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From the Editor’s desk Dear Readers, Department of Ayush issued guidelines for manufacturing of Rasaushadhies or Rasamarunthukal and Kushtajat (Herbo-mineralmetallic compounds) of ASU medicines. These guidelines provide general and minimum technical requirement for quality assurance and control in manufacturing Rasaushadhies or Rasamarunthukal and Kushtajat. The guidelines deal with Bhasmas, Sindura, Pishti, Kajjali, Khalviya Ras, Kupipakwa, Rasayan, Parpati, Potali Rasa, Satwa (of metals and minerals origin) Druti Parpam, Karpu, and Kushta etc used in ASU systems of medicine. The GMP guidelines for Rasaushadhi or Rasamarunthukal and Kushtajat are required to establish the authenticity of raw drug, minerals and metals, in-process validation and quality control parameters to ensure that these formulations are processed and prepared in accordance with classical texts and for which safety measures are complied. Only those manufacturing units which have GMP for ASU drugs and supplementary certificate for Rasaushadhies or Rasamarunthukal and Kushtajat formulations shall be allowed to manufacture the same. As per the supplementary guidelines, the manufacturing area of Bhasma and Kupipakawa and Rasaushadhi preparations made from metals and minerals should be completely segregated from the production area used for preparation of plants and animal byproduct based formulation to avoid cross-contamination. The guideline specifies the minimum area that the manufacturers have to use for each and every stages of manufacturing the medicines. As per the guidelines, the manufacturers have to keep a Shodhan Register for ready reference, providing even minute details. For quality control, the guidelines specify that the specifications for finished Rasaushadhi are primarily intended to define the quality rather than to establish full characterization, and should focus on those characteristics found to be useful in ensuring the quality. Consistent quality for Rasaushadhi can only be assured if the starting material-metals and minerals are used of pharmacopoeial standards. The manufacturers must ensure in-house standards for the uniform quality of product. Quality testing shall be carried out as per official Pharmacopoeia or Schedule books for texts. The Particle size of the product should also be tested by adopting microscope fitted with micrometer or particle size analyzer or any other appropriate techniques. Required physio-chemical characterization of the product should be undertaken by appropriate analytical equipment. The Standard Manufacturing Process of the product should be evolved/follow up. The disintegration time of pillsvati and tablets should also be recorded. You will find inside this issue the detailed guidelines for manufacturing of Rasaushadhies as guided by the Dept. of Ayush for your ready reference & implementation at your respective units. Let us all extend our support to Department of Ayush for its implementation. Besides this the current issue also contains our regular features like “Pharmocopial standards of an ayurvedic product and other regulatory updates. Hope you will find them useful too. We wish our readers a very a Happy New Year! Dr. Manju Rakesh On behalf of full editorial board Disclaimer: Articles in the newsletter are written by independent individuals. News Clips of Upcoming Events, Govt. Notifications, Schemes have been taken from different sources. Their opinions do not necessarily reflect those of Info Ayurveda. They are put here for interest and reference only. None of the contributors, sponsors, administrators, or anyone else connected with Info Ayurveda in any way whatsoever shall be responsible for the appearance of any inaccurate information or for your use of the information contained in the newsletter. Editorial Board: Chief Editor: Mr. Pradeep Multani, Honorary General Secretary AMAM Chairman Multani Pharmaceutical Limited 36-H Connaught place, New Delhi- 1 Editor: Dr. Manju Rakesh Dabur India Limited, Plot No. 22, Site IV, Sahibabad - 201010, Ghaziabad (U.P.) Mr. Anurag Sharma, Executive Director Shri Baidyanath Ayurved Bhawan Pvt. Ltd. (Jhansi) B- 6/5, Safdarjung Enclave, New Delhi Mr. Asad Mueed, Director Hamdard (WAKF) Laboratories, Asaf Ali Road, New Delhi – 110 002 