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.”
PMRA, NAC call for vigilance against false claims about HIV cure
The Pharmacy and Medicines Regulatory Authority (PMRA) and the National AIDS Commission (NAC) have called for vigilance against increasing spread of social media claims about supposed permanent cure for HIV.
PMRA Director General Mphatso Kawaye and NAC Chief Executive Officer Dr. Beatrice Matanje made the call in Lilongwe on Wednesday when the two organizations addressed the media.
The call follows recent joint investigations by NAC and PMRA, in collaboration with Malawi Police Service (MPS), which have uncovered disturbing trend where some unscrupulous individuals are tampering with labels of known medicines and later advertise the falsified medicines as “Gammora HIV Cure”, falsely claimed to be permanent cure for HIV.
PMRA and NAC stress that there is no cure for HIV and that consistent treatment with Anti-retroviral drugs (ARVs) is the only effective way to manage HIV. They have since advised people living with HIV to consult healthcare professionals and avoid taking medication without prescriptions.
Read the full joint statement here.
Parliament praises PMRA’s commitment to fighting corruption
The Legal Affairs Committee of Parliament has commended Pharmacy and Medicines Regulatory Authority (PMRA) for demonstrating serious commitment to the fight against corruption within the organization.
Committee Vice Chairperson Hon. Yusuf Nthenda made the remarks in Lilongwe on Friday when PMRA Institutional Integrity Committee (IIC) appeared before the parliamentary committee to appraise it of the progress the IIC has made in the implementation of anti-corruption activities in line with the National Anti-Corruption Strategy (NACS II).
Nthenda applauded PMRA Management’s commitment to allocating adequate funds for IIC activities, citing it as a tangible demonstration of the seriousness and resolve required to combat corruption effectively.
“We can only contain corruption if we are serious in our fight against the vice. PMRA has demonstrated that they are serious and as a Committee we are satisfied with the progress they have made so far,” he said.
The Committee has since urged PMRA to ensure it has in place a whistleblower protection policy to facilitate safe and confidential channel for employees to report corruption.
In his remarks, PMRA Director General Mphatso Kawaye assured the Committee of management’s resolve to supporting activities of the IIC. He reiterated the Authority’s commitment to pursuing zero tolerance to all forms of corruption, strengthen PMRA’s institutional integrity, foster a culture of transparency and accountability, and ultimately contribute towards promotion of good governance in the pharmaceutical sector.
On her part, PMRA IIC Chairperson Irene Dzanjalimodzi expressed her committee’s commitment to implementing the recommendations and guidance provided by the Legal Affairs Committee. She assured that the IIC will utilize this expert advice to ensure effective implementation of its future anti-corruption activities.
PMRA established its IIC in February, 2023 to spearhead anti-corruption efforts within the organization. The objectives of the PMRA IIC are to ensure increased knowledge on corruption prevention mechanisms to members of staff and stakeholders; strengthened measures for the prevention and detection of corruption; and enhanced reporting mechanisms for suspected corrupt practices.
PMRA participates in India-Malawi Pharma Cooperation webinar
Pharmacy and Medicines Regulatory Authority (PMRA) Director General Mr. Mphatso Kawaye, was on Thursday 15 February 2024 among key speakers at the Second Hybrid Webinar on “India-Malawi Pharmaceutical Cooperation and Regulatory Developments” organized by the Indian High Commission in Malawi in collaboration with Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) in Lilongwe.
The DG made a presentation on Registration Procedures in the Pharmaceutical Sector in Malawi.
Other speakers included Indian High Commissioner to Malawi His Excellency Shri S. Gopalakrishnan, PHARMEXCIL Director General Mr. Ravi Uday Bhaskar, Director of Technical Services at Ministry of Health Mr. Godfrey Kadewere, and Central Medical Stores Director of Procurement Mr Charles Kombeni.
India is the largest supplier of Malawi’s imported pharma products.
India is the largest global supplier of generic drugs accounting for 20% of its global exports. It is also the leading vaccine manufacturer globally with a market share of 60%.
Major segments of the Indian Pharmaceutical Industry include generic drugs, OTC medicines, bulk drugs, vaccines, contract research & manufacturing, biosimilars and biologics. India manufactures about 60,000 different generic brands across 60 therapeutic categories and ranks 3rd globally in manufacturing generic drugs.
The objective of the Webinar was to facilitate and promote more pharma trade between India and Malawi. The webinar was followed by Business-to-Business (B2B) meetings. Over 100 companies from both India and Malawi participated at the second Hybrid Buyer-Seller Meet on pharma sector. The first Buyer-Seller Meet was organised in February 2022.
PMRA has new Board
Government has appointed new Board members for the Pharmacy and Medicines Regulatory Authority (PMRA) effective 31st January, 2024. The appointment is in accordance with Section 6(1) of the PMRA Act No. 9 of 2019.
The appointment is for a tenure of three years expiring 30th January, 2027.
The Composition of the Board is as follows:
- Ms. Frider Chimimba – Chairperson
- Dr. Enock Ludzu – Member
- Mr. John Mhango – Member
- Mr. William Mpute – Member
- Mrs. Flossy Lombola – Member
- Mr. Chance Munthali – Member
- Dr. Marvin Phonera – Member
- Ms. Mary Chinkhadze Kamtimaleka – Member
The ex-officio members of the Board are as follows:
- The Secretary for Health
- The Solicitor General; and
- The Controller of Statutory Corporations
PMRA unveils new five-year strategic plan
PMRA has today launched its new five-year strategic plan at a colourful ceremony held at the Bingu International Convention Centre (BICC) in Lilongwe.
