardiovascular and diabetes treatments from VAT

The Philippine Food and Drug Administration (FDA) has exempted more medicines from value-added tax (VAT).

Philippine authorities have exempted some medicines from VAT under a law passed in 2021. The Corporate Recovery and Tax Incentives for Enterprises Act was intended to spur domestic and foreign investment in the country. FDA provided an initial list of medicines and medical devices to exempt from VAT in 2021. The agency has added more products to the list in subsequent years.

Today, the exemption covers more than 500 products, including different dosages of the same medicine, for hypertension alone. DRAP recently added another 16 products, across multiple therapeutic areas.

The new additions included the diabetes medicines saxagliptin and dapagliflozin, which AstraZeneca sells as Onglyza and Farxiga, respectively. The inhibitors of DPP-4 and SGLT2 were the only diabetes products included in the latest round of VAT exemptions.

Cancer treatments accounted for most of the new additions. All of the oncology active ingredients were already on the exemption list but FDA has agreed to eliminate VAT on more dosages. The list of cancer drugs with doses recently added to the list includes bortezomib, lenvatinib and lenalidomide. FDA also added medicines for hypertension, kidney disease and tuberculosis to the list of VAT-exempt products.

FDA Notice

DRAP switching to online filings for drug export certificates, ending manual submissions

DRAP is transitioning applications for certificates needed to export products from Pakistan to an online portal this week.

The agency has been moving its services online in recent years to streamline operations, cut processing times and improve overall efficiency. As part of the initiative, DRAP launched a module on the Pakistan Single Window (PSW) system last year. The module launch marked the start of a push to integrate DRAP services into PSW, an online portal designed to facilitate trade involving Pakistan.

Starting 1 May, PSW will become the only way companies can apply for certain certificates needed to export medicines from Pakistan. Companies can either use PSW or make manual submissions until then.

The change will make PSW the exclusive platform for submitting and processing applications for export no objection certificates, certificates of pharmaceutical products, free sale certificates and good manufacturing practice certificates.

“To ensure seamless transition to this digital platform, DRAP has already conducted virtual training sessions for stakeholders,” DRAP said. “All pharmaceutical manufacturers and exporters are advised to familiarize themselves with the DRAP-PSW Gateway and utilize it for all export certificate applications. DRAP is committed to providing the necessary support and guidance during this transition.”

DRAP Notice

TGA seeks applications to fill vacancies on multiple Australian advisory committees

Australia’s Therapeutic Goods Administration (TGA) has put out a call for experts who want to take part in its advisory committees.

TGA is seeking applications from people who are interested in sitting on one of seven committees. The list of committees seeking new members includes the groups TGA convenes to discuss medicines, biologicals, vaccines, and medical devices. The groups meet three to six times a year to give independent advice to TGA.

The agency has scheduled a webinar for 7 May to share more information on the opportunity. Past and current members of advisory committees will attend the webinar to share their experiences and answer questions.

TGA is accepting applications until 3 June.

TGA Notice

Other News:

India’s Pharmaceutical and Medical Devices Bureau of India (PMBI) is recruiting a CEO. PMBI, which was set up in 2008 under the Department of Pharmaceuticals, is the implementing agency for an initiative intended to make quality generic medicines available at affordable prices. The government will consider experienced civil servants and senior managers at pharma companies for the role. Job Listing

The Philippine FDA has presented a roadmap and strategy for addressing its backlog. FDA shared details of its plans at a Philippine Association of Pharmacists in the Pharmaceutical Industry event about how to re-engineer regulatory systems and processes. FDA is reorganizing its Center for Drug Regulation and Research to operationalize a strategy intended to achieve its zero-backlog target. Press Release

TGA shared an update on Stryker’s urgent recall and product correction of certain lots of the HeartSine Samaritan Public Access Defibrillator Pak. Stryker began the recall in August 2023 after learning Pad-Paks could fail to power on the HeartSine Samaritan PAD. A separate product correction began last year. Stryker is trying to reach “a small percentage of customers who cannot be identified.” TGA Notice, More

Asia-Pacific Roundup: DRAP advises firms in Pakistan on preventing DEG, EG contamination

Related topics

Recommended content

Welcome to the new RAPS Digital Experience