SA government investigating the quality of TB Drugs

The Department received information suggesting that the ingredients in two fixed-drug combination products supplied by Pharmascript were not at the level stated in the label after storage.

A whistleblower provided information to the Department.

These products are:

ANTIB-4 (which is a four-in-one combination of PZA, Ethambutol, Isonazid and Rifampicin)
And EBSAR (two-in-one combination of Isoniazid and Rifampicin).
A WHO accredited laboratory at the North-West University was requested to conduct an assay of the products. A three month accelerated stability test was conducted as well as dissolution tests.

The results of the assay conducted on the stock that had been on the shelves for six months indicated that the products were compliant with the levels claimed in the label.

However, the results of the three month accelerated stability test on the same batch indicate that in the four-in-one drug (ANTIB-4), at least two of the four ingredients were found to be below the level claimed in the label.

On the two drug combination, both ingredients were found to be below the required level. Further tests are being conducted on the stability of these products.

Investigations are also underway to establish the reasons for this, including interaction between the various ingredients, the effect of packaging and / the sub-optimal formulation.

Confirmatory tests of the above results are being conducted before action can be taken by the Medicine Control Council with regard to the registration status of these two products. All TB fixed-drug-combinations on tender are also being tested.

The registration process was conducted in accordance with normal registration procedures.

The results from these parallel processes are expected by the end October 2008.

As a precautionary measure, the Department of Health has decided to withdraw all ANTIB-4 and EBSAR products that are four months and older from circulation. The supplier has agreed to provide the replacement stock at the required frequency pending the investigations.

The products were tested at 6-months shelf life and found to be acceptable.

The Department of Health is committed to take any action necessary to ensure the quality of drugs used in the country. The Department also urges TB patients to assist in stopping the spread of TB in country by continuing to adhere to treatment.

Read the full announcement here http://www.doh.gov.za/docs/pr-f.html