Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
inordinate delay, my self and Mr. Ranjit Puranik booking the stalls in great numbers so as to avail
could not wait for this meeting. maximum discount for ADMA members.
7. Expert Committee Meeting on Access and Benefit 11. We are seeking for interactive meeting with the
sharing for processing of applications was held Secretary, Department of AYUSH to discuss on
on 13th September 2012 at National Biodiversity latest notification GSR 597(E) dated 30th July
Authority, Chennai. Dr. Amit Agarwal represented 2012 received in regard to Prefix and Suffix ,
ADMA in this meeting. We are awaiting to receive GSR 249(E) dated 22nd March 2012 in regard to
the minutes of the meeting. mention of the additional information on label, the
true list of all ingredients with their official and
8. 5th World Ayurveda Congress & Arogya Expo 2012
botanical names along with part used and form of
with the support of ADMA and local Associations
ingredient, and proposed amendment in Rule 153
had already organized Road Shows at the following
and 158B and introduction of Schedule Z (related
places:-
to requirement and guidelines for permission to
Ahmedabad on Saturday,18th August 2012 manufacture of ASU drugs for sale or to undertake
Nashik on Sunday,2nd September 2012 clinical trials) in relation to amendment in these
Rules in Drugs & Cosmetics Rule 1945. There
Nagpur on Wednesday,12th September 2012 are so many other unsolved matters which are
Indore on Saturday,15th September 2012 to be resolved. We have already circulated the
agenda points to all members and other Industry
Amritsar on Saturday,22nd September 2012 Associations and requested for their feed back for
Patna on Saturday,29th September 2012 the collective representation.
Along with the Road Shows Seminar also was 12. We wish to inform all members that WAC authorities
Organized by ADMA with the Support of the Local have given an opportunity to conduct Industry
Association and we are happy to inform that ADMA related Workshop/Seminars on the following
up dated on various recent amendments in Drugs & Topics in parallel with 5th World Ayurveda
Cosmetics Act, 1940 & Rules 1945 and its impact Congress and Arogya Expo 2012 being organized
on Industry to all the ASU Industry members. In from 7 th – 10th December 2012 at Lal Parade
addition to this, members were made awareness Ground at Bhopal. ADMA planned to conduct
on Quality Control and Technology in Ayurvedic industry related workshops / seminars on the
Medicines etc. Members of the local association had following topics for the benefit of ASU industry
an opportunity to interact with Licensing authorities manufacturers.
with regard to the common problems faced by the i. Workshops on GLP and GMP on Technology
ASU Industries. and Upgradation
9. Next Road show would be held at Kerala on sunday, ii. Seminar on GCP (Good Clinical Practices)
6th October 2012. We are planning for further Road including Schedule Z.
shows of 5th World Ayurveda Congress & Arogya Expo
in Chennai, Kolkata, Guwahati, Delhi, Bangalore, iii. Interactive meet of Stakeholders in medicinal
and Hyderabad during the month of October 2012 plants.
and the exact dates would be communicated in due iv. An Interactive session to discuss issues of the
course. All members are requested to support this Industry with department of AYUSH
Event.
We request all the ASU Industry members to participate
10. While thanking WAC authorities for the opportunity in the above Workshop / Seminar and make the event
provided to interact with all the Associations of the a grand success.
State, we request all the members to Support 5th
Chandrakant Bhanushali
World Ayurveda Congress & Expo scheduled to be
Hon. General Secretary
held at Bhopal from 7th to 10th December 2012 by
Nilgiri (Eucalyptus globules) with a bluish white bloom. The adult leaves are alternate,
lanceolate and are 6-12 inches long and 1-2 inches
Eucalyptus Tree - Classification broad. It flowers are cream in colour. The appearance
of its bark varies with the age of the tree. Its bark
consists of long fibers and can be can be pulled off in
Kingdom : Plantae long pieces. Stems of the seedlings and coppice shoots
are quadrangular. Flowers are in cymose panicles. The
Division Magnoliophyta fruit is a capsule.
