Friday, 17 August 2012

Central Drugs Standard Control Organization

The Central Drugs Standard Control Organization is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. It  functions under the Directorate General of Health Services.The Central Government have established four zonal offices of the Central Drug Standard Control Organisation at Mumbai, Kolkata, Chennai, and Ghaziabad. 

Other important institutions in this respect are:
  • The Central Drugs Laboratory, Kolkata is the national statutory laboratory of the Government of India for quality control of Drug and Cosmetics and is established under the Indian Drug & Cosmetics Act, 1940.
  • Indian Pharmacopoeial Commission is an autonomous Institution under the Ministry of Health & Family Welfare, Govt. of India dedicated for setting of standards for drugs, pharmaceuticals and healthcare devices/ technologies etc besides providing Reference Substances and Training

Major functions of CDSCO:
1. Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs  Technical Advisory Board (DTAB), approval of certain licences (for drug manufacturing, testing laboratories etc). 
2. Zonal offices carry out joint inspections and coordinate with the State Drugs Controllers under their jurisdiction.
3. Quality control of drugs imported is exercised by the port offices.
4. Drugs testing laboratories test drug samples forwarded to them for test.

The CDSCO was in the news recently (August 2012) with respect to guidelines on clinical trials.

Revised the National List of Essential Medicines  in 2011.
In 2004 launched National Pharmacovigillance Program (to capture Adverse Drug Reactions data in Indian populations in a systematic  way and protect the health of patients nu assuring drug safety). 
Kandla Port made as port of entry for import of drugs into the country.


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