Pharmaceuticals Registration In India


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Describes the process of registering a pharmaceutical drug substance in India

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Pharmaceuticals Registration In India

  1. 1. Pharmaceutical Registration In India DIA – Training Course Surya Chitra, Savio Group Inc Sunder Venkatraman, Asian Clinical Trials
  2. 2. Regulations in India Central Governments State Governments Statutory Functions Statutory Functions
  3. 3. Major Regulatory Bodies DCGI: Drugs Controller General of India DGFT: Directorate-General of Foreign Trade DBT:Department of Biotechnology GEAC: Genetic Engineering Approval Committee RDAC: Recombinant DNA Advisory Committee IBSC: Institutional Biological Safety Committees RCGM: Review Committee on Genetic Manipulation
  4. 4. State Government Statutory Functions Licensing of Drug testing labs Approval of drug formulations for manufacture Monitoring for quality of drugs and cosmetics, manufactured by respective states units and those marketed in India Recall of substandard drugs Investigation and prosecution in respect to contravention of legal provisions Pre and Post licensing inspection Administrative actions
  5. 5. Central Government Statutory Functions Approve licenses to manufacture certain categories of drug as Central License Approving Regulate CR in India Establish regulatory measures, amendments to acts and rules Screening drug Formulations available in Indian Market Regulate MA of new drug Regulate the standards of imported drugs Conduct training programs for regulatory officials and catalyst In India Publication of Indian Pharmacopoeia
  6. 6. The Regulatory Affairs Organization Chart National Government Ministry of health and Ministry of Chemicals & welfare Ministry of Environment Petrochemicals GEAC DCP NPPA Central Drug Standard& Control Organization Drug Controller General of India HQ Zonal Offices
  7. 7. Beyond Guidelines Trial can be initiated only after permission from Licensing Authority and approval from ethics committee.
  8. 8. Drug Registration and Biologics/Pharmaceuticals in India Drugs are registered with DCGI( Drug Controller General of India) which is the main regulatory body.
  9. 9. Clinical Research Guidelines/Regulations in India Drugs & Cosmetics Act & Rules (Schedule Y1988) GCP Guidelines, 2001 National Pharmacovigilance Programme, 2004 Schedule Y, 2005 ICMR Guidelines, 2000 (being revised)
  10. 10. New Regulations Governing Clinical Research in India In keeping with Global regulatory standards India specific cultural, social, political and administrative condition
  11. 11. Sponsor’s Responsibilities Protocol Reporting timelines Adequate Training Sponsor’s Study team, Investigators team Resources /Infrastructure Insurance/Expenses for medical management of AEs Monitoring
  12. 12. Sponsor’s Responsibilities Compilation /Evaluation of safety reports Dissemination •Information (AEs /Safety Updates/ PSURs) •All concerned parties (Regulators/ Investigators/ Ecs) Generate “Investigator Notifications” when required Generate periodic safety update reviews and submit to DCGI
  13. 13. Investigator’s responsibilities Understand Protocol requirements Training of his team members Provision of necessary resources & infrastructure Monitor, capture & documents ALL AEs Medical care including follow up AE Report to sponsor and IEC Archives
  14. 14. Responsibilities of Ethics Committees and DSMBs ECs Review: safeguard rights, safety and well-being of participant Monitor: SAE reports, annual reports, project reports DSMBs Ongoing Review
  15. 15. Schedule Y(2005 Amendment) -Statute Guidelines: Declaration of Helsinki ICH-E6 GCP Guidelines ICMR Guidelines
  16. 16. Schedule Y Ethics Committee – Composition, quorum prescribed – SOPs mandatory – Amendment approvals – Review of agreements – Approval format prescribed (http://
  17. 17. Ethical Issues Freely given, informed, written consent in prescribed form Appendix V Constitution, quorum and approval format as per Appendix VIII
  18. 18. Provisions for Using Independent EC Investigators may accept Approval granted by EC of another site or approval granted by an independent ethics committee
  19. 19. Sponsors Roles and Responsibilities PSUR mandatory Protocol Format (Appendix X) Report format (Appendix II) Reporting Timelines specified: Unexpected SAEs within14 days to DCGI and other investigators Stability testing
  20. 20. Investigators Training/Qualifications Investigators to document SOPs for all tasks performed by them Responsible for conduct of trial according to protocol and GCP Compliance as per undertaking Medical care for AEs SAE reporting to EC (7days) and Sponsor (24hrs) Informed consent
  21. 21. PSURs 6 monthly for 2 years; annually for 2 years Within 30 calendar days Different dosage forms/formulations/ indications in one report New studies planned for safety to be described