Class: Magnoliopsida Other Species :
Order : Myrtales Eucalyptus abdita, Eucalyptus acies, Eucalyptus api-
culata, Eucalyptus albopurpurea, Eucalyptus alligatrix,
Family : Myrtaceae Eucalyptus ammophila, Eucalyptus amplifolia, Eucalyp-
tus andrewsii are the other related species of Eucalyp-
Genus : Eucalyptus tus. There are 700 species of Eucalyptus.
Zoological name : Eucalyptus globulus, Eucalyptus
Location :
polybrachtea
It is widely grown in Tamil Nadu, Andhra Pradesh,
Found In : Gujrat, Haryana, Mysore, Kerala and in the Nilgiri Hill.
Nagarhole National Park and
Bandipur National Park It grows well in deep, fertile, well drained loamy soil
with adequate moisture. It is also found in Nagarhole
National Park and Bandipur National Park in India. .
Cultivation methods :
Eucalyptus grown in well drained sandy soil. It is
propagated through seeds, soft wood cuttings and semi
hard wood cuttings. At the time planting it must be taken
into account that ts roots are not broken. It needs water
before and after planting. It requires full sunlight.
Medicinal uses :
Eucalyptus is known for its use either as an essential oil
or leaf tea for its ability to relieve congestion and ease
breathing in colds. It oil is also used as the pain reliever
foe sore and overextended muscles. The essential
oil of Eucalyptus contains cineole, a potent antiseptic
that helps in killing the bacteria and fungi. It helps in
increasing cardiac action. It is taken in all types of fever.
It helps in purifying the blood. It lowers the blood sugar.
It brings relief to the patients of Asthma and bronchitis.
It is the excellent topical remedy for aching joints and
rheumatism. It helps in improving the blood circulation.
Issue No 2: Requirements are Elaborate, In the ASUDTAB Sub-committee meeting there was a
Exhaustive & Unrealistic specific category based discussion with respect to the
various categories given in tabular format. ADMA held
Example 1: Requirements/concepts like analysis by
the viewpoint that Pilot Study is an acceptable solution
GLP labs [Appendix-I (Of Proposed Schedule ‘Z’), para
at this stage for ASU Medicines instead of the proposed
2.2 & 2.3, Geno-toxicity [Appendix-III (Of Proposed
Phases I, II, III.
Schedule ‘Z’] point 3, Animal Toxicology (non-
clinical toxicity study), Reproductive toxicity, animal Some Ground realities:
pharmacology Appendix-IV (Of Proposed Schedule
‘Z’) excipient compatibility, Multicentre studies, (Sec a) Current level of Expertise & need for Training &
3.1.15) etc. A major part of the Ayurvedic Industry Capacity Building: ADMA indicated that neither majority
being small scale in nature would be significantly of ASU practitioners have adequate expertise to conduct
impacted. Meetings were held by ADMA at Ahmedabad Clinical Trials following such Guidelines nor do most
on 18th August 2012 & 2nd September 2012 at Nashik the Allopathic doctors have adequate exposure to the
attended by State Licensing Authorities. Overall small ASU philosophy to be able to build these principles in
scale & medium scale manufacturers are very much to a trial design. Thus there is a great void which can
disturbed & affected with these proposed changes. be filled only by proper training and capacity building.
Example 2: Reference Standard Characterization (Ref. Since it took more than 10-15 years for Schedule Y to
Appendix I to Sch Z para 2.6): Problems concerning come to its present level a similar approach should be
lack of standard agencies to provide for such reference adopted for ASU Industry. b) Nature of ASU Industry:
compounds at reasonable costs are well known to Further, it was pointed out that the status of compliance
those involved in such work & there is an urgent need to Schedule T is still wanting and how slow the process
to resolve the same. of upgradation really is in context of the ASU Industry
(especially the SSI & MSME component) which is not
Issue no.3: Disharmony 158 B, 170 and organized to expected levels & which is lacking in
financial capacity.
