Latest news with #DEG
Business Recorder
22-04-2025
- Health
- Business Recorder
DRAP issues advisory regarding oral liquid preparations contaminated with DEG, EG
ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) in accordance with the World Health Organisation (WHO) guidelines has issued an advisory due to global concern regarding oral liquid preparations contaminated with Diethylene Glycol (DEG) and Ethylene Glycol (EG), which has caused severe health issues, especially in children. The DRAP has proactively addressed this by issuing advisories and guidelines to pharmaceutical manufacturers regarding the safety of Glycerin, Sorbitol, and Propylene Glycol. These previous directives included testing for DEG/ EG, using pharmaceutical-grade solvents from qualified vendors, performing identity tests, requiring Certificates of Analysis, reporting analysis results, and risk-based sampling. The DRAP has also enhanced surveillance, issued advisories, and extended surveillance to raw materials in coordination with Provincial Drug Control Administrations. Given these concerns, DRAP has taken serious note of the online sale of excipients such as Glycerin, Sorbitol, and Propylene Glycol via unverified platforms, including social media and ecommerce sites, posing risks to traceability, authenticity, and potential adulteration. To mitigate these risks, DRAP has inspected manufacturers and vendors, ordered sampling, shared WHO guidelines with health departments and testing labs, investigated supply chains, taken regulatory actions (seizures, FIRS, suspensions, recalls, etc.), collaborated with WHO, and extended DEG/ EG testing facilities at federal and provincial drug testing laboratories. To address 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 APIs per the DRAP Act 2012, the Drugs Act 1976 and section 3.5.2 read with 6.2.2. of Schedule B-ll of the Drugs, LR&A Rules, 1976. Manufacturers must procure these materials from qualified vendors and authorized distributors, adhering to DRAP guidelines that include audits, documentation review, and risk assessment. They must also continue impurity testing of Glycerin, Sorbitol, and Propylene Glycol on each batch, in-house or through CDL, Karachi or Provincial Drug Testing laboratories having said facilities, and conduct risk assessments of their excipient supply chains. The DRAP clarifies that adulterated or substandard raw material or finished product samples due to DEG/ EG impurities will render the manufacturer liable to regulatory action under Drug Act, 1976, the DRAP Act, 2012 and rules framed there under these Acts. DRAP reiterates its commitment to public health and safety. Manufacturers must prioritise these concerns by adhering to these guidelines and ensuring the quality and authenticity of materials used in therapeutic goods production. The DRAP urges enhanced vigilance in procurement and quality control to prevent contaminated materials from entering the supply chain. Copyright Business Recorder, 2025
ME Construction
03-03-2025
- Business
- ME Construction
AMEA Power launches construction of a 50MW Solar PV project
Energy AMEA Power launches construction of a 50MW Solar PV project By The Bondoukou Solar PV power plant will generate 85GWh of clean energy a year AMEA Power has announced the official groundbreaking of a 50MW solar photovoltaic (PV) project in the Ivory Coast. The US $60mn project is being financed by FMO and DEG, and will support the government's goal of increasing the share of renewable energy in its electricity mix to 45% by 2030, said a statement. The Bondoukou Solar PV plant will generate 85GWh of clean energy annually, enough to power 358,000 households, while offsetting more than 52,000t of CO2 emissions. The project is being implemented by AMEA Goutougo, a project company registered in Ivory Coast and fully owned by AMEA Power. The project is located in Bondoukou, in the north-eastern region of Gontougo. Hussain Al Nowais, Chairman of AMEA Power said, 'Today, we turn vision into reality. The 50MW solar plant is a landmark achievement for Ivory Coast and a testament to AMEA Power's dedication to delivering clean energy solutions across Africa. This groundbreaking ceremony is an important symbol of partnership, we are proud to partner with the government and the people of Ivory Coast on this transformative journey.' Once commissioned, it will be AMEA Power's first operational asset in the country. The company also has an additional 50MW solar PV project in advanced development in Ivory Coast. AMEA Power said that it is dedicated to driving socio-economic development and will work closely with local communities. Through its 'Community Investment and Development Programs' the company will launch key social initiatives focused on gender equality, education, and skills training, ensuring a lasting positive impact.
