Pakistan is one of the few countries where medicines, which are used to treat the illness, also become euthanasia pills without the knowledge of the user. Replicating and reverse engineering could prove to be a turning point for nations but if wrongly handled, it can prove to be a fatal move. Selling counterfeit medicines and illegal trafficking not only endangers a particular set of people but puts every individual at risk. Quality assurance and regulatory bodies need to work together in order to curb the problem. Counterfeit medicines are usually substandard and may be contaminated and ultimately unsafe for use. Falsification of medicines is an underground phenomenon and hard to get accurate numbers on therefore an effective management system needs to be in place at all times. The risk is so high that any corrective controls used would be extremely futile. The use of quality standards for pharmaceutical industry should encourage organizations to move beyond the use of checklists and physical checks, to take it up a notch quality should be embedded in processes instead of additional testing or inspections. While compliance with FDA and ISO standards is a necessity, the system should support controls that prevent the damage from occurring. An effective quality management system should offer several core features to promote the adoption of a customer-focused culture, employee involvement, and other QMS principles in highly regulated industries.

Pharmaceutical companies face an overwhelming pressure to adapt to changing market conditions. From coping up with medical technologies to enabling pharmaceutical customers to engage deeply with their healthcare providers in order to create effective and safe treatment plans. Advancements in the life sciences field have created an increasing amount of possibilities for patients to receive personalized care in order to make it innovative. The use of big data on patient populations can reveal emerging opportunities to strengthen patient engagement. Every employee has an impact on the company’s ability to deliver a quality product, from research scientists to janitorial staff. Quality isn’t a checklist but rather a core component of the culture which should be embedded and instilled in every stakeholder of the organization. To involve employees in improvement, practical training should be imparted on each level to make clear channels for communicating opportunities for efficient use of resources. Process-centred Quality Management Systems are vital for regulatory compliance. An efficient PQMS software provides transparency throughout the product lifecycle which further sets clear guidelines for supply chain partners. An organization can only optimize products and performance by measuring it as it helps in understanding the results to know what needs to be monitored and controlled. A strategic approach to leadership allows a company to become more forward-thinking. Decisions are made based on accurate documentation for risk management, statistical input and clear quality objectives with defined roadmaps.

Although healthcare is a serious issue yet the quality of medicines is not ensured in most of the countries. Pakistan being one of the unfortunate countries where the selling of fake medicines hasn’t stopped till date, the government and regulatory bodies need to step in and do something substantial about it. The problem should have been nipped in the bud but with all the negligence it has blown out of proportion. Reportedly, government hospitals continue to purchase substandard medicines from unregistered pharmaceutical companies without even getting them tested from laboratories. Breach of health standards should be counted as heinous crime and be given a status of a murder. The lives of millions of poor patients in these government hospitals are endangered due to negligent behaviour of unlicensed manufacturers and lack of efficiency in regulatory bodies. To tackle the problem of counterfeit drugs, the Drug Regulatory Authority of Pakistan in coordination with provincial health departments need to enforce policies from grass root level to eradicate the risks it creates for the patients. They should ensure the easy accessibility and safe quality of drugs. Quality Management Systems need to in place to prevent the problem, in a digital era the use of smart scanning systems to prevent all of the unregistered drugs from entering the market would be a stepping stone for now.