RASASHALA IN ACCORDANCE WITH GMP....pptx

Rasashala is the place for the manufacturing of Rasashastra medicines. Since it has significance in terms of business and auspiciousness, a suitable place with specific features has been advised

1. RASASHALA IN ACCORDANCE WITH GMP By: Dr.Anusha Baseganni. 1 st year PG Scholar Dept. of RSBK AMV HUBBALLI

2. CONTENTS Introduction to Rasashala Word meaning Four components of Rasashala Rasamantapa Guna’s of Rasavaidya,Sishya,Paricharaka & kalini stree GMP Recommendations of GMP Research article Discussion Conclusion

3. INTRODUCTION Ayurveda mainly aims at Swastha Rakshana an Rogi Chikitsa for which chikitsa chatuspada ie .[ Bhisag,Rogi,Aushadha & upastha ]plays an important role Aushadhi acts as tool for Vaidya in eradicating the Roga For preparation of such Aushadhi the special place is built by our Acharyas in ancient period Known as Rasashala which is dealt under Rasashastra and Bhaishajya kalpana . Acharya’s concentrated not only on the construction,but also on interior plans , arrangements, appointment of skilled attendants for different sections of Rasashala Rasashala / Rasayanashala / Bheshajagara ,/ Aushadha nirmana kendra or pharmacy is always expected to be clean and hygiene and workable place for all facilities and it is put up with many rules and regulations for establishment under the concept of GMP now a days GMP deals with all the aspects from collection of raw drug till the dispensary of final product Though the concept of GMP came into existence recently, the concepts related to this can be found in the samhitas of Ayurveda many years back.

4. Word meaning of Rasashala RASA-PARADA SHALA-BHAVAN ;the word shala is derived from root word ‘ shalgatho ’ शाला तरूस्कन्दशखा शाला भवनमिष्यते। The word Rasashala was first mentioned in Rasendra Chudamani The term Rasashala denotes the place wherein different processes pertaining to Rasa[ Parada ] and other Rasa dravyas are carried out

5. Four Important components of Rasashala Sthana आतङ्क रहिता देशे धर्मराज्य मनोरमे। उमा महेश्वरोपेते समृद्धे नगरे शुभे।। | कर्तव्य साधनम् तत्र रसराजस्य धीमता। [R.R.S 6\11] STHANA BHAVANA ADIKARI EVAM KARMACHARI KARYAVIBHAJANA

6. 1. According to Rasendra Chudamani 3/1,2 Sarvabadavivarjitha Sarva aushadhi mahe deshe Ramye Kupasamanvithe 2. According to Rasatarangini 1/13 Vimalo upavana pradeshe Ramye Jalayantra shobhete Kamaniya gavaksh samyukta Nikila aushadha varga mandala Janabhada rahita sankulat Rasa siddheshwara chitra bushithe 3. According to Ananda Kanda 2/22 Asthika prani subage . Su rakshithe dware naranga , dadima,jambhira,nimba , tala,hintala , bakula,amla,patola,ashoka etc.

7. BHAVANA NIRMANA [Ref: R.R.S 6/12] ATYANTA UPAVANE CHATHURDWARA UPASHOBITE SUVISTIRNA SAMYAK VATAYANAPETE DIVYA CHITRA VICHITRITAHA

8. KARYAVIBHAJANA RASASHALA RASABHAIRAV SIDDHAVASTU VEDHA KARMA PASHANA KARMA AGNIKARMA SHOSHANA KARMA KSHALANA KARMA SHASTRA KARMA PURVA(E) AGNEYA(SE) DA KS HINA(S) NAIRUTYA(SW) PASCHIMA(w) VAYUVYA(NE) UTTARA(N) ESHANYA(NE)

9. ADHIKARI EVAM KARMACHARI ADIKARI RASAVAIDYA DHATUVADA SADAKA[ Minerologist ] RASAYANA SADAKA[pharmacologist] BAHUBASHYAKARA[linguist] KARMCHARI AUSHADA SANGRAHAKARTA [Drug collector] RASAKARTA SAHAYAKA[Pharmacy assistant] BALI SADAKA[Security guard] PARICHARAKA[ Attender ]

10. GUNAS OF RASA VAIDYA [Ref- R.R.S 6/3-4] JNANAVAN DAKSHA RASASHASTRA VISHARADA MANTRA SIDDHA MAHAVEERA NISCHALA SHIVAVATSALA BAKTHA SADHADEERA DEVATA ACHARYA TATPARA SARVA KUSHALO RASA KARMANI

