Resent nutraceutical practices in Nepal.pptx

The term ‘Nutraceuticals’ has been defined as:
“any substance that may be considered a food or a part of food and provides medical and health benefits including the prevention and treatment of disease [1].

People all over the world are frustrated with the expensive, hi-tech, disease treatment approach prominent in modern medicine, so the consumer is seeking alternative beneficial products and care which makes Nutraceuticals particularly appealing [2].

1. Phr. Bibek Singh Mahat B Pharm, M Pharm (KU) Advisory Committee Member NPA Advisory Committee M ember PhAN Ex-Consultant Govt. of Nepal, Nepal Ausadhi Limited Nutraceuticals Practices in Nepal

2. Nutraceuticals : (Definitions) The term ‘Nutraceuticals’ has been defined as: “any substance that may be considered a food or a part of food and provides medical and health benefits including the prevention and treatment of disease [1]. People all over the world are frustrated with the expensive , hi-tech , disease treatment approach prominent in modern medicine, so the consumer is seeking alternative beneficial products and care which makes Nutraceuticals particularly appealing [2]. [1] Di Felice LS. The neutraceutical revolution, its impact on food industry R&D. Trends in Food Sci and Tech. 1995;6:59-61. [2] Dureja H, Kaushik D, Kumar V. Developments in Neutraceuticals . Indian Journal 9/25/2019 [email protected] 2

3. Nutraceuticals : (Definitions) Many individuals suffering from ischemic heart disease, obesity, diabetes mellitus type II, malignancies, osteoporosis and neurological diseases such as Parkinson’s and Alzheimer’s diseases have been benefited by Nutraceuticals. Nutraceuticals’ role in many biological processes gives us ample evidence that they have protective action against various diseases [3]. Nutraceuticals will play an important therapeutic role in the near future and its success will be determined by how effective they are with minimum or no side-effects [4 ]. 3] Rajasekaran A, Sivagnanam G, Xavier R. Nutraceuticals as therapeutic agents: A review. Res J Pharm Technol. 2008;1(4):328-40. http ://rjptonline.org/RJPT_%20 Vol1(4)/ 6.pdf [4] Srividya AR, Venkatesh N, Vishnuvarthan VJ. Nutraceutical as medicine:132-42http://www.researchgate.net/publication/2363471 9/25/2019 [email protected] 3

4. Nutraceuticals : (Definitions) Prevalence of hospital malnutrition ranges between 20% to 50% Furthermore , nutritional status is known to worsen during hospital stay. Studies have repeatedly shown that clinical malnutrition however has serious implications for recovery from disease, trauma and surgery and It is generally associated with increased morbidity and mortality both in acute and chronic diseases. Ref : Norman K, Pichard C, et al. Prognostic impact of disease-related malnutrition; Clin Nutr . 2008;27:5-15 9/25/2019 [email protected] 4

5. Nutraceuticals Classifications : 9/25/2019 [email protected] 5

6. Nutraceuticals Global Market Dublin, Jan. 29, 2019 (GLOBE NEWSWIRE) -- The "Nutraceuticals - Global Market Outlook ( 2017-2026) states that .. “Global Nutraceuticals market accounted for $379.06 billion in 2017 and expected to grow at a CAGR ( Compound Annual Growth Rate) of 7.6% to reach $734.60 billion by 2026”. Global nutraceuticals market size is expected to reach $302,306 million by 2022 from $184,092 million in 2015 with a CAGR of 7.04% from 2016 to 2022. https:// www.alliedmarketresearch.com/nutraceuticals-market 9/25/2019 [email protected] 6

7. Nutraceuticals Global Market 9/25/2019 [email protected] 7

8. INDIAN Nutraceuticals Market 9/25/2019 [email protected] 8 The Indian nutraceuticals market was worth around US$4 billion in 2017 and is expected to grow at 21% CAGR to US$10 billion by 2022. This will be fuelled by 25% per annum growth . Dietary supplements account for more than 60% of this market. https :// www.austrade.gov.au/australian/export/export-markets/countries-and-economies/india/industries/health-supplements-to-india

9. INDIAN Nutraceuticals Market 9/25/2019 [email protected] 9 https :// www.austrade.gov.au/australian/export/export-markets/countries-and-economies/india/industries/health-supplements-to-india

10. INDIAN Nutraceuticals Market 9/25/2019 [email protected] 10 A report by the Associated Chambers of Commerce and Industry of India ( Assocham ) found that:- V itamins and Minerals account for about (40%) This is followed by Herbal Supplements (30 %), Probiotics (10%), O mega-3 Fatty acids (5%), P roteins , Amino acids and other essential elements (15 %). https :// www.austrade.gov.au/australian/export/export-markets/countries-and-economies/india/industries/health-supplements-to-india

11. INDIAN “Nutraceuticals Market” REGULATIONS 9/25/2019 [email protected] 11 Food Safety and Standards Authority of India (FSSAI) is an autonomous body established under the Ministry of Health & Family Welfare, Government of India. FSSAI is responsible for protecting and promoting public health through the regulation and supervision of food safety.

