Asian Pacific Journal of Health Sciences

Yazarlar: Poonam Yadav, Kavita Bahmani, Neelam Pawar, Ankita Sharma

Konular:-

Anahtar Kelimeler:Central Drugs Standard Control Organization approved drugs,Common technical document filing,Drug approval process,Regulatory bodies

Özet: Regulatory authorities and organizations play a crucial part in responding to the requirements of regulatory proceedings related to drug development in a region. Each country has its owned regulatory body, that is, liable for implementing laws and regulations, as well as offering guidance to control the evolution, grant/licensing, and registration of drugs. The Indian pharmaceutical industry is one of the most organized industries in the country. Knowing the scenario of regulatory bodies plays a vital importance because of the fast and continuous change and because of the pressure placed on regulators to maintain a steady availability of quality medicines at an economical price to the Indian masses. Current article focuses on the drug approval process and regulatory requirements according to the Central Drugs Standard Control Organization.

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