regulatory system on the herbal drug approval and

Regulatory System on the Herbal Drug Approval and Management in INDIA

2013 International Regulatory Workshop on the Herbal Drug Products, Seoul- Korea

From 4th to 6th September 2013

Ministry of Health & Family WelfareGovernment of India11

Regulatory System on the Herbal Drug Approval and Management in INDIA

Navneet MarwahaState Drugs Controller, HP, India,

Ministry of Health & Family WelfareEmail : [email protected]

Medical Systems and Drugs Used in India

Pluralistic healthcareØ Synthetic drugs and pharmaceuticals, vaccines, sera, toxoids, diagnostics, devices

(bio-medicines)Ø Ayurveda, Yoga & naturopathy, Unani, Siddha, Homeopathy (AYUSH)Ø Sows-rigpa ( recentyl added)

70% of Indian population depend on AYUSH

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Both systems well regulated and promoted by government

> 95% of ayurvedic medicines are herbal/ herbo-mineral

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Health Care Infrastructure

400 large manufacturers and >8000 small and medium scale pharmaceutical manufacturers

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Domestic production is ≈ $11.6 billion (Rs. 58000 Cr.)9

Bio Medicine

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Export is ≈ $9 billion (Rs. 42000 Cr.)9

Import is ≈ $2.2 billion (Rs. 12500 Cr.)9

Third largest in world in terms of volume and ranked 13th in terms of value

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Herbals in Indian Market

80% of the population of developing countries uses herbal medicines for treatment of various diseases

India is one of the three richest developing countries in the world in terms of Biodiversity


India is the lead manufacturer of herbal medicines

Many of the modern medicines are also derived from herbal sources


Rs. 9800 Cr. (≈ $ 1.8 billion) is the quantum of ayurvedic/ herbal drugs sold in India

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Ayurvedic/ Herbal

20 large and >7000 small and medium setup ayurvedic production firms9


More than 20 standardized herbal extract manufacturers (Rs. 2800 Cr. ≈ $ 519 million)

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- Traditional medicines exported - Rs. 780 Cr. (≈ $ 144 million) - Standardized herbal extracts exported - Rs. 800 Cr. (≈ $ 148 million)

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The current Ayurveda education in India is regulated, and provides the following courses :

1 Undergraduate colleges 260 9927 seats (BAMS)

2 Postgraduate Colleges 67 1293 seats (MD)

Ayurveda Education and Health Care Infrastructure in India


2 Postgraduate Colleges 67 1293 seats (MD)

3 PhD (Ayurveda) 5 App. 35 seats

4 PG in Pancakarma 2 10 seats

5 No. of Ayurvedic hospitals 2420 42271 beds

6 No. of Ayurvedic dispensaries 15017

7 No. of registered Ayurvedic physicians 429246

Definition Range and Kind of Herbal Drugs

The ayurvedic drugs are defined under section 3(a) of Drugs and Cosmetics Act 1940 as under –Ayurvedic, Siddha6 or Unani drug” includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha6 and Unani (Tibb) systems of medicine, specified in the First Schedule

Proprietary Ayurvedic Medicine

Ayurvedic Drugs


The patent/ proprietary ayurvedic medicines are defined under section 3(h)(i) of Drugs and Cosmetics Act 1940 as under –

in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a)

The Government of India has also recognized experience based new combinations by tradition doctors and made a provision of proprietary ayurvedic medicines. Any recipe or ingredient blended to get a new combination with all ingredients mentioned in any of the authoritative books when processed as per traditions is given a proprietary ayurvedic medicines product license.

Proprietary Ayurvedic Medicine

Definition Range and Kind of Herbal Drugs

Phytopharmaceutical drugs include processed or unprocessed standardized materials derived from plants or parts thereof or combination of parts of plants, extracts or fractions thereof in a dosage form for internal or external use of human beings or animals and intended to be used for the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals but does not include administration by parenteral route.

ØDevelopment of scientific approaches and technologies resulted in new botanicals extracts, fractions, solvent treated extracts which undergo both safety and efficacy evaluation.

ØSuch developments are not permitted normally in the above 2 categories i.e. ayurvedic or proprietary ayurvedic medicines, hence government of India is adding new provisions to drug rules to promote innovations and scientific developments of herbal drugs. This addition is under active consideration.

