CDSCO

In my last blog entry on CDSCO, i had mentioned that i shall be giving you a brief information on roles played by Central and State governments enforcing provisions of various aspects from drug development to marketing. Here is a list of functions of central and state governments:

Central Government
1. Laying down standards of drugs, cosmetics, diagnostics and devices.
2.Laying down regulatory measures, amendments to Acts and Rules.
3.To regulate market authorization of new drugs.
4.To regulate clinical research in India.
5.To approve licenses to manufacture certain categories of drugs as Central Licence Approving Authority i.e. for Blood Banks, Large Volume Parenterals and Vaccines & Sera.
6.To regulate the standards of imported drugs.
7.Work relating to the Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC).
8.Testing of drugs by Central Drugs Labs
9. Publication of Indian Pharmacopoeia.

State Government
1.Licensing of drug manufacturing and sales establishments
2.Licensing of drug testing laboratories.
3.Approval of drug formulations for manufacture.
4.Monitoring of quality of Drugs & Cosmetics, manufactured by respective state units and those marketed in the state.
5.Investigation and prosecution in respect of contravention of legal provisions.
6.Administrative actions.
7.Pre- and post- licensing inspection
8.Recall of sub-standard drugs.

If we see the functions of various state governments and central governments, these functions are a part of various Acts that regualtes the profession of pharmacy such as Pharmacy Act 1948, Drugs and Cosmetics Act 1940 and rules 1945 and amendments that have taken place in these Acts over a period of time.
In essence, it is a very important functions that CDSCO does, regulate manufacture, sale and import of medicines.

Source:http://cdsco.nic.in/html/Drugs_ContAd.html