Pharmaceuticals – Indian Regulations & Guidelines

Pharmaceuticals – Indian Regulations & Guidelines

The National Regulatory Authority (NRA) of India is Central Drugs Standard Control Organizations (CDSCO),which controls import,manufacturing,distribution and sales of drugs in India.CDSCO is headed by the Drugs Controller General of India,DCG(I).The mission of CDSCO is to safeguard and enhance public health by assuring the safety,efficacy and quality of drugs,cosmetics and medical devices.  

The Indian drug regulatory system originated in 1940, with the implementation of Drugs & Cosmetics Act. The Drugs Rules were framed in 1945 to give effect to the provisions of the Act. Both the Act and Rules were subsequently amended many times to regulate the drugs.

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations (FDA) by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act (Central Drugs Standard Control Organization (CDSCO) is the national level regulator, where as State Drug Regulatory Authorities (SDRAs) are the state level regulators. Powers are shared between the center and states). Sate drug controller (SDC) heads the SDRA.  

 

CDSCO	Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, Government of India provides general information about drug regulatory requirements in India.
NPPA	Drugs (Price Control) Order 1995 and other orders enforced by National Pharmaceutical Pricing Authority (NPPA), Government of India.
D & C Act, 1940	The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in India.
Schedule M	Schedule M of 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.
Schedule T	Schedule T of the D&C Act prescribes GMP specifications for manufacture of Ayurvedic, Siddha and Unani medicines.
Schedule Y	The clinical trials legislative requirements are guided by specifications of Schedule Y of The D&C Act.
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.
The Pharmacy Act,1948	The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India.
The 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.
The 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.