Table of Contents

Introduction of CDSCO......................................................................................................................3
Organization of CDSCO.....................................................................................................................3
FUNCTIONS..........................................................................................................................................4
Drug and Cosmetic Act.......................................................................................................................5
Schedule of the act and rules......................................................................................................................5
Schedule Y............................................................................................................................................7
Conclusion..........................................................................................................................................10
References..........................................................................................................................................11
Introduction of CDSCO

The CDSCO of India is main regulatory body for regulation of pharmaceutical, medical
devices and Clinical Trials. Head office is located in New Delhi and functioning under the
control of Directorate General of Health Services, ministry of health and family welfare
Government of India.
Drugs Controller General of India (DCGI}, is a responsible for approval of New Drugs,
Medical devices and Clinical trails to be conducted in India, appointed by the central
government under the DCGI.
The DCGI is advised by the Drug Technical Advisory Board {DTAB) and the Drug
Consultative Committed {DCC}.
CDSCO has six zonal offices, four sub-zonal offices, thirteen port offices and seven
laboratories under its control.

Organization of CDSCO

 Head Quarter- New Delhi

 Zonal Office- Ghaziabad, Chennai, Kolkata, Mumbai
 Sub Zonal Office- Bangalore, Chandigarh, Jammu, Goa
 Laboratories- Kausali, Kolkata, Guwahati, Chandigarh, Mumbai, Chennai

Head Quarter Staff

1. Drug controller general of India

2. Joint drug controller
3. Deputy drug controller
4. Assist t drug controller of India
5. Drug inspector
6. Assistant. Drug inspector
7. Technical officer

CENTRAL LICENSING AUTHORITY

 Approval of new drugs and clinical trials

 Import Registration and Licensing & approving of Blood Banks, LVPs, Vaccines, r-
DNA products & some Medical Devices.
  Amendment to D &C Act and Rules
 Banning of drugs and cosmetics
 Grant of Test l icense, Personal License
 NOCs for Export Testing of New Drugs

STATE LICENSING AUTHORITY

• Licensing of Manufacturing Site for Drugs including API and Finished Formulation
• Licensing of Establishment for sale or distribution of Drugs
• Approval of Drug Testing Laboratories
• Monitoring of Quality of Drugs and Cosmetics marketed in the country
• Investigation and prosecution in respect of contravention of legal
• provision
• Recall of sub-standard drugs

FUNCTIONS

 Approval of new drugs and clinical trials.

 Import Registration and Licensing
 Licensing of Blood Banks, Vaccines, Medical devices, Diagnostic agents.
 Amendment to D&C Act and Rules.
 Participation in WHO GMP certification schemes.
 Banning of drugs and cosmetics.
 Grant to test license, personal license, NOC's for export.
 Testing of drugs by Central Labs.
 Publication of Indian Pharmacopoeia.
 Monitoring adverse drug reactions.
 Guidance on Technical matters.
Drug and Cosmetic Act

Introduction
This act was originally passed on 10th April 1940 for regulating the import, manufacture
and distribution of drugs in India. This act was prepared in accordance to the
recommendations of the Chopra Committee formed in 1930. The Drug Rules was passed
in 1945.
 Drugs and Cosmetic Act was passed on 10th April 1940 by the Indian Legislature
 Rules passed on 1945 by Indian Legislature
 This act is amended on 1955 by the Indian Parliament
 Subsequently amended on 1960, 1962, 1964, 1972,1982,1986,1995,2008,2011 and
2018
Objectives
1. This is an act to regulate the import, manufacture, distribution and sales of drugs, by
qualified persons only.
2. To prevent substandard in drugs.
3. The act also provide for the control over the manufacture, sale & distribution of
Ayurvedic, Siddha, Unani & Homeopathic drugs.

Schedule of the act and rules

Schedule to the act-

 First Schedule- Name of books under Ayurvedic, Siddha and Unani, Tibbs Systems
 Second Schedule- Standards to be complied with by import drugs and by drugs
manufactured for sales, stocked or exhibit for sales and distributed.

 Schedule A- Forms for application of licensing etc.

 Schedule B- Fee structure for drug analysis by CDI.

 Schedule C- Biological and special products for parenteral administration whose

import, manufacture, sale and distribution are governed by special provision.

 Schedule C1- other special products for non- parenteral administration whose import,
manufacture, sale and distribution are governed by special provisions.

 Schedule D- Drugs exempted from the provision of import of drugs.

 Schedule E1- Poisonous substances under Ayurvedic, siddha and Unani system of
medicine.

 Schedule F& F1- Special provisions applicable for the production, testing, storage,
packing and labelling of biological and other special products.

 Schedule F2- Standards of surgical dressing.

 Schedule F3- Standard of sterilized umbilical tapes.

 Schedule FF- Standard for ophthalmic Preparations.

 Schedule G- Various drugs to be used Under the medical Supervision.

 Schedule H- Various drugs to be sold on prescription of an RMP.

 Schedule J- Diseases that cannot be treated by any drug.

 Schedule K- Drugs exempted from provision related to manufacture of drugs.

 Schedule M- Requirements of Good manufacturing practices and factory premises

and the requirements of plant and equipment.

 Schedule M1- Requirements for factory premises, etc. For the manufacture of
Homeopathic drugs.

 Schedule M2- Requirements for factory premises for the manufacture of cosmetics.

 Schedule M3- Requirements for factory premises for the manufacture of medical
devices.