Chairperson of the Parliamentary Committee on Health Dr. Matthews Ngwale presided over the launch which was also attended by USAID Health Office Deputy Director Dr. Haldon Njikho, WHO Rep Dr. Neema Kimambo and key players in the pharmaceutical sector, among others.
Chairperson of PMRA Board of Directors, Mrs Frider Chimimba described the development of the 2023/24-2027/28 blue print as a milestone towards enhancing service delivery.
Said Chimimba: “The Strategic Plan is part of the major strides the Authority is undertaking in its quest to further enhance the medicine regulatory system in the country. It comes at a time when PMRA has undergone functional review aimed at establishing new organizational structure in line with the PMRA Act, 2019 and formal WHO global benchmarking whose outputs include an institutional development plan (IDP) and a roadmap towards achieving WHO Maturity Levels II & III of a functioning national regulatory authority.”
The U.S. Agency for International Development (USAID) through its Promoting the Quality of Medicines Plus (PQM+) program supported the development of the SP.
PMRA, MACRA set August 1 deadline for commencement of joint enforcement of traditional medicine ads regulation
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.
PMRA employees urged to embrace professional integrity at workplace
Pharmacy and Medicines Regulatory Authority (PMRA) Director General, Mphatso Kawaye, has called on members of staff at the Authority to exemplify professional ethical behaviour and say not to corruption in discharging their duties.
Kawaye made the remarks Friday in Lilongwe when he presided over a half-day corruption awareness meeting for management and staff which was jointly facilitated by the Anti-Corruption Bureau (ACB) and PMRA’s Institutional Integrity Committee (IIC).
“Our commitment is to be a corruption free zone and each member of staff has a role to play for us to achieve this status and maintain it,” he said.
The Director General further said, by establishing an institutional integrity committee the Authority had demonstrated commitment to the fight against corruption and urged members of staff to rally behind efforts of the IIC in leading the institution in the prevention of the vice.
He then pledged the PMRA Board of Directors’ and management’s support towards activities of the IIC which he said are for the good of the organisation and the country.
among other topics, participants were taken through an overview of the NACS II and mandate of IIC, overview of corruption, and workplace ethics.
PMRA established the IIC in January this year to spearhead the Authority’s efforts in the fight against corruption in line with the National Anti-Corruption Strategy (NACs II), a government policy document in the fight against corruption.
The corruption awareness meeting was part of a series of activities which the IIC is geared to implement in the 2023/24 calendar year.
PMRA, MACRA court dealers of traditional medicines, broadcasters on TCM adverts
The Pharmacy and Medicines Regulatory Authority (PMRA) and Malawi Communications Regulatory Authority (MACRA) have jointly held orientation meetings with dealers of traditional and complementary medicines (TCM) and broadcasters in Blantyre, Lilongwe and Mzuzu on advertisement and promotion of traditional medicines.
The two organisations were in Blantyre on Tuesday, Lilongwe on Thursday and Mzuzu on Friday to orient the TCM dealers and owners of broadcasting media houses on the regulation of advertisement and promotion of traditional medicines as provided for in the PMRA Act, 2019.
Section 68 (2) of the PMRA Act states that advertisement of any medicine or allied substance shall require prior screening and approval by the Authority.
Speaking when he presided over the orientation meeting in Blantyre, Allied Substances Sub-Committee Chairperson Bright Lipenga said regulation of the TCM products advertisements was aimed at ensuring that only true information is being disseminated to the public and that the public makes informed decisions based on this true information.
Said Lipenga: “Production of traditional and complementary medicines at industrial scale has resulted in the need for advertisement and promotion of the same.
“Considering that these advertisements are for specialised products and main target are vulnerable people, some of them who are in a desperate need to be helped, there is a need to regulate information being disseminated to the public.”
On his part, MACRA’s Deputy Director of Broadcasting, Kelton Masangano echoed Lipenga’s sentiments saying the Communications Act, 2016 also empowers MACRA to regulate broadcast media content including advertisements hence his organisation’s decision to work with PMRA on the enforcement of regulation of TCM products advertisements.
PMRA and MACRA in November last year signed a memorandum of understanding (MoU) on collaboration on advertisement and promotion of traditional medicines with the overall objective to jointly oversee operationalisation of the requirement of the PMRA Act to have all advertisements traditional medicines vetted before they are broadcast.
PMRA aware of concerns by medicine store operators
The Pharmacy and Medicines Regulatory Authority (PMRA) says it is aware of the concerns being raised by some medicine store owners and operators under the banner, Medicine Store Owners in Malawi.
A statement by the Authority released on Thursday says while the regulator acknowledges that the issues being raised by the medicine stores are pertinent, the same cannot be discussed now as they are before the court.
Reads the statement in part: “The Authority acknowledges that the issues being raised by the medicine store owners and operators are very pertinent. However, stakeholders and the public may wish to know that the issues in question are also before the Lilongwe High Court. Both PMRA and the medicine store operators are waiting for the court’s guidance on the same.”
The statement further said other related issues which also affect operations of medicine stores in the country are being addressed through new Regulations of the PMRA Act, 2019, which Ministry of Health is currently formulating as part of on-going efforts of improving the country’s pharmaceutical industry.