  22. 22. Pharmacovigilance in India 1998: •India established national centre at AIIMS •Joined Uppsala programme •WHO Special Centre at KEM Hospital 2004: •National Pharmacovigilance Programme launched on 23rd November 2004
  23. 23. National Pharmacovigilance Advisory Committee Advisory Committee to Government 16 members Supervise activities of National Pvig Program
  24. 24. Protocol Amendments Amendments which do not require notification or permission of the Licensing Authority Administrative and logistic changes, Minor protocol amendment and additional safety assessments Amendments which require notification to Licensing Authority, but sponsor need not wait for permission. Additional investigator sites, Change in investigator, with the consent to withdraw from the earlier investigator., Amended IB or ICF • Amendments which require prior permission of the Licensing Authority Additional Patients to be recruited Major changes in protocol with respect to study design, dose and treatment . Any change in inclusion/exclusion criteria
  25. 25. Global Clinical Trials are classified into 2 categories: Category A: Category B: It includes clinical trials whose It includes clinical trials whose protocols protocols have been approved by have been approved in other countries USA, UK, Switzerland, which are not listed in category A. Australia, Canada,Germany, The regulatory (DCGI) turnaround time South Africa, Japan or the EMEA. for these applications The regulatory (DCGI) will reach to a will be 8-12 weeks. decision whether to approve the trial within 2-4 weeks.
  26. 26. Advances in Schedule Y Removal of Phase Lag Statutory support of GCP & GLP Conversion of EC, Sponsor, Investigator responsibilities to legal requirements Uniform processes for submission and approval of EC documents and Informed Consent Reinforcement of pharmacovigilance through Phase IV studies, SAE reporting, PSUR etc
  27. 27. Future directions Implementation of Schedule Y GCP: Shared responsibility amongst different stakeholders in clinical trials Need for imparting training to all the players
  28. 28. Drugs and Cosmetics Act 1945 Rule Permission for Import 122 A Manufacture [except drugs 122 B under schedule C and C(1)] Fixed dose combination 122 D Clinical trial 122 DA CT definition 122 DAA 122 E New drug definition
  29. 29. 122 E: New drug definition Not used in the country Approved drug : 1. New claims (Indications, dosage, dosage form, route) 2. FDCs (New / Modified All Vaccines are considered New drugs unless certified by Licensing Authority under Rule 21 A New drug is considered new for the period of 4 years from the date f its first approval or the date it is included in the Indian Pharmacopoeia, whichever is earlier
  30. 30. Intent to conduct Phase I*,II or III Pharmaceutical product or Medical Device Clinical Trial in India Parallel submission to Determine if Ethics Committee Submission to be made under Category A or B In Case Central lab outside Category B Category A India used Note: fill aayat niryath form according to category A or B
  31. 31. In case of category A Category A Clinical trial already approved by other regulatory agencies (US-FDA, MRHA etc. as defined in the MoM-DCG(I) Oct-06) and approval letters are available NOC received from Application compiled DCG(I) per checklist on APPROVED if trial approved CDSCO website (Internal process) Export license Application made to DCGI received for approval in form 44 Resubmit Apply to Jt.DGFT Within & import license in Application of the respective city/state 2 weeks form 12; fees paid with cover letter & NOC from DGFT Delhi Application evaluated for REJECTED DGFT (Delhi) Completeness if found appropriate Approval received approval normally granted in within 4-6 weeks 4-6 weeks
  32. 32. In case of category B Determine if Submission to be made under Category A or B NOC received from DCG(I) if trial approved Category B (Internal process) If study approvals DGFT (Delhi) as required for Category A approval received within are not available 4-6 weeks Application compiled Apply to Jt.DGFT per attached appendix of the respective city/state with cover letter & NOC from DGFT Delhi Application evaluated If found appropriate Application made to DCGI approval normally for approval in form 44 & granted in 8-12 weeks Import license in form 12; Export license received fees paid as required. within 2 weeks
  33. 33. Medical Device guidelines Medical Device guidelines amended in Mar. 1, 2006 bringing discipline to medical devices sector The newly included “drugs” are Cardiac stents, drug eluting stents, catheters, intraocular lenses, IV Cannulae, Bone cements, heart valves, scalp vein set, orthopedic implants and internal prosthetic replacements.
  34. 34. Recombitant Pharma guidelines New guidelines have been introduced on Recombitant Pharma. There Approval bodies is DCGI but there are asissting bodies like GEAC, RCGM, IBSC.