AYURBIZ- April to June 2013 1

Dear Members,

We are thankful to the Department of AYUSH for taking the initiative by inviting our Association for the meeting to discuss on ‘Draft Guidelines on Benefit Sharing’ brought out by the National Biodiversity Authority of India, and other industry issues on 30th May 2013 and also Meeting to discuss the matter regarding making exemption for medicinal use in India from UN resolution

for total ban on world wide business of mercury held on 27th June 2013.

Our Association had an opportunity to brief the concerns of the ASU Industry in the above meetings.

I am happy to note that following new members were enrolled as a Annual member of our Association from 1st April 2013 to 30th June 2013.

1. M/s Omkar Ayurved Mandir, Mumbai

2. M/s. G.D. Pharmaceuticals Pvt. Ltd., Kolkata

3. M/s NSF Safety and Certification India Pvt. Ltd, Haryana

4. M/s S.R. Medicare Pvt. Ltd., New Delhi

5. M/s Nirogam India Pvt. Ltd., Haryana

6. M/s Tevapharma India Pvt. Ltd., Mumbai

7. M/s. Salveo Life Sciences Ltd., New Delhi

I warmly welcome all of them and look forward to their active participation in the Association’s activities.

I also warmly welcome M/s.Olive Life Sciences Pvt. Ltd., Bangalore who have enrolled as a Life member of our Association. With this our Association has a strength of 14 Life Members.

I understand from the Secretariat that some of the members have still not renewed their membership which was due on 1st April 2013.

I hereby urge all Members who have not yet renewed their membership for the current year to renew immediately along with outstanding membership, if any, at the earliest.

Kindly note that your financial support is utmost important for the Association to provide the better service to the members.

Dr. P.M. Varier

President - ADMA

A QUARteRlY NewsletteR foR AYURVeDIc & HeRBAl INDUstRY

From the President’s Desk

for Private & Restricted circulation only Vol.1 No. 10 April to June 2013

PResIDeNtDr. P. M. Varier

Arya Vaidya Sala, Kerala

IMMeDIAte PAst PResIDeNtsubharthee Dey

Dey’s Medical Stores (Mfg.) Ltd., Kolkata

VIce PResIDeNts Debarshi Dutta Gupta (east)

East India Pharmaceutical Works Limited, Kolkata

Ranjit Puranik (west)Shree Dhootpapeshwar Ltd, Mumbai

Dr. Rajesh thapar (North)Herbotech India, LudhianaDr. Anil Kumar (south)

Kerala Ayurveda Ltd, Kerala

HoN. GeNeRAl secRetARYchandrakant Bhanushali

Ayurchem Products, Mumbai

JoINt secReAtRY Nimish shroff

Charak Pharma (P) Ltd, Mumbai

tReAsUReRshashank sandu

Sandu Brothers Pvt Ltd, Mumbai

ReGIoNAl secRetARIesJasmeet singh (North)

Fidalgo Healthcare, LudhianaHardik Ukani (west)

Vasu Healthcare Pvt. Ltd., VadodaraDr. saji Kumar (south)

Dhathri Ayurveda Pvt Ltd, Kochi

MeMBeRsPrabodh V. shah

Virgo UAP Pharma Pvt. Ltd., AhmedabadDr. J.P. singh

Shree Dhanwantri Herbals, Amritsarchanpreet singh chawlaDr. Asma Herbals, Amritsar

Dr. Amit Agarwal Natural Remedies Pvt. Ltd., Bangalore

Vd. Punarvasu Agnihotri Shree Shanker Ayurvedic Pharmacy, Ahmedabad

Pushkar sharad PathakChaitanya Pharmaceuticals Pvt. Ltd., Nashik

Vd. Uday DeshpandeThe Ayurvedeeya Arkashala Ltd., Satara

sunil Balchandra tambeSantulan Ayurveda Pvt. Ltd., Karla

Aniruddha Milind Raj PathakKoral Pharma, Nashik

Dr. c.K. KatiyarEmami Limited, Kolkata

Dr. J.l.N.sastryDabur India Limited, Ghaziabad

Dr. Dilip trivediShriji Herbal Products, Mumbai

Jaideep NagrathPentavox Herbals P. Ltd., Ludhiana

sanjeev Passi Prabhat Ayurvedic Pharmacy, Amritsar

shriram GandhiLVG Healthcare Pvt. Ltd., Ahmedabad

Ashwani Kumar GuptaAbhishek Pharmaceuticals, Ludhiana

Rajendra DobriyalHindustan Unilever Ltd., Delhi

AYURBIZ- October to December 2012 1

Dear Members,

Wishing you all Season’s Greetings and A Happy & Prosperous New-Year 2013

You are all aware that our industry is seriously affected with the notifications issued by the Department of AYUSH on Schedule Z, Prefix Suffix and of Labeling issues.

