Indian Drugs Regulatory Bodies and Guidelines

Indian Drugs Regulatory Bodies and Guidelines are as follows-

1 CDSCO - Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, Government of India provides general information about drug regulatory requirements in India.
Website - http://www.cdsco.nic.in/forms/Default.aspx
2 NPPA - Drugs (Price Control) Order 1995 and other orders enforced by National Pharmaceutical Pricing Authority (NPPA), Government of India.
Website - http://www.nppaindia.nic.in/index1.html
3 Drugs and Cosmetics Act, 1940 - The Drugs and Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in India.
Website - cdsco.nic.in/html/copy%20of%201.%20d&cact121.pdf
4 Schedule M - Schedule Mof the D&C Act specifies the general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs.
Website - cdsco.nic.in/html/copy%20of%201.%20d&cact121.pdf
5 Pharmacy Act, 1948 - The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India.
Website - www.ipapharma.org/pdf/Pharmacy_act_1948.pdf
6 Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 - The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 provides to control the advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities.
Website - www.rfhha.org/images/pdf/Hospital_Laws/Drugs_magic_remedies_%28%20advertisement%29_act.pdf
7 Narcotic Drugs and Psychotropic Substances Act, 1985 - The Narcotic Drugs and Psychotropic Substances Act, 1985 is an act concerned with control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances.
Website - india.gov.in/my-government/actsrules
8 GCP Guidelines - The Ministry of Health, along with Drugs Controller General of India (DCGI) and Indian Council for Medical Research (ICMR) has come out with draft guidelines for research in human subjects. These GCP guidelines are essentially based on Declaration of Helsinki, WHO guidelines and ICH requirements for good clinical practice.
Website - www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf
9 Schedule Y - The clinical trials legislative requirements are guided by specifications of Schedule Y of The D&C Act.
Website - cdsco.nic.in/html/schedule-y%20(amended%20version-2005)%20original.htm
10 Schedule T - Schedule T of the D&C Act prescribes GMP specifications for manufacture of Ayurvedic, Siddha and Unani medicines.
Website - 202.54.104.237/intranet/eip/legislation/uploads/Schedule-T.pdf


Please login your account first to take Free Trial Test and join the Online Test Series.
If you are a new user, Please create your account, its free.