EXPLANATOR | Comments from Sisulu meds: What does the law say about importing medicines?

  • South Africa’s Health Products Regulatory Authority speaks with Tourism Minister Lindiwe Sisulu after reports she brought medicine from Russia for ANC Deputy General Secretary Jessie Duarte.
  • Duarte died Sunday after a battle with cancer.
  • News24 examined the laws in place to control the importation of drugs.

The Health Products Regulatory Authority SA (Saphra) approached the office of Tourism Minister Lindiwe Sisulu for clarification after she reportedly said on Sunday she had brought medicine from Russia for anti-ANC stalwart Jessie Duarte.

Duarte died of cancer earlier today.

TimesLIVE reported that Sisulu was speaking at Duarte’s home at the Johannesburg Observatory at the time and that she said she had arrived with the medication too late in South Africa.

But when she spoke to Weekend Argus, she said the media had misinterpreted his words outside Duarte’s house and the drugs were all “in my head”.

“The medicine is in my head, not in my pocket.”

News24 looked at the rules in place to control the import and export of drugs.

What does the law say about bringing drugs into the country?

In a statement on Wednesday, Sahpra CEO Boitumelo Semete said he took note of the many press reports on the issue and was therefore engaging with the minister.

Semete said there are strict rules for importing and exporting drugs and only a company registered in South Africa and authorized by Sahpra can import drugs.

Semete added that Sahpra has a mechanism in place that allows access to specific quantities of a product for a specific patient if a treating oncologist needs to obtain an unregistered drug for a patient.

Neil Kirby, head of healthcare and life sciences at Werksmans Attorneys, told News24 that while the circumstances surrounding Sisulu’s comments were unclear, the importation of drugs was strictly controlled in accordance with promulgated regulations. under the Medicines and Related Substances Act 1965.

“Specifically, Rule 6, which requires a person importing drugs or scheduled substances to have a license to do so,” Kirby added.

He said:

A person may, however, import drugs or scheduled substances for personal use within the meaning of Regulation 8, but only under certain conditions.

Conditions include Schedule 3, 4 or 5 substances whose quantity does not exceed the quantity required for a six-month period of use, or Schedule 6 substances whose quantity does not exceed the quantity required for a period of 30 days.

Times 3 to 6 drugs are drugs that are only available on prescription.

Kirby said a person must be in possession of the original prescription for such a substance, a certified copy of the prescription, or a certificate or letter issued by the person who prescribed and delivered the substance.


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