INTRODUCTION OF RETAIL SALE LICENCE FOR ASU DRUGS

INTRODUCTION OF RETAIL SALE LICENCE FOR ASU DRUGS Dr. D Ramanathan General Secretary. AMMOI Director, Carekeralam Managing Editor, Oushadham Managing Director, Sitaram. Ayurveda. Pharmacy Ltd. Chief Physician, Sitaram Ayurveda Hospital Member, TC Medical Council Member, State Medicinal Plant Board

ASU INDUSTRY – 9000 nos. • Total turn over - 8000 crores • Generic products - 2500 crores • P&P and OTC - 55

Total no. of RM – 384 Vegetable origine – 310 Animal Origine – 25 Mineral origine - 47 Total no. of schedule E 1 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 E 1 Rule 161(2) • Drugs of Vegetable Origin(14) 1. Ahiphenam 2. Arkam 3. Bhallathaka 4. Bhanga 5. Dhanti 6. Dhathura 7. Gunja 8. Jepalam 9. Karaveeram 10. Langali 11. Parasikayavani 12. Valsanabhi 13. Vishamushti 14. Shringivisham Karuppu Erukku Cherkuru Ganjha Nagadhanthi Ummam Kunni Neervalam Karaveeram Methonni Kurarsani Valsanabhi Kanjiram Variety of valsanabhi

Schedule E 1 Rule 161(2) • Drugs of Animal Origin: (1) 1. Sarpavisham - • Drugs of Mineral Origin(9) 1. Gowripashanam 2. Arithalam 3. Manassila 4. Paradha 5. Rasakarpoora 6. Thutha 7. Hingulam 8. Sindoora 9. Girisindoora Sarpavisham Arsenic Arsenosulphide Rasam Mercuric chloride Copper sulphate Chayilyam Red oxide of lead Red oxide of 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 9 220 32 3 Total 963 medicines Ayurvedic Formulary of India(3 vol. ) – Formulations of medicines - 963

Formulations with schedule E 1 drugs(Vegetable origin) • • • • • RASAYANAM/LEHAM(8) Bahusala gudam(AFI II Cherkuru, Nagadanthi Brahma rasayanam(AFI 1) Neela ummam Danthi harithaki(AFI 1 - Nagadanthi Hrudya virechanam(AFI 1 Nagadanthi Narasimha rasayanam Cherkuru Pancha jeeraka gudam Kurasani Vasishta rasayanam 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 E 1 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 Neela Ummam Cherkuru Ummathin Veru - Chayilyam, Neervalam Nagadanthi Chayilyam Gowripashanam, Manassila, Thuthu Valsanabhi, Manayola, Chayilyam Nagadanhi Chayilyam Valsanabhi, Chayilyam Nagadanthi Neervalam -

Formulations with schedule E 1 drugs(Vegetable origin) • • • • • CHOORNAM(3) Avaltholadi Bhasmam Kalyana Ksharam(AFI 1 Yogaraja gulgulu Choornam GRUTHAM(9) Charngeryadi Grutham(AFI 1 Dhanwanthara Grutham(AFI 1 Gulgulu thikthaka Grutham Kalyanaka Grutham(AFI 1 Karaskara Grutham Maha. Kalyanaka Grutham(AFI 1 Maha Panchagavya Grutham (AFI 1 Varanadi grutham Mishrakasneham OIL(1) Nimbamruthadi Castor Oil ……………. . - Nagadanthi - Nagadanthi, Erukku, Cherkuru, Valsanabhi Nagadanthi Kanjirakkuru Nagadanthi Cherkuru Neervalam - Cherkuru, Valsanabhi

Schedule E 1 drugs • Schedule E 1 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.

Precaution measures • The label clearly mention a caution regarding Schedule E 1 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 study • The schedule E 1 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 E 1 drug.

Vaidyas do not require any sale license for manufacturing • 33 EEC. 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 E 1 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 • The sub committee recommended the following suggestions on 23/07/2012 1. There should be a unified list of poisonous substances for Ayurveda, Siddha and Unani medicines and schedule E 1 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 E 1 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 E 1 ingredients. 3. A regulatory provision be inserted in the relevant Drugs & cosmetics Rules to prohibit sale of ASU medicines containing schedule E 1 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.

Schedule E 1 drugs • Sir, what will be the future of schedule E 1 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 E 1 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.

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