The decision on the ban was made following a thorough health technology assessment which concluded that ozone therapy does not confer any therapeutic benefits that were backed by scientific evidence.
"Health Technology Assessments done by Malaysian Health Technology Assessment Section (MaHTAS) revealed that there is no scientific evidence to support any therapeutic benefit from the usage of the abovementioned therapies for any illnesses," said Health Minister Datuk Seri Dr S. Subramaniam.
"Ozone therapy is not recognised by any country in the world,” he also said. “It can also cause severe medical complications including leading to death.”
Ozone therapy may cause severe medical complications
Earlier this January, local news reports exposed unscrupulous practices by local beauty parlours, unveiling that ozone machines operated by such premises were not registered under the Health Ministry despite requirement under the Medical Device Act 2012. The disclosures led authorities to clampdown practices and tighten regulations in the local beauty industry.
Not only did the assessment by MaHTAS reveal a lack of scientific evidence to support the beneficial claims of ozone therapy, it was found that the therapy may, in contrary, cause severe medical complications that could endanger the lives of individuals who opt for the “treatment”.
"Among others, the therapy potentially exposes users to risks of bleeding from the usage of heparin (blood thinning medicine), embolism (blockage of blood vessel from air bubbles), and infection from non-sterile instruments,” Subramaniam said.
"It could also lead to permanent disability resulting from impairment of organs such as the kidneys.”
Ozone therapy machines in Malaysia not registered with Medical Device Act
Beauty parlours often promise consumers that ozone therapy can rejuvenate one’s beauty and lead to fairer skin, going as far as to market ozone therapy as a remedy for many health issues and chronic illnesses. However, such advertisements contravene the Medicines (Advertisement and Sale) Act 1956 (Revised 1983) Act, which outlines that 20 chronic illnesses are off-limits to advertisers.
Subramaniam also noted that all operators of ozone therapy machines have failed to register their equipment with the Medical Device Authority (MDA).
"Under the Medical Device Act 2012, the machine is defined as a medical device which must be registered with the Medical Device Act (MDA),” he explained. "Therefore, any establishment, manufacturer, importer or distributors who import or place the machines in the Malaysian market need to apply for an establishment licence and register the licence under the Act.”
"So far, we haven't received any applications or registrations for such machines in the country," he said.
Stern action to be taken against offenders
Many operators of ozone therapy have expressed their disappointment towards the sudden announcement of the ban, calling the move premature and unfair.
“We want the minister to know the benefits of ozone therapy," said Ahmad Hassan Masduki, an operator of ozone therapy, who explained that only a small number of business operators are profit-driven and do not comply to procedures when administering the therapy.
“They should pick and choose their patients and conduct blood tests before providing therapy," he added. “Not all illnesses can be addressed with ozone therapy.”
Owner of Nexzeal Ozone Therapy Centre, Nurul Faizaa Sabani, also protested against the ban, adding that they adhere to necessary procedures. “All our employees are staff nurses, and we sent them for training with the Malaysian Ozone Practitioners Association," she said.
Nonetheless, by 1 July of this year, all manufacturers, importers and distributors of ozone therapy machines are required to withdraw distribution and use of such machines from the market, of which failure to comply would result in a prosecution under the Medical Device Act 2012. If convicted, offenders can be fined RM200,000 or face imprisonment not exceeding three years, or both.
According to Subramaniam, ozone therapy falls under the ambit of medical treatment, as the procedure involves injecting into a person’s vein and running their blood through the machine. As such, legal action can also be taken against healthcare centres that are registered under the Private Healthcare Facilities and Services Act 1998, should these premises offer ozone therapy.
The use of heparin during ozone therapy is also an offence under the Poisons Act and the Sale of Drugs Act 1952, which is enforced by the Pharmacy Enforcement Division, he added.
"The Ministry views the practice of ozone therapy seriously and the regulation of this device and practice should be in accordance to existing medical legislation," he said. "Therefore, it is compulsory for the practice to fulfil every aspect of existing medical laws and action can be taken against the providers should they fail to comply.” MIMS
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