We were repeatedly requesting the Secretary, Department of AYUSH for an appointment to resolve the

burning issues of the ASU industry. However, department is not showing any interest in having dialogue with industry members. We are still trying our level best to meet the Secretary, Department of AYUSH to resolve the issues at the earliest.

The present Executive Committee of the Association will be retiring according to the Constitution of the Association at the Annual General Meeting scheduled to be held on 22nd February 2013. Notice of the AGM along with the nomination forms for election of new Managing Committee members would be sent to all Members shortly. We earnestly request the Members to actively participate in the activities of the Association by sending their nomination forms duly filled, by specified date.

I am thankful to all the members for the active support and co-operation extended to the Managing Committee for the successful completion of one term.

From October to December 2012, eight new members have been enrolled as a member of our Association. I warmly welcome them and look forward to their active participation in the Association’s activities. The names of the new members are as follows:

1. M/s SG Pharma Pvt. Ltd, Mumbai2. M/s Dynamic Remedies Pvt. Ltd., Mumbai3. M/s SciTech Laboratories Pvt. Ltd., Mumbai4. M/s Saiba Industries Pvt. Ltd., Mumbai5. M/s Bluemax Pharmaceuticals – Solapur6. M/s Eupharma, Ludhiana7. M/s Virgo UAP Pharma Pvt. Ltd., Ahmedabad8. M/s Capro Labs Exports India Pvt. Ltd., Bangalore

I hereby urge all Members who have not yet renewed their membership for the current year to renew their membership immediately as the same is overdue. Kindly note that your financial support is utmost important for the Association to provide the better service to the members.

Subharthee Dey President-ADMA

A QUARTERLY NEWSLETTER FOR AYURVEDIC & HERBAL INDUSTRY

From the President’s Desk

For Private & Restricted Circulation Only Vol.1 No. 8 October to December 2012

AYURBIZ- April to June 20132

From the Secretary’s Desk

AYURBIZ- October to December 20122

From the Secretary’s Desk

A gist of activities and updates are given below for your information.

1. ADMA had coordinated/associated 5th World Ayurveda Congress &

Arogya Expo 2012 and organized further Road shows with the support of local Associations in the following cities:-

i. Thrissur on 6-10-2012

ii. Hyderabad on 14-10-2012

iii Bangalore on 3-11-2012

By this, ADMA had organized nine WAC programmes all over the country. This has resulted on booking good number of stalls especially by members of Gujarat (39 Members – 52 Stalls) in addition to the members of other states.

2. ADMA with World Ayurveda Congress had organized Two days Pre-Conference Workshop on 5th and 6th December 2012 in collaboration with VNS Pharmacy College at Bhopal. We are thankful to Dr. D.K. Swamiji, Group Director, VNS College for providing us their premises and facilities with personnels for organizing this Workshop. We also wish to state that we have received a good response for this programme. We also appreciate the effort and support by Dr. Kirti Laddha, Dean, ICT & Professor of Pharmacognosy Institute of Chemical Technology, Matunga, Dr. Nagesh Sandu, Technical Head, ADMA, Dr. Gopal Garg, Professor, VNS College (Associate Programme Head), and Dr. Nimish Vador, Technical Committee Member, ADMA, without whom this Programme would not have been successful.

3. ADMA with World Ayurveda Congress had also organized GLP / GMP Workshop on 7th December 2012 at the 5the WAC & Arogya Expo 2012 at Bhopal in addition to Seminar on Sustainable Management of Bio Resources on 9th & 10th December 2012 in collaboration with NMPB. We are thankful to Dr. N.B. Brindavanam for his painstaking efforts in organizing this Seminar.

4. We have received Notification GSR No. 844(E) dated 26th November 2012 issued by the Department of AYUSH with regard to the amendments in the Drugs & Cosmetics in Rule 161, and we sent our submission to Shri Ganeriwalji, Joint Secretary, Department of AYUSH on 21st December 2012.

