Prepared by: Marlan Cole- Director Food and Drug Department (GA-FDD)
|
Activity/Event: International Regulators Meet
Dates:19–20, September 2019
Place: Hotel Taj Krishna, Hyderabad, India
|
|
Objectives: 1. Outreaching to Food and Drug Regulatory officials to establish network.
2. Create awareness on regulatory practices and initiatives of the FDA’s across the regions.
3. To deliberate on possible cooperation on harmonization of regulatory standards
4. Presentation of initiatives taken by the CDSCO, to promote India Pharma as a dependable and credible source for the supply of quality generic medicines at affordable prices to the global committee.
|
|
Justification This meeting is expected to give the Government Analyst –Food and Drug Department (GA-FDD) of Guyana an opportunity to become familiar with and gain in-depth knowledge of India’s regulatory and registration procedures that are used to facilitate the export of pharmaceutical products from their country.
Exporters from India will also be given an opportunity to have a first-hand experience of Guyana’s regulatory requirements for the registration and importation of pharmaceuticals and medical devices.
Guyana in turn,will be given the opportunity to interface with other Drug Regulatory Authorities and experience systems they have in place or that are used to facilitate the import of pharmaceutical and medical devices from India. |
|
Summary – 2 Days Meeting in INDIA
DAY 1 • Inaugural Session and Award Ceremony – India Pharma 2019 and India Medical Devices
• Media Interaction with the Minister of Chemical & Fertilizer, Ministry of Chemical & Fertilizer. Govt. India
• India Pahrma CEO’s Roundtable with Minister of Chemical & Fertilizer Govt. India.
• Pannell Session – INDIA PHARMA: Promoting Innovation Ecosystem in India for Pharmaceuticals Industry
• Pannell Session – INDIA MEDICAL DEVICE: Diagnostics Ecosystem in India: Ensuring Access, Quality & Innovation for All
• Round Table Medical Devices – With Hon’ble Minister
• Pannell Session – INDIA PHARMA: Enhancing cross-border trade: Discussing Import and Export related opportunities and challenges for Indian Pharmaceutical Industry
• Pannell Session – INDIA MEDICAL DEVICE: Workshop on Sensitizing the Medical Devices Industry on BIS Standards
• Interaction – INDIA PHARMA: Industry interaction with State Drug Controllers and CDSCO for harmonization of regulatory requirements
• Conference Session- INDIA MEDICAL DEVICE Conference Session 3: Promoting Make-in-India: Revitalizing Ease of Doing Business.
• Joint International Drug Regulators Interaction with Pharmaceutical and Medical Devices Industry
• Dinner hosted by the Department of Pharmaceutical, Govt of India.
Day 2 • Session -hosted by WHO: WHO Regulatory Systems Strengthening and Prequalification Programme of Medical Products- Recent Updates
• Joint Session: Decoding applications of Artificial Intelligence in Pharmaceutical and Medical Devices Industry
• INDIA PHARMA: Promoting Growth of Biologicals Sector in India by Enabling Quality in Manufacturing Standards and Ease of Market Access
• INDIA MEDICAL DEVICE: Road to Universal Healthcare through Health Technology Assessment (HTA)
• Joint Session: Med-tech and Pharmaceuticals – Gearing up for Ayushman Bharat
• Close
|
|
Key Outcomes – Recommendations/follow-up:
•Fist hand experience and insight was gained into the Indian Government efforts to regularize their Pharmaceutical industry.
• Each state of India is currently responsible for independently inspecting drug manufacturers and issue Marketing Authorization MA’s.
• If India could achieve the status of being a Serious Reference Authority, this would significantly mitigate the risk associated with medicines and medical products / devices exported from India.
• Direct contact was made with many current and potential exporters of pharmaceuticals from India to Guyana and the Central Drug Standard Control Organization (CDSCO), India’s National / Federal Regulatory Authority- Data Base can be used to screen medicines / medical devices manufacturers / suppliers from India.
• Closer screening or examination of Certificates of Pharmaceutical Product – finish or API’s should be establish for Over-The-Counter (OTC’s)medications imported from India.
•
 |