Consumers and patients must wait, and suffer, for the availability of quality pharmaceutical products such as tablet/capsule as well as their genuine and affordable prices. The reason may surprise you!

It is important to note that at present availability of the pharmaceutical products such as tablet and capsule is heavily regulated, more accurately controlled, by the regulatory authorities worldwide. Manufacturers and suppliers have to follow extensive suites of protocols (national and/or international) to get their products approved for marketing. These protocols are often described by different names such as regulations, guidelines, standards etc. The manufacturers have to be in compliance with these protocols literally to the letter, which are mostly arbitrary in nature. Thus, in practical terms contrary to popular belief, there is limited or no room for deviation, simplification and/or innovation from these protocols at least from the manufacturers’ side.
In simple terms, these protocols may be considered as formats for data/results presentations, may these be for the product development or manufacturing – promoted as regulatory science. However, unfortunately, these are administrative and procedural requirements, not the practice and/or requirement of the science. The underlying “science” remains based on traditional practices and assumptions, more accurately may be considered as rituals. Therefore, with the passage of time and the introduction of extensive sets of standards and requirements, the burden of adhering to these regulatory formats (“guidelines”) has become increasingly frustrating, time consuming and financially challenging for the both, authorities and the manufacturers, without any added value to the product quality and/or benefit to the users.
In addressing these challenges, manufacturer bashing approaches (implied or explicit) are common and fashionable, often criticizing lack of their integrity and competencies. This approach certainly appears to be a deviation away from the regulatory mandate or requirements which is establishing and monitoring quality of the products and not that of assessing and criticizing manufacturing ability or capacity. Regulators’ and their associates should be able to establish if the manufactured products, at the consuming stage, are of the required quality, and by extension, safe and efficacious. However, they can’t at present – thus deviation from their mandated objective!
There are two reasons for this regulatory shortcoming: (1) Regulatory authorities have never defined required quality, and its associated parameter, for the product assessments. In fact, it could be argued that it is unknown to them. (2) Authorities require and enforce a large array of flawed product testing requirements for compliance purposes without their validations and relevance. As these requirements lack scientific credibility and validity, anybody, not just the manufacturers, would have difficulty in meeting or will be unable to meet the current regulatory requirements and expectations. For a more technical description of this aspect please consider viewing the links provided below.
Therefore, there is a clear need for re-evaluating the practice of setting regulatory standards and requirements starting with the definition of a quality product followed by the use of scientifically/GMP valid instruments and procedures. Otherwise, it is impossible for the manufacturers to produce quality products, and for the regulators developing and implementing appropriate guidelines and standards for product evaluation.

Some suggestions are provided to address these issues, and it is sincerely hoped that authorities will give consideration to these thoughts.

For further reading:
(1) http://www.drug-dissolution-testing.com/?p=3022
(2) http://www.drug-dissolution-testing.com/?p=3007
(3) http://www.drug-dissolution-testing.com/?p=2956
(4) http://www.drug-dissolution-testing.com/?p=3037
(5) http://www.drug-dissolution-testing.com/?p=2922

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