Latest news with #ControlofDrugsandCosmeticsRegulations1984
New Straits Times
an hour ago
- Health
- New Straits Times
Off-label drug prescriptions a growing challenge in Malaysia
Off-label drug prescriptions — where medications are used outside their approved indications, dosages, age groups or routes of administration — have become a significant issue in Malaysia's healthcare landscape. This practice raises legal, ethical and safety concerns for patients and practitioners. Legal ambiguity continues to surround off-label prescriptions in Malaysia, with loopholes giving practitioners some leeway. However, this flexibility raises ethical questions, particularly regarding patient safety. Simply obtaining patient consent or informing them about the off-label nature of a prescription does not eliminate the risk of adverse drug reactions associated with such use. The core issue is that legal or procedural compliance alone cannot protect patients from harm when clinical evidence is lacking for off-label use. Off-label prescribing occurs when doctors prescribe a drug for a purpose, patient group or method not included in its official approval by regulatory bodies, such as Malaysia's Drug Control Authority (DCA) or the US Food and Drug Administration. For example, Methotrexate, originally approved for cancer, is sometimes prescribed off-label for psoriasis, potentially exposing patients to severe side effects not anticipated for their condition. Studies indicate that off-label prescriptions may account for up to 50 per cent of all medication use, with particularly high rates in paediatric and geriatric populations. In children, this practice is often driven by a lack of suitable paediatric formulations, insufficient clinical trial data and the absence of approved medications for certain conditions. In Malaysia, common off-label prescriptions for children include anti-asthmatic and cough and cold medications. The primary concern with off-label drug use is the risk of adverse drug reactions (ADRs), which can range from mild side effects to life-threatening complications. Notable historical examples include the thalidomide tragedy of the 1950s, where off-label use in pregnant women led to thousands of birth defects. Pharmacists play a critical role in monitoring and reporting suspected ADRs, while doctors are expected to be fully informed about any drug they prescribe off-label, basing their decisions on scientific evidence and clinical judgment. In Malaysia, the Control of Drugs and Cosmetics Regulations 1984 mandates that all pharmaceutical products must be registered with the DCA, including details of intended use, dosage and target patient groups. However, many drugs used in hospitals, especially for children, are either unlicensed for paediatric use or are prescribed off-label due to the exclusion of children from clinical trials during drug development. This regulatory gap places the burden of responsibility on medical practitioners, who must carefully weigh the risks and benefits when considering off-label prescriptions. The lack of clear legal guidance means that the practice is largely left to the discretion of individual doctors, with potential medico-legal implications if adverse outcomes occur. The Patents Act 1983 should also support incremental innovations but with safeguards requiring full disclosure of clinical trial safety data. Experts and researchers emphasise the urgent need for well-designed clinical studies on commonly prescribed off-label medications, especially in vulnerable groups like children and the elderly. Enhanced monitoring, better practitioner education and clearer legal frameworks are essential to ensure patient safety and uphold ethical standards in medical practice. As off-label prescribing continues to be a common, yet controversial, aspect of modern medicine, striking the right balance between innovation, patient safety and regulatory oversight remains a pressing challenge for the healthcare system.
New Straits Times
2 days ago
- New Straits Times
Two arrested over RM600k worth of unapproved goods from Myanmar
BUKIT MERTAJAM: Authorities have arrested two men, including a foreign national, after uncovering a storage facility containing hundreds of boxes of unapproved food, medicines and cosmetics from Myanmar. The operation was a joint effort involving the intelligence branch of Battalion 2 General Operations Force (GOF), the Seberang Prai Tengah District Health Office, and the Penang Pharmaceutical enforcement cranch. GOF Northern Brigade commander, Senior Assistant Commissioner Shahrum Hashim, said the raid led to the seizure of 868 boxes of food items and 1,567 boxes of medicines and cosmetics, all of which lacked approval certificates from the Health Ministry and the National Pharmaceutical Regulatory Division. "The total estimated value of the seized goods is RM559,190. "Preliminary investigations revealed that the storage site had been in use for two years, with the products intended for sale to Myanmar nationals living and working in Bukit Mertajam and surrounding areas," he said in a statement today. Shahrum said the authorities identified the location and thwarted the suspects' efforts to distribute unsafe food, medicines and cosmetics in Malaysia. The foreign suspect is being investigated under Section 6(1)(c) of the Immigration Act 1959/63, which carries a fine of up to RM10,000, imprisonment of up to five years, or whipping. The local suspect is being investigated under Section 55B of the same Act, which provides for a fine of between RM10,000 and RM50,000 or imprisonment of up to 12 months. The Penang Pharmaceutical Enforcement Branch is continuing investigations under the Control of Drugs and Cosmetics Regulations 1984. Shahrum added that enforcement efforts would continue across Perak, Penang and Kedah. "We urge the public to assist us by reporting any suspicious activities," he said.
New Straits Times
16-05-2025
- Health
- New Straits Times
Selangor health dept seizes unregistered products worth over RM7mil
SHAH ALAM: The Pharmaceutical Enforcement branch of the Selangor State Health Department (JKNS) seized 133 types of unregistered health products worth more than RM7 million last month. JKNS director, Dr Ummi Kalthom Shamsudin, said the seized health products, including foreign-branded items, were confiscated from a premise operated by a supply company and two other companies providing logistics hub services during inspections conducted on April 15 and 22. She said the enforcement action was taken following public complaints regarding the online sale of health products not registered with the Drug Control Authority (PBKD), Ministry of Health (KKM). "On April 15 and 22, 2025, inspections were carried out at three premises used as storage and distribution locations for unregistered health products intended for consumers in Malaysia. "The companies involved utilised e-commerce platforms as a medium to sell these products to consumers. As a result of cooperation with the Royal Malaysia Police, JKNS's Pharmaceutical Enforcement Division successfully seized 133 types of unregistered health products, including foreign-branded items, with the total value estimated to exceed RM7 million," she said in a statement. She added that the sale of unregistered health products contravenes Regulation 7(1)(a) of the Control of Drugs and Cosmetics Regulations 1984, which is punishable under Section 12(1) of the Sale of Drugs Act 1952. The enforcement action is part of the department's ongoing efforts to combat the sale of unregistered health products in the market to ensure public safety. "We advise all logistics hub operators to ensure that the health products they handle are registered, as legal action can be taken against them in addition to the product owners. "Furthermore, the public is advised to ensure that health products carry a hologram safety sticker and product registration number (MAL) before purchase. "The registration status of health products can be verified by visiting the website under the 'Product Search' section or by contacting the National Pharmaceutical Regulatory Agency (NPRA) at 03-7883 5400," she said.