Phytopharmaceuticals


Phytopharmaceutical drugs include processed or unprocessed standardized materials derived from plants or parts thereof or combination of parts of plants, extracts or fractions thereof in a dosage form for internal or external use of human beings or animals and intended to be used for the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals but does not include administration by parenteral route.

ØDevelopment of scientific approaches and technologies resulted in new botanicals extracts, fractions, solvent treated extracts which undergo both safety and efficacy evaluation.

ØSuch developments are not permitted normally in the above 2 categories i.e. ayurvedic or proprietary ayurvedic medicines, hence government of India is adding new provisions to drug rules to promote innovations and scientific developments of herbal drugs. This addition is under active consideration.

Authoritative text recognized by Drugs and Cosmetics Act in India

The traditional experience has been documented and government of India in its wisdom has given regulatory status to these preparations as ayurvedic drugs and there are more than 57 books recognized by Government of India and is laid down under The First Schedule of Drug and Cosmetic Act 1940

The First Schedule has been inserted in regulatory book more than 50 years back and has been amended time to time

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The First Schedule has been inserted in regulatory book more than 50 years back and has been amended time to time

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The latest inclusion in 2010 was ayurvedic pharmacopoeia of India and its parts

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Note : Drug and Cosmetic Act is available at site www.cdsco.nic.in

1. Arogya Kalpadruma2. Arka Prakasha3. Arya Bhishak4. Ashtanga Hridaya5. Ashtanga Samgraha6. Ayurveda Kalpadruma7. Ayurveda Prakasha8. Ayurveda Samgraha9. Bhaishajya Ratnavali10. Brihat Bhaishajya Ratnakara11. Bhava Prakasha12. Brihat Nighantu Ratnakara13. Charaka Samihita – 1500 BC14. Chakra Datta15. Gada Nigraha16. Kupi Pakva Rasayana17. Nighantu Ratnakara18. Rasa Chandanshu19. Rasa Raja Sundara

20. Rasaratna Samuchaya21. Rasatantra Sara Va Siddha Prayoga

Sangraha—Part 122. Rasa Tarangini23. Rasa Yoga Sagara24. Rasa Yoga Ratnakara25. Rasa Yoga Samgraha26. Rasendra Sara Samgraha27. Rasa Pradipika28. Sahasrayoga29. Sarvaroga Chikitsa Ratnam30. Sarvayoga Chikitsa Ratnam31. Sharangadhara Samhita32. Siddha Bhaishajya Manimala33. Sidha Yoga Samgraha34. Sushruta Samhita35. Vaidya Chintamani36. Vaidyaka Shabda Sindu37. Vaidyaka Chikitsa Sara38. Vidya Jiwan

39. Vasava Rajeeyam40. Yoga Ratnakara41. Yoga Tarangini42. Yoga Chintamani43. Kashyapasamhita44. Bhelasamhita45. Vishwanathachikitsa46. Vrindachikitsa47. Ayurvedachintamani48. Abhinavachintamani49. Ayurveda-Ratnakara50. Yogaratnasangraha51. Rasamrita52. Dravyagunanighantu53. Rasamanijari54. Banagasena55. Ayurvedic Formulary of India (Part-I)56. Ayurveda Sara Samgraha]57. Ayurvedic Pharmacopoeia of India

Authoritative text recognized by Drugs and Cosmetics Act in India

The First Schedule


1. Arogya Kalpadruma2. Arka Prakasha3. Arya Bhishak4. Ashtanga Hridaya5. Ashtanga Samgraha6. Ayurveda Kalpadruma7. Ayurveda Prakasha8. Ayurveda Samgraha9. Bhaishajya Ratnavali10. Brihat Bhaishajya Ratnakara11. Bhava Prakasha12. Brihat Nighantu Ratnakara13. Charaka Samihita – 1500 BC14. Chakra Datta15. Gada Nigraha16. Kupi Pakva Rasayana17. Nighantu Ratnakara18. Rasa Chandanshu19. Rasa Raja Sundara

