Regulatory Issues

#pharmacognosy #drsiddhiupadhyay #sigmainstituteofpharmacy

1. REGULATORY ISSUES Dr. Siddhi Upadhyay ( M.Pharm , Ph.D ) Associate Professor HOD, Dept. of Pharmacognosy and Phytochemistry Sigma Institute of Pharmacy

2. Role of Pharmacists in Drug Regulatory Affairs

3. Drug Regulatory Affairs For a ny activity with D rugs ; 3 By whom? (the authority) no (=does not belong to drug regulatory affairs) yes Prior authorisation needed? Based on which (objective and subjective) criteria? Subject to regular control (quality, inspection)? By whom? (the authority)

4. 4 Some drug related a ctivities : Research (Chemical, Biological) Clinical Trials o n Human Beings Manufacture Import Registration Evaluation Authorisation (Wholesale) Distribution continued

5. 5 Some drug related a ctivities (cont’d) … (Retail) Distribution Pricing Prescribing Reimbursement/Subsidy Advertising ( i f a ny) Special Control ( eg . Narcotic Drugs ) Post-marketing Surveillance Central Drug Control Lab Pharmacovigilance ( Adverse Effect Reporting System )

6. 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.

7. 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 .

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 : 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 4 th Largest in world in terms of Volume & ranks 13 th 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 6 th 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. Regulations In India: ASU DTAB

15. Drugs Technical Advisory Board Constituted by Central Government to advise the Central and State Governments on technical matters arising out of administrations of the Act It consists of 18 members of whom 8 are ex-officio, 5 nominated and 5 elected members. Ex-officio members Director General of Health Sciences ( Chairman) Drugs Controller of India Director, Central Drugs Laboratory Calcutta Director Central Research Institute, Kasauli Director Indian Vetenary Research Institute, Izantnagar President, Pharmacy Council of India President, Medical Council of India Director, Central Drug Research Institute, Lucknow.

16. Nominated Members 1) Two persons nominated by central Government from amongst persons who are in charge of drugs control in states. 2) One person from Pharmaceutical Industry nominated by the Central Government. 3) Two Government Analysts, nominated by Central Government. Elected Members 1) A teacher in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an Indian university or an affiliated college, elected by the Executive Committee of Pharmacy Council of India. 2) A teacher in medicine or therapeutics on the staff of an Indian University or an affiliated College, elected by the Executive Committee of PCI 3) One Pharmacologist elected by the Governing body of ICMR 4) One person elected by council of Central Medical Education 5) One person elected by Council of IPA. The nominated and elected members hold the office for three years but are eligible for renomination and re-election. The Central Government appoints a Secretary and provides the clerical and other staff to the board. The board may appoint sub-committees and may appoint persons who are not board members either temporarily or for some period not exceeding 3 years.

17. Regulations In India: ASU DCC

18. The Drugs Consultative Committee (DCC) DCC is constituted by the Central Government in order to secure uniformity in the Act throughout India. It is an advisory committee for the central and State Governments and the DTAB. It consisted of two representatives nominated by the Central Government and one nominee of each of the state Governments. The committee meet when required by the Central Government & is empowered to regulate its own procedure.

19. Regulation of manufacture of ASU drugs - Schedule Z of Drugs & Cosmetics Act for ASU drugs

20. Requirements and Guidelines for permission to manufacture of ASU Drugs for Sale or to undertake clinical trials [(Proposed) Schedule Z]: Dept. of AYUSH, Ministry of Health & Family Welfare, Govt. of India has drafted guidelines on Good Clinical Practices (GCPs) for Clinical trials on Ayurveda , Siddha , Unani (ASU) Medicines, which have been circulated very recently in November 2011

21. Good Clinical Practice (GCP) is a set of guidelines which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects. The fundamental tenet of GCP is that in research on man, the interest of science and society should never take precedence over considerations related to the well being of the study subject.

22. It aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the ASU medicine under investigation are properly documented. The guidelines seek to establish two cardinal principles: protection of the rights of human subjects and authenticity of ASU medicine clinical trial data generated.

23. These guidelines should be followed for carrying out all ASU medicines research in India at all stages of drug development, whether prior or subsequent to product registration in India.

24. In brief these guidelines consists of information on the Protocol, Ethical issues, Safety considerations, Informed consent process, Responsibilities of the involved personnel in research, Record keeping, Data management, Quality assurance, Statistics and areas on special concern like studies with Contraceptives, Surgical procedures, Panchakarma , Medical devices etc.

25. Draft of this schedule is under consideration and within few months it may come in to force