Drugs of Animal Origin: (1) - Ayurvedic Drug Manufactures Association
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Transcript Drugs of Animal Origin: (1) - Ayurvedic Drug Manufactures Association
INTRODUCTION OF
RETAIL SALE LICENCE
FOR ASU DRUGS
Dr.D Ramanathan
General SecretaryAMMOI
Director,Carekeralam
Managing Editor, Oushadham
Managing Director,SitaramAyurvedaPharmacy Ltd.
Chief Physician, Sitaram Ayurveda Hospital
Member, TC Medical Council
Member, State Medicinal Plant Board
ASU INDUSTRY – 9000 nos.
• Total turn over
• Generic products
• P&P and OTC
- 8000 crores
- 2500 crores
- 55
Total no.of RM – 384
Vegetable origine – 310
Animal Origine – 25
Mineral origine - 47
Total no. of schedule E1 drugs – 24
(Ref: AFI III volumes)
350
300
250
200
150
100
50
0
percentage
Series 2
Series 1
Vegetable
origine(14)
Animal
origine(1)
Mineral
origine(9)
Schedule E1 Rule 161(2)
•
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
Drugs of Vegetable Origin(14)
Ahiphenam
Arkam
Bhallathaka
Bhanga
Dhanti
Dhathura
Gunja
Jepalam
Karaveeram
Langali
Parasikayavani
Valsanabhi
Vishamushti
Shringivisham
-
Karuppu
Erukku
Cherkuru
Ganjha
Nagadhanthi
Ummam
Kunni
Neervalam
Karaveeram
Methonni
Kurarsani
Valsanabhi
Kanjiram
Variety of valsanabhi
Sch ed
u le E1 R
u le 161(2)
•
1.
•
1.
2.
3.
4.
5.
6.
7.
8.
9.
Drugs of Animal Origin: (1)
Sarpav ish am
-
Sarpav ish am
Drugs of Mineral Origin(9)
Go
w ripash anam
Arith alam
Manassila
Parad
h a
Rasak arpoora
Th uth a
Hin
g ulam
Sindoora
Girisindoora
-
Arsenic
Arsenosulp
h ide
Arsenosulp
h ide
Rasam
Mercuric ch loride
Copper sulp
h ate
h ayilyam
C
Red oxide o
f lead
Red oxide o
f mercury
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Arishta/asava
Avaleha
Choorna
Kwatha choorna
Vati/gutika
Grutha
Arka
Guggulu
Thaila
Dravaka
Lepa
Varthi
Satwa
Kupipakwa rasayana
Parpati
Bhasma
Mandura
Rasayoga
Lauha
Pishti
-
57 nos
59
127
88
75
48
20
21
105
1
40
12
1
10
8
27
32
3
Ayurvedic Formulary of India(3 vol.) – Formulations of
medicines
-
9
220
Total 963 medicines
963
Formulations with schedule E1
drugs(Vegetable origin)
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
RASAYANAM/LEHAM(8)
Bahusala gudam(AFI II
Brahma rasayanam(AFI 1)
Danthi harithaki(AFI 1
Hrudya virechanam(AFI 1
Narasimha rasayanam
Pancha jeeraka gudam
Vasishta rasayanam
-
Cherkuru,Nagadanthi
Neela ummam
Nagadanthi
Nagadanthi
Cherkuru
Kurasani
Nagadanthi
KASHAYAM/KASHAYA TABLET/KASHAYA CHOORNAM(7)
Gulguluthikthakam Kashayam
Cherkuru,Vatsanabhi
Gulguluthikthakam Kashaya Tablet
Cherkuru,Vatsanabhi
Gulguluthikthakam Kashaya-sookhma choornam
Cherkuru,Vatsanabhi
Kalyanakam Kashayam
Nagadanthi
Varanadi kashayam
Cherkuru
Varanadi kashaya tablet
Cherkuru
Varanadi kashaya- sookshma choornam
Cherkuru
Formulations with schedule E1
drugs(Vegetable origin)
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
ARISHTAM(8)
Chavikasavam
Danthyarishtam(AFI 1
Devadarvarishtam(AFI 1
Duralabharishtam(AFI III
Kumaryasavam(AFI 1
Kanakasavam(AFI 1
Madhookasavam(AFI 1
Mruthasanjeevani(AFI 1
PILLS(12)
Ashtakshari(AFI 1
Anthrakutaram
Chandraprabha(AFI 1
Charngeryadi
Chukkum thippalyadi(AFI 1
Kasthuryadi(AFI 1
Kaisoragulgulu(AFI 1
Suryaprabha
Swasanandam
Vettumaran
Yogaraja gulgulu(AFI 1