20. Rasaratna Samuchaya21. Rasatantra Sara Va Siddha Prayoga

Sangraha—Part 122. Rasa Tarangini23. Rasa Yoga Sagara24. Rasa Yoga Ratnakara25. Rasa Yoga Samgraha26. Rasendra Sara Samgraha27. Rasa Pradipika28. Sahasrayoga29. Sarvaroga Chikitsa Ratnam30. Sarvayoga Chikitsa Ratnam31. Sharangadhara Samhita32. Siddha Bhaishajya Manimala33. Sidha Yoga Samgraha34. Sushruta Samhita35. Vaidya Chintamani36. Vaidyaka Shabda Sindu37. Vaidyaka Chikitsa Sara38. Vidya Jiwan

39. Vasava Rajeeyam40. Yoga Ratnakara41. Yoga Tarangini42. Yoga Chintamani43. Kashyapasamhita44. Bhelasamhita45. Vishwanathachikitsa46. Vrindachikitsa47. Ayurvedachintamani48. Abhinavachintamani49. Ayurveda-Ratnakara50. Yogaratnasangraha51. Rasamrita52. Dravyagunanighantu53. Rasamanijari54. Banagasena55. Ayurvedic Formulary of India (Part-I)56. Ayurveda Sara Samgraha]57. Ayurvedic Pharmacopoeia of India

Note -Books shown in green fonts are most famous and commonly referred

Regulation for Herbal Drugs

Herbal drugs (pharmaceuticals) are regulated under chapter IV of Drugs and Cosmetics Act

ØIndian Pharmacopoeia Commission established to develop and publish standards for pharmaceuticals

ØIn 2014 edition will have >100 quality monographs on herbal drugs [current I.P. 2010 has 79 monographs]

ØUSP and BP have reproduced many of these quality monographs in their Pharmacopoeia


Herbal drugs (pharmaceuticals) are regulated under chapter IV of Drugs and Cosmetics Act

ØIndian Pharmacopoeia Commission established to develop and publish standards for pharmaceuticals

ØIn 2014 edition will have >100 quality monographs on herbal drugs [current I.P. 2010 has 79 monographs]

ØUSP and BP have reproduced many of these quality monographs in their Pharmacopoeia

Regulation for Herbal Drugs

Ø Good manufacturing Practices prescribed in schedule T

Ø Quality control and testing requirements specifiedØ Pharmacopoeia commission of Indian medicine/

Ayurvedic Pharmacopoeia committee established Ø 7 volumes of Ayurvedic Pharmacopoeia (raw drugs

standards for 600 herbs published) *Ø 2 volumes of Ayurvedic Pharmacopoeia (part II

formulations) for >100 ayurvedic medicines published) *

Ø 2 volumes of Ayurvedic Formulary of India publishedØ Similarly Pharmacopoeia for Unani & Homoeopathy

drugs also published

* Ref : www.ccras.nic.in

Traditional ayurvedic herbal drugs are regulated under chapter IV-A of Drugs and Cosmetics Act


Ø Good manufacturing Practices prescribed in schedule T

Ø Quality control and testing requirements specifiedØ Pharmacopoeia commission of Indian medicine/

Ayurvedic Pharmacopoeia committee established Ø 7 volumes of Ayurvedic Pharmacopoeia (raw drugs

standards for 600 herbs published) *Ø 2 volumes of Ayurvedic Pharmacopoeia (part II

formulations) for >100 ayurvedic medicines published) *

Ø 2 volumes of Ayurvedic Formulary of India publishedØ Similarly Pharmacopoeia for Unani & Homoeopathy

drugs also published

* Ref : www.ccras.nic.in

Herbal Monographs in IP 2014 Edition


Herbals in Indian Pharmacopoeia

Indian Pharmacopoeia Commission is an autonomous body under Ministry of Health and Family Welfare, Government of India, which publishes Indian Pharmacopoeia

IP is the legally recognized book for standards of medicines in India


It specifies the standards in terms of identity, purity and strength of medicines

Therefore, Indian Pharmacopoeia (IP) laid down monograph for herbs and herbal products to maintain their quality