5. We have sent our letter dated 6-11-2012 sent to Mr. Anil Kumar. Secretary, Department of AYUSH enlisting therewith some of the issues and requesting for an appointment for the Interactive meeting with the industry members as per the date convenient for him. However, we have not received any response for the same.

6. As you are all aware that our Association had made a submission on 12th September 2012 while receipt of Notification GSR 597(E) dated 30th July 2012 from the Department of AYUSH with regard to Prefix & Suffix. The same was circulated to all the members for their information. Our Association has now received a Meeting Notice from the Department of AYUSH to discuss on the said draft Notification which is scheduled on 10th January 2013 at New Delhi. We would inform the outcome of the meeting after the meeting takes place.

7. While on request for appointment, the Chairman, National Biodiversity Authority was kind enough to give the appointment for 6th December 2012. However, due to WAC Programmes, ADMA had requested for an appointment after 17th December 2012 for a Brainstorming Session to resolve issues Regarding Biodiversity Act & Rules. However, we have not yet received the appointment and we are on follow up for the same.

8. We have requested Secretary, Department of AYUSH vide our letter no. 1212/ADMA/530 dated 13-12-2012 for an Arogya Calendar for the financial year 2013-14, as some of the members have communicated for the same. We are awaiting for the response.

9. Our Association had received the Minutes of the meeting of Sub-Committee under ASUDTAB regarding examination of proposed Schedule Z held on 4-9-2012 at CCRUM which was circulated to all the Members. We had received draft minutes of the meeting from Dr. Gaurav Sharma, co-opted member of the Sub-Committee inviting the inputs on the said draft minutes and our Association had sent its comments. However, it was observed that our comments have not been considered while finalizing the minutes.

10. Department of AYUSH had requested to intimate the name of the ADMA Representatives for the Technical Committee constituted to deliberate the

Dear Members,

A gist of activities and updates are given below for your information.

1. Roundtable on Business and Biodiversity was organized on April 18, 2013 at New Delhi by the Ministry of Environment & Forests. Dr. Badari Narayan, Dy. Gen. Manager, Agro biotech, Dabur Research, represented ADMA in this Roundtable Meeting on Business and Biodiversity

2. We have received BIS Amendment Bill 2012 from IPR Division, FICCI requesting to send ADMA comments on the same. With the co-ordination of our Technical Committee Dr. Nagesh Sandu and Mr. M.K. Vahalia, we have sent our comments vide our letter ref. no. 0413/ADMA/59 dated 20-4-2013.

3. ADMA sent its comments to the Chairman,National Biodiversity Authority, Chennai on Draft Guidelines on Access and Benefit Sharing prepared by NBA,vide letter no. 0413/ADMA/88 dated 29-4-2013. The same is reproduced in this AYURBIZ Page No.5-7

4. Centre of Excellence on Medicinal Plants and Traditional knowledge-Steering Committee meeting was held on 3-5-2013 at MoEF, New Delhi. Dr. N.B.Brindavanam attended this meeting on behalf of ADMA..

5. National Consultation on the ‘Legal and Policy Framework for Medicinal Plants and Associated Traditional knowledge in India’ under the aegis of the GEF-GoI-UNDP project entitled ‘Mainstreaming Conservation and Sustainable Use of Medicinal Plant Diversity in Three Indian States’ was held on 9th -10th May 2013 at Casuarina Hall, India Habitat Centre, Lodhi Road, New Delhi. Dr.C.K. Katiyar and Shri Rajendra Dobriyal participated in this National Consultation on behalf of ADMA.

6. As requested by the MoEF, ADMA submitted Base Paper on regulatory framework for Medicinal Plants – Industry Perspective prepared jointly by Dr. Amit Agarwal and Dr. N.B.Brindavanam.

7. ADMA Representatives were invited for a National herbal workshop on May 27-29,2013 on the topic

“medicinal plants & NTFP” at New Delhi, organized by Dr. U. V. Ghate, Director, Covenant Centre for Development (CCD). Myself , Mr. Nimish and Dr. Amit attended this meeting.

8. Department of AYUSH had invited the Representatives of ADMA for the Meeting on 30-5-2013 at New Delhi to discuss on “Draft Guidelines on Benefit Sharing” brought out by the National Biodiversity Authority of India, and other industry issues. Myself, Mr. Ranjit Puranik, Dr. Amit Agarwal and Mr. Rajendra Dobriyal, Dr.Vijendra from Himalaya attended this meeting.

