PHARMEXIL MEETING

6th June,2007,Hyderabad
“Roadmap for Promotion of Exports of
Herbal / Ayurvedic products”

“The barriers/constraints in the Exports of

ASU Products and Expectations of the
Industry from Indian Govt”

Dr. Anantha Narayana D B

Head: Herbals Research, Hindustan Lever Research Center, Whitefield,
Bangalore 560 066.
Email ID; dba.narayana@unilever.com

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Export Potential of ASU Products

Export potential can be summarized as :

† Ayurvedic Classical / Generic Medicines
† Ayurvedic Prescription and Branded
Medicines
† Herbal Remedies
† Dietary Supplements
† Food products
† Herbal Extracts / Phyto chemicals
† Cosmetics with Ayurvedic
Actives/Ayurvedic Cosmetics
† Herbs, Essential oils, Oils, colors etc

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 “Avenues for ASU products”

TRADITIONAL MEDICINES*

BOTANICAL HERBAL
DRUGS (USA) REMEDIES

Herbs/Herbal material
Intention of use
FOOD/FOOD DRUG/MEDICINES/
SUPPLEMENT/FOSHU PARA MEDICINES

COSMETICS

* Ayurvedic Products Not recognised in any country so far as a category.

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“Key barriers in export of ASU products”

† Biggest Barriers are –Mind set and Absence of Clarity all

around.
† Every thing is evolving for Herbals.
† Each country is a new learning for any exporter.
† Strategy needs to be tuned for each country, each route
and each market.
† Reductionist vs Holistic approach-Latter almost absent
† Application of rules & standards for Conventional Products
blindly
† Scientific possibility and capability not recognised
† Barrier is not only outside but also within the Country.

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“Key barriers in export of ASU
products”

† Need to Recognise and differentiate

between Traditional Medicines (say
Ayurvedic, Unani, etc) and Herbal products
-What do we want to promote?-Latter
seems to be happening & possible.
† Need to define the barriers as-
- Regulatory Barriers
- Technical Barriers
- Non-Tariff Trade Barriers

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“Regulatory barriers in export of ASU products”

† Regulatory barriers-
™ D&C Law does not Recognise Herbal Products
™ D & C Law Recognises only a Food, Drug, ASU drug, ASU
Proprietary drug, Cosmetics.
™ Countries abroad Recognise only Food, Drug, Devices, Food
supplement, Cosmetics.
™ Only Hungary, Malaysia, Russia, Recognise Ayurvedic therapy
™ US FDA has now announced “Guidance for Botanicals as
Drugs". Very expensive, time consuming route needing lot of
data generation.
™ TGA, Australia/ Green Book France/ Fitotherpay (Com E)
Germany Recognise Botanicals as drugs and have guidelines for
registration.
™ Food Supplements (EU) /FOSHU (Japan) /DSHEA( US,FDA)
™ Cosmetics-generally Guidelines Available, but complications
when herbs are added if quantification is demanded. India has a
BIS Standard for Herbal Cosmetics Guidelines in Published in
2006.
™ Hence exporter needs to decide his strategy of how the Indian product
he would export? & under what category?
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“Technical barriers in export of ASU products”

† GMP is a big issue

™ D & C Rules have Schedule T -as GMP-Primarily a hygiene
standards for herbals form of TM ; Indian Laws Has no GMP
for any Herbal products.
™ Importing countries after looking for technical matters
demand GMP certificates- Schedule T is not well recognised.
™ Importing countries ask for WHO GMP certificate ; where
none exist for ASU’s or HP ; WHO GMP is basically for Drugs
& Pharmaceuticals (that too it is Product wise now)
™ Can we request DCG(I) to help in solving the problem; Also
take it up with WHO for any Clarifications/Action; Can GOI
issue a General Letter Clarifying this issue about Schedule T
and make Copies of the same on Letter head available to
Exporters and also on its website.
™ Solve the Pin Pricks by using a Letter head for all Schedule
T compliance Certificates and for FREE Sale Certificates
issued. Dept of Ayush to issue Guidelines to all Directorates
of Ayurveda and Licensing Authorities to help.

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“Technical barriers in export of ASU products”

† QA/QC
™ Physico-chemical testing's are questioned HPTLC/HPLC/GC testing
demanded
™ HPTLC profiles with Photodocumetation is being accepted as minimum QC
specs: Equipment is costly and needs heavy investments – can a Scheme
be done to help industry acquire the Equipment.
™ Standards for Compound formulations not available world wide.
™ Polyherbal nature of composition is frowned upon and multiple questions
are asked.
™ THMP EU guide has some way forward-Mfg’r to decide which are the
active ingredients and which are all “ non-actives” Can we learn form this
and review our policy?
™ Guidelines for Stability studies minimal or absent but data demanded.
™ Common Technical Document mooted –Under Consideration.

‰ Freedom from Contamination testing

™ Export certification Scheme is about to be announced by GOI. Level
1,Level 2, and Level 3 certifications method, Protocols announced,
™ May adversely affect small quantity Consignments as cost of such testing
is high for each consignment.( Estimate of testing Charges-
2600+4500+1700+3000 +ST =13282/-)

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“Technical barriers in export of ASU
products”
‰ Freedom from Microbial Contamination & Technology to reduce it.