Inclusion Criteria For herbal Monographs in IP

Herbs with specific name and a definitive botanical identity up to

species

Availability and usage in trade and commerce

Regulatory interest


Knowledge and availability of specific

chemical compound of well characterized

structure

Availability of a quantitative method

for estimation of such a compound

Knowledge of safety of the herb and its

sustainability

Monographs in IP 2010 Edition

Acacia (Acacia nilotica)Ajwain (Trachyspermum ammi)Amalaki (Emblica officinalis)Amra (Mangifera indica)Anantmula (Hemidesmus indicus)Arjuna (Terminalia arjuna)Artemisia (Artemisia annua)Ashwagandha (Witahnia somnifera)Belladonna Leaf (Atropa belladonna)Bhibhitaki (Terminalia bellirica)Bhringraj (Eclipta alba)Bhuiamla (Phyllanthus amarus)Brahmi (Bacopa monnieri)Coleus (Coleus forskholli)Daruharidra Roots (Berberis aristata)Daruharidra Stems (Berberis aristata)Garcinia (Garcinia cambogia)Gokhru (Tribulus terrestris)Gudmar (Gymnema sylvestre)Guduchi (Tinospora cordifolia)Guggul (Commiphora wightii)Haridra (Curcuma longa)Haritaki (Terminalia chebula)Ispaghula Husk (Plantago ovata)

Kalmegh (Andrographis paniculata)Kunduru (Boswellia serrata)Kutki (Picrorhiza kurroa)Lasuna ( Allium sativum bulb)Lavang (Syzygium aromaticurn)Mandukaparni (Centella asiatica)Manjistha (Rubia cordifolia)Maricha (Piper nigrum)Methi (Trigonella foenum-graecum)Neem (Azadirachta indica)Pippali Large (Piper retrofractum)Pippali Small (Piper longum)Punarnava (Boerhaavia diffusa)Sarpagandha (Rauwolfia serpentina)Saunf (Foeniculum vulgare)Senna Leaf (Cassia angustifolia)Senna Pods (Cassia angustifolia)Shatavari (Asparagus racemosus)Shati (Hedychium spicatum)Sunthi (Zingiber officinale)Tulasi (Ocimum sanctum)Vasaka (Adhatoda vasica)Yasti (Glycyrrhiza glabra)

Table-1 (Raw Herbs)


Acacia (Acacia nilotica)Ajwain (Trachyspermum ammi)Amalaki (Emblica officinalis)Amra (Mangifera indica)Anantmula (Hemidesmus indicus)Arjuna (Terminalia arjuna)Artemisia (Artemisia annua)Ashwagandha (Witahnia somnifera)Belladonna Leaf (Atropa belladonna)Bhibhitaki (Terminalia bellirica)Bhringraj (Eclipta alba)Bhuiamla (Phyllanthus amarus)Brahmi (Bacopa monnieri)Coleus (Coleus forskholli)Daruharidra Roots (Berberis aristata)Daruharidra Stems (Berberis aristata)Garcinia (Garcinia cambogia)Gokhru (Tribulus terrestris)Gudmar (Gymnema sylvestre)Guduchi (Tinospora cordifolia)Guggul (Commiphora wightii)Haridra (Curcuma longa)Haritaki (Terminalia chebula)Ispaghula Husk (Plantago ovata)

Kalmegh (Andrographis paniculata)Kunduru (Boswellia serrata)Kutki (Picrorhiza kurroa)Lasuna ( Allium sativum bulb)Lavang (Syzygium aromaticurn)Mandukaparni (Centella asiatica)Manjistha (Rubia cordifolia)Maricha (Piper nigrum)Methi (Trigonella foenum-graecum)Neem (Azadirachta indica)Pippali Large (Piper retrofractum)Pippali Small (Piper longum)Punarnava (Boerhaavia diffusa)Sarpagandha (Rauwolfia serpentina)Saunf (Foeniculum vulgare)Senna Leaf (Cassia angustifolia)Senna Pods (Cassia angustifolia)Shatavari (Asparagus racemosus)Shati (Hedychium spicatum)Sunthi (Zingiber officinale)Tulasi (Ocimum sanctum)Vasaka (Adhatoda vasica)Yasti (Glycyrrhiza glabra)

Monographs in IP 2010 Edition (Cont.)

