1. Role of Pharmacists in Drug Regulatory Affairs
Dr Dehghan M H
M.Pharm. PhD.
Y.B Chavan College of Pharmacy,
Aurangabad, M.S

2. Drug Regulatory Affairs
For any activity with Drugs;
no (=does not belong to drug regulatory affairs)
Prior authorisation needed?
yes
By whom? (the authority)
Based on which (objective and subjective) criteria?
Subject to regular control (quality, inspection)?
By whom? (the authority)

3. Some drug related activities :
Research (Chemical, Biological)
Clinical Trials on Human Beings
Manufacture
Import
Registration
Evaluation
Authorisation
(Wholesale) Distribution
continued

4. Some drug related activities (cont’d)…
(Retail) Distribution
Pricing
Prescribing
Reimbursement/Subsidy
Advertising (if any)
Special Control (eg. Narcotic Drugs)
Post-marketing Surveillance
Central Drug Control Lab
Pharmacovigilance
(Adverse Effect Reporting System)

5. Organization and Regulations related to Health in India
Based on the federal nature of constitution, areas of operation have been divided into Central Government and State Government
7th schedule of constitution describes 3 items namely:
Union List, State List and Concurrent list.
Some items like Public health, Hospitals, Sanitization etc fall in the State list.
The items having wider ramification at the national level like Family Welfare, Population Control, Medical Education, Prevention of Food Adulteration, Quality Control in manufacturing of drugs etc have been included in the Concurrent list.

6. Drug Regulatory System in India
Drug is in concurrent list of Indian Constitution. It is governed by both Centre and State Governments under the Drugs & Cosmetics Act, 1940 and Rules 1945 thereunder.
The principle on which the Drugs & Cosmetics Act function is by a system of licensing under which all the activities involved in manufacture, sale and distribution of Drugs & Cosmetics are controlled.

7. Indian Drug Regulatory System:
Government of India
Ministry of Health & Family Welfare
DGHS
Central Drugs Standard Control Organization (CDSCO)
Ministry of Science & Technology
Indian Council of Medical Research
(ICMR)
Council of Scientific & Industrial Research
(CSIR)
BARC
(Radioactive)
Ministry of Chemicals & Petrochemicals
National Pharmaceutical Pricing Authority (NPPA)
Department of Chemical & Petrochemicals (DCP)
Department of Pharmaceuticals
Ministry of Commerce & Industry
Patent Office
Dept. of Commerce & Pharmexil
Controller General of Patent
DGFT
Ministry of Environment & Forest
GEAC-[Genetic Engineering Approval Committee]
Department of Biotechnology
r-DNA Advisory Committee
Review Committee Genetic Manipulation

8. Regulatory/Apex/Committee
Functions
CDSCO
Central Drugs Standard Control Organization (1948)
Laying down standards, Clearance of new drugs, Banning Drugs, Clinical Trails etc.
ICMR
Indian Council of Medical Research (1911)
Formulates, Coordinates and Promotes biomedical research & Ethical Principles
GEAC
Genetic Engineering Approval Committee (1989)
Manufacture, Use, Import of Hazards Microorganisms/Genetically Engineered Organisms or Cells 
DBT
Department of Biotechnology (1986)
It promote transgenic research, molecular biology of human genetic disorders, brain research, and commercialization of diagnostic kits and vaccines for communicable diseases
AERB
Atomic Energy Review Board (1983)
Promotes Radio therapy & Research, Safety review for Gamma Irradiators (Devices)
BARC
Bhabha Atomic Research Centre (1967)
Promotes Isotopes application in Medicine & also monitoring usage of radioactive materials
DTAB
Drug Technical Advisory Board (1950)
To advise Central & State Govt. on Technical Matters arising out of the Drugs & Cosmetics
RCGM
Review Committee on Genetic Manipulation (1989)
No Objection Certificate for Clinical Trial & also r-DNA strains,
DCC
Drug Consultative Committee (since 1951)
Advisory Committee to DTAB and Central & State Govt. for uniform implementation of Various provisions of the Act

9. Central Drugs Standard Control Organization
CDSCO is a separate division comes under DGHS, headed by DCG(I)
Public health is one of the major objectives of Govt. of India and to achieve this it is important that drugs/vaccines are available to the public are of Quality, Safety, Purity and Efficacious.
CDSCO zonal (N,S,E,W)& sub zonal (Andhra, Gujarat) offices

10. State Drug Control Authority
Responsible for the testing, manufacturing, sale and distribution of drug:
Licensing , approval of drug formulations manufacturing, monitoring quality of manufactured and marketed drug & cosmetics, inspection, investigation & prosecution, recall of substandard drugs

11. Some Regulatory Authorities and Agencies Worldwide
USFDA (United States Food and Drug Administration)
CFR (Code Of Federal Regulations)
Centre for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)
Centre for Drug Devices and Radiological Health (CDRH)
Centre for Food safety and Applied Nutrition (CFSAN)
Centre for Veterinary Medicine (CVM)
TGA (Therapeutic Goods Administration)
MHRA (Medicines & Healthcare Regulatory Agency)
MCC (Medicine Control Council)
ICH guidelines (International Conference on Harmonization)
WHO (World Health Organization )