Sch Z:
There is considerable overlap & disharmony amongst Guidelines for ensuring Rationalization of P&P
various rules & Schedules which are in vogue & Category of Ayurvedic Medicines: There was a 2 Day
some which are proposed when compared with the Seminar on “Herbal Products: Regulatory Aspects” held
proposed GCP Guidelines such as Rule 158(B):[10th by Dept of Clinical Pharmacology, TNMC & BYL Nair
August 2010] Guidelines for issue of license with Ch. Hospital, Mumbai on 29th & 30th June 2012. It was
therein proposed that the formation of an Expert Group
respect to Ayurveda, Siddha or Unani Drugs; Rule
to formulate Guidelines for Recipe Formulation of P&P
170: Guidelines for evaluation of Ayurveda, Siddha,
Products could work on generation of such Guidelines
Unani Drugs and Traditional Herbal Medicines and
to resolve issues such as Irrational Combinations, etc
proposed [vide communication dated 9th July 2012]
Schedule Z: Requirements & Guidelines for Permission Conclusions:
to Manufacture of ASU Drugs for Sale or to Undertake
Clinical trials. This has already caused undue confusion GCP Guidelines: ADMA recommends that the GCP on
in Industry as well as at level of State Licensing ASU drugs should come out in a phased manner where
Authorities (SLA’s). There is a need to harmonize the initially there would be a preliminary document on
same & remove the overlaps. Rule 170: Guidelines Introduction on ASU drugs / brief operational guidance
for evaluation of Ayurveda, Siddha, Unani Drugs document in the simplest version along with a brief
and Traditional Herbal Medicines) ADMA proposes regulatory law on Clinical Trial on ASU drug.
scrapping of Rule 170. Capacity Building: Currently adequate capacity is
not available in ASU industry. It is essential to build
Issue no.4: Contradiction of prevailing
this capacity. Manpower needs to be trained on the
Statutory Provisions: guidelines for proper compliance. Once the capacity is
Schedule Z specifies requirements & guidelines for built in, it would only be fair for the regulatory bodies to
Permission to manufacture of ASU Drugs for Sale or be gradually stringent and aim for higher standards.
to undertake Clinical Trials. This is contradicting the
existing statutory provisions as currently according to Schedule Z: Pilot studies/Proof of Effectiveness instead
the Sec 33 EEC of the The Drugs & Cosmetics Act- of Phase I, II & III of Clinical Trials.
1940- no permission is required to manufacture an ASU Proposed changes have a direct bearing on Cost of New
drug for Clinical Trial. There would thus be a need to Product Development. Further, the Product Approval
ammend Sec 33 EEC also. process would become very lengthy.
AYURBIZ- July - September 2012 7
You will agree that Rule 161 which deals with and market acceptance. Your latest Notification under
aspects as specific as labeling of medicines is discussion is mute to such considerations and such
also silent on the aspect of ‘naming’ and as such drafting can at best be termed incomplete and thereby
the Drugs & Cosmetics Act, 1940 can be said irresponsible. You are requested to withdraw as a whole
not to cover this subject at all. this Notification proposed and oblige.
May we request you to seek and share legal May we as always request the Dept of AYUSH to call
opinion on this fine point and prevent downstream a meeting of stakeholders and their Associations for a
hardship to AYUSH industry who would have to discussion on this subject matter and to explore solutions
cope with this confusion and flip flop in regulatory which meet the expectations of transparency and yet
environment. do not create hardships to AYUSH industry almost
4. We draw your specific attention to the past instantly. We look forward to a considered opinion from
Notifications, clarifications and communication your good office and indication of an early date for our
issued by the Department of AYUSH on this same discussions on the matter.
