How to Begin Manufacture of Ayurvedic Medicines
Obtaining a drug manufacturing license is mandatory in the Republic of India for manufacturing ayurvedic medicines for sale inside the country, as well as for export. The manufacturing license is renewable. Every state government appoints licensing authorities. The Director of the Department of Ayurveda or A.Y.U.S.H. of the state is the licensing authority. Applications are usually filed through a District Ayurvedic Officer or the Drugs cell of the A.Y.U.S.H. directorate. Some of the procedures may differ from state to state (Saroya 2016b), but the format is unchangeable.
The manufacture of ayurvedic medicines is governed by the rules of the Drugs and Cosmetics Act, 1940. All classical and proprietary formulations have to be cleared by the Authority before commencing commercial production. Rules 151-155 В of the Act relate to the manufacture and regulation of licensing of ayurvedic medicines. Rules 156-160 specify the conditions of licensing, and Rules 160 A-160 J are concerned with approval of testing laboratories and regulation of testing and quality control.
If a company manufactures ayurvedic medicines on more than one set of premises, a separate application shall be made and a separate license shall be obtained in respect of each such set of premises. An application for the grant or renewal of a license to manufacture for sale any ayurvedic medicines shall be made in Form 24-D to the Licensing Authority along with a fee of 1000 rupees. Subject to the conditions of Rule 157 being fulfilled, a manufacturing license shall be issued by the Licensing
Authority in Form 25-D. The license shall be issued within a period of three months from the date of receipt of the application. An original license in Form 25-D or a renewed license in Form 26-D, unless suspended or cancelled earlier, shall be valid for a period of five years from the date of its issue or renewal (Anonymous 2014a).
If a unit does not have its own manufacturing facilities, it can avail them from another unit which has those facilities. This arrangement is called loan licensing. An application for the grant or renewal of a loan license shall be made in Form 24-E to the Licensing Authority along with a fee of 600 rupees. A loan license shall be issued in Form 25-E. An original loan license in Form 25-E or a renewed loan license in Form 26-E, unless suspended or cancelled earlier, shall be valid for a period of five years from the date of its issue or renewal (Anonymous 2014a).
Before a manufacturing license or loan license is granted, the applicant shall comply with the following conditions:
i) The manufacture shall be carried out in such hygienic conditions as given in Schedule T of Rule 157 under the Drugs and Cosmetics Act, 1940
ii) The manufacture shall be carried out under the direct supervision of technical staff including at least one person who possesses (a) a degree or diploma in Ayurveda or Ayurvedic pharmacy conferred by a university or government or (b) a graduate in pharmacy, pharmaceutical chemistry, chemistry or botany of a university or government with experience of at least two years in the manufacture of ayurvedic drugs or (c) a vaidya registered in a State register of indigenous systems of medicine, having an experience of at least four years in the manufacture of the medicines
Applying for a Manufacturing License
The application is to be supported by blueprints of the manufacturing facility as per specifications laid down in Rule 157 pertaining to G.M.R; a list of technical staff with qualifications; a list of formulations for which the license is sought, indicating the name and reference book in the case of classical medicines, and a complete details of ingredients, quantities and method of preparation in the case of proprietary medicines; a list of machinery and equipment, including those used in the testing laboratory and an application fee, which may vary from state to state. In addition to these the applicant has to submit several documents and affidavits related to ownership of the company and the premises in which the manufacturing facility is located (Saroya 2016b).
The manufacturing facility should have an office (100 sq. feet), a crude drug store (150 sq. feet), a finished medicine store (150 sq. feet), a laboratory (150 sq. feet), rejected medicine store (100 sq. feet), a ciirna room (200 sq. feet), a furnace (200 sq. feet), and a packaging area (Saroya 2016b).
