1. Central Drugs Testing Laboratory (CDTL), Kolkata:
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The Central Drugs Testing Laboratory, Kolkata is the national statutory laboratory of the Government of India for quality control of drugs and cosmetics and is established under the Indian Drugs and Cosmetics Act, 1940. It is the oldest quality control laboratory of the drug control authorities in India. It functions under the administrative control of the director-general of health services in the ministry of health and family welfare.
The major functions of the laboratory include:
1. Analytical quality control of the majority of the imported drugs available in the Indian market.
2. Analytical quality control of drugs and cosmetics manufactured within the country and on behalf of the central and state drug controller administration.
3. Acting as an appellate authority in matters of disputes relating to the quality of the drug.
1. Collection, storage, and distribution of international standard international reference, preparation of drugs and pharmaceutical substances.
2. Preparation of national reference standard and maintenance of such standard. Maintenance of microbial cultures is useful in drug analysis distribution of standards and cultures to state quality control laboratories and drug manufacturing establishments.
3. Training of drug analysts deputed by state drug control laboratories and other institutions.
4. Training of World Health Organization follows from abounding or modern method of drug analysis.
5. To advise the central drug control administration in respect of quality and toxicity of drugs awaiting license.
6. To work out the analytical specification for the preparation of monographs for the Indian Pharmacopoeia and the Homeopathy Pharmacopoeia of India.
7. To undertake analytical research on standardization and methodology of drugs and cosmetics.
8. Analysis of Cosmetics received a survey sample from a central drug standard control organization.
9. Quick analysis of life-saving drugs on an all-India basis received under the national survey of quality of essential Drug Program from zonal offices of Central Drug Standard Control Organization.
2. Central Drugs Testing Laboratory (CDTL), Chennai:
Central Drugs Testing Laboratory, Chennai is one of the national laboratories in India engaged in the research and analysis of drugs and cosmetics as per the Drugs and Cosmetics Act, 1940.
3. Central Drugs Testing Laboratory (CDTL), Mumbai:
The Central Drugs Testing Laboratory, Mumbai is another national statuary laboratory of the Government of India, functioning under the administrative control of the Drug Controller General (India), DGHS Ministry of Health and Family Welfare.
The major functions of the laboratory include:
Testing of imported bulk drugs and formulations:
The Laboratory is notified as an appellate laboratory for copper T intra-uterine. Contraceptive devices and tubal rings under the drug and cosmetic rules, (Medical stores) and regional directors of the department of family welfare and procurement and field samples of oral contraceptive pills, copper T, and tubal rings referred by the department of family welfare.
4. Regional Drugs Testing Laboratory (RDTL), Guwahati:
The Regional Drugs Testing Laboratory, Guwahati is one of the five National Laboratories of the Government of India for quality control of Drugs and Cosmetics and was established under the Indian Drugs and Cosmetics Act, 1940 functioning under the administrative control of the Drugs Controller General of India and subordinate office under Directorate General of Health Services, Ministry of Health and Family Welfare. The laboratory was set up in the year 2002 for the entire North Eastern States including Sikkim and is housed in its building at Guwahati.
Statutory Functions of Laboratory include:
1. Analytical quality control of Drugs and Cosmetics manufactured within the country on behalf of the Central and State Drugs Controller Administration.
2. To assist the Central Drugs Standard Control Organization in the testing of drugs and cosmetics.
5. Regional Drugs Testing Laboratory (RDTL), Chandigarh:
The Regional Drugs Testing Laboratory (RDTL), Chandigarh has become operational since November 2007. Presently the laboratory is testing the drugs at an average of 50 samples per month, primarily to cater to the requirement of CDSCO (North-Zone) The laboratory is in the process of up-gradation in the infrastructure of CDSCO (North-Zone). The laboratory is in the process of up-gradation in infrastructure and manpower to increase the testing capacity.
Functions are undertaken by the 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 License approving authority i.e. for blood banks, large volume parenteral and vaccines, and 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.
1. Coordinating the activities of the State Drugs Control Organization to achieve uniform administration of the Act and Policy Guidance.
2. Guidance of technical matters.
3. Participation in the WHO GHP certification scheme.
4. Monitoring training program for regulatory officials and Government Analysts.
5. Conducting training programs for regulatory officials and Government Analysts.
6. Distribution of quotes of Narcotic drugs for use in medicinal formulations.
Functions Undertaken by State Government:
1. Licensing of drug manufacturing and sales establishments.
2. Licensing of drug testing laboratories.
3. Approval of drug formulations for manufacture.
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