Reuters reports unregulated Chinese chemical companies are making active pharmaceutical ingredients (API). API producers and brokers indicate sub-standard drug ingredients are entering the global supply chain.
Europe and US markets are relatively safe because of well-resourced regulatory authorities and controls but the situation is different in places like Africa, where there are a lot of local medicine manufacturers who use API’s from China. About 70-80% of all active drug ingredients, the biologically active component in medicines, originate from China and India. The effects of faulty active ingredients or the wrong dose can lead to the emergence of drug-resistant strains of dangerous diseases, such as malaria, cholera, pneumonia and tuberculosis, etc placing extra pressure on our already dysfunctional public health system.
According to a recent story by a Pakistani activist blog, factors that help in counterfeiting of medicines are:
- Lack of political will and commitment
- Lack of appropriate drug legislation.
- Absence of or weak drug regulation.
- Weak enforcement and penal sanctions.
- Corruption and conflict of interest.
- Demand exceeding supply.
- High costs of medicines.
- Insufficient cooperation between stakeholders.
- Lack of regulation by exporting countries and within free trade zones.
- Trade through several intermediaries.
- Impact on public health (Safety, Efficacy and Quality of drugs)
This developing trend raises fundamental questions as to the moves Ghana’s local pharmaceutical companies and regulatory authorities spearheaded by the FDB, Standards board, and CEP’s are undertaking to ensure quality across board from our local manufacturers to ensure the integrity and safety of drugs. Private end-user technology initiatives like mPedigree being pioneered by the likes of Bright Simons are very good steps at addressing this menace. For it to work effectively however, the involvement of all these major stakeholders is needed to ensure the integrity of the certification system during the manufacturing and transportation stages remains sacrosanct. A legal framework could also be put in place which requires all end-user medications – both locally manufactured and imported drugs be subject to third party verification checks by such a system.