Mr. Ajay Sharma, President Shri Baidyanath Ayurved Bhawan, Naini, 28, Ishwar Nagar East, New Delhi – 110065 Executive Committee Patron Vaidya Brahaspati Dev Triguna Ashok Chand Burman Suresh Sharma Pradip Burman President Vaidya Devender Triguna Tel: 011-24354141 Vice President Anurag Sharma Shri Baidyanath Ayurved Bhawan Ltd., (Jhansi) e-mail: anurag@baidyanathayurved.com Asad Mueed Hamdard (WAKF) Laboratories e-mail: amueed@hamdardindia.com Devendra Garg Dabur India Limited e-mail: gargd@dabur.com Ravi Prasad The Himalaya Drug Co. e-mail: ravi.prasad@himalayahealthcare.com Hon. Gen. Secretary Pradeep Multani Multani Pharmaceuticals Ltd. e-mail: chairman@multaniayurved.org Jt. Secretary Ajay Sharma Shri Baidyanath Ayurved Bhawan, New Delhi e-mail: ajdelhi@msn.com Dr. C.K. Katiyar Dabur India Limited e-mail: chandra.katiyar@dabur.com Arun Chauhan BACFO Pharmaceuticals (India) Ltd. e-mail: chauhanarun@akcgroup.com Rajiv Bansal Divya Pharmacy e-mail: rajivbansal20@gmail.com Members Vijay Grover Kamal Pharmacy, New Delhi e-mail: vijay@kamalpharmacy.com Pramod Sharma Shri Baidyanath Ayurved Bhawan Ltd. Patna e-mail: pramodsharma54@yahoo.com Dilip Bhujbal Dabur India Limited e-mail: bhujbald@dabur,com Dr. Manju Rakesh Dabur India Limited e-mail: rakeshm@dabur.com Amit Agarwal Natural Remedies e-mail: amit@naturalremedies.com A. V. Anoop Cholayil Pharmaceuticals e-mail: av_anoop@satyam.net.in M. J. Saxena Sanat Laboratories Ltd. e-mail: mjsaxena@sanatproducts.co.in Treasurer Tejinder Singh Dabur India Limited (M) 98112 05266 e-mail: singht@dabur.com Executive Secretary Jagdish Prasad (M) 0 96543 50711, 0 96543 50712 A Publication of: Association of Manufacturers of Ayurvedic Medicines Regd. Office: 22, Site –IV, Sahibabad, Ghaziabad - 201010 (UP), Tel: 0120 4378400, Fax: 0120 4376909 Correspondence Address: H-36, Connaught Place, New Delhi-110001, Tel: 011-23350062, Fax: 011-23350063 E-mail : amamindia@gmail.com website: www.amam-ayurveda.org www.amam-ayurveda.org 2
Regulatory Update Dear Members, The department of Ayush has issued a notification on supplementary guidelines for manufacturing of Rasaushadhies or Rasamarunthukal and Kushtajat (Herbomineral-metallic compounds) of Ayurveda, Siddha and Unani (ASU) medicines in the country. The supplementary guidelines are to provide general and minimum technical requirement for quality assurance and control in manufacturing Rasaushadhies or Rasamarunthukal and Kushtajat. These guidelines deal with Bhasmas, Sindura, Pishti, Kajjali, Khalviya Ras, Kupipakwa, Rasayan, Parpati, Potali Rasa, Satwa (of metals and minerals origin) Druti Parpam, Karpu, and Kushta etc used in ASU systems of medicine. Given below is a copy of notification on the same for your ready reference please. “Supplementary guidelines for manufacturing of Rasaushadhies or Rasamarunthukal and Kushtajat (Herbo-mineral-metallic compounds) of Ayurveda, Siddha and Unani medicines” These guidelines are intended to complement those provided above and should be read in conjunction with the parent guidelines. The supplementary guidelines are to provide general and minimum technical requirements for quality assurance and control in manufacturing Rasaushadhis or Rasamarunthukal and Kustjat (Herbo-mineral-metallic formulations). These supplementary guidelines deal with Bhasmas, Sindura, Pishti, Kajjali, Khalviya Ras, Kupipakwa, Rasayan, Parpati, Potali Rasa, Satwa (of Metals and Minerals origin) Druti Parpam, Karpu, and Kushta etc. used in Ayurvedic, Siddha and Unani Systems of medicine. The supplementary GMP guidelines for Rasaushadhi or Rasamarunthukal and Kustajat are needed to establish the authenticity of raw drug, minerals and metals, in-process validation and quality control parameters to ensure that these formulations are processed and prepared in accordance with classical texts and for which safety measures are complied. Only those manufacturing units which have Good Manufacturing Practices for ASU drugs and supplementary certificate for Rasaushadhies or Rasamarunthukal and Kustajat formulations shall be allowed to manufacture the same. Supplementary Good Manufacturing Practices certificate for Rasaushadhies shall be issued by the State Licensing Authority only after thorough inspection by an expert team including Rasashstra experts nominated by the Department of AYUSH. 