Supply chain risk in pharmaceutical industry

Author: Amna Ahmad

Pakistan has about 759 pharmaceutical manufacturing units, including those run by 25 multinational companies present in the country. The Pakistani pharmaceutical industry meets about 70 percent of the state’s demand for medicine. Although the pharmaceutical and healthcare sectors in Pakistan are expanding and developing rapidly, about half of the population does not have access to modern medicines.

The pharmaceutical industry faces manufacturing risks, such as mixing raw inputs that are incorrect, cross-contamination by manufacturing more than one drug in the same facility, or incorrect labelling of the finished product; retailer risks including incorrect temperature control and handling; transportation risks caused by improper handling, improper temperature control, use of improper charging mode; storage risks, such as the use of improper temperature controls, improper handling in the warehouse and mixing of products with raw materials.

Counterfeit and converted medicines can erode consumer confidence in a particular brand or the safety of a particular product category

The pharmaceutical industry today relies on an extensive network of subcontractors to produce medicines. Pharmaceutical manufacturers cannot easily move from an unreliable third party to another because the pharmaceutical industry takes a long time to develop new relationships and manufacturing capacity. Any new relationship must also meet Food and Drug Administration facility. Building new manufacturing capacity is not cheap, and many large pharmaceutical companies have little money to invest in new devices.

Pharmaceutical manufacturers are also subject to regulatory scrutiny to ensure the quality and safety of their products, as well as compliance with environmental protection, labour laws, tax laws and a number of other issues. These requirements can make it difficult for companies to quickly adapt to supply chain disordering. Counterfeit medicines (including diverted, adulterated and bargained drugs) pose a lot of risks to the pharmaceutical supply chain. Counterfeit drugs pose an immediate danger to consumers; these products are not properly handled and stored, or are adulterated with hazardous substances. For example, insulin should be stored at a specific temperature or will not work properly. Counterfeit and diverted medicines also pose a greater public health risk by failing to act as intended, or worse, increasing drug resistance.

Counterfeit and converted medicines can erode consumer confidence in a particular brand or the safety of a particular product category. Business executives often claim that weather is the main cause of supply chain disruption. When severe weather events, such as droughts, storms, fires and floods become more common, supply chain disruptions will increase. New investigative drugs can be put on hold to further access quality of the investigative product, and ensure patient safety before administering the new drug to humans if significant safety concerns arise.

When requests are in place in clinical suspensions, the most common deficiencies leading to these pending cases are product quality problems or facility compliance, followed by clinical problems. In the digital age, drug makers are facing cyber risks. These risks can have unpredictable consequences for the reliability and safety of the pharmaceutical supply chain.

Identifying and preventing risks in pharmaceutical companies can not only improve processes, increase productivity and cut business risks, but will also help health systems meet supply chain management goals, accessibility, quality and affordability.

The writer is a freelance columnist

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