subject scope of Prefix and Suffix : Any delay in submission of this communication may
kindly be condoned and we may also lodge as always
i. No.K.11024/7/2002-DCC (AYUSH) dated 4th
a note of protest with your good office of not receiving
February 2008
the said Notification directly from the Dept of AYUSH
ii. D.O.No.K-11024/7/2002-DCC (AYUSH) dated 15th but from our agency who keeps us abreast of such
April 2008 Notifications. We receive and re-circulate for the Dept of
iii. F.No.K.11020/1/2008-DCC (AYUSH) dated 18th AYUSH communications to the AYUSH Industry almost
July 2008 on daily basis and are surprised that almost every time
iv. F.No.K.11020/1/2008-DCC (AYUSH) dated 14th such important communication is received only from
August 2008 third party agencies and not directly. We have followed
v. F.No.K.11024/7/2002-DCC (AYUSH) dated 26th your advise and attempted registering on your website
August 2008 for updates and even written to your official with regards
the hopeless attempts to find the registration space to
You will notice that the subject and scope of the
no avail. Kindly rectify this anomaly and habit of not
Notification and further clarifications and communications
keeping stakeholders abreast of developments, Rules
were considerable in coverage and sensitive to the
and regulations that affect their existence.
nuances and ‘tradition’ that governs the AYUSH Industry
Light on Ayurveda
Journal of Health.
Light On Ayurveda is a journal published from USA, and has 4 issue per
year. LOA is a peer-reviewed journal edited by Balram Singh, and has an
Advisory and Editorial Boards with eminent experts from different parts of
Globe. It has interesting “Features” and regular columns like-“Guidelines
for Practitioners, Light on Science Discovery, Healthy through summer
with Ayurveda, book reviews’. In the “Summer issue of 2012”, I find a very
interesting “Glossary of Sanskrit Terms” with their meaning in English. It
also has a very informative article on “Impact of Nutritionally Engineered,
processed, packaged Food regimen on Type 2 diabetes’ based on patient
data. One finds articles written by Vasant Lad, Devesh Rastogi, Diana Luire,
Thomas Mueller, and the like authors of repute.
I recommend your readers and members to Subscribe to this Journal apart
from contributing articles/papers to the same. For Details Visit www.loaj.
com and contact in India Mr R P Jain at mlbd@mlbd.com
D B A Narayana, Bangalore, 14th August, 2012.
AYURBIZ- July - September 2012 9
MSP Panel for Forest Produce soon. – Move aims to help tribals
earn enough for minor forest produce they collect
The Centre is set to constitute a Minimum Support Price or agencies, which would acquire MFPs. NGOs would
(MSP) commission to fix ‘assured price’ tribals would be roped in to train tribals, in adding value to MFPs,
receive for collecting minor forest produce. The produce so that they can fetch a better price for the produce.
includes tamarind, medicinal plants, bamboo, mahua, “Every state has cooperatives or agencies to procure
sal seeds and tendu leaves. these MFPs. But middlemen creep into the system.
The panel, which would be formed under the tribal affairs The commission would identify specific cooperatives
ministry, would get lists of products that each state has or agencies and only these would be identified to
declared as non-timber forest produce or minor forest work in the market”. The panel would be headed by
produce (MFP). The panel would link MSP to minimum an additional secretary - level officer, who would have
wages paid under the National Rural Employment an entire secretariat to assist him. It would coordinate
Guarantee Scheme, transportation cost for the tribal to with chief secretaries of states and would review prices
push the produce in the market, value addition to the every year.
produce and local market prices. The MSP of each The mechanism was suggested by a committee headed
produce would be reviewed every year by the panel. As by T. Haque. The report, submitted last year, had
per an official, the ministry is working on a Cabinet note, observed there was widespread exploitation of tribals
which would be moved after Parliament session ends since the state corporations acquired forest produce from
on Tuesday. tribals at very low prices, fixed randomly by contractors.
