S.No

Laws

Guidelines

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.

2.

NPPA

Drugs (Price Control) Order 1995 and other orders enforced by National Pharmaceutical Pricing Authority (NPPA), Government of India

3.

D & C Act 1940

The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in India.

4.

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.

5.

Schedule T

Schedule T of the D&C Act prescribes GMP specifications for manufacture of Ayurvedic, Siddha and Unani medicines

6.

Schedule Y

The clinical trials legislative requirements are guided by specifications of Schedule Yof The D&C Act

7.

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.

8.

The Pharmacy Act, 1948

The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India

9.

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.

10.

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.