Prepared by: Mr Shemroy Pompey – Drug Inspector at Government Analyst Food and Drug Department.Activity / Event: Recent Trends and Challenges in Regulation and Standardization in Herbal Drugs and FormulationsDate : 14th-24th October 2019
Place : National Institute of Pharmaceutical Education and Research (NIPER) Sector 67,S.A.S. Nagar,Punjab,India
Goal: To have regulation in place for the Manufacturing, Importation and Sale of Herbal Drugs and Formulation used by the Guyanese population.
Objective: To develop Regulation for Herbal Drugs used to treat diseases in the Guyanese population.
Participants:
Country No of Participants
Afghanistan 1
Cote D’ivoire 1
Egypt 4
Guyana 1
Iran 1
Iraq 1
Mauritius 2
Nigeria 3
Oman 1
Papua New Guinea 1
Sri Lanka 3
Sudan 1
Tanzania 2
Thailand 1
Summary:
Lectures Delivered
Standardization of Herbal Drugs And Formulations-Pro I.P Singh
Basic Principles - Dr Vishal K,Manger Marketing,Waters India
Applications of UPLC Pvt ltd,Delhi
Herbal drugs from Plants-Dr VineetKumar,Scientist-G,FRI Dehradun
Herbal to Phytopharma: A new -Dr GirishGupta,Head R& D,Zeon Lifescience
Trend in industry-“Its challenges and way forward” ltd
Understanding the Basic of Chromatography-Pro ManiderKaran,UIPS,Panjab, University,Chandigarh
Basic Principles and Applications of
HPTLC
Bottlenecks in Regulation of Herbal Drugs
Nutraceutical and Phytopharmaceutical Products-Prof. Sanjay Jachak NIPER-SAS Nagar
Development: A paradigm shift in Herbal Drug research
Application of modern analytical Techniques in Pharmacokinetics study of Natural/Herbal drugs
Pharmacological cold mimicking: TR(I)P to Obesity and Diabetes-Dr Mahendra Bishnoi,Scientist
PreventionD,NationalAgri-Food
Biotechnology Institute,Mohali
Quality control and standardization of Ayurvedic/Unani formulations- Dr SayeedAhmad,Jamia Hamdard,New Delhi
Phytopharmaceuticals-Dr SandipBharata, Principal Scientist,CSIR-IIM,Jammu
Synthetic Biology and Bioprocessing for production -Dr Sudesh,Scientist-F,center of innovative of value Added functional moleculesand Applied Bioprocessing(CIAB),Mohali from Agri-biomass
Heavy metals analysis in -Mr Santosh k Singh Scientist PBTI,Mohali
Herbal Drugs-Principles and Application of ICPMS
Regulation of Herbal/AYUSH Drugs-Pro Raghuram Rao, Director NIPER Mohali
Highlights of the Course
– Visit to various facilities of NIPER– Hands on training session(6), department of Natural Products(HPTLC,HPLC,UPLC,GC-MS,LC-MS& SCFE)
– Visit to Zeon life Sciences ,Paonta Sahib– Visit to Ind Swift laboratories,Dera Bassi– Visit to RDTL,Chandigarh– Visit to NABI AND CIAB,SAS Nagar– Local sightseeing at Chandigarh
Regulatory Aspects of Herbal Drug Products in India
The national policy on TM/CAM was introduced in 1940 with the publication of the Drugs and Cosmetics Act and updated in 1964, 1970 and 1982 . Herbal medicines are regulated as prescription and over the counter medicines and dietary supplements.
AYUSH, Herbal Products and Drugs of Natural Origin
Under 3(h) of the Drugs and Cosmetics Act uses the term “Patent or Proprietary (P&P) Medicine” ASU drugs. Schedule ‘T’ of the act: GMP requirements for herbal drugs. The conditions for licensing should be amended to demand rationale for the P or P medicine either on ISM basis or on the basis of the data that are generated by adopting a current scientific methodology.For promoting excellent recipes of AYUSH in both domestic and international markets, a new category, which could be defined as Ayurvedic Cosmetics, should be introduced Adoption of herbs in the ISM system could be permitted if herbs from outside India are adequately researched using research methodology of ISM and their characteristics are evaluated on ISM guidelines (like Rasa, Guna, Veerya, Vipaka, Prabhava, etc)
Standard monographs of important and most commonly used medicinal plants and their standardized extracts be prepared and published.
Recommendations/follow-up:
1. Establish regulatory guidelines / legislation for Herbal Drugs and Formulations in Guyana.2. Train staff on GMP checklist of Herbal Drugs and Formulations for manufacturers.3. Acquire the relevant equipement, standards and training for laboratory staff to analyze Herbal Drugs and Formulations.
