26 September, 2012

Applications invited as Consultant (New Drug) in CENTRAL DRUGS STANDARD CONTROL ORGANIZATION ( CDSCO )

 

CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

Post: Consultant (New Drug)

Essential Qualifications:-
i) A recognized medical qualification included in the First or Second Schedule orPart II of the Third Schedule (Other than licentiate qualifications) to the Indian Medical Council Act, 1956. Holders of Educational Qualifications included in thePart II of the Third Schedule should also fulfil the conditions stipulated in sub-section 3 of the Section 13 of the Indian Medical Council Act, 1956;
ii) Postgraduate Degree in Pharmacology of a recognized University or equivalent;
iii) 8 years experience in the planning of clinical trials including drawing up of protocols of the trials and designing of suitable proforma or in the screening of pre-clinical data and examination of clinical information on 'New Drugs'.

Desirable: Experience of administration of the Drugs and Cosmetics Act, 1940 and/or of manufacture and testing of drugs and knowledge of procedures for approval of New Drugs and/or drawing up of standards of drugs.

Duties:-
The duties in brief of the post are as follows:-
(i) Screening of pre-clinical and clinical data on new drugs molecules from the angle of safety and efficacy;
(ii) Examination of clinical trial protocols in India;
(iii) Liaison with agencies like ICMR, Central Drugs Laboratory, CIPL;
(iv) Examination of packaging insert of promotional materials and monitoring of adverse reactions to drugs.

TORs:- The Consultant will be given specified tasks and deliverables by way of TORs in terms of the assignment which will be monitored at appropriate level/s in CDSCO.

LAST DATE: 8th Oct, 2012

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