9. We have been requested to comment on revised draft Centrally Sponsored Scheme of Quality control of ASU &H drugs to be implemented in 12th Five Year Plan . Our comments to Department of AYUSH was already sent vide our letter ref. no. 0613/ADMA/197 dated 11-6-2013.

10. Department of AYUSH had invited the Representatives of ADMA for the Meeting on 18-6-2013 to discuss the matter regarding Notification on Normally Traded Commodities under Section 40 of the Biological Diversity Act. Mr. Ranjit Puranik, Dr. Amit Agarwal, Dr. N.B. Brindavanam and Mr. Rajendra Dobriyal attended this meeting.

11. Department of AYUSH had invited the Representatives of ADMA for the Meeting on 27-6-2013 to discuss the matter regarding making exemption for medicinal use in India from UN resolution for total ban on world wide business of mercury. Mr. Ranjit Puranik and Dr. J.L.N. Sastry participated in this meeting.

12. Members interested for the copy of our submissions may kindly write to ADMA Secretariat for the same.

13. Members are also requested to send their feedback as and when requested to enable us to make effective submission.

chandrakant Bhanushali Hon. General Secretary

AYURBIZ- April to June 2013 3

Aging is an inevitable process for any living being. Aging can be defined as a multifactorial phenomenon characterised by a time-dependent decline in physiological functions. It is related to many metabolic alterations, such as dyslipidaemia, atherosclerosis, obesity, type-2 diabetes, arthritis and neurodegenerative diseases.

The detrimental effects of the aging process are numerous and diverse. They affect cells, tissues, organs, systems and the body as a whole. Ayurveda defines the body as:

Meer³e&les leled Mejerjced ~

- which means the body consistently goes on eroding. The only way to delay the aging is to increase the youth-span, which means to arrest or minimise the erosion of the body.

effects of aging

cells and tissues: The cellular functions decline in efficiency with advancing age. For example, the abilities of mitochondria to survive a hypoxic insult and perform oxidative phosphorylation, the synthesis of structural, enzyme and receptor proteins, the abilities of cells to take up nutrients and repair chromosomal damage, all decline with age. Organelles, particularly nuclei, Golgi apparatus and endoplasmic reticulum, in the aged cells also have irregular and abnormal shapes, which affects their normal functioning. Aging also affects all tissues. For example, muscle mass is subject to muscle atrophy, which results in a decreased capacity for work.

organs: Age-related changes to organs include a decrease in the size and activity of several major organs. Reduction or complete loss in the function of sense organs is frequent with the advancing age. Aging also affects the vital internal organs. There is a decrease, for example, both in the size and elasticity of the lungs, resulting in a reduced gas exchange capacity. The weight and volume of kidneys may decrease by 20–30% with age as a huge number of nephrons are lost and replaced by scar tissue. The brain loses weight with age, reducing from a typical mass of 1.4 kg at 20 years of age to about 1.3 kg at the age of 60. The loss is due to changes in composition that include enlargement of the ventricles, widening of the surface channels and loss of nerve cells. Similarly, the liver shrinks on account of gradual loss of hepatocytes. There is a concomitant decline in some liver functions especially in the metabolism and detoxification of drugs and xenobiotics. This is clinically significant as most of the medications are metabolized and cleared from the body more slowly in the elderly population, and thus this fact must be taken into account while prescribing the drugs and determining the dose in these subjects.

systems: The most easily recognized effects of aging are the changes to the skin. These changes include wrinkling, changes in skin pigmentation and graying and loss of hair. Skin wrinkling is caused by changes to collagen, with increased cross-linking and a reduction in elasticity. Endocrine functions also decline with age

because of a reduction both of hormone production and of the numbers of hormone receptors on target cells e.g. age-related decline in functions of reproductive system and increased risk of type-2 diabetes. Immune function also declines with age. Numerous well-documented defects may occur in the cardiovascular system as it ages. Connective tissues, which are essential components of blood vessel walls, lose elasticity making the vessels more rigid. Arterial walls may harden causing atherosclerosis.

causes of aging

A number of theories have been proposed to explain cellular aging. All these theories can be broadly categorized under two heads. First one is ‘wear-and-tear’ of the body, which includes free radicals theory, formation of advanced glycation end products (AGEs), accumulation of cellular waste products and Error-catastrophe theory. The other group of ‘Genome based theories’ include programmed aging and gene-mutation. Although Free-radicals theory is the most studied one, no single theory explains the process of aging satisfactorily. Many scientists in this field believe that all these theories are interlinked and all together lead the individual to age.

