1. DRUG REGULATIONS ASSIGNMENT
TOPIC-CENTRAL TESTING LABORATORIES
IN INDIA
MADE BY:- RISHABH SHARMA
BSc. CLINICAL RESEARCH (3rd Sem)
SUBMITTED TO - ASIF SIR

2. INTRODUCTION:-
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 and seven laboratories under its
control.

3. FUNCTIONS:-
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.

4. Major functions of CDSCO:
1.Regulatory control over the import of drugs, approval of
new drugs and clinical trials, meetings of Drugs Consultative
Committee (DCC) and Drugs Technical Advisory Board
(DTAB), approval of certain licenses as Central License
Approving Authority is exercised by the CDSCO
headquarters.

5. FUNCTIONS OF DCGI:-
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.

6. ABOUT NABL
NABL is a Constituent Board of Quality Council of India. NABL has been
established with the objective of providing Government, Industry Associations and
Industry in general with a scheme of Conformity Assessment Body’s accreditation
which involves third-party assessment of the technical competence of testing
including medical and calibration laboratories, proficiency testing providers and
reference material producers.

7. NABL is a Constituent Board of Quality Council of India. NABL has been
established with the objective of providing Government, Industry Associations and
Industry in general with a scheme of Conformity Assessment Body’s accreditation
which involves third-party assessment of the technical competence of testing
including medical and calibration laboratories, proficiency testing providers and
reference material producers.
NABL provides accreditation in all major fields of Science and Engineering such as
Biological, Chemical, Electrical, Electronics, Mechanical, Fluid-Flow, Non-
Destructive, Photometry, Radiological, Thermal & Forensics under testing facilities
and Electro-Technical, Mechanical, Fluid Flow, Thermal, Optical, Medical Devices &
Radiological under Calibration facilities. NABL also provides accreditation for
medical testing laboratories.

8. BENEFITS OF NABL ACCREDITATION:-
1. Increased confidence in Testing/ Calibration Reports issued by the laboratory
2. Better control of laboratory operations and feedback to laboratories as to whether they
have sound Quality Assurance System and are technically competent
3. Potential increase in business due to enhanced customer confidence and satisfaction.
4. Customers can search and identify the laboratories accredited by NABL for their specific
requirements from the NABL Web-site or Directory of Accredited Laboratories
5. Users of accredited laboratories enjoy greater access for their products, in both
domestic and international markets.
6. Savings in terms of time and money due to reduction or elimination of the need for re-
testing of products.

9. ETHICS COMMITEE :-
For the purpose of the Rule 122DD, an Ethics Committee is a
committee comprising of medical, scientific, non-medical and
nonscientific members, whose responsibility is to ensure the
protection of the rights, safety and well-being of human subjects
involved in a clinical trial and it shall be responsible for
reviewing and approving the protocol, the suitability of the
investigators, facilities, methods and adequacy of information to
be used for obtaining and documenting informed consent of the
study subjects and confidentiality safeguards.

10. Bioavailability (BA) : Bioavailability refers to the relative
amount of drug from an administered dosage from which
enters the systemic circulation and the rate at which the drug
appears in the systemic circulation.
Bioequivalence (BE): Bioequivalence of a drug product is
achieved if its extent and rate of absorption are not
statistically significantly different from those of the reference
product when administered at the same molar dose.

11. The Licensing Authority after being satisfied that the requirements have been
complied with, may grant registration to the Ethics Committee subject to such
conditions as may be stated therein.
The registration of Ethics Committees is valid for a period of three years. The re-
registration applications need to be made within 3 months before the expiry of
registration. Registration remains deemed continued unless otherwise orders are
passed or until the registration is Suspended or Cancelled. Accordingly applicant
shall apply to CDSCO for re-registration as per checklist.

12. ABOUT NEW DRUGS :-
Demonstration of safety and efficacy of the drug product for use in humans
is essential before the drug product can be approved for import or
manufacturing and marketing in the country. The Rules 122A, 122B, 122
DAB, 122DAC, 122 DD and 122E of Drugs and Cosmetics Rules and
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.

13. Background & Rules For Conducting global Clinical Trial :-
Global Clinical Trial means any clinical trial which is conducted as part of multi-
national clinical development of a drug. Clinical Trial means a systematic study of
any new drug(s) in human subject(s) to generate data for discovering and/or
verifying the clinical, pharmacological (including pharmacodynamic and
pharmacokinetic), and/or adverse effects with the objective of determining safety
and/or efficacy of the new drug.
No clinical trial for a new drug, whether for clinical investigation or any clinical
experiment by any institution, shall be conducted except under, and in accordance
with, the permission, in writing, of the Licensing Authority defined in clause (b) of
Rule 21.

14. CENTRAL TESTING LABS IN INDIA:-
There are seven Central Drug Testing Laboratories under CDSCO.
These are at Kolkata, Mumbai, Chennai, Guwahati, Chandigarh,
Kasauli and Hyderabad. The Central Drug Laboratory, Kolkata is the
appellate laboratory for testing of drugs and is NABL accredited for
Chemical and Biological Testing. The Central Drug Testing
Laboratory, Mumbai is a statutory Laboratory involved in testing of
samples of Drugs from the ports, new drugs and oral contraceptive
pills.It is an appellate laboratory for copper T-intrauterine
contraceptive device and tubal rings. The Central Drugs Testing
Laboratory, Chennai is an appellate Laboratory for condoms and is
NABL accredited for both chemical and mechanical sections.

15. The Regional Drugs Testing Laboratory, Guwahati tests the samples
of drugs received especially from States in the East Zone and is
NABL accredited for both chemical Zone and biological testing.