LATEST TREND OF PHARMACEUTICAL AND MEDICAL DEVICE REGULATION AND INTERNATIONAL COOPERATION

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1 LATEST TREND OF PHARMACEUTICAL AND MEDICAL DEVICE REGULATION AND INTERNATIONAL COOPERATION Dr. S. Eswara Reddy Drugs Controller General (I) CDSCO 9/4/2018 1

2 Goal of Indian Drug Regulators To built trust and confidence in public mind on quality of Medical Products To have predictable, transparent and efficient regulatory system To ensure accessibility, availability and affordability of Medical products To hormonise Indian drugs regulations with International standards to the extent feasible To promote innovation by providing regulatory support Ease of doing business 9/4/2018 2

3 Measures taken to further improve Quality Submission of Formulation Development Data Excipients Compatibility and Toxicity data Stability data of API and Finished product Process Validation /Analytical Method validation data Mandatory submission of BA/BA data for drugs of Class II and IV All the applicants obtaining new drugs permission are mandated to have a pharmacovigilance system in place. Joint Inspection of manufacturing facilities. Enhanced Capacities of Drugs Testing Laboratories Conducting Risk Based Inspections

4 Transparency CDSCO established Public Relation Office: Single Window System To address public grievances, To facilitate innovators, To aid and advise start up companies, To provide clarifications on drug regulations, and No prior appointment required Video Conference with innovators on regulatory requirements. Online Applications, Review, Communications with applicant and approvals In house timelines for processing of various applications prescribed 9/4/2018 4

5 Public Relations Office Ground Floor, CDSCO, HQ, FDA Bhawan, Kotla Road, New Delhi Toll Free No

6 Type of Applications Applications Processed in Month of July-2018 Total received Jul-18 Disposed Under Process & taken on priority %age Disposal Pending cases Clarification Sugam portal issue Information on D & C Act Misc Minor error Innovator/Start up Complaints Total

7 Graphical status of applications for March to June data

8 Enforcement An Intelligence cell has been created at CDSCO HQ in March the major functions of the cell are: To gather information on the contraventions under the Act and Rules, To carry out surprise raids, and To investigate international quality complaints received from foreign regulatory agencies, Raids have been conducted on regular basis. Actions are being taken on the offenders. 9/4/2018 8

9 Ease of Doing Business Perpetual validity of various licenses Established a common forum of Indian drugs/ pharmaceutical manufacturers to address their issues Waiver of requirements of export NOC from port offices Delegation of powers of CDSCO to state authorities for grant of NOC for export purpose. Increased Validity of COPP Single window grievance address mechanism FAQs posted on website. 9/4/2018 9

10 E- governance 1. SUGAM portal an egovernance initiate of CDSCO has been launched in November On an average applications are received annually. 3. Majority of the services rendered by CDSCO are now online. 4. A separate portal for Medical Devices has been launched in late Pharmaceutical manufacturers Data Management 6. The national portal SUGAM is further proposed to be extended to all the states which then will become single platform for all drugs regulatory services in the country. 9/4/2018

11 New Drugs and Clinical Trials Rules 1) Waiver of local clinical trials for drugs approved by identified countries 2) Application process timelines is 30 days, deemed approved 3) Pre and post submission meetings 4) Separate provisions for approval of Orphan drugs 5) Accreditation of investigator and clinical trial sites 6) Separate provision for academic clinical trial. 7) Provisions for Post trial access as per recommendation of Investigator and EC 8) Manufacture of Unapproved New Drug for Treatment of Patients in Government Hospital and Government Medical Institution

12 Medical Devices Regulations Medical Device Rules 2017 have become made effective from 01st January Harmonized inline with the practices being followed in the developed countries across the globe. Online Submission of applications Risk based Classification (Class A, B, C and D) Low Risk devices (A& B) are regulated by States, Audit by Notified bodies High Risk Devices (C&D) are regulated by CDSCO Standards are well defined Devices approved in Japan, Wavier of Clinical Investigations Separate regulations for IVD Perpetual validity of licenses

13 International co-operation CDSCO has signed MoU on cooperation in the field of regulation of pharmaceuticals with Japan, Russia, Sweden, Brazil, UK, Afghanistan, Indonesia and USFDA. CDSCO has been actively participating at various multilateral fora. These include: WHO, ICDRA, ICMRA, ICH, AHWP, etc. Also exploring the possibility of CDSCO becoming a PIC/S member. SEARN for SEARO region 9/4/

14 Way forward Regulation of the following emerging areas: Regenerative Medicine/Gene Therapies Nutraceuticals Radiopharmaceuticals Medical Devices 9/4/

15 Thank You 15