Virechanagulika
-
Nagadanthi
Nagadanthi
Nagadanthi
Nagadanthi
Nagadanthi
Neela Ummam
Cherkuru
Ummathin Veru
-
Chayilyam
Chayilyam,Neervalam
Nagadanthi
Chayilyam
Gowripashanam,Manassila,Thuthu
Valsanabhi,Manayola,Chayilyam
Nagadanhi
Chayilyam
Valsanabhi,Chayilyam
Valsanabhi,Chayilyam
Nagadanthi
Neervalam
-
Formulations with schedule E1
drugs(Vegetable origin)
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•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
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•
CHOORNAM(3)
Avaltholadi Bhasmam
Kalyana Ksharam(AFI 1
Yogaraja gulgulu Choornam
-
Nagadanthi
Nagadanthi
Nagadanthi
GRUTHAM(9)
Charngeryadi Grutham(AFI 1
Dhanwanthara Grutham(AFI 1
Gulgulu thikthaka Grutham
Kalyanaka Grutham(AFI 1
Karaskara Grutham
MahaKalyanaka Grutham(AFI 1
Maha Panchagavya Grutham (AFI 1
Varanadi grutham
Mishrakasneham
-
Nagadanthi
Nagadanthi, Erukku,Cherkuru
Cherkuru,Valsanabhi
Nagadanthi
Kanjirakkuru
Nagadanthi
Nagadanthi
Cherkuru
Neervalam
OIL(1)
Nimbamruthadi Castor Oil
-
Cherkuru,Valsanabhi
……………..
Sch ed
u le E1 dru gs
• Schedule E1 drugs (vegetable origin)
manufacturing out of 963 formulations are
only around 50 formulations for internal use.
• The total market of this 50 formulations is
below 25 crores
• The present sale license rule suggests for
externally applying medicines also.
Precau tion measu res
• The label clearly mention a caution regarding
Schedule E1 drug is provided on the label as per
the Rules 161 clearly mention “Caution:-To be
taken under medical supervision” both in English
and Hindi
• The modern medicines like paracetamol etc are
salable for itinerent vendors( person who travels
from place to place) and other dealers who do
not engage the service of a qualified person
Toxicity stu dy
• The schedule E1 drugs processed with different
methods like sodhana, marana ,amrithikarana etc
to render such drugs non-toxic
• Research was conducted on toxicity of
Bhallathaka at Kottakkal Aryavaidya sala and
proved that it is free from toxicity
• No drastic toxicity cases reported in AYUSH Dept.
for medicines containing schedule E1 drug.
Vaidyas do not require any sale
license for manufacturing
• 33EEC. Prohibition of manufacture and sale of certain
Ayurvedic, Siddha and Unani drug
• Provided that nothing in this section apply to Vaidyas and
Hakims who manufacture Ayurvedic, Siddha or Unani drug
for the use of their own patients:
• If the same vaidyas manufactures schedule E1 drug under
The Drugs and Cosmetics Act with a GMP certificate, is the
sale license required? what is the logic behind a sale license
?
• All the ASU manufacturing units are under the strict
supervision of Qualified Institutional Vaidyas(Physicians)
HISTORY OF THE SALE LICENSE
• The ASUDTAB MEETING HELD ON 28/12/2006 decided
that the exiting situation where no sale license was
required for ASU medicine should continue.
• The ASUDTAB MEETING HELD ON 29/06/2007 the
need was again raised
• ASUDTAB MEETING HELD ON December 2007
recommended for a thorough discussion.
• ASUDTAB MEETING HELD ON 24/08/2009 found the
non feasibility of the license due to lack of
infrastructure and suggests the implementation of
safety measures in labeling.