Age-related diseases

Factors that may contribute to age-related diseases include the physiological and biochemical changes associated with normal aging, the cumulative exposure to harmful agents, and an increased sensitivity to agents or the environment. All these factors cumulatively alter the immune, nutritional, metabolic and endocrine status of the body making the internal environment of the body favorable to many fatal diseases. These include cancer, cardiovascular disease, type 2 diabetes, cataracts, arthritis, Parkinson’s disease and Alzheimer’s disease (AD) (Figure 1).

Scientific measures to delay aging

calorie Restriction

A reduced energy intake (‘calorie restriction’) is known to slow down the rate of aging and onset of age-related disorders, such as cancer (breast, lymphomas, prostate), nephropathy, cataract, diabetes, hypertension, hyperlipidemia and autoimmune diseases. This has been demonstrated in a variety of species including chickens, rats, rhesus monkeys and other animals, and is also believed to be true for humans. Calorie restriction may, however, be difficult to apply to humans because many

eDGe oUt AGING : PAUse tHe PRocess

Figure 1. Increasing incidence of invasive cancers and Alzheimer’s disease with advanced age. (Source: Biology of Disease, Taylor & Francis Group Publications, 2007)

AYURBIZ- April to June 20134

people may be unable to reduce their calorie intakes by an appreciable amount for the extended period of time required. However, it may be possible to motivate people to do this, especially those with family histories of age-related diseases such as cancer and neurodegenerative disorders. Another way of maintaining calorie-balance is ‘burning the calories’ by way of exercise, such as walking, cycling, swimming, sports, aerobics.

Antioxidants

One important line of defense against free radical damage is the presence of antioxidants. Some antioxidants are produced during normal metabolism in the body. Other lighter antioxidants are found in the diet. There is an inverse correlation between the levels of antioxidants present in tissues/blood samples and the occurrence of fatal diseases like cardiovascular disorders, cancer etc. Phyto-antioxidants have promising therapeutic potential in delaying the onset of aging as well as in preventing the aging related complications. Phyto-antioxidants are preferred due to their holistic, multifaceted, synergistic effect as they are enriched with the polyphenols (flavonoids).

Amalaki (Emblica officinalis) is regarded highly in Ayurveda as the most potent anti-aging (Rasayan) herb. Chyavanprash, an avaleha containing Amalaki as main ingredient, was said to be administered in ancient days to reverse the aging, that is reducing the signs of aging and enhancing the youth span. Strikingly most of the therapeutic properties of Amalaki are attributed to its antioxidant properties. It is an important dietary source of vitamin C, minerals, and amino acids and also contains phenolic compounds, tannins, phyllembelic acid, phyllemblin,

rutin, curcuminoides and emblicol. The fruit extract has demonstrated hypolipidaemic, antidiabetic and anti-inflammatory activities. Fruits have also been reported to inhibit rhesoviruses such as HIV-1 and tumour development. Antioxidant properties are exhibited through the potent inhibition of lipid peroxidation and prolyl endopeptidase, and scavenging of hydroxyl and superoxide radicals in vitro. Many scientists working on the phyto-antioxidants believe that India can create world-class products by using ancient wisdom and modern science.

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AYURBIZ- October to December 2012 3

issue on Order passed by High Court, Jammu & Kashmir with regard to the procurement policy for purchase of Ayurveda drugs under CGHS/ Research Council, and the names of the President Shri Subharthee Dey or Hon. General Secretary Shri Chandrakant Bhanushali were informed for this Committee.

Two meetings were held on 23rd November 2012 and 10th December 2012. Since President and General Secretary could not attend the meeting due to prior commitments, Dr. J.P. Singh represented ADMA in both the meetings. A final meeting has been called by the Department on 28th December 2012 and ADMA has nominated Dr. J.P. Singh to attend this meeting and the outcome of the meeting would be informed to the members.

11. We are receiving queries from the members with regard to applicability of the Bar coding for the

exports of the Ayurvedic products. We wish to clarify that as per the notification of the Commerce ministry implementation of barcoding is effective from January 1, 2013.

