**Summary:**
This notice, issued by the Central Drugs Standard Control Organisation (CDSCO), Office of Drugs Controller General India, on March 4, 2014, announces that the year 2014 will be observed as the "Patient & Animal Safety year." As part of CDSCO's mission to safeguard and enhance public health by assuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices, all drug products imported into India will be checked for compliance with the Drugs & Cosmetics Act, 1940, and the Drugs & Cosmetics Rules, 1945. The notice emphasizes that patient safety is of paramount importance, and therefore, the import of drugs will only be permitted if they fully comply with the aforementioned Act and Rules. This directive is issued by Dr. G.N. Singh, Drugs Controller General India, and is addressed to all officers of CDSCO HQ/Zonal/Sub-Zonal Offices/Port Offices of CDSCO. Copies have been sent to PS to DGPS to ASDGPS to JS (R), Ministry of Health & Family Welfare.
Key Entities Referenced
Central Drugs Standard Control Organisation: The organization celebrating Patient Animal Safety year and ensuring the safety, efficacy, and quality of drugs, cosmetics and medical devices.
CDSCO: Abbreviation for Central Drugs Standard Control Organisation.
Drugs Controller General India: The head of the Central Drugs Standard Control Organisation.
New Delhi: Location of the Central Drugs Standard Control Organisation headquarters, New Delhi, Delhi, India.
Drugs Cosmetics Act, 1940: Indian legislation concerning the regulation of drugs and cosmetics.
Drugs Cosmetics Rules, 1945: Rules established under the Drugs and Cosmetics Act, 1940, providing detailed regulations for drugs and cosmetics.
Ministry of Health Family Welfare: The Indian government ministry responsible for health policy.
Dr. G.N. Singh: Drugs Controller General of India.
Central Drugs Standard Control Organisation
Office of Drugs Controller General India
FDA Bhawan, New Delhi-110002.
Dated: 4" March, 2014
NOTICE
The Central Drugs Standard Control Organization (CDSCO) is
celebrating the year 2014 av “Patient & Animal Safety” year. In its endeavour
to ensure the Mission of CDSCO “To safeguard and enhance the public health
by assuring the safety, efficacy and quality of drugs, cosmetics and medical
devices” in letter and spirit, it has been decided that the drug products which are
being imported in the country be checked for their compliance with the
provisions of the Drugs & Cosmetics Act, 1940 and Drugs & Cosmetics Rules,
1945. As the patient’s safety is of paramount importance, it has been decided
that the drugs for import into the country shall be allowed only if these are in
compliance to the requirements of the Drugs & Cosmetics Act, 1940 and Drugs
& Cosmetics Rules, 1945.
(Dr. G.N. Singh)
Drugs Controller General (India)
To
All Officers of CDSCO HQ/Zonal/Sub-Zonal Offices/Port Offices of CDSCO
Copy to: PS to DG/PS to AS&DG/PS to JS (R),
Ministry of Health & Family Welfare