The panel would also work out a mechanism with It had recommended this three tier mechanism that the
different agencies or cooperatives in each state so that MSP panel would be implementing.
the benefits of each tribals. Speaking to ET, tribal affairs Under the Forest Rights Act, while tribals can collect
minister V. Kishore Chandra Deo said: “ At present, bamboo and tendu leaves, they can transport them only
the system works against the interests of the tribal as head-loads. At the same time, the forest department
people. They collect the minor forest produce, but the can transport these on its vehicles. “The rules are
middlemen get all the money. If you take bamboo, the loaded against tribals and also make them vulnerable
poor tribal sells it at Rs 5. piece and when it reaches the to exploitation at the hands offorest officials”, Deo said.
local market, the retailer sells it for Rs. 250 a piece. The These rules would be changed via an amendment.
price is increased by the number of layers between the Source Economic Times, Bangalore-21st May 2012
tribal and the market. We would work out a mechanism
that would reduce middlemen”.
Every state would be asked to work through cooperatives New Members enrolled from June to September 2012
1. M/s Shashi Nutraceuticals, Rajasthan
2. M/s Jolly Pharma (India), Ludhiana
AVAILABLE ON LEASE 3. M/s Sava Provate Ltd., Pune
4. M/s K. Patel Phyto Extractions Pvt. Ltd., Mumbai
5. M/s. Navnath Herbals, Nashik
A fully equipped Ayurvedic 6. M/s. Chirayu Pharmaceuticals, M.P.
7. M/s. Robo Remedies, Bangalore
Factory, near Saki Naka having 8. M/s. Grace Drugs & Pharmaceuticals, A.P.
9. M/s. Kamson Healthcare Pvt Ltd, A.P.,
Syrup and Capsules sections 10. M/s. Sai Pharmaceuticals, Pune
11. M/s. Abeers Pharmaceticals Pvt Ltd, New Delhi
available on lease 24 hours water 12. M/s. Dr. Anil Patil’s Vedicure Pvt Ltd, Mumbai,
13. M/s. Kuligai Chemicals & Pharmaceuticals Pvt. Ltd.,
facility available Chennai
14. M/s. Kudos Laboratories India, New Delhi
15. M/s. Everest Pharma, Pune
Contact: 9820561835 / 16. M/s. Reve Pharma, Nashik
17. Mr. Ashok Gaikwad, Mumbai
5th World Ayurveda Congress and Arogya Expo 2012 Road Shows
and Seminars held at various cities
GAAMA, ADMA Seminar at Ahmedabad on Saturday, 18th August 2012
(From L to R )- Vd. Punarvasu Agnihotri (Secretary, GAAMA), Vd. Tanuja Gokhale (WAC), Dr. G.Geethakrishnan (WAC), Dr.
Kamlesh J. Bhatt ( Licensing Authority, ASU, FDA,Gujarat), Mr. Chandrakant Bhanushali (Hon. General Secretary, ADMA), Shri
Prabodh V. Shah, President, GAAMA.
From L to R - Mr. Chandrsekharan Nair(WAC), Mr. Mahesh K. Vahalia (Shree Dhootapapeshwar), Mr. Chandrakant Bhanushali
(Hon. General Secretary,ADMA), Dr. J.P. Singh, (President , Punjab Ayurvedic Drug Manufacturers’ Association), Mr. Jayakumar
(WAC), Vd. Tanuja Gokhale (WAC), Dr. Bakhsish Singh (Licensing Authority, Punjab), Dr. Rakesh Sharma (Director, Ayurved,
Punjab), Dr. Shamsher Dilawari (Chairman, Herbal Health Research Consortium Pvt. Ltd- AYUSH Cluster)
AYURBIZ- July - September 2012 11
VDMA, ADMA Seminar held at Nagpur on Nashik Division Ayurvedic Drug Manufacturers’
Wednesday, 12th September 2012 Association, ADMA Seminar at Nashik on
Sunday 2nd September 2012
We undertake systematic
From L to R , Dr. Samondra Mishra (Divisional Officer),Shri
product development work at our DSIR
Khandelwal ( Commissioner, AYUSH, M. P.), Shri T.S. Bhandari
(Secretary, M.P. Ayurvedic Medicine Mfg. Association, approved R & D facility for entire
Vd. Praful Dave (President, M.P. Ayurvedic Medicine Mfg.