11. SISHYA GUNA YOGYA AYOGYA Guru bhaktha 1. Nasthika Satyavanta 2. Durachara Sadhachari 3. Chumbaka Drudavruta 4. Guruto apara Niralasya 5. Vidya grahito michanti Dharmagnya 6. chaurya Sadha agnya paripalaka 7. Na Sidhayet manimatraaushdhikam Dambha matsarya nirmuktha 8. Eha loka sukam paraloka cha Kula acharya dakshita Atyantha sadhaka Shanta Mantra aradhana tatpara [Ref- R.R.S 6/5-6]

12. PARICHARAKA GUNA SA UDYAMA SISHYASTHE KULINA SWAMI BHAKTHA SHUCHI SHURA BALISTHA

13. KALINI STREE [Ref-R.R.S 6/33-37] She represents the goddess parvati and attained Rutu chakra in krishna paksha Characteristics of kalini stree Kinchita keshya Shyama padma lochana Surupa Taruni Mrudhu bhasini Ashwatha patra sadrusya yoni Kalini stree abava - 1 karsha shuddha gandhaka with go ghrita for 3 saptaha .Then she will attain the qualities of kalini stree Importance of kalini stree - success in Rasabandha and other Rasayana kriya

14. RASAMANTAPA Rasa Mantapa ia the unique place & platform which is constructed for placing and worshipping Rasa Linga . It should be constructed within the rasashala in the eastern direction It should posses shat kona , asta dala kamala Samatala Atigupta , suvistirna Should possess large arches and gates The upperpart of Rasamantapa ia attaches with dwaja and chatra Decorated with pushpa and mala There be ringing sounds of beri,kahala , shrunga , ghanta In the centre Rasa Linga is placed , and other rasa dravyas are placed in systemaic order , worshiping of Rasa Linga is carried by chanting the Agora mantra and Rasankushi mantra

15. Rasalinga [Ref: R.R.S 6/17] Swarna patra - 3 Niskha Suddha Parada - 9 Nishka Bhavana dravya - nimbu swarasa for 1 yama kala further subjected to swedhana in dolayantra with jambira rasa or kanji for 1 day Importance of Rasa Linga Regular worshipping of rasalinga should be done by chanting Agora and Rasankushi mantra to attain prosperity and to get rid of paap mukti Equvalient to worshipping one thousand crore shiva Linga & and siddhi in all rasa kriya

16. INSTRUMENTS & EQUIPMENTS REQUIRED FOR RASASHALA [ Ref:R.R.S 7/6-13] Kostiyantra-satvapatanakosti,bhumikosti,chalakosti,patalakosti etc Water storage tanks and containers of different sizes Bhastrikas - 2[blowing bellows] Metallic pipes-2,bamboo pipes -2 Kunda [vessels]-prepared with gold,silver,iron,copper,bronze,stone,leather Kandani [small pounders]& peshini of different varietes Droni (water tubs) , khalwa yantra , perhani of different sizes Sieves Chalani,shalaka and kundali (circular stands) Mrittika for preparation of mushas ( sweta,krishna,valmiki mritika ) Tusha (husk) , karpasa (cotton), pistaka (dough) Raw material for preparation of medicine [ herbal,mineral,animal origin] shikitra (coal), upala,valuka Varaka [bottle] –made up of kacha,mritrika Different Patra of different kinds for heating boiling etc.

17. GMP Good Manufacturing Practices is a set of legal guidelines that have been regulated by W.H.O since 1975. It aims to ensure that drugs and other pharmaceutical products are safe and effective History of GMP -The GMP was first introduced in NASA in rocket technology, named as zero defect. In India, GMP was introduced in 1988 as an amendment to Drug and Cosmetic rule 1945. In India licenses for manufacture of ASU drugs are issued only which fulfill the GMP requirement Definition - A good manufacturing practice (GMP) is one that conforms to the guidelines set by the regulatory agencies that control authorization and licensing for the production and sale of food, beverages and active pharmaceutical products .

18. RECOMMENDATIONS OF GMP Factory premises: Receiving & storing of raw material Manufacturing process areas Quality control section Finished goods store Office Rejected goods/drugs store

19. Guidelines according to GMP Location and Surrounding Building Water supply and disposal of waste Containers cleaning and stores Raw material Production Packaging materials and finished goods stores Working place Clothing and Hygiene Medical services Equipment Batch manufacturing records Distribution records Labeling Records of market complaints Quality control

20. 1. LOCATION AND SURROUNDINGS Away from open sewage, drain, public lavatory & factory , To avoid contamination And to prevent from disagreeable or noxious odour or fumes or excessive dust or smoke. 2. BUILDING Free from insects/rodents. Adequate light, ventilation and space. Floor and wall should not be moist. According to provision of factory act Should permit easy cleaning and disinfection , the interior surface should be smooth and free from cracks proper drainage system in the processing area .the sanitary fitting and electrial fixtures should be proper & safe There should be fire safety measures & emergency exits

21. 3. WATER SUPPLY AND DISPOSAL OF WASTE Pure and of potable quality Adequate provision of water for washing the premises Provision for waste disposal should be made properly to avoid microbial contamination. And high degree of hygiene in the manufacturing area 4. CONTAINERS CLEANING AND STORES Containers such as bottles, vials and jars are properly washed, cleaned, and dried. stored properly Storage area should have proper ventilation &free from dampness Different storage area should be maintained for Raw material, Packaging material and Finished product.