Conditions of License
A license issued in Form 25-D shall be subject to the following further conditions also:
- (i) The licensee shall maintain proper records of the details of manufacture and of the tests carried out by him regarding the raw materials and finished products
- (ii) The licensee shall allow an Inspector appointed under the Act to enter any premises where the manufacture of ayurvedic medicine is carried out. He should permit the Inspector to inspect the premises, to take samples of the raw materials as well as finished products and to inspect the records maintained under the Rules
- (iii) The licensee shall maintain an Inspection Book in Form-35 to enable an Inspector to record his impressions and the defects noticed (Anonymous 2014a)
Conditions of Loan License
A loan license in Form 25-E shall be subject to the following conditions as well:
- (i) The license in Form 25-E shall be deemed to be cancelled or suspended, if the license owned by the licensee in Form 25-D whose manufacturing facilities have been availed of by the licensee is cancelled or suspended
- (ii) The licensee shall comply with the provisions of the Act and of the Rules and with such further requirements if any, as may be specified in any Rules subsequently made under Chapter IV-A of the Act, provided that where such further requirements are specified in the Rules, these would come into force four months after publication in the Official Gazette
- (iii) The licensee shall maintain proper records of the details of manufacture and of the tests carried out by him regarding the raw materials and finished products
- (iv) The licensee shall allow an Inspector appointed under the Act to inspect all registers and records maintained under these Rules and shall furnish to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the Rules have been observed
- (v) The licensee shall maintain an Inspection Book in Form-35 to enable an Inspector to record his impressions and the defects noticed (Anonymous 2014a)
Proof of Effectiveness
Traditional ayurvedic formulations with ingredients, dosage form and indications according to authoritative texts of First Schedule do not require any safety study. However, evidence of effectiveness is required from authoritative texts. Traditional ayurvedic formulation with a change in dosage form also does not require safety studies. Nevertheless, evidence of effectiveness is required from published literature. Traditional ayurvedic formulations for new indication also do not require a safety study. However, evidence of effectiveness needs to be provided from published literature and pilot studies (Anonymous 2014a).
Formulations based on R.&D. efforts and textual rationale fall into this category. The class also includes nutritive formulations, cosmetics and formulations based on aqueous, hydro-alcoholic and other extracts. Proprietary formulations with ingredients not from Schedule E (I) and based on textual rationale from authoritative texts do not require any safety study, but evidence of the effectiveness of ingredients needs to be supported by published literature and a pilot study. Proprietary formulations with any of the ingredients from Schedule E (I) and based on rationales from authoritative texts also do not require any safety study. However, effectiveness needs to be proved from published literature and a pilot study (Anonymous 2014a).
Extract-based formulations fall into five varieties. Only references from authoritative texts are required for formulations manufactured with aqueous extracts and based on authoritative texts. Formulations manufactured with aqueous extracts as per authoritative texts, but with new indications, do not require a safety study. However, proof of effectiveness is required. Evidence of the effectiveness of medicines manufactured with hydro-alcoholic extracts and based on textual information is required on a case-to-case basis. Safety study is required for formulations manufactured using specific hydro-alcoholic extracts and intended for a new indication. Proof of effectiveness is also required. The license requirements for medicines manufactured with various organic solvents are stringent. Data on acute toxicity, chronic toxicity, mutagenicity and teratogenicity are required in such cases. The effectiveness of these products needs to be proved with published literature and clinical studies (Anonymous 2014a).
Records of Raw Material Used
Each licensed manufacturer of ayurvedic medicines shall keep a record of raw materials used by the manufacturing unit in the preceding financial year in the proforma document given in Schedule ТА. The information shall be submitted to the State Drug Licensing Authority and to the National Medicinal Plants Board by 30 June of the succeeding financial year (Anonymous 2014a).
To ensure the quality of products, the Government of India has made it mandatory for all Ayurveda medicine manufacturing units to adopt good manufacturing practices. G.M.P. Certification came into force as per the Gazette Notification No. GSR 561(E) dated 23 June 2000. The certificate will be issued to those manufacturers who comply with the requirements of G.M.P. as laid down in Schedule T of Rule 157 of the Drugs and Cosmetics Act, 1940. Those manufacturers who had registered their units prior to the date of the Gazette were asked to obtain the certificate within two years from that date. The certificate of Good Manufacturing Practices to manufacturers of ayurvedic medicines shall be issued for a period of five years to licensees who comply with the requirements of Good Manufacturing Practices (G.M.P.) for Ayurveda, Siddha and Unani drugs as laid down in Schedule T (Anonymous 2014a).