molekula 500

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.

The whole 11 pages article is available for download here.

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.

The whole 11 pages article is available for download here.

Featured Events

baen94 banner 150x150
150 x 150socila
150x150 cold chain
150x150 lsdata17
150 x 150 cell
ivd 150x150
150 x 150
immune profiling congress 2016 150x150
bals195 banner 150x150
bals192 banner 150x150