Introduction for Ayurvedic Medicine Manufacturing License
For starting the Ayurvedic Medicine Manufacturing License in India, it is compulsorily require taking license from licensing authority. Before making the application, premises should be duly registered /licensed as per Factories Act, 1948 (if required by state authority), Environment Act, Air Act, Water Act, Fire NOC etc.
Manufacture on More than One Set of Premises
If Ayurvedic (including Siddha) or Unani drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be obtained in respect of each such set of premises.
Application for Ayurvedic Medicine Manufacturing License
An application for the grant or renewal of a Ayurvedic Medicine Manufacturing License for sale any Ayurvedic (including Siddha) or Unani drugs shall be made to the Licensing Authority along with fee.
In the case of renewal the applicant may apply for the renewal of the licence before its expiry or within one month of such expiry.
The applicant may apply for renewal after the expiry of one month but within three months of such expiry with additional fee. Duplicate copy of a licence can be issued issued, if the original licence is defaced, damaged or lost on payment of fee.
Conditions for the Grant or Renewal of Ayurvedic Medicine Manufacturing License
Before a Ayurvedic Medicine Manufacturing License is granted or renewed the following conditions shall be complied with by the applicant, namely:
- The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be carried out in such premises and under specified hygienic conditions.
- For issuing of the certificate of Good Manufacturing Practices, the Licensing Authority shall verify the requirements as per schedule and issue the Good Manufacturing Practices certificate, simultaneously along with grant or renewal of licence.
- No manufacturer shall use any prefix or suffix with the name of any Ayurvedic, Siddha or UnaniTibb drug falling u/s 3(a) of the Act, except as described in the specified authoritative books.
- A formulation without any specific name, described in the authoritative books may be named on the basis of the ingredients of the formulation.
- The name of any Ayurvedic, Siddha or UnaniTibb drug falling u/s 3(a) of the Act shall not be used for naming any patent or proprietary medicine relating to Ayurvedic, Siddha or UnaniTibb systems of medicine referred u/s 3(h)(i). However, this will not be applicable for single plant-ingredient based Ayurvedic, Siddha or UnaniTibb formulation licensed or to be licensed as patent or proprietary medicine u/s 3(h)(i).
- the licensee of the Ayurvedic, Siddha or UnaniTibb drug, which is not in conformity with sub-above rules, shall seek renewal of the licence with appropriate name of the drug within a period of one year from the date of commencement of Drugs and Cosmetics (4th Amendment) Rules, 2015. However, this shall not be applicable to any batch of Ayurvedic, Siddha or UnaniTibb drugs manufactured prior to the date of commencement of the Drugs and Cosmetics (4th Amendment) Rules, 2015.
- The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be conducted under the direction and supervision of competent technical staff consisting at least of one person, who is a whole time employee and who possesses the specified qualifications.
- The competent technical staff to direct and supervise the manufacture of Ayurvedic drugs shall have qualifications in Ayurveda and the competent technical staff to direct and supervise the manufacture of Siddha drugs and Unani drugs shall have qualification in Siddha or Unani, as the case may be.
Certificate of Good Manufacturing Practices (GMP) of Ayurveda, Siddha and Unani Drugs
The Certificate of Good Manufacturing Practices (GMP) to manufacturers of Ayurved, Siddha or Unani drugs shall be issued for a period of 5 years to licensee who comply with the requirements of Good Manufacturing Practices [GMP] of Ayurveda, Siddha and Unani drugs.
The Good Manufacturing Practices (GMP) are prescribed to ensure: –
- raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination;
- the manufacturing process is as has been prescribed to maintain the standards;
- adequate quality control measures are adopted;
- (iv) the manufactured drug which is released for sale is acceptable quality;
- to achieve the objectives listed above, each licensee shall evolve methodology and procedures for following the prescribed process of manufacture of drugs which should be documented as a manual and kept for reference and inspection. However, under IMCC Act 1970 registered Vaidyas, Siddhas and Hakeems who prepare medicines on their own to dispense to their patients and not selling such drugs in the market are exempted from the purview of Good Manufacturing Practices (GMP).
Issue of Ayurvedic Medicine Manufacturing License
A licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be within a period of 3 months from the date of receipt of the application.
A licence shall be granted by the licensing authority after consulting such expert in Ayurvedic (including Siddha) or Unani systems of medicine, as the case may be.
Conditions of Licence
- The licensee shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or by any other person on his behalf, of the raw materials and finished products.
- The licensee shall allow an Inspector appointed under the Act to enter any premises where the manufacture of a substance in respect of which the licence is issued is carried on, to inspect the premises, to take samples of the raw material as well as finished the products, and to inspect the records maintained under these rules.
- The licence and certificate of renewal in force shall be kept on the approved premises and shall be produced at the request of an Inspector, appointed under the Drugs and Cosmetics Act, 1940.
The licensee shall maintain an Inspection Book to enable an Inspector to record his impressions and the defects noticed.
Free Sale Certificate and Non-Conviction Certificate
The State Drug Controller or Licensing Authority shall, on request by the Ayurveda, Siddha and Unani Drugs manufacturer, issue, within 15 days from the date of application, Free Sale Certificate for original License holder or for loan license and Non Conviction Certificate for both original and loan license holder or in the format as specified by the importing country or tenderer respectively, after fulfilment of all requisite formalities as required in the respective formats.
Procedure for Ayurvedic Medicine Manufacturing License
Documents Required (It may vary from state to state)
- List of Equipment and Machineries Provided for Manufacturing
- List of Equipment Provided for Testing.
- List of Technical Staff for manufacturing along with their Self Certified photocopies w.r.t. Certificates of Education Qualification, Experience Certificate, Biodata on Proforma, Appointment Letter, three photographs.
- List of Technical Staff for testing along with their Self Certified photocopies w.r.t. Certificates of Education Qualification, Experience Certificate, Biodata on proforma, Appointment Letter, three photographs.
- Key Plan and Site Plan in Blue Print / Ammonia Print
- Proof of Constitution of Firm in case of Partnership / Pvt. Ltd./ Ltd. /Trust.
- Copy of Resolution passed by Board of Directors.
- Proof of Possession: (a) Rented: Rent Receipt & Rent Agreement. (Notary Attested) (b) Self Occupied.
- Proof of Ownership : Copy of Regd. GPA / Sale Deed / Property Tax Receipt
- Affidavit of Non Conviction
- Affidavit from employer and or Technical Staff for full time working with the firm as per format given in Guide Line Booklet.
- List of Formulations to be permitted alongwith product information separately for each drug and affidavit about owner / user of the trade name applied for.
- Consent of Approved Testing Laboratory for Sophisticated Testing.