Veterinarian in Society

VETERINARIANS DRUG REGULATORY AUTHORITIES

• At present, the Indian pharmaceutical sector enjoys the status of being the largest amongst the developing nations.
• The Indian pharmaceutical industry is one of the world’s largest ranking, fourth in terms of volume and thirteenth in terms of value, in the global pharmaceutical market.
• The main objective of regulations and good practices is the protection of public health. Regulators and the general public are more and more sensitive to safety issues, leading to more stringent ways of considering the benefit risk ratio of new products.
• Indian pharmaceutical sector enjoys the status of being the largest amongst the developing nations. The Indian pharmaceutical industry is one of the world’s largest ranking, fourth in terms of volume and thirteenth in terms of value, in the global pharmaceutical market.
• The main objective of regulations and good practices is the protection of public health. Regulators and the general public are more and more sensitive to safety issues, leading to more stringent ways of considering the benefit risk ratio of new products. Presently, the following Acts and Rules regulate the manufacture, export and Clinical research of Drugs and Cosmetics in India:
  • Drugs and Cosmetics Act,1940
  • Drugs and Cosmetics Rules,1945
  • Pharmacy Act,1948
  • Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954
  • Narcotic Drugs and Psychotropic Substances Act, 1985
  • Medicinal and Toilet Preparations (Excise Duties) Act,1955
  • Drugs (Price Control) order, 1955 (under the Essential Commodities Act.)
• There are some other laws which have a bearing on manufacture, distribution and sale of Drugs and Cosmetic in India .The important ones are:
  • Industries (Development and Regulation) Act, 1951
  • Trade and Merchandise Marks Act,1958
  • Indian Patents and Designs Act,1970
  • Factories Act,1948
• Following are the regulatory and administrative authorities in India for drugs (medicines)
  • WHO (World Health Organization)
  • ICH (International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use)
  • CFR (Code of Federal Regulation)
  • FDA (Food and Drug Administration)
  • ICMR (Indian Council of Medical Research)
  • CDSCO(Central Drugs Standard Control Organization)
  • DCGI (Drugs Controller General of India)