SUB COMMITTEE SUGGESTIONS
• ASUDTAB MEETING HELD ON 12/01/2012 decided to set up a sub committee
• Th e sub committee recommended th ef ollo
w in
g su
g g estions on 23/07/2012
1. There should be a unified list of poisonous substances for Ayurveda, Siddha and
Unani medicines and schedule E1 be revised accordingly providing the specific
plant parts of the medicinal plants, which are known to be poisonous
2. The label of medicines containing schedule E1 ingredient should be marked
with some special sign like green dot for vegetarian products and red dot for
non vegetarian products .It was proposed to use a blue triangle /dot within a
square on the labels of ASU medicines containing schedule E1 ingredients.
3. A regulatory provision be inserted in the relevant Drugs & cosmetics Rules to
prohibit sale of ASU medicines containing schedule E1 ingredients without
medical prescription from a registered practitioner
4. System for registration of sellers of ASU medicines be put in place
INFRASTRUCTURE OF RETAIL SHOPS IN
INDIA
• The ratio of Ayurvedic drugs to allopathic
drugs in a chemist shop is 1:500 . For this
negligible sale why the chemist will take
license and invite hurdles?
• The retail sale will slow down which is in
grooming stage
INFRASTRUCTURE OF RETAIL SHOPS IN
INDIA (contd)
• 90% of the retail shops sales is less than Rs. 1500
-2000/day
• They are getting a maximum commission of 20 25%
• The rent ,electricity charge, rate of interest ,
salary etc are not profitable for ayurveda retail
shops
• Introduction of the sale license need a
pharmacist with an Ayurvedic background. He
will ask for salary not affordable to the retailer
have a meager sale of ayurvedic drugs
INFRASTRUCTURE OF RETAIL SHOPS IN INDIA
(contd)
• An Ayurveda Pharmacy Council is not present at
National level
• Some states even don’t have an Ayurveda Medical
council or Ayurveda Medical college
• The fact is that just having a new license may not serve
the intended purpose of the regulating movement. The
license will only regulate the purchasing and stocking
of medicines by a Dealer, and it may not be capable of
controlling the actual sale to a customer.
• Sir, The Inspector match the stock with the prescription
of Vaidya. If the product is sold without prescription
the retailer will be sued.
Sch ed
u le E1 dru gs
• Sir, what will be the future of schedule E1 drugs if
implements this rule?
• Eg: In olden days the opium and Bhang were used as
medicines in ayurveda.But after the introduction of
Narcotic rule, no single drug is available in the market.
• If a widely exporting product like Neelibhringadi for
external applications needs a prescription as it contains
a schedule E1 drug Gunja(Abrus precatorius), the
prescription regulation will badly affect the export
market
• The time tested medicines will be vanished forever
from the market
OUR HUMBLE SUGESTIONS
• This is too early to introduce the license
• Postpone the implementation of retail sale
license for Ayurveda medicines for a period
of 10 – 15 years
Extracts are used NOT JUST BY AYUSH IND.
1.
2.
3.
4.
5.
6.
7.
8.
As Rasakriya under 3(a) dosage forms ?
3(h) formulations of Ayurveda
Siddha formulations
Unani formulations
Phytopharma for modern medicines
Cosmetics
Foods
Nutraceuticals, Supplements etc
Implications in separate licensing System
• It may not be possible to take an Ayurvedic license for
extract first and then take a separate license for capsule or
syrup where extracts and powders are used in the same
formulation.
• It may not be possible for other categories (foods, cosmetics,
drugs etc) to take an Ayurveda license first (for the extract)
and then take respective licenses for the finished goods.
• It may not be possible to have two or three separate licenses
by the manufacturers of extracts for the purpose of
Ayurveda, Cosmetics, Foods, Drugs etc.
Problem of Licensing Extracts
• Certain States are asking to take license as Finished
Product
• Being intermediate it can not be equated with
finished product for the purpose of licensing
• It would lead to change in HS Code classification and
regulatory requirements
Recommendation
Exempt extract from licensing since it is used as
intermediate.
THANK YOU