22. 5 . RAW MATERIALS stored properly Good quality raw material should be selected & protected from microbial contamination stored under different categories like the Raw material of metallic origin, mineral origin, animal origin, Fresh herbs, Dry herbs and plant parts. Each container used for raw material storage shall be properly identified by name of the material, source of supply and status of the of raw material such as „UNDER TEST‟ or „APPROVED‟ or „REJECTED‟ All the raw materials shall be sampled and got tested by the laboratories approved by Govt. for authentication, morphological , Organoleptic evaluation, microscopy evaluation, chemical evaluation 6. PRODUCTION Only approved materials are used. Samples are taken, as appropriate, during or after processing, transfer or filling for testing. Packages of finished products bear permanent code marks, to ensure not only quality, but also safety and efficacy of complex products of biological origin, such as herbal medicines, it is essential that their production is clearly defined

23. 7. PACKAGING MATERIALS AND FINISHED GOODS STORES Packaging materials such as bottles, jars are stored properly. All containers and closure should be adequately cleaned and dried before packing the product. The finished goods from the production area after proper packing are stored in finished goods stores marked as“Quarantine ” After the quality control laboratory experts have checked the finished goods and then it is moved to “Approved Finished Goods Stock” area. Only approved goods are dispacted as per marketing requriements . 8. WORKING SPACE Adequate space for orderly placements of equipments & material. To minimize or to eliminate any risk of mix-up between different drugs, raw materials to prevent the cross contamination of one drug by another drug that is manufactured, stored or handled in the same premises should be prevented

24. 9. CLOTHING AND HYGIENE Free from contagious disease . clothing for workers consistes of proper uniform suitable according to nature of work & climate The uniform also include cloth or synthetic covering for hands, feet and head wherever neccesary Adequate facilities for personal cleanliness such as clean towels, soap and scrubbing brushes are also provided Seprate provision for lavatories used by men & women ,& located seprate from processing rooms. seprate sections for keeping their personal belongings & for changing clothes 10. MEDICAL SERVICE Manufacturer shall provide: Adequate facilities of first aid And during the time of employment & periodical medical examination to workers. It is done with particular attention keeping all the safety measures to avoid the spreed of infections. And Records should be properly maintained

25. 11. EQUIPMENT Suitable equipment depending on the size & nature of production either manually ,semi-automatically or fully automatic machinery are made available Different machines for crushing, grinding, powdering, boiling, mashing ,filtering, labelling etc. Properly installed and cleaned periodcally Space should be maintained b/w two machines for easy movement of worker. Dried immediately after cleaning to avoid growth of microorganisms 12. DISTRIBUTION RECORDS Record date, manpower, machines and equipments should be maintained. Records of sale and distribution of each batch of ASU medicine shall be maintained in order to facilitate prompt and complete recall of the batch, if necessary

26. BATCH MANUFACTURING RECORDS The licence should be maintain for each batch of ASU drugs manufactured irrespective of type of the product List of raw materials, quantities and various tests with record should be maintained. Record of quality control to finish product should be maintained Only after the manufactured drugs have been verified and accepted shall be allowed for sale. Tests conducted during the various stages of manufacture like taste, colour , physical characteritics & chemical test is necessary as mentioned in the First Schedule of the Drugs and Cosmetic Act , 1940. 14. RECORD OF MARKET COMPLAINTS Manfactures shall maintain a register to record of market complaints received regarding the products when sold Reports of adverse reaction resulting from use of ASU drug shall also be maintained in seprate record by each manfacture Once in six months the reports should be submitted to licensing authority. The manufacturer shall investigate any of the adverse reaction if found , due to any defect in the product, and whether such reaction are already reported earlier or it is new observation.

27. 14. LABELING The label on outer container should bear - Name of the product. Statements of identifications and net contents, Address of the firm manufacturing unit General information about the product regarding the ingredients, quantity of ingredient, reference of the product. self life, date of manufacturing, & date of expiry Any contraindication of particular product 16. QUALITY CONTROL Each manufacture shall provide facility for quality control section in their premises or through government approved testing laboratory .The test shall be as per the ASU pharmacopeia standard Quality control section shall verify all raw materials, quality of finished product. Quality control should have separate expert.

