Use only registered nasal inhalers

NASAL inhalers may be less popular than other dosage forms of medication, such as inhalers and nasal sprays. Nonetheless, registered nasal inhalers can be purchased easily without a prescription from community pharmacies, convenience stores and supermarkets. 

Formulations and Indication

A nasal inhaler is a medicinal dosage form that consists of a tube containing active ingredients. When inhaled through the nostril, the active ingredients will be released in the form of vapour. Normally, active ingredients in nasal inhaler formulations include menthol, camphor and herbal-based compounds such as eucalyptus, rosemary and peppermint oils. These substances are used for relieving nasal congestion resulting from cold or allergies. 

Registration Requirements 

Nasal inhalers, like other medicinal dosage forms, must comply with the registration requirements stipulated by current laws and regulations. The registration of nasal inhalers is based on several criteria, such as the active ingredient they contains and its indication. 

Nasal inhalers with active ingredients that exert a pharmacological effect are classified as medicines and regulated by the Sale of Drugs Act 1952. As such, it is required to be registered with the Drug Control Authority (DCA), Ministry of Health (MOH) before they can be imported, manufactured, or marketed in Malaysia. 

Typically, registered medications are distinguished by their unique registration numbers and hologram safety labels. These registration numbers begin with MAL, followed by eight digits, and conclude with either A, X, T or N, signifying the medication’s classification. 

Currently, registered nasal inhalers are exclusively categorised as X or T. The designation X denotes an over-the-counter (OTC) product, while T signifies natural remedies (traditional and homeopathic medicines). The hologram safety label, affixed to the packaging, boasts several safety features. Across all registered medications, this hologram safety label is recognised as the FarmatagTM. 

Nasal inhalers that specifically act as a moisturising layer, protecting the nasal mucosa, are classified as medical devices. Thus, nasal inhalers in this category are subject to the Medical Devices Act 2012 and its regulation, and supervised by the Medical Devices Authority of Malaysia. 

Ways to Verify Registration Status

The public is encouraged to verify the registration status prior to purchasing or using a nasal inhaler. This is essential to prevent the public from falling for scams perpetrated by irresponsible sellers. Using unregistered nasal inhalers poses a risk of harm because these medicines do not undergo a comprehensive evaluation process for quality and safety. 

The public can verify the registration status of the nasal inhalers by using the “Product Search” feature on the National Pharmaceutical Regulatory Agency’s (NPRA) website at https://npra.gov.my. 

Alternatively, checking can be conducted using the smartphone application “NPRA Product Status” by inputting search criteria such as product name, active ingredient, or registration number. This application is accessible for download on the Google Play Store, Apple App Store or Huawei App Gallery. 

Furthermore, it’s recommended to confirm the authenticity of the hologram safety label on the packaging before purchasing a nasal inhaler by utilising the FarmaCheckerTM smartphone application. 

Meanwhile, the registration status of a nasal inhaler categorised as a medical device can be verified through the Medical Device Authority’s website. 

Advice for Public 

When encountering advertisements with exaggerated claims or the use of words such as “best”, “effective” and “proven safe”, the public should exercise caution. It’s essential to carefully evaluate claims regarding the efficiency and safety of products before making a purchase. Unproven medical claims and testimonials from other users should not be relied upon. 

The public is advised not to purchase nasal inhalers from unauthorised sellers, including street vendors, night markets, foreign sellers and online sellers with unclear physical locations. All advertisements for nasal inhalers making health claims should display an approval number issued by the Medicines Advertisement Board. An example of a medicine advertisement approval number is KKLIU 3993, expiring on Dec 31, 2025. 

The public is encouraged to report the sale of unregistered nasal inhalers. Complaints can be submitted to the Pharmacy Enforcement Division, MOH, through https://pharmacy.moh.gov.my or by calling 03-78413200. Alternatively, individuals can contact the nearest Pharmacy Enforcement Branches or file a report using the MOH Sistem Pengurusan Aduan Awam (SisPAA) portal at https://moh.spab.gov.my. 

It’s important to note that selling unregistered medicines violates Regulation 7(1)(a) of the Control of Drugs and Cosmetics Regulations 1984. If found guilty, individuals could be fined up to RM25,000 or face a maximum of three years in prison for the first offense. Subsequent offenses could result in fines of up to RM50,000, imprisonment for up to five years, or both. Companies found in violation may face fines of up to RM50,000 for the first offense and up to RM100,000 for subsequent offenses. 

Know your medicines. For any inquiries regarding medications, please call the National Pharmacy Call Centre (NPCC) at the toll-free number 1-800-88-6722 during weekdays from 8am to 5pm, except on public holidays. 

  • Mohd Shahiri Abd Ghapar Pharmacist Pharmacy Practice and Development Division, MOH 

  • This article first appeared in The Malaysian Reserve weekly print edition