Role of Regulatory Authorities in Marketing Regulation of Drugs in India
Approval of the drug product for import, manufacturing and
marketing in India, its demonstration for safety and efficacy in humans is
essential. The Rules 122A, 122B and 122D, 122 DA, 122DAA, 122E and Appendix I,
IA and VI of Schedule Y of the Drugs & Cosmetics Act, 1945, describes the
information/data required for approval of clinical trial and/or to import,
manufacture, or market any new drug in the country. However, the requirements
for approval of clinical trials and new drugs may vary depending on the nature
of new drugs.
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Government
oversight of the pharmaceutical industry is usually classified into preapproval
and post-approval categories. Most of the therapeutically significant compounds
marketed today are the subject of new drug applications (NDAs) and abbreviated
new drug applications (ANDAs). Preapproval activities, based on these detailed
applications, are used to assure the drug is safe and effective before
marketing.
After the drug is approved and marketed, periodic unannounced
inspections of drug production and control facilities by FDA’s field
investigators and analysts are conducted. The FDA uses different mechanisms for
assuring that firms adhere to the terms and conditions of approval described in
the application and that the drug is manufactured in a consistent and
controlled manner. The Federal Food drug and Cosmetic Act (FD&C Act)
provides legal authority for inspection. These regulations, Current Good
Manufacturing Practice for Finished Pharmaceuticals, are contained in Part 211
of Title 21 of the U.S. Code of Federal Regulations. This regulation contains
requirements for Organization and Personnel; Buildings and Facilities;
Equipment; Components, Containers, and Closures; Production and Process
Control; Packaging and Labeling; Distribution; Laboratory; and Reports and
Records.
The regulations are general
enough to be applied to a wide variety of dosage form drugs from topical
ointments and creams to sterile injectables and ophthalmics. FDA investigators
often use additional information from a variety of market surveillance systems
to assist them in identifying a manufacturing or control problem. These
laboratories confirm suspected chemical, physical, and microbiological problems
with pharmaceuticals; verify and develop analytical methods; and conduct
research. This system of regulation
has grown with the pharmaceutical industry through many crises and challenges.
The FDA welcomes dialogue with other regulatory bodies, industry organizations,
Congress, and the public to improve the efficiency of its regulatory and
administrative processes.
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