Association)’ Mr. Chandrakant Bhanushali (Hon. General
range of Ayurvedic formulations &
Secretary, ADMA), Dr. Nagesh Sandu, (Director, M/s Sandu cosmetics as per customer requirement
Brothers Pvt. Ltd.)
with excellent analytical development
support provided by our NABL
accreditated public testing laboratory.
ADMA Conference INTERESTED PARTIES MAY RUSH
Room is available for WITH THEIR REQUIREMENTS TO
Meetings/ Workshops
CHARAK PHARMA PVT. LTD, MUMBAI
For enquiry, kindly contact the Tel No.: 022 3301 6664 / 5 /6.
Secretariat Fax No.: 022 24938215,
E-mail: drnaik@charak.com
Forthcoming Events
AROGYA 2012 - Hyderabad. 27th to 29th November 2012 at World Trade Centre,Dubai.
FICCI with the support of Department of AYUSH Contact: Global Links Dubai L.L.C. P.O. Box: 34351,
12th to 15th October 2012 at Exhibition Ground, Near Dubai, U.A.E.
Gandhi Bhawan, Nampally, Hyderabad. Phone: + 971 4 3322283, 3327274
Email: info@naturalproductme.com Website: www.
2nd Chinese Medicine Expo naturalproductme.com
Organized by Shenzhen-based Asia Pacific Media Co. in
collaboration with China Association of Chinese Medicine
5th World Ayurveda Congress and Arogya Expo 2012
and China Medical Pharmaceutical Material Association.
1st to 3rd November, 2012, at Guangzhou Poly World Trade Organised by World Ayurveda Foundation and Government
Center, China. of Madhya Pradesh
Website: http://www.zycexpo.com/english/intordution.html 7th to 10th December 2012 at Bhopal
Contact: WAC Secretariat, World Ayurveda Foundation,
IInd International Herbal Fair – Bhopal 107/1, Margosa Road, Between 13th & 14th Cross,
Co- Organised by the Madhya Pradesh Forest Department, Malleswaram , Bengaluru-560003. Phone 080-23467439
Government of Madhya Pradesh (www.mpforest.org) Email: info@ayurworld.org , Website: www.ayurworld.org
and Madhya Pradesh State Minor Forest Produce (Trade
& Development) Co-operative Federation Ltd.(www. Raj Ayu Con 2013
mfpfederation.org) and supported by Department of AYUSH, Organised by Mission Ayuved, Rajkot in collaboration
Govt. of India
with Gujarat Ayurved University, Jamnagar, International
22nd to-26th November, 2012 at Lal Parade Ground,
Academy of Ayurved, Pune, Academy of Indo European
Jahangirabad, Bhopal.
www.mpintherbalfair.com Integrated Health Sciences, Germany, Gujarat Ayurved
Medical Association, Gujarat, National Integrated Medical
Middle East Natural & Organic Product Expo 2012 Association,Gujarat, Ayurved Vyaspith.
(MENOPE 2012) 23rd – 24th February 2013 at Rajkot, Gujarat.
Organised by Global Links Website: http://rajayucon2013.org/template/index.php
l Syrup l Avleh
For further details, please contact:
Plot No-9 to 11, Ratnamani Industrial Estate,
022 3301 6702 Sarkhej-Bavala, N.H. 8-A,
Changodar, Ahmedabad-382213.
Fax No.: 022 3301 6705, Telephone no. 079-22149710
E-mail – ctl@charak.com. Email Address: - shriramgandhi@gmail.com
Website: - www.lvg.co.in