The Medicines Control Council (MCC) is restricting public access to affordable medicines by delaying their registration for years, generic drug companies charged this week.
South Africa' s third-largest generic manufacturer, Cipla Medpro, supported by other pharmaceutical companies, has instructed its attorneys to take action.
Cipla Medpro has more than 60 products waiting for registration and a large number of them had met the MCC's requirements for safety and efficacy, the company contends. It said one of the drugs was a generic of nevirapine, a key Aids drug required for the government's treatment programme.
The MCC approved the drug in April 2003, but had still not authorised the package insert, thereby preventing registration. The approval of package inserts was the final step before registration - and this was holding up more than half the products.
Cipla Medpro's chief executive Jerome Smith said: Such approval should really be no more than an administrative formality.
He added that Cipla had instructed its attorneys to take all and any steps as may be necessary to address the situation because it had been unable to resolve the problem through discussion, negotiation and co-operation with the MCC and the Registrar of Medicines [Precious Matsoso].
Another manufacturer, who asked not to be identified, released figures showing that the registration time for its products had more than doubled since 1998.
At that time, it took an average of 15 months to register 12 of its products. By 2002 this had risen to 41 months for 13 products.
Another manufacturer said that, on average, it took about 39 months to register a product.
MCC chairman Professor Peter Eagles responded to the complaints, saying: The MCC is committed to registering drugs in as short a time as possible.
But an executive of another generic company said of the registration delays: There's an absolute deadlock. If you say something against them, you're put at the bottom of the pile.
You can get two, three or four companies that are inefficient, but it's unlikely that 120 companies will all be inefficient at once.
He also claimed that the MCC was delaying the registration of new chemical entities which could treat conditions where there aren't currently drugs to treat them.
Dr Mzi Mabenge, the executive director of the National Association of Pharmaceutical Manufacturers, said he was against taking legal action, as the MCC was looking at a way to speed up the package insert problems by authorising package insert templates.
Although Mabenge advocated a conciliatory approach to the council in the monthly meetings of the Industry Task Group - saying that members largely supported this approach - other members maintained that it had failed.
Cipla Medpro medical adviser Dr Skhumbuzo Ngozwana said: The executive director has, in the past, repeatedly tried to set up meetings with the MCC, and has repeatedly been rebuffed.
Ngozwana proposed to other association members that they ask the Health Ministry or presidency to intervene - since the delays conflicted with the government's support for generic drug use.
Vicki Ehrich, chief operating officer of the Pharmaceutical Manufacturers' Association, which represents the patent-protected industry, declined to comment on the matter. (Source: Claire Keeton and Adele Shevel, Sunday Times, 18 April 2004)
Medicines Control Council of South Africa