Malawi and India sign Memorandum of Understanding on pharmacopoeial cooperation
The governments of Malawi and India have signed a Memorandum of Understanding (MoU) on pharmacopoeial cooperation.
The signing of the MoU on Friday at Kamuzu Palace was part of bilateral talks between His Excellency President Dr. Lazarus McCarthy Chakwera and his Indian counterpart President Smt. Droupadi Murmu. The Indian President is in Malawi for a three-day state visit.
Among key areas under the agreement is to enhance cooperation in pharmacopoeia standards, specifically promoting understanding of Indian Pharmacopoeia (IP) in regulatory frameworks, requirements, and processes, considering that a significant proportion of medicines consumed in Malawi are manufactured in India.
This collaboration will facilitate the exchange of information and documentation related to the development of analytical methods published in IP.
PMRA Board Chairperson Mrs. Frider Chimimba and Indian High Commissioner to Malawi Mr. S. Gopalakrishnan signed the MoU, representing the Pharmacy and Medicines Regulatory Authority (PMRA) and the Indian Pharmacopoeia Commission (IPC), respectively.
President Chakwera and President Droupadi Murmu witnessed the signing of the agreement.
Commencement of baseline survey on PMRA mandate and functions
The Pharmacy and Medicines Regulatory Authority (PMRA) is notifying stakeholders, clients and the general public of commencement of a baseline survey on public awareness of the Authority’s mandate and functions.
The survey will be conducted from 20th October to 8th November, 2024, covering all 28 districts of Malawi.
The primary objective of this survey is to establish a public awareness index (PAI) for the Authority. The findings will inform strategic communication initiatives, enhance transparency, and foster accountability, ultimately enabling PMRA to better serve the public’s needs and interests.
Read more about the survey here.
PMRA engages judiciary on medicine regulatory legal framework
The Pharmacy and Medicines Regulatory Authority (PMRA) hosted a two-day interface meeting with a section of magistrates from on Thursday to Friday at Chikho Hotel in Mponela, Dowa. The meeting aimed to reflect on the legal framework of the medicines regulatory system in Malawi and identify ways to enhance its effectiveness.
The Authority recognizes the judiciary as a vital partner in combating pharmaceutical crimes, including medicine theft, illegal possession of medicines, and the trafficking of falsified and substandard medicines.
By collaborating with the Judiciary, PMRA aims to ensure a more effective regulatory environment, discouraging non-compliance and promoting a healthier Malawi through assurance of quality, safe and efficacious medicines and allied substances.
PMRA is mandated by the PMRA Act, 2019 to ensure that medicines and allied substances that are used in the country are of acceptable quality, safe and efficacious.
Notice of November, 2024 registration examinations
The Pharmacy and Medicines Regulatory Authority (PMRA) is pleased to announce that the next registration examinations for Pharmacists, Pharmacy Technologists and Pharmacy Assistants will be administered as follows:
| MZUZU | LILONGWE | BLANTYRE | |
| Time | 08h00 | 08h00 | 08h00 |
| Date (s) | 25th – 26th November, 2024 | 25th – 26th November, 2024 | 25th – 26th November, 2024 |
| Venue | Grand Palace Hotel | Crossroads Hotel | Victoria Hotel |
Eligible candidates who are interested to sit for these examinations are requested to confirm to PMRA by submitting duly filled registration application form with all required documents not later than 17h00 of 2nd November, 2024.
Application forms for both new applicants as well as those resitting the examinations, can be accessed on PMRA website www.pmra.mw or directly from PMRA office’s reception.
For further information and/or clarification please contact PMRA on 0999 708 450 / 0881 790 993/0999379544 or email at info@pmra.mw.
PMRA participates in Leadership Summit on aligning ATM Strategy towards Malawi 2063
The Pharmacy and Medicines Regulatory Authority was on Monday at Sunbird Nkopola in Mangochi participating at the Leadership Summit on aligning the Agriculture, Tourism and Mining (ATM) Strategy towards Malawi 2063.
The Authority’s mission of safeguarding the health of the population of Malawi through assurance of the quality, safety and efficacy of medicines and allied substances; and enforcement of standards for the pharmacy practice, is in line with Enabler 5: Human Capital Development of the Malawi 2063 which aims at ensuring universal health coverage with quality, available, equitable and affordable health care for all Malawians.