 Schedule N- List of manufacture equipment for the efficient running of a pharmacy.

 Schedule O- Standard for disinfectant fluids.

 Schedule P- Life period and storage of various drugs.

 Schedule P1- Regulations regarding retail package size.

 Schedule Q- Permitted dyes and coal tar colours in cosmetics.

 Schedule R- Standards for condoms and mechanical contraceptives.

 Schedule R1- Standard for medical devices.

 Schedule S- Standard for cosmetics.

 Schedule T – Requirements for factory premises and manufacture of Ayurvedic,

siddha, Unani, products.

 Schedule U – Maintenance of manufacturing and analytical records of drugs.

 Schedule V- Standard for patent and proprietary medicines.

 Schedule W- List of drugs which can be marketed under generic names only.

 Schedule X- List of drugs which are habit forming, psychotropic to be misused for
addictive purposes.

 Schedule Y – Requirement and guidelines for clinical trials.

 Schedule Y

Requirements and Guidelines for Permission to Import and /or Manufacture of New Drugs
for Sale or to Undertake Clinical Trial:
To frame guidelines for conduct of clinical research, control and regulation for new drugs
CDSCO and DTAB formulated GCP under schedule Y in 2005.
Schedule Y Rules:
•Rule 122A – To import new drugs.

•Rule 122B – To manufacture new drugs.

•Rule 122D – To import or manufacture fixed dose combinations.

•Rule 122DA- To conduct clinical trials for new drugs/ investigation new drugs.

•Rule 122DAA – Definition of clinical trial.

•Rule 122E – Definition of new drugs.

Requirements and Guidelines on clinical trials for Import and Manufacture of New
drugs:
1. Application for permission
2. Clinical trial
3. Studies in special population
4. Post marketing surveillance
5. Special studies: BA / BE studies.

1.Application for permission

It shall made in Form 44 accompanied with the following data in accordance with
appendices, namely:
• Clinical and pharmaceutical information
• Animal pharmacology data
• Animal Toxicology data
• Human Clinical pharmacology data
• Regulatory status in other countries Prescribing information
• FORM 12· To import Study drug for examination, test or analysis
2. Clinical Trial
(a) Approval for Clinical trials
• CT on a New drug shall be initiated only after permission by licensing authority and
approval from EC
(b) Responsibilities of Sponsor
• Implementing and maintaining QA
• Submit status report to the licensing authority periodically SAE should be reported to
the licensing authority within 14 calendar days.
(c) Responsibilities of Investigator
• Ensure adequate medical care is provided to the subject
• SAE and unexpected AE should be reported to the sponsor within 24 hrs
and to the EC within 7 working days
(d) Informed consent
• Freely given informed written consent
• Provide information about the study verbally
• Non-Technically and understandable language
e) Responsibilities of ethics committee
Approval trial protocol to safe guard RSW of all trial subject and to protect RSW of all
vulnerable subjects. Conduct ongoing review of trials 6. Human Pharmacology (Phase I)
Safety and tolerability
(f) Therapeutic Exploratory Trials (Phase 2nd)
To evaluate the effectiveness of a drug for a particular indication To deter1nine the short term
side effects and risk associated with the drug to determine the dosage regimen for phase Ill
trials
(g) Responsibilities of ethics committee
Approval trial protocol to safe guard RSW of all trial subject and to protect RSW of all
vulnerable subjects. Conduct ongoing review of trials 6. Human Pharmacology (Phase l)
Safety and tolerability .
(h) Therapeutic confirmatory trials ( phase 3rd)
Demonstration of therapeutic benefit
Drug is safe and effective for use provide and adequate basis for marketing approval
(i) Post marketing surveillance
Performed after drug approval and related to the approved indication Includes drug-drug
interaction, dosage response and safety studies, mortality/ morbidity studies.
3. Studies in special population
(a) Geriatrics
(b) Pediatrics
(c) Pregnant or Nursing Women

4. Post Marketing Surveillance

 Closely monitored new drugs clinical safety I

 PSUR- to report all relevant new information

 PSUR shall be submitted every 6months for the first 2 years

5. Special Studies- BA/BE studies

• Conducted according to the guidance for BA and BE studies Evaluation of the effect of food
on absorption following oral administration.
Conclusion

The conclusion regarding the Drug and Cosmetic Act is that it serves as a crucial regulatory
framework governing the manufacture, distribution, and sale of drugs and cosmetics,
ensuring consumer safety and product quality. It establishes standards for labelling ,
packaging, and advertising, as well as requirements for drug approval and registration.
Overall, the act plays a vital role in safeguarding public health and promoting transparency in
the pharmaceutical and cosmetic industries.

Schedule Y provides guidelines for the conduct of clinical trials for drugs and
pharmaceuticals in India. It outlines requirements for obtaining permission for clinical trials,
the responsibilities of investigators and sponsors, and ethical considerations. In conclusion,
these regulations aim to ensure the safety, efficacy, and quality of drugs and cosmetics
available in the market.
References

1. https://cdsco.gov.in
2. https://www.pharmacy180.com/article/important-definitions-1751/
3. Pharmacovigilance by Dr. Snehalatha, Vaishnavi S. Nirali Prakashan Publishers, First
Edition
4. Annapurna S, Rao S. New drug and clinical trial rules.
doi-https;//doi.org/10.18203/2349-3259.ijct20204486
5. An Introduction to Pharmacovigilance: Patrick Waller, Wiley Publishers