SA has a huge backlog of medicines awaiting registration - here's how that can hit your pocket


Global generic pharmaceutical manufacturer Cipla is excited to see progress made at the South African Health Products Regulatory Authority in trying to clear a huge backlog of applications to have medicines registered, Paul Miller, CEO of Cipla Medpro, Cipla's South African subsidiary, told Fin24 on Thursday.

SAHPRA was launched in February 2018, replacing the Medicines Control Council (MCC) and inheriting a backlog of approximately 16 000 Category A medicine applications for both new registrations and variations.

According to Miller, Cipla has "a significant number of dossiers across about seven therapy areas waiting for approval. These range from treatments related to cancer to that of diabetes and depression."

Miller added: "There is a lot of pent up demand and we are hopeful that, as more of our applications are approved, a number of our products would come onto the SA market for the first time.

"There is a lot of innovation among these products."

He said that if these generic products are launched in SA, prices could fall by up to 60% for consumers.

Greater affordability

"So, affordability will become that much greater and the number of patients that can get access to these medicines would increase - both in the private and public sector," he said.

Originating from India, Cipla has increased its footprint to over 100 countries during the past 80 years. Its portfolio includes over 1 000 products.   

Cipla's global CEO, Umang Vohra, told Fin24 the company treats both India and SA as a home market.

"In both we have taken on the digital approach seriously," he told Fin24. Cipla acquired a 30% stake in SA digital health company Brandmed for R65m in April this year.

"We believe the movement in the world is from illness to wellness. People want to be more proactive in their approach to healthcare," said Vohra.

"Tracking measures allow health care systems to obtain the best outcomes."

OTC expansion

Miller says Cipla's acquisition of Durban-based over-the-counter (OTC) pharmaceutical manufacturer and distributor Mirren last year will enable growth in its OTC medicines footprint.

The capacity of Mirren's manufacturing plant in Durban has already been expanded by 70%.

Vohra said currently Cipla supplies more than a million patients with HIV/Aids medication in SA each month. There is also an effort being made to look at the possibility of introducing injectable products.


Cipla has a further interest in research regarding antimicrobial resistance. This relates to the ability of a microbe to resist the effects of medication that once could successfully treat the microbe.

"We answered the call for HIV treatment several years back and now we are trying to see if Cipla can step up in the area of antimicrobial resistance treatment too. It is a growing problem in the developed as well as developing world," said Vohra.


He added that Cipla would like to replicate the success it has had in SA also in the rest of Africa. Currently Africa accounts for 25% of Cipla's global revenue.

"We want to be innovators for the good of society and partner with governments to make health outcomes better than in the past," said Vohra.

As for the SA governments plans for National Health Insurance (NHI), Miller said Cipla looks forward to engaging with the SA government to understand what it proposes going forward.

"Cipla welcomes any attempt to make sure there is universal coverage for every South African," said Miller.

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