New law to curb unapproved medicines

MASERU – PARLIAMENT is working on a new law that will ban the advertising, sale and distribution of unapproved medicines in Lesotho.

Health Minister Selibe Mochoboroane distributed the statement of objects and reasons of the Medicines Regulation Authority Bill in parliament on Monday.

If passed into law, the Bill will curb the advertising on local radio stations of traditional herbs that are said to cure all sorts of ailments.

It will also see several herbal medicines sold both in the streets and in some chemists subjected to scientific scrutiny before they are sold.

The Bill seeks to establish a Medicines Regulation Authority which will be a statutory body responsible for regulation and control of medicines and medical devices.

The Authority shall regulate the manufacture, sale and use of medical products and ensure that such products meet the required standards of safety, efficacy and quality thus protecting and promoting public health.

The Authority shall also ensure the appropriateness of the information provided to the public and health professionals concerning medical products.

The Bill provides for the establishment of a Board which shall be the governing body of the Authority.

The functions of the Board, among others, shall be to advise the health minister on matters relating to medical products and declare and exempt any article as a medical product.

“It shall be an offence to manufacture, sell, distribute or circulate in the country a medical product which is not registered,” the Bill reads.

“The sale and use of unregistered medical products shall also be prohibited except where it is allowed by the Board,” it reads.

The Board may authorise the sale of unregistered medical products for a specified purpose and only for a specified period.

The Bill also provides for licensing of people handling medical products depending on their qualifications.

The premises on which the medical product is manufactured, sold or distributed will also be licensed and has to comply with the required standards.

It will be an offence to import and export medical products unless a person is licensed by the Authority.

The medical product shall also be registered and comply with the Board’s requirements for quality, efficiency and safety.

Also, the container or package in which the medical product is contained in should bear a label written in Sesotho and English and a certificate should be issued by the Board.

The Bill also provides for the scheduling of registered medical products by set international standards.

The purpose of classification is to regulate who utilises, acquires, manufactures, sells, distributes, imports and dispenses medical products to ensure the safety of the public.

Under the Bill, “it is an offence to have a medical product which is not in the public interest”.

Where a product already in the market is considered not fit for consumption, the Authority shall prohibit its sale, recall the product from the market and return the product to the manufacturer or dispose of it.

The Bill provides for the appointment of inspectors who will determine that all requirements and conditions for licensing of the personnel and premises are complied with.

Nkheli Liphoto