12. INDIAN “Nutraceuticals Market” REGULATIONS 9/25/2019 [email protected] 12

13. Quality control requirements for oral solid dosage forms (Tablets, Capsules Powders) Evaluation for visual appearance, labelling , odour , taste, texture, hardness and friability. Moisture content: Standards and tests of identity: designed to demonstrate clearly that the specimens examined contain the active ingredient(s) . Standards and tests of homogeneity: Apply test for uniformity of weight. Standards and test for purity: for potentially harmful degradation compounds that may be generated during production and storage of dosage forms . 9/25/2019 [email protected] 13

14. Quality control requirements for oral solid dosage forms (Tablets, Capsules Powders) Standards and assays for the active ingredient(s) and for degradation. Uniformity of content. Standards and tests of performance. Dissolution rate tests for poorly soluble drugs, potent drugs and cases with dissolution problems; disintegration test to supplement dissolution rate tests. Stability indicating tests. 9/25/2019 [email protected] 14

15. Quality control requirements for oral solid dosage forms ((Ointments, Creams,) Evaluation for visual appearance, colour , odour , labelling , and homogeneity Loss of water Consistency Ph Assay of active ingredients and of degradation products Identification test for active ingredient and possible contaminants Stability of the active ingredient in the dosage form Release of the active ingredient from the dosage form and Storage conditions. 9/25/2019 [email protected] 15

16. Quality control requirements for oral solid dosage forms (Liquid Preparations ) Evaluation for visual appearance, colour , taste, odour , labelling , and homogeneity, Assay of active ingredients and of degradation products. Pourability Viscosity Crystallization and precipitation Gas evolution 9/25/2019 [email protected] 16

17. Quality control requirements for oral solid dosage forms (Liquid Preparations ) pH Microbial limit tests Stability of the active ingredient(s), and identification tests Light stability Container and closure compatibility Redispersibility Suspensibility Storage condition 9/25/2019 [email protected] 17

18. References [ 1] Assocham , India Nutraceutical Industry Report [2] Assocham , India Nutraceutical Industry Report [3] BCG, The New Indian: The Many Facets of a Changing Consumer [4] Assocham , Indian Nutraceuticals Industry report , July 2018 [5] Assocham , Indian Nutraceuticals Industry report , July 2018 Samir A. Hanna (1989) Quality Assurance. Drug Development and Industrial Pharmacy, 15:6-7, 869-894, DOI: 10.3109/03639048909043654 World Health Organization (2007). Quality assurance of pharmaceuticals: A compendium of guidelines and related materials Volume 2, 2nd updated edition. Switzerland: WHO Press 9/25/2019 [email protected] 18

19. Challenges in Nutraceuticals 9/25/2019 [email protected] 19

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23. Government of Nepal has banned the following medicines for production, sale-distribution and import.. 9/25/2019 [email protected] 25

24. Adult Pediatric Vitamin A, I.U not less than 5000 & not more than 10000 not less than 1500 & not more than 5000 Vitamin D, I.U not less than 400 and not more than 1000 not less than 100 & not more than 400 Vitamin B1 mg not less than 4.5 & not more than 10 not less than 1 & not more than 4.5 Vitamin B2 mg not less than 5 & not more than 10 not less than 1 & not more than 5 Vitamin B6 mg not less than 1.5 & not more than 3 not less than 1 & not more than 3 Niacinamide mg not less than 45 & not more than 100 not less than 10 & not more than 40 d-panthenic mg acid or its salts & Panthenol, mg not less than 5 & not more than 50 not less than 2.5 & not more than 10 Folic acid mcg not less than 1000 & not more than 1500 not less than 100 & not more than 500 Vitamin B12 mcg not less than 5 & not more than 15 not less than 1 & not more than 5 Vitamin C mg not less than 75 & not more than 150 not less than 30 & not more than 80 Vitamin E I.U not less than 15 & not more than 25 not less than 5 & not more than 20

25. Are dietary supplements safe? The health benefits of supplements are debatable in some instances and dangerous in many situations ….

26. An analysis by the Food and Drug Administration (FDA) found that 776 dietary supplements sold over the counter between 2007 and 2016 contained unapproved ingredients . "These products have the potential to cause severe adverse health effects or interaction with other medications, underlying health conditions, or other drugs within the same dietary supplement ," https:// jamanetwork.com/journals/jamanetworkopen/fullarticle/2706496 Are dietary supplements safe?