Amla Juice PowderArjuna Dry ExtractAshwagandha Dry ExtractBelladonna Dry ExtractBhibhitaki_Aqueous_ExtractBrahmi ExtractColeus Dry ExtractGarcinia Aqueous ExtractGugulipidHaritaki Aqueous ExtractHaridra Dry ExtractHaritaki ExtractKalmegh Dry ExtractSarpagandha PowderSenna Dry ExtractSunthi ExtractTulasi Dry ExtractVasaka ExtractYasti Dry Extract Opium

Arachis OilCastor OilClove OilCoconut OilCoriander OilEucalyptus OilGuar GumHydrogenated_Castor OilMalt ExtractMentha OilPapainPeppermint OilShellacStarchTolu BalsamTragacanth

Belladonna TinctureGugulipid TabletsIpecac Tincture Sarpagandha TabletsSenna TabletsOpium Powder

Table-2 Herbal Extracts

Table-3 Processed Herbs/ Excipients/ Pharma Aids

Table-4 Herbal Products


Amla Juice PowderArjuna Dry ExtractAshwagandha Dry ExtractBelladonna Dry ExtractBhibhitaki_Aqueous_ExtractBrahmi ExtractColeus Dry ExtractGarcinia Aqueous ExtractGugulipidHaritaki Aqueous ExtractHaridra Dry ExtractHaritaki ExtractKalmegh Dry ExtractSarpagandha PowderSenna Dry ExtractSunthi ExtractTulasi Dry ExtractVasaka ExtractYasti Dry Extract Opium

Arachis OilCastor OilClove OilCoconut OilCoriander OilEucalyptus OilGuar GumHydrogenated_Castor OilMalt ExtractMentha OilPapainPeppermint OilShellacStarchTolu BalsamTragacanth

Monographs in IP 2010 Edition (Cont.)

Amaltas (Cassia fistula)Bakuci (Psoralea corylifolia)Bala (Sida acuta)Ergot (Claviceps purpurea)Ivy Leaf (Malvella leprosa)Kaunch (Mucuna pruriens)Nagakesar (Measa ferra)Valerian Root Vidanga (Embelia ribes)Vijayasara (Pterocarpus marsupium)

Belladonna Soft ExtractIvy Leaf Dry Extract Prepared ErgotValerian Dry Extract

Basil OilBlack Pepper OilCaraway OilCardamom OilClove Bud OilClove Leaf OilClove Stem OilCumin OilDill Seed OilLavender OilLemon Grass OilLemon OilLime OilMentha Arvensis OilNutmeg OilRosemarry OilThyme Oil

Table-1 Raw Herbs

Table-2 Herbal Extracts

Table-3 Processed Herbs/ Excipients/ Pharma Aids


Amaltas (Cassia fistula)Bakuci (Psoralea corylifolia)Bala (Sida acuta)Ergot (Claviceps purpurea)Ivy Leaf (Malvella leprosa)Kaunch (Mucuna pruriens)Nagakesar (Measa ferra)Valerian Root Vidanga (Embelia ribes)Vijayasara (Pterocarpus marsupium)

Basil OilBlack Pepper OilCaraway OilCardamom OilClove Bud OilClove Leaf OilClove Stem OilCumin OilDill Seed OilLavender OilLemon Grass OilLemon OilLime OilMentha Arvensis OilNutmeg OilRosemarry OilThyme OilCOVERAGE IP 2014

(in Press)

Some Examples of Quality Monographs in I.P.

RAW HERB EXTRACT


Some Examples of Quality Monographs in I.P.

CHROMATOGRAMSFINSHED PRODUCT


Ø Approval of new drugs and clinical trials

Ø Import registration and licensingØ Amendment of Drug and Cosmetics

Act and RulesØ Banning of drugs and cosmeticsØ NOC for exportsØ Testing of drugs

Ø Licensing of manufacturing sites fordrugs including API and formulations

Ø Approval of drug testing laboratoriesØ Monitoring of quality of drugs

marketed in the countryØ Investigation and prosecution in

respect of contravention of actØ Recall of sub-standard drugs

Functions of CDSCO Functions of State

Health and Drugs are in the concurrent list of Indian constitution, They are governed by both Central and State Governments under Drug and Cosmetics

Act 1940

Regulatory Organization (Bio-medicines)


