The Pharmacy and Medicines Regulatory Authority (PMRA) and the Malawi Communications Regulatory Authority (MACRA) will from 1st August, 2023 commence joint enforcement of requirements for the advertisement of TCM products as provided for under the Pharmacy and Medicines Regulatory Authority Act, 2019.
According to a joint statement by PMRA and MACRA, the two organisations entered into a Memorandum of Understanding (MoU) to oversee, supervise and interact with each other in respect to any matters relating to regulation of broadcasting of advertisements related to traditional medicines.
Effective 1st August, 2023, all advertisements of TCM products must be submitted to PMRA for prior screening and approval before broadcasting. Meanwhile, all running advertisements will continue until 31st July, 2023. However, where paid-up slots for such adverts are likely to spill over the grace period, the dealers are encouraged to submit copies of the adverts and any other new adverts to PMRA for vetting.
Reads the statement in part: “Dealers of TCM products and broadcasters are being reminded that it is an offence under section 68(2) as read with section 68(5) of the Pharmacy and Medicines Regulatory Authority Act, 2019, to advertise medicines and allied substances, including traditional and complementary medicines, without prior screening and approval by PMRA.
“Further, the Second Schedule to the Communications Act (Cap. 68:01), in section 22(c), prohibits broadcasters from airing content that is untruthful and inaccurate. The prohibition upholds the principles for content regulation under section 2(a) of the Second Schedule on the need to protect the public against harmful content and under section 2(f) of the Second Schedule to ensure the propriety of advertising aired to the public using radio and television platforms.”
PMRA and MACRA are expected to carry out joint monitoring exercises to ensure compliance by both dealers of TCM products and broadcasters.
The Authority is mandated to regulate and control sale of herbal medicines. Regulatory procedures for registration of medicines are however not finalized and registration of the same has not commenced. Due to public health concern and as provided for in the Authority’s Act, the Authority is regulating advertisement. According to the requirements, any advertisement of herbal medicines is supposed to be vetted and authorized by PMRA.
Parliamentary Committee on Health has said failure by Pharmacy and Medicines Regulatory Authority (PMRA) to commence regulation of traditional and complimentary medicines is putting lives of citizens at risk of exposure to harmful substances.
The committee, led by Salima North West Member of Parliament (MP) Enoch Phale, made the remarks Tuesday when the parliamentarians visited the Authority’s National Medicine Quality Control Laboratory in Lilongwe.
“Our worry is that we are not safe in as far as we are consuming herbal medicines which have not gone through the processes of PMRA,” said Phale.
The Authority is mandated under Section 4 of the PMRA Act No 9 of 2019 to, among other functions, regulate and control distribution and sale as well as advertising and promotion of medicines and allied substances such as traditional and herbal medicines.
However, according to Chairperson for Finance and Administration Committee of the PMRA Board George Jobe delays in developing regulatory framework to enable the Authority enforce provisions of the Act is a major setback preventing PMRA to act on herbal medicines.
Said Jobe: “Delays in developing the regulations are heavily impacting on the Authority’s regulatory functions because in the absence of the legal tools, the Authority is failing to function as expected.”
He pleaded with the Committee for its urgent intervention to enable the Authority fully perform its rightful role, particularly in the area of regulation of traditional and herbal medicines which he said were also of concern to the Authority.
The delegation which also included Legal Affairs Committee Chairperson Peter Dimba has since pledged to engage Ministry of Health to expedite formulation of the regulations which according to Phale would ensure sanity in the herbal medicine industry and also enable the Authority realise much needed additional revenue in market authorization fees.
“We will work hand-in-hand with Legal Affairs Committee of Parliament to take up this issue with the line ministry and ensure that we give you the regulations,” he said.
Meanwhile, Phale expressed satisfaction with the operations of the laboratory which he said has enough capacity to fulfill its intended functions in accordance with the PMRA Act.
The National Medicines Quality Control Laboratory was established under section 79 of the PMRA Act to verify quality, safety and efficacy of medicines and allied substances such as medical devises, traditional and herbal medicines, and cosmetics, among others.
Pharmacy and Medicines Regulatory Authority (PMRA) has met Media Council of Malawi (MCM) and Malawi Chapter of Media Institute of Southern Africa (MISA – Malawi) on possible collaboration to control advertisement of traditional and complementary medicines (TCM) by local media houses.
The Authority is also expected to engage Malawi Communications Regulatory Authority (MACRA) in the coming days in what PMRA Director General Mphatso Kawaye says is a series of stakeholder engagements aimed at ensuring that media houses are complying with legal requirements for advertisement and promotion of herbal medicines.
PMRA is mandated under the PMRA Act No. 9 of 2019 to regulate advertising of medicines and allied substances.
Section 68 (2) of the Act states that “Advertisement of any medicine or allied substance shall require prior screening and approval by the Authority.”
Traditional medicines and food supplements with medicinal value fall under allied substances.