2. Manufacturing Process Areas.- For the manufacture of Bhasma and Kupipakawa and Rasaushadhi preparations made from metals and minerals the following specific areas shall be provided, which should be completely segregated from the production area used for preparation of plants and animal byproduct based formulation to avoid cross contamination. The following exclusive areas are required for Rasaushadhies or Rasamarunthukal and Kustajat:- 2.2 (a) Bhatti or Heating Devise Section for Bhasma and Rasaushadhies:- 100 Sq. feet for heating, burning, putta and any heat related work with proper ventilation, exhaust and chimney. This could be tin shed also. (b) Grinding, Drying and Processing Section for Bhasma and Rasaushadhies:- 100 Sq. feet (Manual or Mechanical, oven etc.). Drying may be done in a space which is covered by glass or other transparent material to allow entry of sunrays on the material to keep for the purpose. If drying is being done in oven the temperature of the same may be selected specific temperature. (c) Rashaushadi Related Store:- 100 Sq. feet. The size and dimensions of each Bhatti Section would be so designed to suit the batch size or quantity of materials to be processed, keeping in mind the processing is done as per the conditions of Drug and Cosmetics Act mentioned under Schedule I official books. In addition to the fuels prescribed in the schedule books namely coal, fire wood, cow dung cakes etc., use of other heating devices e.g. electrical heating, oil or gas fired furnaces and others may be employed so as to provide the required temperature as per the nature of material and object of heating. Depending on the formulation being manufactured, manufacturers may adopt aerobic or anaerobic process. Properly baked andclean earthen pots of other crucibles and glass containers or appropriate design shall be used. The manufacturing area should be designed with special attention to process the products that generate toxic fumes like SO2, arsenic and mercury vapor, etc. When heating and boiling of the materials is necessary, suitable ventilation and air exhaust flow mechanism should be provided to prevent accumulation of unintended fumes and vapors. Such areas may be provided with properly designed chimneys or ducts fitted with exhaust system and suitable scrubbing system to remove fumes and smoke, so that safety of personnel and environment is taken care of. Since processing of Rasaushadhis may introduce heavy metal contamination and cross contamination etc., therefore, cleaning of equipment is particularly important after every process by using appropriate cleaning agent which should not react with material of equipment and must be free from unwanted properties e.g. corrosiveness. 2.3 Records shall be maintained specially for temperatures attained during the entire process of Bhasmikaran, while employing different kinds of classical puta, furnaces using oil, gas or electricity. Appropriate temperature measuring instrument should be employed such as pyrometer and, pyrograph for manual reading or recording by heat sensors, connected to computer as the case may be. In order to handle large quantities, appropriate technology like use of hand operated extruders for makingchakrikas or pellets may be adopted. However, such equipments made of aluminium or its alloys should not be used. Access to manufacturing areas shall be restricted to minimum number of authorized personal only. 3. Quality Control.- A. In Process Quality Control:- The registers as indicated below should exclusively be maintained for ready reference:- (a) Shodhan Register with following details:- 1. Sl. No. 2. Batch No. and Size 3. Date, time and duration 4. Name of the Raw-material with Quality reference and quantity 5. Quantity of Shodhana Dravya 6. Book Reference followed 7. Methodology www.amam-ayurveda.org 3
Page 1: Volume. 1 No.7 Jan - March. 2011 Pr
Page 5 and 6: 7. Dosage form of Rasaushadhi.- The
Page 7 and 8: Dear Members, Regulatory Update You
Page 9 and 10: Industry Event - QCI Seminar In con
Page 11 and 12: Organization Send AYUSH Application
Page 13 and 14: THERAPEUTIC USES - Kasa, Shwasa, Ks
Page 15 and 16: Pharmocopial Standards For Vasavleh

ishing You Happy New Year - amam-ayurveda.org

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