DRUG REGULATORY STATUS ASSIGNMENT CRITERIA: A CONTRAST AMONG 2 COUNTRIESAbstract
After a laborious and extravagant procedure the drug finally enters the market for use. But who determines the new drug status as a prescription only or an OTC? There is a clear cut contrast between the US and India with respect to their assignment guidelines and the future prospect of a new drug. In the US the regulatory status of the approved drug is determined as per the FDA guidelines (FDCA of 1938) in accordance with the Durham-Humphrey act of 1951 which depicts the criteria required for a pharmaceutical product to be marketed as a prescription drug or an OTC product. CDSCO headed by the DCGI is the authority responsible for determining the regulatory status which acts as per the regulations listed in Drugs and Cosmetics Act of 1940 in India. The US regulatory system stipulates the malleability for the inter conversion of the drugs regulatory status known as “Rx to OTC switch” which is deficient in India. Perfect implementation of regulations in India will promote effective use of OTC’s and forestall illicit sale of prescription drugs as OTC’s.
Anoop Paruchuri*, Vini Pavithran , M. Pavani , S. Selvamuthukumaran and G. P. Mohanta
Department of Pharmacy Practice, Annamalai University, Annamalai Nagar-608002, Tamil Nadu, India.
03 October, 2012
16 December, 2012
29 December, 2012
01 January, 2013