June 2012

About Authors:
Pavitra Solanki¹, Satyaveer Singh Solanki²
1- Research Scholar, KIET school of Pharmacy, Ghaziabad.
2- Asstt. Professor, Nehru Mahavidhyalaya, Lalitpur, Uttar Pradesh
*pavitra.bpharma@gmail.com

Abstract
The goal in designing controlled floating delivery system to reduce the frequency of dosing and / or to increase effectiveness of drug by localization at the site of action, reducing the dose required or providing uniform drug delivery with high bioavailability of buoyant drugs and also reduce the severity and frequency of side effects by maintaining patient blood levels of the drug above the minimum effective level and below the minimum toxic level.
Oral route has been the commonly adopted and most convenient route for drug administration. Oral route of administration has been received more attention in the pharmaceutical field because of the more flexibility in the designing of dosage form than drug delivery, design for other routes.  For sustained drug delivery dosing interval can be extended either by manipulating the drug molecule to reduce the rate of elimination or by altering the release rate of a dosage form to retard the rate of absorption. Both these approaches decrease fluctuating in plasma level in case of multiple dosing extending the dosing interval without under or over dosing.

National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad is an autonomous body which has been established under the aegis of the Ministry of Chemicals and Fertilizers, in the Government of India, to provide leadership in Pharmaceutical Sciences and other related areas. The Indian Institute of Chemical Technology, Hyderabad is its Mentor Institute for providing the institutional support in respect of its management and as a nodal point for the Ministry.

Sterling Hospitals, established in 2001 and owned and managed by Sterling Addlife India Ltd., is the largest chain of Corporate Hospitals in Gujarat.

About Authors:
Geetanjali Sengar*, Pranab Tripathy
Drug Regulatory Affairs Dept.
Belco Pharma, 515, Modern Industrial Estate,
Bahadurgarh-124507(Haryana), India.
*geetanjali.sengar@gmail.com, geetanjalisengar87@gmail.com

ABSTRACT:
As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, regulatory agencies are being established in various countries across the globe. Regulatory agencies and organizations play a vital role to meet the requirements of legal procedures related to drug development process in a country.

In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process,licensing, registration, manufacturing, marketing and labeling of pharmaceutical products. USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa),ANVISA (Brazil) , EMEA (European Union), SFDA (China),NAFDAC(Nigeria), MEDSAFE(Newzeland), MHLW(Japan), MCAZ(Zimbabwe), SWISSMEDIC(Switzerland), KFDA(Korea), MoH (Sri Lanka) are the few regulatory  agencies and organizations established in respective countries.

Shambhunath Institute of Engineering and Technology was set up by the UTTHAN, a world renowned N.G.O. in 2004 with an objective of imparting quality education in Engineering and Technology.