28. It should have fallowing facilities : Should be 150 sq.feet For identification drugs, reference books & samples should be maintained To verify the finished products, samples of finished products of each batch will be kept for 3 year Manufactures of ASU medicines shall provide their own specification & control referances in respect of such formulated drugs The record of specific procedures such as “ Bhavan ”, “ Mardana ” & “ puta ” shall be maintained The standards for identification, purity,and strength as given in respective pharmacopoeia of ASU system of medicines published by government of india shall be complied All raw materials are monitored for fungal,bacterial contamination with a view to minimise such contamination [a] one person with degree qualification in ASU as per schedule 2 of MEDICINE CENTRAL COUNCIL ACT 1970 [b] Bachelor of pharmacy, pharmacognosy & chemistry

29. Minimum Manufacturing Premises Required for the manufacture of Ayurvedic Medicines CATEGORY OF MEDICINE MINIMUM MANUFACTURING SPACE REQURIED Arka , pills/ vati / gutika , ointment , capsule,Anjana / Pisti , Tila,ghrita 100 Sq.feet Kupi pakva / Ksara / Parpati / Lavana Bhasma / satva / sindura / karpu / avaleha / khand / modaka / panak /syrup/ kwath 150 Sq. feet 3. churna / nasya manjan / lepa / asava / aris ta / kwathchurna 200 Sq.feet

30. COMPARISIONS BETWEEN RASAMANTAP AND GMP As Ayurveda origined from the vedic period they belived more on divinity so worshipping of Rasalinga has been given prime importance , where as in GMP they is no such referance about worshipping god Rasashala ia mainly built on vastu shastra , but according to GMP premises are built according the guildlines and convinience In Rasashala placement of instrunment & processes pertaining to parada & other Rasa dravya are done in 8 direction keeping view of asta dikh palakas where as in GMP they concentrated only on the infracuture In Rasashala , particular characteristics for appointment of Rasavaidya , Sishya,Parichara and kalini stree is mentioned where as in GMP appointments are done only on qualifications of individual

31. Research article conclusion GMP is an essential and significant step taken by the Government in improving the quality and standard of ASU drugs being manufactured in about 9000 licensed ASU pharmacies in our country. In the similar way our ancient Acharyas were much more concerned about minutest parts of the bhesajagara / rasasala . In almost every classical text of Rasashastra usually a separate chapter is devoted in describing building of a production unit. In such description right from selection of the place, to accurate and well thought of directions regarding various departments section and staff, financial requirements and security are also given. It must be remembered that all these texts date back to a period between 1st to 16th centuries. It therefore need not be stated that the description are as per need of the period, however if we can separate the basic thought-process or principle, it can be very well seen that they adhere to modern period also.

32. DISCUSSION Acharyas were very much concerned about minutest parts of the rasasala . They concentrated not only on the construction of the manufacturing unit but also on the selection of place for construction, interior plans and arrangement etc. The building, water supply, disposal of waste, containers cleaning and stores, etc are similar to those mentioned in Ayurveda . For working Space, different sections are mentioned for agni karma, sastra karma, kshalana karma etc which are related to vastu shastra . The different equipments mentioned in samhitas for Rasashala are according to the materials avaiable , quantity of medicine manufactured and the type of medicine prepared during those days. With times, advancement in science, growing demand of medicines these instruments have been replaced by more sophisticated machinaries which can meet the demands of the society in a short span of time. Acharyas were very well aware of the quality and hence mentioned about dravya sangrahana and dravya samrakshana vidhi which assured good quality of the medicines. Acharyas used to prepare their own medicines with utmost care and hence the need to maintain the batch manufacturing records, distribution records, records of market complaints did not arise in those days. There is also explatation about aushadhi sangrahakar , rasavaidya , paricharaka , bali karta which can be related to the drug collector,phamacognosist , attender , security guard, supervisors etc. to ensure that the medicine were prepared in a genuine way having good quality and also protected from any external problems.

33. CONCLUSION In Rasashala , medicines are prepared according to classics and in traditional way In GMP certified pharmacy, medicines are prepared in bulk. Concepts of GMP were followed from the vedic period and the references can be seen in ayurvedic textes which have given elaborate description about the Rasashala and also about the production of medicine To meet the worldwide demand for herbo -mineral drugs ,it is essential to maintain GMP Implementing GMP for herbo -mineral drugs, as per the recent amendment of the DRUGS AND COSMECTIC ACT of the government of india with a buffer period of two years,is a great challenge for ayurvedic drugs. Recently Govt. of India has notified GMP for ISM .this is also aimed to ensure production of good quality medicines for the consumer in the domestic & international market.

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