12. Indian Pharmaceutical Industry
Industry size : Bn USD
Exports : Bn USD
Imports: Billion USD
Industry is 20% p.a
Domestic Market : 12.6 Bn USD
4th Largest in world in terms of Volume & ranks 13th in terms of Value
Export of Biotech products & Biopharmaceuticals ~US $1.36 Bn
Export of Vaccines- US $507.9 million (US $ 42 Bn by year 2015)
Manufacturing Facilities US FDA Approved
India Stood First Globally with 2759 DMF filling Out of 7886 DMFs
US Pharmacopoeia has office in Hyderabad, India
USFDA has country office in Delhi, Mumbai
9,000 manufacturing units in the country
600,000 Retail & Wholesale Shops in India
6th largest supplier of HIV drugs after Germany
Drugs from India are exported to more than 200 countries
Vaccines from India are exported to more than 151 countries

13. Pharmacists in the Pharmaceutical Industry
AREA OF PHARMA INDUSTRY
HANDS ON/SUPERVIOSORY ROLE
RESEARCH & DEVELOPMENT
Drug discover, reserve engineering, formulation and process development, up scaling from pilot to manufacturing, trouble shooting, stability, packaging development
PRODUCTION/MANUFACTURING
Production/manufacturing of bulk drugs & intermediate finished medicines, vaccines & other biological products, veterinary medicines, ayurvedic medicines, diagnostic products & medical devices.
PACKAGING
Various stages of packaging of pharmaceuticals
QUALITY CONTROL
Testing throughout the life cycle of the drug and finished product.
QUALITY ASSURANCE
Preparing, reviewing & submitting documents, conducting trainings, internal audits, assuring total quality management.
SALES & MARKETING
Strategic planning, team management and marketing of pharmaceuticals. Working as medical representative.
REGULATORY AFFAIRS
Preparing, reviewing, communicating, submitting registration documents on pharmaceuticals to regulatory agencies to get R&D testing, production & marketing approvals, issues related to patents

14. Importance of Regulatory Affairs
Authorization for Journey of Product from the Laboratory to Pharmacy Shop (Discovery to Market)
Huge investments and high stake in commercialization of new pharmaceutical product.
“Right First Time” approach is necessary as time taken for the product to reach market is critical for success
Foremost point of contact between the company and regulatory authorities.
Coordination of scientific endeavors with regulatory demands throughout life of the product.
Helps company meet all regulations and guidelines thus maximizes profits.

15. Pharmacists As Drug Regulatory Affairs Professionals
Drug Regulatory Affairs Department
Industry
Regulatory Authority
Government
Teaching & Training
Academia

16. Regulatory Affairs Department
Drug regulatory affairs starts right from drug discovery and product development, its manufacture up to the marketing for end use.
Keeps track on the legislation of countries where company wishes to market their products.
Analysis of legal as well as scientific requirements for marketing authorization.
Prepares submissions for regulatory review and ensures all regulatory compliance.

17. Regulatory Authorities
Assessment of all submissions and technical reports.
Generation of assessment report after critical review of scientific evidences submitted by the DRA department to establish quality, safety, efficacy within acceptable limits.
Final Decision/Authorization.

18. Regulatory Process Pharmaceutical product Judgment taken
Submitted to regulatory authority
Verification
Repetition of experiment or Reconstruction of all
activities activities
(Direct confirmation) (Indirect confirmation)
Judgment taken
Accept / Reject

19. DRUG DISCOVERY & DEVELOPMENT: REGULATORY REQUIRMENTS

20. GMP :REGULATORY ASSESMENT OF FACILITIES
Buildings and Facilities
Warehouse Facilities
Sampling & Dispensing
Manufacturing Areas
IPQC areas
Records and Reports
Process Controls
Cleaning
Process Validation
SOPs
Reworks
Ingredients controls
Training
Investigations
Lab Controls
Utilities
Stability Programs

21. GLP : Concerns as Per Schedule L1 (Rule 74, 78 & 150E), Drugs & Cosmetics Act 1940
Storage and Archival
General Requirements
Premises
Raw Data
Personal
Protocols and
Specifications Archive
Equipments
Chemicals and Reagents
Standard Operating
Procedures
GLP
Good House Keeping
and Safety
Management Review
Maintenance, Calibration,
and
Validation of Equipments
Internal Quality
System Audits
Reference Materials
Quality System
Microbiological Cultures 21

22. Requirements of an Ideal Regulatory Affairs Professional
Considerable Knowledge and understanding of legal and scientific matters.
Communicative Competencies both Written and Oral.
Analytical skills.
Presentation skills
Diligent, Sensitive and Sincerity in executing the strategies and tactics needed to obtain approvals/permissions /licenses.

23. THANK YOU