Ø Approval of new drugs and clinical trials

Ø Import registration and licensingØ Amendment of Drug and Cosmetics

Act and RulesØ Banning of drugs and cosmeticsØ NOC for exportsØ Testing of drugs

Ø Licensing of manufacturing sites fordrugs including API and formulations

Ø Approval of drug testing laboratoriesØ Monitoring of quality of drugs

marketed in the countryØ Investigation and prosecution in

respect of contravention of actØ Recall of sub-standard drugs

CDSCO H.Q. FDA Bhawan , New Delhi


Ø Medical Education management through Central Council of Indian Medicines

Ø Promote the cultivation of herbsØ Promote the research work on Indian system of medicinesØ To lay down standards to maintain the quality of drugsØ Develop regulation to promote the traditional system of medicinesØ To provide financial subsidy to Small Scale Industries to promote

the manufacture of traditional drugsØ Regulate Clinical trials of these drugs to prove the safety and

efficacy Ø Amend the regulation for the betterment of the system in the

interest of general public

* Department of Ayurveda, Yoga and Naturopathy, Unani, Sidha and Homeopathy (AYUSH)

Role of AYUSH* in India


Ø Medical Education management through Central Council of Indian Medicines

Ø Promote the cultivation of herbsØ Promote the research work on Indian system of medicinesØ To lay down standards to maintain the quality of drugsØ Develop regulation to promote the traditional system of medicinesØ To provide financial subsidy to Small Scale Industries to promote

the manufacture of traditional drugsØ Regulate Clinical trials of these drugs to prove the safety and

efficacy Ø Amend the regulation for the betterment of the system in the

interest of general public

* Department of Ayurveda, Yoga and Naturopathy, Unani, Sidha and Homeopathy (AYUSH)

Ø State Licensing Authority / Director Ayurveda issues licensesØ Each premises of Manufacturer-Inspection-License issuedØ Each product needs licenseØ The requirements for license are –

v Reference to official books, formulation, process, packing specification of finished products, shelf life data .

v For traditional preparation, no mandatory requirement of safety and efficacy data

v For herbal ayurvedic products where modification in process (different from the official books) safety and efficacy data required

Regulation of Ayurvedic/ Herbals in India


Ø State Licensing Authority / Director Ayurveda issues licensesØ Each premises of Manufacturer-Inspection-License issuedØ Each product needs licenseØ The requirements for license are –

v Reference to official books, formulation, process, packing specification of finished products, shelf life data .

v For traditional preparation, no mandatory requirement of safety and efficacy data

v For herbal ayurvedic products where modification in process (different from the official books) safety and efficacy data required

Regulation of Ayurvedic/ Herbals in India (Cont.)

Ø The requirements for license are (Cont.) –

v Use of pharmaceuticals aids (excipients) permitted to improve stability and quality of ayurvedic herbal products

v Mandatory shelf life marking for herbal products already notifiedv Labeling requirements and exemptions for export labeling provided


Ø The requirements for license are (Cont.) –

v Use of pharmaceuticals aids (excipients) permitted to improve stability and quality of ayurvedic herbal products

v Mandatory shelf life marking for herbal products already notifiedv Labeling requirements and exemptions for export labeling provided

Phyto Pharmaceutical – Regulations *

Ø Information on botanical source and detailØ Specification for Raw HerbsØ Process of extraction/ fractionation or other details

of process along with specificationsØ Formulation for herbal drugs, excipients,

specifications, test methods, stability data.Ø Pharmacology and safety data (published or

generated)Ø Clinical trial data or protocol for conducting clinical

trialsØ Copy of proposed label, package insertØ Regulatory information in any other country

Documents Required


Ø Information on botanical source and detailØ Specification for Raw HerbsØ Process of extraction/ fractionation or other details

of process along with specificationsØ Formulation for herbal drugs, excipients,

specifications, test methods, stability data.Ø Pharmacology and safety data (published or

generated)Ø Clinical trial data or protocol for conducting clinical

trialsØ Copy of proposed label, package insertØ Regulatory information in any other country

Under active consideration*

Phyto Pharmaceutical - Regulations (Cont.)

Ø Broad guidelines (Ethical Guidelines for Biomedical Research on Human Participants) for human clinical trials of biological substances including trials of traditional medicine and herbal products published by Indian Council of Medical Research (www.icmr.nic.in)

Ø Clinical trial establishment registrationØ All human clinical trials to be registered in ICMR site “ Clinical Trial

registry of India [CTRI] (www.ctri.nic.in)

Ø Total trials registered on CTRI - 3914v Herbals - 102 (2.6%) v Ayurvedic - 150 (3.84%)

Clinical Studies


Ø Broad guidelines (Ethical Guidelines for Biomedical Research on Human Participants) for human clinical trials of biological substances including trials of traditional medicine and herbal products published by Indian Council of Medical Research (www.icmr.nic.in)

Ø Clinical trial establishment registrationØ All human clinical trials to be registered in ICMR site “ Clinical Trial

registry of India [CTRI] (www.ctri.nic.in)

Ø Total trials registered on CTRI - 3914v Herbals - 102 (2.6%) v Ayurvedic - 150 (3.84%)

Herbals - 102 Ayurvedic - 150

Total trials registered on CTRI - 3914

Ø Pharmacovigilance is the science and activity related to the detection, assessment, understanding and prevention of adverse effects and adverse events of drugs or any other possible drug related problems.