12. We have given to understand that Mercury usage around the world is being hastily curtailed by which developed countries would declare their environment to be `Mercury free’ in a few years. As such all use of Mercury in Ayurveda is being banned and the effects of this are seen in phenomenon raise of Mercury prices. We are going to make a submission in this regard to the Department of AYUSH the draft of which is circulated to all members for their feedback

Chandrakant Bhanushali Hon. General Secretary

ADMA now accepts Advertisement in AYURBIZ. For enquiry kindly contact the Secretariat

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AYURBIZ- April to June 2013 5

The Association has submitted the Comments to the Chairman, National Biodiversity Authority, Chennai on the ‘Draft Guidelines on Access and Benefit Sharing’ prepared by NBA, on 29th April 2013. The announcement seeking comments relates to two documents which are closely interrelated. The first draft relates to the Access of Biological Resources. The legislation and the allied rules have distinctly spelt-out the procedure under which, certain individuals/ institutions/ body corporate need to seek prior approvals from NBA for accessing Biological Resources (BR) and/ or Traditional Knowledge (TK). Our association realized that, the document provides basic requirements of various applications under the law. This kind of guideline if consulted with attention shall be useful for the applicant to avoid re-submissions on account inadequacies.

oBseRVAtIoNs oN tHe DRAft GUIDelINe:The Biological Diversity Act-2002 and the Rules-• 2004 by their spirit recognized and captured the intent of CBD- which does not restrict the use of Biological Resources but encourages its sustainable use based on fair and equitable sharing its benefits. However, the draft of guideline does not make any specific attempt to address at least, some part of these factors. For example, the paragraph-3 speaks about the asymmetry of resources for negotiations between the holder of BR and the developer and marketer of the final product. In today’s scenario, the Experts Committee on ABS of National Biodiversity Authority seems to play a negotiating role on behalf of BR holders. Almost all the agreements made between NBA and the applicants arriving at 2% ABS stand to testify the agreement between a “regulator” and an “applicant”. To our view, it is desirable to change this kind of existing mechanism for negotiations. We also observe that, the guideline didn’t make any • specific attempt to create “transparent platform for negotiations”- while most of the “Criteria for Benefit sharing” are meant actually, to be transparent in the draft. The draft Guideline revolves around the cases/ • applications pertaining to bio-prospecting/development of new leads for therapeutic products/ drug discovery and new molecules/ analogues. The guideline also restricted itself to the applications/ proposals made to NBA under Section-3 of Biological Diversity Act-2002 and Rule-14 of Biological Diversity Rules-2004. Further, the draft guidelines are too subjective & • some degree of interpretations may be necessary. In the past, our association has pointed out the • conventional uses of BR in Ayurveda, Siddha,

Unani and Homoeopathy- which our association represents citing instances of using BR by tanneries, non-edible industrial oils, Essential Oils, Natural Perfumes, Natural Flavours, Colours and dyes etc. The legislation per-se and its allied regulatory instruments unfortunately, didn’t pay any attention to these “Conventionally Traded BR”. In absence of any specific provisions, these categories of BR utilization- will be subject to “convenient extrapolation of law” .ADMA had expressed its concerns about the 1• st Draft of guidelines formulated by NBA during 2009 in this very context. There are several opportunities to attain various objectives of BDA through these segments. Unfortunately, latest guideline didn’t take these opportunities into cognizance.

coMMeNts:These are enclosed as Annexure, in tabulated form.

sUGGestIoNs: Elaborations on Criteria for BS & Options for BS: • In order to reduce subjectivity and to make the contents more objective, each of the criteria may be illustrated further so that the guideline document will be self-explanatory to the extent possible.Need for Creation of Platforms for Negotiations • under NBA/ SBBs: In absence of a negotiating platform, the “Criteria for Benefit Sharing” (which is listed pragmatically as far as possible in the guideline) may lose its spirit. the guideline should spell-out a distinct mechanism by which the negotiations on ABs shall take place. the direct involvement of experts committees/ Officials of NBA/ SBB for ABS negotiations will lead to undesirable apprehensions and create psychological barriers for the applicants. Extension of Guidelines to All the States: • ADMA suggests that the Final Guideline on Benefit sharing be extended to all the applicants- approaching respective state Bio Diversity Boards under section-7 of the Biological Diversity Act. this will bring a clear degree of Uniformity and fairness in terms of criteria, options for Bs across the country. In this context, it may be noted that, the Individuals/ Institutions/ organizations/ Body corporate of Indian Origins may also be interested to access BR and/or associated TK for bio-prospecting/ new product development purposes. Ideally, there should not be discretionary approaches/ variability in principles and practices for these applications- just because they seek BR through SBBs. Today, 15 states also

