World Journal of
Pharmaceutical and Life Sciences

A REVIEW ON NEW DRUG APPROVAL PROCESS IN INDIA

Pooja Agarwal* and K. Maneesha

ABSTRACT

A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This work focuses on the drug approval process in India. The new drug approval process in India is standardized and well controlled, involving multiple steps and organizations. At the central level, DCGI, under the Ministry of Health and Family Welfare, approves the drug or medical device for marketing. Manufacturing licenses are approved at the state level by state drug control authorities. Monitoring is also performed by state agencies in coordination with the CDSCO.

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