CDSCO

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.   Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.  Central Drugs Standard Control Organization Head quarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and functions under the Directorate General of Health Services.

Drugs Controller General (India), MoH&FW intends recruiting a suitable person against the position of Research Scientist (Medical Devices & Diagnostics) on purely contractual basis.

Post : Research Scientist

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.   Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.  Central Drugs Standard Control Organization Head quarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and functions under the Directorate General of Health Services.

Post : Drugs Inspector

On August 7, 2014 vide extraordinary Gazette notification Part –II Section-3, Sub Section(ii) New Delhi Thursday August 7, 2014, Department of AIDS Control has been merged with Department of Health & Family Welfare and now be known as National AIDS Control Organization (NACO). As per the amendment in allocation of business rules vide Cabinet secretariat’s Notification Number- 1/21/35/2014-Cab dated December 8, 2014,Department of AYUSH has been made Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) with focused attention on development of education and research in Ayurveda, Yoga & naturopathy, Unani, Siddha and Homoeopathy systems. Now Ministry of Health and Family Welfare comprises the following two departments, each of which is headed by a Secretary to the Government of India:-  Directorate General of Health Services (DGHS) is attached office of the Department of Health & Family Welfare and has subordinate offices spread all over the country. The DGHS renders technical advice on all Medical and Public Health matters and is involved in the implementation of various Health Services.

Applications are invited from eligible candidates for appointment on Deputation (including short-term-contract) to 03 posts of Assistant Drugs Controller (I) (Medical Devices), Group ‘A’, Level 11 (Rs. 67,700-2,08,700), Central Drugs Standard Control Organisation, Directorate General of Health Services, Ministry of Health and Family Welfare

Post : Assistant Drugs Controller

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.   Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

Post : Veterinary Officers

Drugs Controller General (India), MoH&FW intends recruiting a suitable person against the position of Research Scientist (Medical Devices & Diagnostics) on purely contractual basis.

Post : Research Scientist

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 : Junior Laboratory Assistant

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ABOUT AUTHORS
Ms. NEETU*, Dr. ANUPAMA SETIA, Mr. MUNISH THAKUR
*JCDM COLLEGE OF PHARMACY,
SIRSA-HARYANA (INDIA)
^*neetu.kaushal11@gmail.com

ABSTRACT
Abbreviated New Drug Application (ANDA) is an application used for regulatory submission for the authorization of generics drugs and its entry into a brand drug market. Generic drugs are pharmaceutical equivalent to the brand name drugs and distributed without patent protection. Different countries have different requirements for the registration of generic drugs and its own regulatory authority, which are responsible to enforce the rules and regulations, issue the guidelines to regulate the marketing of drugs. Various government agencies in regulating drugs are CDSCO- India, EDQM-Europe, and USFDA-US. Aim of title was to review the generic drug filing and different aspect of obtaining regulatory approval in order to get the marketing authorization in India, Europe & US. Involvement of regulatory in the generic drug development expedites the approval process and they review the queries carefully raised by the regulatory authorities and minimize them. To harmonize the different requirements, CTD format is used for filing the ANDA in respective countries. In this an attempt was made to highlight the difference between the registration requirements for generics drugs in India, Europe & US. The comparison parameters in the generic drug approval among different regions, which gives clear illustration where India lies in its generic drug approval process.

Applications are invited to fill up One post of Senior Laboratory Assistant ( Group ‘ C' Non , Gazetted) in the office of the Director, Central Drugs Testing Laboratory,CDSCO,Zonal FDA Bhawan,Mumbai in Pay Band -2.Rs.5,200-20,000+Grade Pay Rs.2800 (revised as per 7th CPC Pay matrix level - 5) by direct recruitment.

Post : Senior Laboratory Assistant