‘DRAft GUIDelINes oN Access AND BeNefIt sHARING PRePAReD BY NBA’ – summary of the ADMA submission

AYURBIZ- April to June 20136

have formulated the Biodiversity Rules as applicable in respective states- in addition to the Biological Diversity Rules-2004 formulated by the Union Government. This kind of a regulatory structure may seem to be federal in approach. Exemptions for Certain BR under ABS Regime:• we suggest the need of exempting distinctly and unambiguously, certain Biological Resources from the scope of the guidelines for benefit sharing. this suggestion may please be interpreted under the cBD text and the Biological Diversity Act-2002, which never intended to regulate each and every BR. such an attempt might add only to the process complexities and even may be counterproductive. For this purpose, it may be arduous to compile a negative list but a “suo moto” basis may be followed. For example, the

food crops, NTAC candidates, indigenous flowers etc. Consideration to Value Added Products: • It is suggested to make a distinct reference to the Value Added products in the guideline. the process of Benefit Sharing should ideally be restricted to level-I of Value addition. At present, it is often observed the intent of regulators to bring in, Benefit Sharing Mechanisms at multiple stages- though the legislation per-se exempts the scope of the law for Value added products giving distinct examples. For example, the essential oil extractor obtains BR and converts it into Essential Oil of certain purity and complies with the ABS regime. The next buyer from him obtains this oil and derives a fragrance compound in its pure form. It is obviously unfair if, the 2nd company is forced to shell additional contributions to the primary resource owner.

sPecIfIc coMMeNts oN tHe coNteNts of tHe DRAft GUIDelINe

Part-A: Criteria for Benefits Sharing:

Reference Present text commentsPage no. 6 (d)

Application of technology:

It is not clear as to how the application of technology is correlated to BS. If, • the accessor accrues/ likely to accrue benefit out the BR the case is fit BS- irrespective of its application.Hence, the applicant makes commitment to the effect.• May be deleted. •

Page no. 6 (i)

Annual turnover This is not a relevant criterion. The BS can be ultimately claimed only from the • BR and the product in which it is used.May be deleted.•

Page no. 6 (b)

Milestone Payments While the above two options can be adopted as non –obligatory options for • the “users” to pick up from, they cannot be mandatory for all cases of benefit sharing. If at all they need to be mandatory options, then there should be provisions • to address a situation where the commercial anticipations are not met on real time basis. On the contrary if the commercial returns are achieved much higher than the • anticipated returns, there should be provisions for revising the benefit sharing. Therefore it is preferable to include “Profit after liability for each product using • bio-resource” as an option benefit sharing.

Page no. 6 (g)

Joint Ventures with Indian Institutions and companies

This option is somewhat misleading. Under the law, the Indian and foreign • companies are required to share benefits without visible concessions/ privileges.Forming a JV is more of business decision than an option for BS. Instead, • an option of providing “equity options” for BR owners/ community could be a better option for the entrepreneur of sharing benefit on a continuous basis

Page no. 7 (i)

sharing the Research and Development Results with India

The statement is ambiguous. The MNCs operating in India (Section-3.2 • companies) tend to generate data within India.

Page no. 7 (m)

scholarships, Bursaries and financial Aid to Indians

Ideally, such form of benefit sharing may be restricted to the regions/ sects/ • tribes contributing to the delivery of BR and subsequent profitability if, any.It is not desirable that the company accesses BR from some remote village • and pass on the benefits to a school in Mumbai.

Page no. 7 (q)

Payment of any other monetary or non-monetary benefit as the NBA may deem fit

We propose that, non-monetary benefit sharing initiatives illustrated under • Annexure to Article 5(4) are covered in entirety in the option.These options will motivate corporate entities having structured CSR • programmes. Also, the accessor would consider all avenues to contribute to the sustainability of resource.

