Quality medication goes beyond compliance

Cipla Africa’s viewpoint on quality medication production compliance

The discovery of sub-standard cancer medications across various sub-Saharan markets have understandably raised concerns across the healthcare landscape. CEO of Cipla Africa, Paul Miller explains what quality assurance in medicine production looks like and why manufactures should, at all costs, avoid cutting corners.

The Lancet Global Health journal recently published an explosive article titled “Substandard anticancer medications in clinical care settings and private pharmacies in sub-Saharan Africa: a systematic pharmaceutical investigation”, sending the industry into a muted frenzy.

The article alleges systemic issues in low and middle income countries (LMICs), particularly where regulatory oversight is limited. It does not name specific companies or confirm that any product was definitively falsified, many were suspected based on alleged assay failures.

Clarity from the regulatory authority

The South African Health Products Regulatory Authority (SAHPRA) confirmed that the study did not include South Africa. The seven medicines examined in the study are cisplatin, oxaliplatin, methotrexate, doxorubicin, cyclophosphamide, ifosfamide and leucovorin. These medicines were found to be substandard in certain Sub-Saharan regions. None of the brands mentioned are registered or marketed in South Africa.

In addition, SAHPRA conducted a thorough internal review and confirmed that locally registered cancer medicines with the mentioned Active Pharmaceutical Ingredients (API) are not affected or implicated.

SAHPRA also confirmed that the marketed and registered cancer medicines in South Africa meet the required quality specifications, so no sub-standard cancer medicines were detected. Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA, emphasised SAHPRA’s unwavering committed to quality, safety and efficacy, noting that their rigorous regulatory processes have borne fruit.

What defines quality medication production compliance

Although South Africa wasn’t implicated, it is critical that quality is the cornerstone of our industry’s commitment towards patients. It is also in line with our purpose of “Caring for life”. Cipla takes matters related to quality with utmost seriousness.

We have to uphold the highest level of quality standards throughout our operations as an industry.

Pharmaceutical producers, wherever they are located, need to maintain a culture of compliance and follow systematic interventions to consistently meet or exceed quality standards.

Quality isn’t just a compliance matter. It is embedded at every stage of our operations, including procurement, manufacturing, delivery and safe product disposal.

For instance, we are committed to achieving zero-defect and implement strict quality controls. This ensures that every product released from our manufacturing facility adheres to all applicable quality and regulatory standards.

Cipla ensures zero-defect production

All Cipla products undergo rigorous quality control and are manufactured in facilities that comply with global regulatory standards. These include WHO-GMP (World Health Organization Good Manufacturing Practices), US FDA (Food and Drug Administration) and EMA (European Medicines Agency). 

Locally, Cipla also complies with all SAHPRA standards, applying robust pharmacovigilance monitoring systems for all products.

In addition, a stringent process should govern:

• post-importation testing (PIT) or PITE status
• batch release protocols
• supplier qualification and audits
• ongoing stability and quality monitoring
• pharmacovigilance systems.

The ripple effects of sub-standard medicines

In sub-Saharan Africa, where some of the poorest patients live, any misstep by a medicine supplier calls into question the entire global pharmaceutical sector.

This is why at Cipla, we continue to adhere to and are committed to supporting a world class quality assurance system across the African continent through meaningful collaboration with the relevant regulatory authorities. We do this because we know that ultimately, it is the patient who pays the ultimate price. At Cipla, we’re not just mere manufacturers of life-saving medicines. As part of our ethos of “caring for life”, we make people better and we save lives.