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

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)

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

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)

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.

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.

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

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

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

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

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 )

Indian Pharmaceutical Industry Industry size : 25.8 Bn USD Exports : 13.2 Bn USD Imports: 3.52 Billion USD Industry is growing @ 20% p.a Domestic Market 2011-2012: 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 172 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

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

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.

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

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.

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.

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

DRUG DISCOVERY & DEVELOPMENT: REGULATORY REQUIRMENTS

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

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

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.

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