27. In 2017, a study published in the Journal of Clinical Oncology found that taking vitamin B6 and B12 supplements in high doses seems to triple some people’s risk of lung cancer. Vitamin B6 and B12 Supplements Appear to Cause Cancer in Men.. https ://www.theatlantic.com/health/archive/2017/08/b12-energy/537654/? utm_source=nl-atlantic-daily-082517

28. Poison control centers in the U.S. receive a call every 24 minutes regarding an adverse exposure to a dietary supplement, according to a July 2017 report in the Journal of Medical Toxicology. Study finds 2,75,000 calls to poison control centers for dietary supplement exposures from 2000 through 2012… https:// medicalxpress.com/news/2017-07-poison-centers-dietary-supplement-exposures.html

29. The effects of some of these supplements can be serious, too. Yohimbe , a supplement made from an green tree in western Africa, is touted as a treatment for impotence, erectile dysfunction, weight loss, high blood pressure and many other ills, But the study found that exposure to yohimbe resulted in the largest proportion of serious outcomes among the more than 2750,000 calls to poison centers that the researchers tracked. green tree Yohimbe can cause changes in heartbeat rhythm, kidney failure, seizures, heart attack and death . https:// nccih.nih.gov/health/yohimbe

30. Experts at the National Institutes of Health argued in 2006 that there’s no clear evidence that vitamins from supplements prevent chronic diseases . https:// consensus.nih.gov/2006/multivitaminstatement.htm#q4

31. What about antioxidant pills? Marketing gurus have helped companies make millions by touting the latest antioxidant product ,cranberry , mangosteen , blueberry, Omega 3 4 ……….6 …………the list goes on. But research published in the Journal of the American Medical Association says not only can some antioxidant supplements be ineffective, they can be hazardous to your health. The 2007 study of more than 2,32,000 people concluded that antioxidant supplements can "increase the risk of death." Mortality in Randomized Trials of Antioxidant Supplements for Primary and Secondary Prevention-Systematic Review and Meta-analysis.. https:// jamanetwork.com/journals/jama/article-abstract/205797

32. Nepal “Nutraceuticals Market” REGULATIONS 9/25/2019 [email protected] 34

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34. Rack of one Hospital pharmacy 9/25/2019 [email protected] 36

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44. Prescription analysis of 3 Hospitals of Kathmandu , 100 patient from each hospital, Nutraceuticals prescribed without counseling of patients 9/25/2019 [email protected] 46

45. Nepal “Nutraceuticals Market” REGULATIONS 9/25/2019 [email protected] 47

46. Ausadhi Sallahkar samiti ko 44th meeting, 2070/09/04 9/25/2019 [email protected] 48

47. May 7 th 2015 , 24 B aisakh 2072 9/25/2019 [email protected] 49

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58. Food Act, 2023 (1967) Date of Royal Seal and Publication 2023.5.24 (9 September 1967) 4 . Prohibition on sale of food by lying or misleading: No person shall sell or distribute any food by lying or misleading that food to be another food or any food of lower standard to be of higher standard. . Powers to withhold Food: 1. The prescribed authority may, if s/he suspects that any food is an adulterated food or sub-standard food, seal such food, hand over its custody to the owner of that food and receive a receipt thereof from him/her and withhold it. 2. After the food withheld pursuant to sub-section (1) has been finally decided or held to be an adulterated food or sub-standard food, His Majesty's Government may confiscate such food, by order of the prescribed authority, taking into account of the quantum of guilt, nature of guilt and injury likely to be resulted from it. a. Licenses to be Obtained 1. Any person intending to produce, sell store or process the prescribed food shall obtain the license as prescribed. 2. Notwithstanding anything contained in sub-section (1), in the case of a sealed food, a retailer having obtained the deed of guarantee as prescribed from the licensed producer or wholesaler shall not be required to obtain the license as referred to in this section. 9/25/2019 [email protected] 60

59. Food Rules, 2027 (1970) Date of Publication in Nepal Gazette 2027.5.15 (Aug 31,1970) Part- 938 License 24.39 License to be obtained: A person, who intends to produce, sell, distribute, store or process any food from commercial viewpoint, shall obtain a license as referred to in this Chapter. 9/25/2019 [email protected] 61

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66. (DRAFT) A Checklist for Complying with Good Manufacturing Practices (GMP ) for Dietary Supplements ( Nutraceuticals) 9/25/2019 [email protected] 68

