Latest news with #Glycerin
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
Yahoo
25-02-2025
- Business
- Yahoo
Puma and Brooks Sports settle running-shoe trademark dispute
Germany-based footwear and apparel brand Puma and Brooks Sports, a subsidiary of Berkshire Hathaway, have reached a settlement in running shoe patent and trademark infringements disputes. The resolution comes after both companies filed motions to dismiss their respective lawsuits with prejudice, ensuring that they cannot be re-opened, as reported by Reuters. The legal contention began when Puma filed a lawsuit against Brooks in 2022. Puma claimed that Brooks' advertising campaign for its running shoes, which used the term "Nitro," infringed upon Puma's rights to the name associated with its own line of competing footwear. Puma's lawsuit also accused Brooks of copying its proprietary foam-moulding technology in Brooks' Aurora BL running shoes. Brooks denied these accusations. The company countered that the use of "Nitro" was purely descriptive of the nitrogen-infused midsoles featured in its shoes. The dispute escalated when Puma initiated another legal action in Seattle in June 2024, alleging that Brooks' Hyperion running shoes breached several Puma patents. Brooks dismissed this claim as a "baseless action," interpreting it as an attempt to gain leverage amidst the ongoing trademark dispute. In September 2024, Brooks also launched its own lawsuit against Puma in a Virginia federal court. This was to receive a judicial declaration that its Glycerin running shoes did not violate any Puma patents. A recent filing indicates that this case has also been settled in principle. Brooks also faced a trademark infringement lawsuit brought by Skechers USA in Los Angeles in 2022. Skechers argued that Brooks' use of the numeral "5" on some running shoes could potentially cause confusion with Skechers' own "S" logo. In December 2024, Puma selected Sitoo as its partner to enhance store operations worldwide, aiming to offer a consistent shopping experience to its customers. "Puma and Brooks Sports settle running-shoe trademark dispute " was originally created and published by Retail Insight Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Reuters
24-02-2025
- Business
- Reuters
Puma, Brooks settle lawsuits over running-shoe patents, trademarks
Feb 24 - Puma ( opens new tab and Berkshire Hathaway's (BRKa.N), opens new tab Brooks Sports have agreed to settle litigation over claims that Brooks' running shoes violated Puma's patent and trademark rights, according to filings in Washington federal court. Puma and Brooks asked a federal judge, opens new tab in Seattle on Friday to dismiss the cases with prejudice, which means they cannot be refiled. The companies said on Monday that the dispute had been resolved under confidential terms. Germany-based Puma sued Brooks in 2022, alleging a Brooks ad campaign using "Nitro" to advertise its running shoes violated Puma's rights in the name, which it uses with competing running shoes. Puma also said in the lawsuit that Brooks' shoes infringed a design patent covering the foam-molding technology Puma uses in its Nitro shoes. Brooks denied the allegations and said it used "Nitro" solely to describe its shoes' nitrogen-infused midsoles. Puma sued Brooks again in Seattle last June, alleging Brooks' Hyperion running shoes infringed several other patents. Brooks denied the allegations and called the lawsuit a "baseless action" to "harass Brooks and seek leverage in the parties' ongoing trademark dispute." Brooks separately sued Puma in Virginia federal court last September, seeking an order that its Glycerin running shoes did not infringe Puma patents. Brooks told the court in a filing last Wednesday that they had settled the case in principle. The Washington cases are Puma SE v. Brooks Sports Inc, U.S. District Court for the Western District of Washington, Nos. 2:23-cv-00116 and 2:24-cv-00940. For Puma: Johanna Wilbert, Michael Piery, Matthew Holohan and Kent Dallow of Quarles & Brady For Brooks: Geoffrey Potter, Aron Fischer, Lachlan Campbell-Verduyn and Jay Cho of Patterson Belknap Webb & Tyler
