The pharmaceutical industry is one of the most sensitive industries affecting human life. Safety, efficacy, and toxicity are the prime concerns for medicines and demand rigorous regulatory and industrial inspection. But the pharmaceutical industry is far from meeting the desired state of product quality. The pharmaceutical industry has a little secret: Even as it invents futuristic new drugs, “its manufacturing techniques lag far behind those of potato-chip and laundry-soap makers.”
The above statement might be shocking to the consumers, but for the most part, it was not surprising to the manufacturers as well as to the regulatory bodies. Industry and regulatory bodies have been working together to improve the situation. In August 2002, the Food and Drug Administration initiated “Pharmaceutical cGMP for the 21st century—A Risk Based Approach,” which not only started to modernize regulations on medicine, but also inspired industries to implement innovative ideas like Quality-by-Design (QbD) in manufacturing. Academia also joined in the venture, and scientific societies such as the American Association of Pharmaceutical Scientists (AAPS) became one of the scientific platforms for sharing ideas, views, and thoughts. ICH guidelines have been published for Pharmaceutical Development (ICH Q8(R2)), Quality Risk Management (ICH Q9), and Pharmaceutical Quality System (ICH Q10). Certainly, the concerns have been raised and consumers in developed countries should be hopeful to get benefits on that, but in developing countries, consumers have yet to hear a knock on their door.
In most developing countries, medicines are manufactured under the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Although the goal was to “promote access to medicine for all,” the question should be: What would be the quality of those accessible medicines? In these areas, any new medicines may be manufactured as generic without infringing the patent law, which not only increases the price competition but also shifts the focus of the drug companies from research and development sector to the production sector. Each and every drug company competes to launch more and more products to grab the market. In a small developing country such as Bangladesh, the top pharmaceutical companies have 500–600 products in their product line. The question needs to be asked again: How many of them are meeting the quality standards? Certainly, quantity has gained the attention, not quality. Ultimately, consumers are being affected by poor quality of medicines.
When we talk about the global objective of AAPS or any other scientific platform, what role they can play to improve this situation?