Kawaye said despite publishing guidelines on herbal medicines adverting in the local papers and issuing communications to individual media houses on the same, the Authority still faces non-compliance by media houses.
“We have an option of invoking the law to prosecute non-compliant media houses, however, we thought it wise to first engage these media regulatory bodies for their help in engaging their members on their role in controlling allied substance adverts.
“It is the general public that continues to be deceived by unauthorized advertisements and promotions of TCM products, hence the need to act now than later,” said Kawaye.
MCM Chairperson Wisdom Chimgwede and MISA Malawi National Director Aubrey Chikungwa have both commended PMRA for taking the route of engagement on the matter saying there is need for more awareness, on the provisions of the PMRA Act, targeting media owners, editors and heads of marketing.
The Authority, through Ministry of Health, is in the process of developing applicable regulations to guide implementation of registration of TCM products and associated businesses as provided for in the Act.
PMRA is a statutory organization established by Act of Parliament No. 9 of 2019 to regulate medicines, allied substances and the practice of pharmaceutical profession in Malawi.
Pharmacy and Medicines Regulatory Authority (PMRA) has warned it will soon start publishing names of all Pharmacy personnel and licensed business premises against whom disciplinary action has been taken for gross professional misconduct including indulging in theft of medicines in public health facilities.
In a statement issued Wednesday PMRA Acting Director General Charles Chimenya said the Authority was concerned with the rise in theft and pilferage of medicines in public health facilities, allegedly involving pharmacy personnel which the Authority regulates, adding it was even more disheartening that such malpractices are happening at a critical time when public health facilities are grappling with shortages and stockouts of medicines and medical supplies.
“PMRA joins the Pharmaceutical Society of Malawi (PHASOM) and all Malawians of goodwill in condemning the vice in its strongest terms and echoes calls for speedy prosecution of the suspected culprits.
“In continuing with its effort to stop the malpractices, PMRA will from this year start publishing names of all Pharmacy personnel and all licensed business premises against whom disciplinary action has been taken for violating dictates of the Pharmacy profession and practice,” said the Acting Director General.
Section 28 of the PMRA Act mandates the Authority to effect disciplinary action against all licensed pharmacy personnel and those operating licensed pharmacy businesses when deemed to be in gross violation of the Act. Penalties include suspension from practice and removal of offenders’ names from the appropriate register.
Similarly, stealing medicines or medical supplies from a public health facility is an offence under the PMRA Act which upon conviction attracts a fine of K20 million and imprisonment for 20 years.
The Authority has since called on potential employers to always check with the Authority the status of any pharmacy personnel before hiring them. Further to this, employers are requested to report to the Authority any pharmacy personnel suspected to be involved in theft or pilferage of medicines and medical supplies whether at a public or private facility in order for the Authority to take appropriate disciplinary action.
Added Chimenya: “Theft of medicines in public health facilities deprives innocent Malawians of access to quality health services. It is for this reason that PMRA calls for concerted efforts in ending the vice.”
Minister of Health Hon. Khumbize Kandondo Chiponda has assured Pharmacy and Medicines Regulatory Authority (PMRA) of full government support to ensure the Authority rises above its challenges and begin to effectively discharge its expanded mandate.
Speaking during a tour of PMRA premises in Lilongwe Wednesday Chiponda observed that the Authority was yet to maximize its potential following its transformation into a regulatory authority from then Pharmacy, Medicines and Poisons Board.
“We’ll give you all the support you need to make [the Authority] a success. The last few years it hasn’t performed well. I know the potential the Authority has and we will do everything possible to make sure that you perform to the level we expect and even do much better,” said the Minister.
She was reacting to earlier remarks by Acting Director General Charles Chimenya who highlighted a number of challenges hampering effective operations of the Authority in line with the new PMRA Act.
The Acting Director General cited delay by the Ministry to gazette regulations that would operationalize the Act, low staffing levels and dwindling cash-flow as some of the bottlenecks choking the Authority to realize its full potential.
He, however, appraised the Minister on the strides the Authority was making in addressing the challenges including the functional review currently underway, development of website and social media presence, on-going development of communication policy and strategy, recruitment of public relations officer, among others.
PMRA Board Chairperson Frider Chimimba thanked the Minister for the visit and her assurances of government’s continued commitment to supporting the Authority to effectively carry out its expanded mandate.
PMRA was established by the Pharmacy and Medicines Regulatory Authority Act No.9 of 2019 to regulate medicines, allied substances and the exercise of the pharmaceutical profession in Malawi.
Other new regulatory areas include pharmacovigilance, quality control, import permits, and the revision of fines and penalties to ensure that they are stiff and deterrent enough against illegal medicine handling practices.
The Authority is mandated under Section 68 of the PMRA Act to screen and approve advertising materials for medicines and allied substances before they are broadcast or publicized.
The applicant is required to submit a completed application form (attached below) together with the advertising material and prescribed fees. Authorization is granted if the application meets the required standards in the guidelines.