Ø The very aim is to protect patient from un-necessary harm by identifying previously unrecognized drug hazards, elucidating pre-disposing factors and quantifying risks in relation to benefits

Ø Herbal drugs are traditionally considered as harmless but as medicinal products they require drug observations in order to identify their risk factors.

Ø WHO guidelines aim to propose the member states of a frame work for facilitating the regulation of herbal medicines used in traditional medicines covering issues like classification, assessment of safety and efficacy, quality assurance Pharmacovigilance and control on advertisements of herbal products.

Pharmacovigilance


Ø Pharmacovigilance is the science and activity related to the detection, assessment, understanding and prevention of adverse effects and adverse events of drugs or any other possible drug related problems.

Ø The very aim is to protect patient from un-necessary harm by identifying previously unrecognized drug hazards, elucidating pre-disposing factors and quantifying risks in relation to benefits

Ø Herbal drugs are traditionally considered as harmless but as medicinal products they require drug observations in order to identify their risk factors.

Ø WHO guidelines aim to propose the member states of a frame work for facilitating the regulation of herbal medicines used in traditional medicines covering issues like classification, assessment of safety and efficacy, quality assurance Pharmacovigilance and control on advertisements of herbal products.

Market Status and Trend in Herbal Drug

Ø Number of licensed herbal drugs continue to be sold, e.g. Belladona preparations and plaster, Pain balms, Senna tablets, Ipecac Tincture, Sarpagandha Tablets, Opium Powder

Ø A number of raw herbs

Ø Standardized herbal extracts, natural colors

Ø Increased trend to use herbs and extracts in capsule and tablet forms to be sold as supplements

Ø Herbal products for Veterinary and Pets usage on the raise


Ø Number of licensed herbal drugs continue to be sold, e.g. Belladona preparations and plaster, Pain balms, Senna tablets, Ipecac Tincture, Sarpagandha Tablets, Opium Powder

Ø A number of raw herbs

Ø Standardized herbal extracts, natural colors

Ø Increased trend to use herbs and extracts in capsule and tablet forms to be sold as supplements

Ø Herbal products for Veterinary and Pets usage on the raise

Approved Botanicals as Drugs (Pharmaceuticals)

Ø Guglip extract and tablets I.P. – standardized Guggulu extract (Cammiphora mukul) – for cholesterol reduction (developed after intensive research on an Ayurvedic herb)

Ø Gingko biloba tablets (Gingko biloba leaf extract)- for treating short term loss of memory

Ø Gingseng tablet (Standardized Gingseng extract along with vitamins and minerals)- for immunity and energy

Ø Silymarin syrup and capsules –for treating liver disorders

Ø Ginger capsules-standardized Ginger – for treating chemotherapy induced nausea


Ø Guglip extract and tablets I.P. – standardized Guggulu extract (Cammiphora mukul) – for cholesterol reduction (developed after intensive research on an Ayurvedic herb)

Ø Gingko biloba tablets (Gingko biloba leaf extract)- for treating short term loss of memory

Ø Gingseng tablet (Standardized Gingseng extract along with vitamins and minerals)- for immunity and energy

Ø Silymarin syrup and capsules –for treating liver disorders

Ø Ginger capsules-standardized Ginger – for treating chemotherapy induced nausea

- long history of documented safe use of herbal products

- put in place stringent regulatory mechanism for herbal drugs - both traditional and emerging for regulating quality, safety and efficacy

- expertise to develop objectively accessible quality standards for herbal products

India has -

In conclusion


- expertise to develop objectively accessible quality standards for herbal products

- is considering regulation for introduction of Phyto Pharmaceuticals

- put in place ethical and other guidelines for conduct of human clinical trials

- offer to collaborate and share on experience/ expertise on herbal drugs

India has -