• Central Drug Standard Control Organization (CDSCO)

• The Central Drugs Standard Control Organization (CDSCO) is the

Central Drug Authority for discharging functions assigned to the
Central Government under the Drugs and Cosmetics Act.

• CDSCO has:

• Six zonal offices

• Four sub-zonal offices
• 13 port offices
• Seven laboratories under its control.
• Vision:
• To Protect and Promote public health in India.

• Mission:
• To safeguard and enhance the public health by assuring the safety,
efficacy and quality of drugs, cosmetics and medical devices.
 • Major functions of CDSCO
Regulatory control over:

• The quality of imported of drugs and licensing

• Approval of new drugs and clinical trials

• License approving of blood banks, LVPs, Vaccines, r-DNA products and some medical devices.

• Laying down the standards of drugs

• Co-ordination with the state drug control organization and give advice regarding the D& C Act.

• Amendment in D& C Act and rules.

• Banning of drug and cosmetics

• Testing of new drugs

• Control over the meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB) ( involve in the amendment of
D& C act and rules, advisory committee to CDSCO)
• ( DCC and DTAB both are the advisory committee that advice to state and central govt regarding the D& C act.)
 The organization chart
Drug controller general of India is responsible for approval
of licenses of drugs, medical devices and clinical trials. He
is advised by the DTAB and DCC
Head office is located in Delhi

RDTL : regional drug testing lab.

DDC – deputy drug controller
JDC – joint drug controller
ADC – assistant drug controller
TDA- technical data asscociate
• Laboratories will include the Central drug laboratories:

• Functions of CDL

• Statutory functions:

• Analytical quality control of majority of the imported Drug available in

Indian market.
• Analytical quality control of drug and cosmetics manufactured within
the country on behalf of the Central and State Drug Controller
Administrations.
• Acting as an Appellate authority ( power to review) in matters of
disputes relating to quality of Drug.
• I. Other Functions:

• Collection, storage and distribution of International Standard , International Reference

Preparations of Drug and Pharmaceutical Substances.

• Preparation and maintenance of National Reference Standards.

• Maintenance and distribution to state quality control laboratories of microbial cultures useful in
drug analysis.

• Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions.

• Training of World Health Organization Fellows from abroad on modern methods of Drug
Analysis.

• To advise the Central Drug Control Administration in respect of quality and toxicity of drug
awaiting license.
• To work out analytical specifications for preparation of Monographs for the
Indian Pharmacopoeia and the Homoeopathic Pharmacopoeia of India.

• To undertake analytical research on standardization and methodology of Drug

and cosmetics.

• Analysis of Cosmetics received as survey samples from Central Drug Standard

Control Organization.

• Actively collaborates with the World Health Organization in the preparation of

International Standards and Specifications for International Pharmacopoeia. It
also undertakes collaborative study on behalf of the Indian Pharmacopoeia
Committee.
 Process of drug regulation
• CDSCO approves new drugs based on a combination of non-clinical data, clinical
trial data (focusing on safety and efficacy) from abroad as well as in India, and
the regulatory status of the drug in other countries.
• The law permits a waiver of requiring local clinical trials if the Licensing Authority
decides it is in the public interest to grant permission to import / manufacture
the new drug on the basis of data available from other countries.
• In special circumstances, such as drugs required in life threatening / serious
diseases or diseases of special relevance to the Indian health scenario, the law
permits the Licensing Authority to abbreviate, defer or omit clinical data
requirements altogether.
• Application for the approval of new drug is evaluated by the new drug
advisory committee( 12persons) from govt. medical colleges and
institute across the India.
• newdrug_advisory_commitee.pdf

• Approval will granted based on the recommendation by this committee

• Besides approval there is another role that is licensing and inspection.

• Drug inspector:
• Power to inspect the premises of drug manufacturing and selling
• Collect the sample on exchange of fair price and written acknowledgement and give it for analysis
from any premises

• Govt. Analyst will analyze the sample and prepare report which will give the quality of the drug.

• Now it mandatory that before the grant of manufacturing license, the manufacturing
establishment is to be inspected jointly by the Drug Inspectors of both the central government
and the concerned state government

• State licensing authority:

• After approval by CDSCO , manufacturer has to take the approval of state authority as well.
 • State licensing authority
• State Drug Regulatory Authorities (SDRAs) established under the DC Act are
responsible for :
• Licensing of manufacturing establishments, sale premises, testing laboratories.
• Approval for drug formulations for manufacturing.
• Undertaking inspections of such premises to ensure compliance with license
conditions ( pre and post approval inspection)
• Drawing samples for testing and monitoring of quality of drugs
• Taking actions like suspension/cancellation of licenses of substandard drugs
• Surveillance over sale of spurious and adulterated drugs
• Administrative matters such as departmental budgeting, appointments,
training of officers, and allotment of funds and resources for inspections, falls
under the jurisdiction of the state governments.
• Head of the State licensing authority is the State drug controller and
report to a joint secretary in the health department of the state
government.

• A typical SDRA has Drug Inspectors reporting to the Deputy Drugs

Controller who also acts as the Licensing Authority for the state.
• Drug approved for the import or manufacture or marketing in the country
must be check for safety and efficacy for use in human

• The Rules of D& C Act

• 122A, 122B, 122 DAB, 122DAC, 122 DD and 122E

• Appendix I- XII of Schedule Y, describe the information/data required for

approval of clinical trial and/or to import or manufacture of new drug for
marketing in the country.