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Bitter pill to slowly swallow

Pharmaceutical companies are again becoming frustrated by South Africa’s Medicines Control Council’s (MCC’s) slow pace in approving dossiers despite previous attempts to help the regulatory body reduce its backlog. Listed groups Adcock Ingram Holdings [JSE:AIP] and Cipla Medpro South Africa [JSE:CMP] recently said each had more than 200 dossiers awaiting registration by the MCC. The delays could potentially upset their organic medicines growth plans.

“Companies are getting increasingly frustrated. That includes both generic- and research-based companies,” says Val Beaumont, executive director of industry association Innovative Medicines South Africa. “An inefficient regulatory system has a negative commercial impact on companies.”

Beaumont says despite all the effort special projects have put into clearing the backlog, the increased time it’s taking to get registrations accepted is resulting in the ongoing accumulation of dossiers in the system. Accordingly, more money was pumped into the MCC and a task team set up in 2009 to help it ease its backlog and improve operations. However, very little seems to have come out of that intervention.

In general, registering medicines takes a long time worldwide. On average it takes 10 years to bring a product from discovery to the point at which it can be submitted for registration. Anti-retroviral HIV/Aids drugs are often more quickly approved, but other submissions average around three years. Beaumont says adding another three years to the development stage leaves little time left of the 20-year patent life of a product, meaning manufacturers are only left with seven years to develop generic versions of the medicine.

MCC registrar Mandisa Hela says the delays are structural. She says the MCC suffers from insufficient in-house capacity to deal speedily with registrations and has to rely on global scientific studies when registering medicines.

Both Adcock and Cipla have ambitious plans to tap into the growing generics market. In its last annual report, Cipla said at year-end 2010 SA’s generics market share was just over 58%, far lower than other markets where generics usage is more than 70%. Cipla hopes to leverage its relationship with Cipla India to grow its generic product range.

Adcock – which recently forged partnerships with multinational groups such as Lilly, Roche, Novartis and MSD – has started producing generics of some of its partners’ dossiers. However, those local firms are at the mercy of the MCC’s laggard approval to put the drugs into the market.
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