PMRA’s strides aimed at ensuring quality, safe and efficacious medicines including product quality assessment, quality control testing, post-market quality and safety surveillance are in sync with the 5-year Quick Wins priority intervention areas of the First 10-Year Implementation Plan (MIP-1) of the Malawi 2063 which, among others, seek to ensure efficient drug supply chain management through monitoring of quality of medicines and medical supplies in the country.
PMRA ranked 2nd in Access to Information compliance
The Pharmacy and Medicines Regulatory Authority (PMRA) was on Friday recognized and awarded 2024 second best performing institution in implementing the Access to Information Act (ATIA) in Malawi.
The award ceremony was part of this year’s commemoration of the International Day of Universal Access to Information (IDUAI) jointly organised by the Malawi Human Rights Commission (MHRC) and Media Council of Malawi (MCM) under the local theme: “Promoting Free Flow of Information towards the 2025 General Elections.”
Reacting to this exciting achievement, PMRA Director General Mphatso Kawaye, expressed delight at the news citing it as a testament to the Authority’s commitment to transparency and accountability.
“We are proud to be recognized among the most transparent and accountable public institutions. This will motivate us to continue to serve the public with excellence,” said Kawaye.
The International Day of Universal Access to Information is observed annually on 28 September. The global theme for the 2024 IDUAI is “Mainstreaming Access to Information and Public Participation Practices across Government Sectors.”
In the picture, PMRA Public Relations Officer (PRO) and designated Information Officer (IO) under the ATI (in the middle), receives a trophy from Secretary for Information and Digitilisation Baldwin Chiyamwaka and MHRC Commissioner Teresa Ndanga.
Notice of release of August 2024 registration exam results
The Pharmacy and Medicines Regulatory Authority (PMRA) is pleased to announce release of results of registration examinations for pharmacists, pharmacy technologists and pharmacy assistants which were administered on 1st and 2nd August, 2024.
For more details click here.
Malawi has capacity to assure quality of medicines
The Pharmacy and Medicines Regulatory Authority (PMRA) has assured the public that Malawi has the necessary capacity to conduct rigorous medicine quality assessments for product registration and ongoing market surveillance, guaranteeing access to high-quality, safe, and effective medicines.
Among others, PMRA boasts of ISO/IEC 17025:2017 accredited laboratory attesting to Malawi’s capability and international recognition to test and assure the quality, safety and efficacy of medicines. ISO 17025 accreditation is a certification that recognizes a laboratory’s technical competence to carry out specific tests, calibrations, or measurements.
PMRA Director General Mphatso Kawaye made the remarks Tuesday in Lilongwe where the Authority addressed a media briefing to respond to findings of a study by Ethiopia’s Bahir Dar University on quality of medicines in Africa.
In particular, the Director General was commenting on an article published in the UK-based Guardian newspaper of 4th August, 2024, titled Fifth of medicines in Africa may be sub-par or fake, research finds which cited the Bahir Dar University study claiming that Malawi has one of the highest prevalence of substandard and falsified medicines in Africa.
“Using its Medicine Quality Control Laboratory which is ISO 17025 accredited, PMRA tests medicine samples prior to distribution and those samples collected through routine quality surveillance activities,” said Kawaye.
Among others, the Director General observed that the Bahir Dar University review referenced a 2015 Malawian study on anti-malarial medicines and used its findings to generalize the quality of all medicines in the country.
Said Kawaye: “The study which the article quoted only examined the quality of anti-malarial medicines which were: LA, Quinine, SP, DHA/SP, DHA/Pp, ATS/SmP, and ATS/SP. In addition, the study did not include samples from the government health facilities which constitute the largest proportion of anti-malarial medicines consumed in the country and whose brands are not found in the private sector.
“This means that the findings of this referenced 2015 study cannot be used to generalize the quality of all anti-malarial medicines let alone the quality of all medicines in the country.”
The DG further observed that the analytical method used for assessing LA in the 2015 reference study was modified from a published well validated method. However, the extent of the modification was quite significant and resulted into inferior validation parameters, rendering the method unsuitable for assessing quality of LA.
He cited an instance where samples from the same batch of LA gave significantly different results, which he said is not normal in medicines analysis especially considering that the samples were collected from regulated facilities.
“The failure rate of LA which had the highest number of samples in the 2015 study was largely due to analytical method problems. Had the analysis been as per the reference analytical method (Arun 2011), the failure rate could have been much different from the 88.4% that was reported in the 2015 Malawi study,” he said.
