It's true that the disaster will make the people to wake up and review the accepted way of doing things. It holds true with the question of drug safety drug quality too.
Sulphanilamide is the first of new generation of wonder drugs. Sulphanilamide Elixir disaster in 1937 in United States killed 107 people, most of them are children. This tragedy alerted US authorities to the concept that the drugs needed to be proven to be safe. The need for drugs to be proven to be "Effective" would, remarkably, has to wait for another 50 years. In 1963 USFDA introduced Good Manufacturing Practices.
The Davenport disaster (Contaminated Intra Venous fluids) became the subject of a British Parliamentary Enquiry in 1972, which killed 6 people. It was not until the marketing in 1972 in the US of contaminated IV fluids manufactured by, two large multinational manufacturers, that the USFDA realized the 1963 GMPs were not of sufficient rigor to prevent quality mishaps occurring in pharmaceuticals manufacturing and testing &embarked on a revision of the GMPs resulting in the 1976 GMP regulations, which are still virtually unchanged today (2005).
GMPs are in effect in over 100 countries, either through national codes, adherence to regional codes or adoption of the WHO code. Whether they are stated to be regulations, as in Japan, Korea & US; or directives, as in the European Union, or Guides as in the United Kingdom, or Codes as in Australia, the intent of the authorities is the GMPs are strictly followed to consis-tently assure pharmaceutical product quality. Japan, Korea & the United States are the only countries where the GMPs have been enshrined in law as legal regulations.
GMPs are a system for ensuring that the products are consistently produced and controlled according to the quality standards. GMPs aims to minimize the risks (contaminations, mix-ups, errors) in Manufacturing, Packaging, Testing, Labeling, Distribution, Importing of drugs, Cosmetics, Medical devices, Blood & Blood products, Foods and the like. All GMP codes (guides, directions, regulations- call it what you will) are concern with Drug quality, purity, safety, identity, and strength. The top 10 cGMP(USFDA) areas of compliance are Quality Assurance, Validations, Laboratory Controls, Change Controls, Documentation, Stability, Standard Operating Procedures, Process Controls, Buildings & Packaging.
INSPECTION SEVERITY
The written word alone is not sufficient to ensure adequate compliance with GMP requirements. Compliance depends on the adequacy of the code of GMP-the written word- and the rigor of the inspections that are performed by national health authorities. If these two elements are combined, a table could be generated signifying which countries have in force the severest GMPs. Such a table would likely look like this.
United States is generally perceived by industry to be the toughest inspection agency due to its inflexibility in Interpretation of the regulations, the British Common Wealth countries rank second due to their hiring practices for inspectors.
United States inspectors, on joining the agency typically don't have any background in Health care Manufacturing & Food Industries where they are entirely trained on the job. Whereas, inspectors in the British common wealth countries are hired and inspect Pharmaceutical manufacturing facilities unless they have 5- 10 years of management experience within the Industry. Hence, not only these inspectors know what skeletons look like, they can understand where skeletons, if they exist, are most likely buried.
American companies inspected by the British MHRA would place the British at the top of above ranking while European & Asian companies place Americans at the top. Likewise a British company, with years of compliance history to British GMPs will fail an US FDA inspection.
India occupying a key place in the global pharma industry, should improve it's inspection standards and be in a position to be among the top three severest inspection agencies.u
(The author is director, Cooperative Education, Department- Pharma & Health Sciences, Acharya Aryabhata University, Hyderabad)