67. A Checklist for Complying with Current Good Manufacturing Practices (CGMP) for Dietary Supplements For each unique formulation, you need a specification and procedure for its batch production. This is an exact recipe/formula that is used each and every time to ensure consistency batch to batch . There must be a master manufacturing record with specifications for each point or stage in the manufacturing process where control is necessary to ensure quality of the end product. It needs to be documented that the product was produced in a controlled environment (clean room). Two people should sign off at each step being performed that the step was completed in accordance with written procedures. The written procedures must provide detailed instructions, precautions to be followed, and what to do to investigate an issue or remediate a problem. 9/25/2019 [email protected] 69

68. A Checklist for Complying with Current Good Manufacturing Practices (CGMP) for Dietary Supplements Each component used must have a procedure for identifying it and ensuring its purity, strength and composition. This needs to be tamper-proof. There needs to be minimum standards for quality/contamination that are adequate to ensure the efficacy and quality of the final end product . You also need a written procedure for being sure a certificate is present with each supply delivery, it is reviewed, and it is stored and recorded in your system for each supply delivery. You also need a written procedure for how each supply is quarantined (not contaminated), stored and labeled at your facility. You need to keep a representative sample of each shipment and record it in your system. 9/25/2019 [email protected] 70

69. A Checklist for Complying with Current Good Manufacturing Practices (CGMP) for Dietary Supplements If water is an ingredient or used for filtering, it needs to be tested and records maintained of the water source and how it meets water quality standards . There must be quality control testing during the manufacturing process for each component. Is it being stored and used under conditions (cleanliness, temperature, light, humidity, etc.) that uphold its integrity and efficacy? How do you ensure it is not being contaminated? For example, you need a written procedure for: Measuring herbs Grinding herbs or powders to finer consistency Blending herbal powders Mixing herbal liquid blends Pressing herbs during liquid extraction 9/25/2019 [email protected] 71

70. A Checklist for Complying with Current Good Manufacturing Practices (CGMP) for Dietary Supplements There must be specifications for product packaging materials and quality control testing during the packaging process for each component. Are all products, labels and containers being stored and used under conditions (cleanliness, light, temperature, humidity, etc.) that uphold its integrity and ensure the product is not contaminated? There must be specifications for product packaging and shipping. Are containers damaged? Seals broken? Labels incorrect or missing? Is there the right amount of product in each shipment? Is it being stored and used under conditions (cleanliness, temperature, light, humidity, etc.) that uphold its integrity and ensure the product is not contaminated? 9/25/2019 [email protected] 72

71. A Checklist for Complying with Current Good Manufacturing Practices (CGMP) for Dietary Supplements There must be specifications for product packaging and shipping. There must be a procedure for validating the packaging and labelling complies with the laws and regulations. 9/25/2019 [email protected] 73

72. A Checklist for Complying with Current Good Manufacturing Practices (CGMP) for Dietary Supplements You need control sheet worksheet for each batch that contains: Equipment used and processing lines used Date & time of all maintenance, cleaning and sanitization of the equipment and processing lines or a cross-reference to separate records with this information Date & time & employee for all testing for in-process quality control or a cross-reference to separate records with this information Date & time & employee for all testing for final product quality control or a cross-reference to separate records with this information Batch numbering (unique identifier for each batch) or a cross-reference to separate records with this information 9/25/2019 [email protected] 74

73. A Checklist for Complying with Current Good Manufacturing Practices (CGMP) for Dietary Supplements Representative samples must be maintained under good organization and storage conditions. They must be maintained for one year past shelf-life/expiration date or 2 years past distribution of last batch associated with the sample . You need written quality control procedures and how the testing will be recorded. It also needs to state what happens in the case of a failed inspection. These can include analysis for color, residue, transparency/clarity and other observations to ensure quality). 9/25/2019 [email protected] 75

74. A Checklist for Complying with Current Good Manufacturing Practices (CGMP) for Dietary Supplements You need written laboratory procedures that detail the methodology and equipment used, as well as the record keeping of each analysis . You need written procedures for handling product complaints and how the person reviewing them is qualified . You need written procedures for calibrating measuring equipment and how the person performing the calibration is trained and qualified. Results must be recorded with date, time and employee. 9/25/2019 [email protected] 76

75. A Checklist for Complying with Current Good Manufacturing Practices (CGMP) for Dietary Supplements You need written procedures for inspecting electronic, automatic and mechanical equipment and how the person performing the inspection is trained and qualified. Results must be recorded with date, time and employee . You need written procedures for cleaning, sanitizing and maintaining equipment, tools, utensils and surfaces and how the person performing the task is trained and qualified. Each time must be recorded with date, time and employee . You need written procedures for handling product return and what happens to the returned product . You need records to detail where every batch was supplied/distributed and how to contact the buyer in the event of a product recall. 9/25/2019 [email protected] 77

76. 9/25/2019 [email protected] 78 Thank you Open floor discussion…. Conclusion …