Malawi | Pharmacy and Medicines Regulatory Authority
Parliament expresses worry over non action on herbal medicines

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.