Johannesburg - JSE-listed pharmaceutical firms have welcomed the Medicines Control Council’s (MCC) plans to reduce the backlogs in the registration of medicines and see roughly 100 new generic medicines on the South African market next year.
The MCC last week announced that plans would involve two phases, the first of which is estimated would be concluded by December.
The industry estimated that this would release about 100 new generic medicines on the market, increasing a patient’s choice of access to treatment.
Pharmaceutical firms have to register their drugs with the MCC after being licensed to produce them before selling.
The National Association of Pharmaceutical Manufacturers (NAPM) said for many years the pharmaceutical industry, and in particular generic medicine manufacturers, had complained about the time it took for the MCC to approve a generic medicine.
“The delay of around five years is detrimental to both the industry and patients in South Africa because it denies access to more affordable medicines and dissuades companies from further investment in the country,” NAPM said.
Cost of living
With the high unemployment rate and slowing growth, consumers are battling with the high cost of living and seek cheaper drug options. A review of the South African Pharmaceutical landscape by ImpactRx, found that the industry was valued at R39.3 billion, with generic medicines gaining market share.
Aspen Pharmacare and Adcock Ingram said the ruling was long overdue and they welcomed the new development that would also benefit both the consumer and the industry.
Stavros Nicolaou, a senior executive at Aspen, said the ruling would make the industry more efficient and prioritise important issues.
“The delay which has resulted to five years before the generic medicine was approved was because of a mismatch between resources and submissions. The number of submissions was increasing about 400 percent and this was not matched by the resources available to MCC to handle those submissions,” he added.
Adcock Ingram’s corporate affairs and investor relations manager, Vicki St Quintin, welcomed the initiative Vivian Frittelli, the chief executive of Napm, said the action by the MCC boded well for the future.
The industry task group said dossiers under review and within the backlog could be grouped in various stages of finalisation by the MCC.
Dossiers within the pre-registration stage had been identified as a priority.
Phase 1 for pre-registration would involve identified post-screening submissions that had not yet been allocated for evaluation and for duplicate applications, the multiple applications guideline would be applied, the MCC said.
The MCC said in Phase 2, all applicants with products pending would receive information pertaining to their products via a letter. Applicants would then be required to indicate the current pharmaceutical, analytical and clinical status of the products listed according to their own records; the company’s list of priority products and said duplicate applications for which the multiple applications guideline would be applicable.
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