How can I get Ayurvedic drug manufacturing license?

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A simple and essential guide to obtain a drug manufacturing license for ayurvedic medicine. It covers procedure, minimum requirements, documents & affidavits and all other necessities.

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How can I get Ayurvedic drug manufacturing license?

  1. 1. dr.surendra.chaudhary@gmail.com, +91-9810004259
  2. 2.       Present status of manufacturing industry About Ayurveda manufacturing license The Drugs and Cosmetics Act and Rules Essential requirements for drug license The state and district drug authorities GMP and other accreditations dr.surendra.chaudhary@gmail.com, +91-9810004259
  3. 3.     Ayurveda, the ancient healing science is gaining popularity day by day at domestic as well as international level. Herbal medicines are the back bone for treating a patient. Quality medicine is in great demand and so many small as well big commercial houses are entering in the Ayurveda manufacturing field. Presently so many pharmaceuticals companies are manufacturing Ayurvedic patent as well as classical drugs like Chavyanprash. Ayurveda drugs and herbs industry has an estimated Rs.35,00 Crore turnover. There is huge demand of herbal medicine and cosmetics in developed countries. Europe and erstwhile Russian countries along with U.S. are the main area for export. Other developing countries completely depend upon export from India. dr.surendra.chaudhary@gmail.com, +91-9810004259
  4. 4. All the requirements and suggestions in this presentations are out of my personal experience as expert of this field based upon Drugs and Cosmetics act& rules. Any discrepancies with the state drugs authorities are subject to verification and rectification with consultation of any expert of the subject. dr.surendra.chaudhary@gmail.com, +91-9810004259
  5. 5. ASU manufacturing units Total 10088 GMP Compliance None GMP 5402 http://indianmedicine.nic.in/showfile.asp?lid=315 4517 accessed on 11-10-2013
  6. 6.   It is necessary to obtain a drug manufacturing licenses for the sale of Ayurvedic medicine and/or cosmetics in India and for export Equally applicable across the country dr.surendra.chaudhary@gmail.com, +91-9810004259
  7. 7.    Ayurvedic manufacturing industry covered by this act Has provision for new license, renewal, definition regarding manufacturing Guidelines for GMP etc dr.surendra.chaudhary@gmail.com, +91-9810004259
  8. 8.   For the purpose of this Part the State Government shall appoint such Licensing Authorities and for such areas as may be specified in this behalf by notification in the Official Gazette. (Part XVI rule 152) In most of the state, Director Ayurveda/ Ayush is the Licensing authority dr.surendra.chaudhary@gmail.com, +91-9810004259
  9. 9. Application on Form 24-D (3 Copies) http://www.scribd.com/doc/105970847/FORM-24D  Blue print as per specification of Rule 157 ( dedicated to GMP)  List of technical staff with qualification and registration certificate( AyurvedacharyaBAMS or B.Sc with two years experience in a reputed registered manufacturing firm are the eligibility for manufacturing chemist/ technical staff)  dr.surendra.chaudhary@gmail.com, +91-9810004259
  10. 10.    List of medicines for which license is applied with name and reference book in case of classical drugs Full detailed ingredient, quantity, uses and method of preparation for proprietary medicine. Each product must have separate sheet. List of machinery and equipments including laboratory apparatus and equipments dr.surendra.chaudhary@gmail.com, +91-9810004259
  11. 11.   Fee- a sum of Rs. 1000(check for any change in your state) Treasury chalan in original with two photo copies (proof of required fee. Fees will be deposit in a particular code assigned for this purpose by the state government and code dully verified by the competent authority) dr.surendra.chaudhary@gmail.com, +91-9810004259
  12. 12. dr.surendra.chaudhary@gmail.com, +91-9810004259
  13. 13. Ownership- if proprietary, name and address of the owner.  Partnership- partnership deed, power of attorney declaring the name of signatory  Premises -Rent agreement if is rented  dr.surendra.chaudhary@gmail.com, +91-9810004259
  14. 14. Technical officer- Appointment letter showing full time nature of the technical staff  Consent letter- agree to work  Others-Photo copies of Degree and registration  dr.surendra.chaudhary@gmail.com, +91-9810004259
  15. 15.          Owner/Proprietor –Affidavit 1 The address Use of premise for the purpose manufacturing of drugs. That the premise not for residential purpose. About raw drugs testing Finished drugs testing Maintenance of testing record of raw & finished good Following all norms of Schedule ‘T’ The owner and partner non-conviction dr.surendra.chaudhary@gmail.com, +91-9810004259
  16. 16.  Owner/Proprietor –Affidavit 2  Manufacturing only approved product No resemblance with other products regarding their name, formulations, packing and labeling  dr.surendra.chaudhary@gmail.com, +91-9810004259
  17. 17.     Technical Officer Non resemblance with other companies product with the best of his knowledge. Preparation of drugs under direct supervision Bound to follow the rules and regulations as laid down by the licensing authority dr.surendra.chaudhary@gmail.com, +91-9810004259
  18. 18. As per drug act Bachelor of Ayurvedic Medicine and Surgery-B.A.M.S.  B.Sc. With two years Ayurvedic drug manufacturing experience from any reputed unit. dr.surendra.chaudhary@gmail.com, +91-9810004259
  19. 19.         Office space 100 sq feet Raw drug store 150 sq feet Finished medicine store 150 sq feet Laboratory 150 sq feet Rejected drug store 100 sq feet Churn room 200sq feet sq feet Furness 200 sq feet- Bhatti/ Furness may have a tin shade Packaging area – › Packaging and other space should be as per kalpnas (dosages forms) to use during manufacturing dr.surendra.chaudhary@gmail.com, +91-9810004259
  20. 20. As per requirements related to number of kalpnas and volume of drugs http://www.scribd.com/doc/105970430/Space  dr.surendra.chaudhary@gmail.com, +91-9810004259
  21. 21.    Director Ayurveda of the respective state Application can be filed through District Ayurvedic Officer or direct to the Drugs cell of the directorate as case may be. Some of the procedure differs from state to state dr.surendra.chaudhary@gmail.com, +91-9810004259
  22. 22.  Classical Ayurvedic drugs › Based on classical text of ayurveda mentioned in first schedule of Drugs & Cosmetics act  Proprietary Ayurvedic drugs › Based upon personal experience and/or research dr.surendra.chaudhary@gmail.com, +91-9810004259
  23. 23.  No change is allowed › Name of the product › Ingredients › Indications   No proof of evidence required Application format› S.N. › Name of medicine › Reference book with adhikar dr.surendra.chaudhary@gmail.com, +91-9810004259
  24. 24.     Reference of ingredients only from the books mentioned in first schedule of Drugs & cosmetics act Proof of efficacy required Clinical trial reports may require in many indications Clinical trials are accepted from government hospitals in most of cases dr.surendra.chaudhary@gmail.com, +91-9810004259
  25. 25. Name of the product followed by “Proprietary Ayurvedic medicine” Each (pharmaceutical forms) containsS.N. Ingredient Botanical Name Part used Quantity Reference Preservatives, additives, binding agents, base materials etc if any Manufacturing process Indications Doses packing dr.surendra.chaudhary@gmail.com, +91-9810004259
  26. 26.   It is advisable to get Good Manufacturing Practice Certificate and other accreditation certificates for better acceptance from the domestic & export market. Technical help –contact dr.surendra.chaudhary@gmail.com dr.surendra.chaudhary@gmail.com, +91-9810004259
  27. 27. . dr.surendra.chaudhary@gmail.com +91-9810004259

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