AYURBIZ- April to June 2013 7

Guidelines for Bs against conventionally traded/ Utilized Biological Resources:

ADMA suggests the need for formulation of • Guidelines, which are specific for the biological resources- which are being Conventionally used for Commercial gains and in different industries like Ayurveda, Siddha, Unani and Homoeopathy formulations, Non-edible vegetable oils from wild flora, Essential Oil industries etc. These guidelines are ideally formulated and included • in the present draft. The NBA may like to cover these guidelines as a separate document- in which case, the present guideline makes a distinct reference to this effect. We also plead NBA to convene a focused stakeholders meet on this aspect of the guideline at the earliest, while we are enumerating an over-view of this suggestion. This guideline shall be applicable for a selected set • of Biological Resources accessed for a scheduled purpose of using the BR exclusively for the scheduled purposes of making ASUH formulations/ for manufacturing herbal extracts/ concentrates/ essential oils/ natural dyes etc – which can be defined with due diligence.

Biodiversity Boards of respective states may be advised to prepare a schedule of species being conventionally collected and traded in their state so as to cover them under the ambit this specific guideline. This exercise may be carried out through local consultations and mechanisms.In these cases, the principles/ Criteria for Benefit • Sharing should be structured on a combination of quantum, purchase value of the BR, Source of BR (wild or cultivated or both) abundance of the resource in wild, sustainability of plant part, resource management needs of the species etc.

These factors may be mapped on a grid to arrive at the amount payable by the user industry per kg/ MT- to the State Biodiversity Board or to BMC in addition to the procurement cost. Due credits may be given to the end-user while fixing the amount of BS for any ground work they do at community level like farming, capacity building, local infrastructure support etc. This particular principle of Benefit sharing is • suggested on the following grounds:Collection and trading of many BR/ NWFPs in India is a source of additional income (in general, it is a supplementary income for the needy communities. From regulatory point of view, this process is faced with a blend of both facilitators and inhibitors. The Biological Diversity Act and its allied instruments need to focus upon optimizing this livelihood opportunities.The commercial utilization of BR is highly varied and complex. Sometimes, the BR is used for a complex application wherein, product based BS may be difficult. For example, the use of Terminalia

chebula in tanneries or for conversion of normal salt into Black salt.In case of ASU formulations, the distribution of Benefit sharing accruals is more expensive than the benefit per-se. This complexity is the outcome of the poly-herbal formulations they tend to manufacture. When a product contains ingredients from multiple states/ origins, compounding the amount of benefit sharing will be associated with many conflicts.By and large, MSMEs may be involved in commercial utilization of BR. For example, the non-edible vegetable oils are extracted by an oil-expeller or many Ayurvedic medicines are produced by small pharmacies. For this set of entrepreneurs, it would simple to comply with basic financial obligations rather than getting into negotiations under the law. New product development, new drug development • based on some remote ethnic experience and/ or bio-prospecting with or without prior leads seems to be very attractive propositions for BR/ TK owners. At the same time, they are long-drawn from the date of agreement. Also, they are associated with their own degree of uncertainties. On the other hand, a pragmatic approach in the context of conventional uses of BR will ensure realization of some economic returns sooner and can grow further, consistently.

coNclUsIoN: Industry’s concerns & Appeal:ADMA has drawn attention of NBA and its expert • bodies towards ASU which are the national systems of Traditional Knowledge Base. The Government of India is taking care to safeguard the interests of these knowledge systems through different mechanisms which are also aiming to ensure economic returns to the country by globalizing this knowledge base. ADMA advocates that, these existing mechanisms and the institutional framework for Biological Resources go in harmony and complement each other. The ASU sector being predominated by small • and medium scale enterprises complex statutory procedures and their interpretations shall be detrimental to their survival. The contents of law have not built any safeguards for these enterprises. A Guideline having distinct provisions for them will definitely go a long way, in bringing about higher compliance rates. Further, individualized interpretations to the legislative intent and spirit can be preempted only through precise and pragmatic guidelines to be fitted within the main regulatory framework. ADMA has underlined the Industry’s concern • that, in absence of clarity- the present guideline shall be over-ambitiously extrapolated to AsU industry & has requested for an opportunity to present our views and proposals related to the additional guidelines for ABs.

AYURBIZ- April to June 20138

Wanted Unit on sale and/or third Party Mfg facilities

We require mfg and packaging facilities in all types of ayurvedic proprietory and classical product range in various dosage forms. Interested Parties should state details of mfg, packaging, Q.C. facilities with persons involved.

require consultants i) Marketing ii) Packaging iii) formulation iv) MedicalPersons having experience in good pharma discipline and willing to offer services full/part time should email their application.

farmak Pvt. ltd. 406, Autocommerce House, Nr. Kennedy Bridge Grant Road (W) , Mumbai -7 Email: farmakltd@gmail.com M: (O) 9320564003