Falsified and substandard medicines have become a worldwide menace in the recent past. In January 2012, 100 people died after receiving substandard medication during treatment in Lahore’s Punjab Institute of Cardiology. Eight years earlier in 2008, more than half the antibiotics sampled in Egypt, Jordan, Lebanon and Saudi Arabia were found to be substandard. In 39 sub-Saharan countries in 2013, 122, 350 children under the age of 5 years died due to poor quality anti-malarial medication.

Many governments such as the United States, Nigeria, Myanmar and Liberia are reacting to this threat by working in partnership with others to ensure falsified and substandard medicines are removed from the supply chain.

Interpol does not have precise figures for the scale of the problem but has indicated that around 30% of the market includes falsified medical products (including medicines and medical devices and equipment) in several countries in Asia, Africa and Latin America. In counties where malaria is prevalent antimalarial tablets are particularly prone to falsification given the weak enforcement processes in these regions.

In 2008, the WHO conducted a study which demonstrated that 64% of antimalarial drugs in circulation in Nigeria were either substandard or falsified. Flooding the market with falsified medicines poses are very serious risk to public health and a challenge to the donor organisations and host countries who are trying to fight the diseases.

What are falsified or substandard medicines?

The EMA describes falsified medicines as “fake medicines that pass themselves off as real, authorised medicines”. Many of these medicines contain poor-quality ingredients, the wrong ingredients of the wrong dosage. Falsified medicines differ from substandard medicines which the WHO defines as “out of specification” products “These are authorised medicinal products that fail to meet either their quality standards or their specifications or both”.

What went wrong?

In the early 2000s, attention was focused on ensuring people in developing countries had access to affordable medicine and there was far less focus on the quality of the drugs. As a result, billions of dollars in aid may have been compromised. Initiatives such as UNITAID, the U.S. President’s Emergency Plan for Aids Relief, and The Global Fund to Fight Aids, Tuberculosis and Malaria are the key organisations where falsified medicines are suspected to have been supplied.

In recent years, access to quality assured medication has taken priority in the interests of public health. Governments are committed to this in the Sustainable Development Goals, in ensuring everyone has “access to quality essential health care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.” In some of the poorest and most vulnerable countries, however, strained health systems and lack of resources to test and detect falsified and substandard pharmaceutical products are undermining these efforts. This poses a serious risk to both patients and to public health.

The risks

Poor-quality medicines can result in treatment failures and, in some cases, contribute to drug-resistance, which can make patients more sick or even result in death. All global strategies for the control, elimination and eradication of AIDS, tuberculosis, malaria and neglected tropical diseases, as well as other communicable diseases rely on sustainable access to affordable, quality-assured medicines. Many low and middle-income countries, often have weak or no medicines regulations and testing capacity, and this lack of regulatory oversight allows the proliferation of falsified and substandard medicines.

Identifying the problem

If countries are unable to test pharmaceutical products, they cannot identify quality medicines from substandard medicines or uphold international standards. This undermines any subsequent regulatory, policy or law enforcement efforts to address both falsified and substandard medication in the supply chain. The private sector then loses confidence to invest in costlier processes and facilities to meet regulatory standards, particularly if they are being undercut by manufacturers producing and selling cheaper, but poorer quality products.
The Promoting the Quality of Drugs (PQM) program is addressing these challenges by collaborating with countries to build capacity of medicines regulatory authorities, strengthen testing capability of national quality control laboratories and provide technical assistance to manufacturers that supply local and international markets to ensure sustainable production of quality-assured essential medicines. PQM assists countries in setting up medicines quality assurance systems that make it easier for authorities to identify and remove poor-quality medicines from the market.