According to Kawaye, the Authority acknowledges the importance of studies conducted by institutions of higher learning whose recommendations inform both public health policy and medicines regulatory practice.
The Authority has since called for adherence to best research practices saying incorrectly done studies may raise alarm and grossly mislead the public to lose confidence in the public health sector. Further, such studies undermine the efforts by government institutions, partners and stakeholders in the health sector in ensuring access to quality health services.
WHO alert on falsified Oxymorphone hydrochloride 40mg tablets
The Pharmacy and Medicines Regulatory Authority (PMRA) is informing stakeholders and the general public that the World Health Organisation (WHO) has issued an alert concerning one batch of falsified (contaminated) Oxymorphone Hydrochloride 40mg tablets. The falsified product was detected in the unregulated supply chain in Finland and reported to WHO in July 2024 by the Finnish Medicines Agency (FIMEA).
Oxymorphone Hydrochloride is a semi-synthetic opioid used to treat moderate to severe pain.
The falsified product imitates Oxymorphone Hydrochloride marketed by AUROLIFE PHARMA LLC., who have confirmed that the product, subject of this Alert, is falsified and was not produced by their company.
PMRA is assuring stakeholders and the general public that Oxymorphone Hydrochloride is not registered with the Authority, making it very unlikely for the falsified product to be available in the country.
However, in case anyone has the affected product, PMRA recommends that they should not use it and report to the Authority immediately.
PMRA urges pharmaceutical importers, retailers, healthcare workers, and consumers to report any suspected falsified medicines or adverse drug reactions to any healthcare facility and to the PMRA by dialing *360# for free on TNM and Airtel networks.
The Authority remains steadfast in ensuring that medicines and allied substances being used in the country are of acceptable quality, safe and efficacious in line with our mandate as provided for under the PMRA Act, 2019.
Full details of the alert are available on: Medical Product Alert N°3/2024
For media enquiries, please contact PMRA Public Relations Officer on +265 899 567 365 or email at jjosiah@pmra.mw
PMRA hails Air Cargo Malawi’s pharma service launch
The Pharmacy and Medicines Regulatory Authority (PMRA) has commended Air Cargo Malawi Limited for launching a pharmaceutical service describing the development as a positive step towards improving healthcare outcomes for the country.
The new pharma service will see Air Cargo Malawi Limited in partnership with Emirates Airlines commence transportation of pharma products from Europe, the UAE, India and China to Malawi. Previously, Emirates did not allow Air Cargo Malawi to carry pharmaceutical products due to safety concerns as pharma products are considered high risk.
Speaking when he presided over the launch, PMRA Director General Mphatso Kawaye noted that the service launch is a significant milestone in ensuring the availability and quality of pharmaceutical products in the country.
“The launch of this service is a testament to the critical role that effective logistics plays in ensuring the availability and quality of pharmaceutical products, which subsequently assure key actors in the health sector that patients get the right treatment outcomes,” said Kawaye.
He described the pharmaceutical industry in Malawi as a very important partner in the implementation of the Health Sector Strategic Plan (HSSP III), Malawi 2063 and Sustainable Development Goals (SDGs), all of which place much emphasis on universal health coverage with quality, available, equitable and affordable health care, on one hand, and efficient drug supply chain management through monitoring of quality of medicines and medical supplies, on the other.
Kawaye observed that the medicines regulatory environment in the country places immerse responsibility on pharmaceutical wholesalers as authorized importers of medicines, to make sure that the right medicine transportation requirements are met.
Added Kawaye: “Although the regulatory environment has placed this responsibility in the hands of the pharmaceutical wholesalers as importers, the quality assurance of products in transit including cold chain products is unfortunately not within their sphere of control.”
He then expressed optimism that the coming of Air Cargo Malawi Pharma Service will fill the gap and provide sustainable support to the importer in complying with the law as it relates to storage and transportation of temperature controlled pharmaceutical products.
He called on players in the pharmaceutical sector to complement the Air Cargo pharma service by ensuring that appropriate regulatory procedures are adhered to, both before and after the shipment of consignments.
Said Kawaye: “Let us realize that our proactive participation on the regulatory side partnered with Air Cargo Pharma’s expertise on the pharmaceutical handling side will create a highly efficient transportation solution for our temperature sensitive pharmaceutical products and contribute towards timely access to quality medicines for Malawians.”