™ Microbiological Quality- Confusions as No standard has yet been arrived

, but demanded.
™ WHO recommends different limits –for herbs not treated and treated,&
Topical use-Problem in the former.
™ Technology for reducing load is not available , and those effective have
regulatory problems eg EtO treatment, Low Dose gamma Radiation.
™ BARC encouraging gamma radiation, more units are being set up.
™ Approved for spices, fruits and many food –Clear Guidelines for
applicability to ASU products needed.
™ cost is currently high. products-APEDA subsidizes rates-Can Ayush
dept do same for ASU products?
™ Many countries do not accept same
™ Needs Loan Licence for getting ASU products treated by Gamma
radiation? Can we do away with this step or make it simpler.
™ Clear labeling of treated material- guidelines need to be announced

™ May adversely affect small quantity Consignments as cost of such

testing is high for each consignment.

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 “Technical barriers in export of ASU products”

† SAFETY data
™ D & C Rules do not demand any safety data for ASU
products.
™ Importing countries do not know ASU/Indian Herbals
& want Safety data. Need to develop frame work for
how and what data would be adequate-Long and
strong History of usage need to be recognised –
Nation wide documentation of Ayurvedic
treatment/ADR’s with IT help would be an answer-
Generate over some years impeccable human use
data on a large number of users.
™ Need to generate selective data like mutagenicity,
teratogenicity, skin sensitivity, photo-sensitization,
etc

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“Technical barriers in export of ASU products”

† EFFICACY data
™ D & C Rules do not demand any efficacy data for ASU products &
such data is minimal or absent, but data demanded.
™ Hence Availability of Efficacy data for ASU/Indian Herbals very limited
, rare, and even if present may not meet the rigor applied for Drugs.
™ Even if one wants to generate Human Use data, Ethical Clearance is
not forth coming, not easy to conduct as Doctors are not willing to
involve in such studies.
™ Protocol development for such studies are not easy, and experts who
can do so are not large in number and those who are there are
heavily occupied.
™ Most doctors demand to know safety and “MOA” before getting
involved –almost impossible to provide
™ “Test Dose” decisions are very difficult , mostly need to be based on
some logic, some arbitrary and some on current usage data.
™ Hugely expensive to perform Human Clinicals, especially RPCDB
studies, Can partial funding be considered for such studies?
™ Development of Multi System Ethics Committees –is an
answer. Can GOI issue Circulars to all Medical Colleges
Encouraging them to take up studies if Industry approaches
them.
™ Experience shows that if Human Studies data are provided
chances of allowing benefit Claims are high, leading to better
marketability.
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“Non Tariff Trade Barriers in export of ASU products”

† Non recognition of Ayurvedic Practitioners for Medical

Practice abroad
† Absence of a clear policies for Educational courses in TM
† Protectionist policies regarding Traditional Medicinal or
Indigenous medicine and prevention of other TM products
getting market access-eg TMHP Directive of EU.
† Absence of established norms and procedures for
recognition of TM products
† Absence of GMP standards and therefore dependence on
WHO guidelines which may not encompass Herbal
products
† Non recognition of Ayurvedic Pharmacopoeia/non-
availability of standard monographs.
† Unclear guidelines on gauging Quality and Standardisation
† High registration and renewal charges

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“Non-Tariff Trade barriers in export of ASU products”

† Non-Tariff Trade Barrier.

™ THMP of EU specifies need for 30 years of safe usage data in any
country out of which 15 years of documented safe usage in any
one EU country is required for marketing the TM product in an
EU country.
™ If above is not available the product would need to be registered
like a drug/ TM product for which Guidelines are yet to be
developed.
™ Italy and Spain have List A and List B of herbs for marketing .
Introduction of herbs into these lists Guidelines are not clear, not
transparently announced, and a hush-hush.
™ Introduction of herbs into TGA list has a clear Guidelines but
would cost a lot, is time consuming and no known case of any
Firm working for the same.
™ Non-appointment of TM experts or even non involvement of TM
Experts in regulations development, leads to one-sided law
without adequate consideration to the aspects of TM.
™ Even WHO be requested to involve adequate number of TM
Experts in the various documents they are developing.
™ Indian D & C act also need to review to fit the Indian Herbals/TM
products in a harmonious way with the ways of the world
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“Way Forward

† New Categories needed that can Drive

Growth as well as Exports.
† Create Ayurvedic Cosmetics category and
remove the hurdles for industry.( being
tossed form one dept to another)*
† Create Ayurvedic Supplements category
and drive growth/exports.*

* Were recommendations of Dr Mashelkar Committee Report

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“Starters and Pushers”

† Starters & Pushers:

™ Promotion of Generic Products: GOI to identify 50
Classical Products which meet safety, Environmental
considerations and develop Common Monographs on
their Quality, Safety and Efficacy as well as PIL’s, to
promote exports.
™ Push by introducing Ayurvedic cosmetics and
Ayurvedic supplements categories urgently
™ More reward for investment in this sector
™ Encouragement and full support for adoption of
modern dosage forms and technology and reward the
same with some proprietorship which can bring more
investments.
™ Effort to adopt good things form Herbals/TM’s with
conventional treatment in interest of patients benefit
in our own country first.
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Thanks!

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