What Are Different Types Of Ayush License Required By Manufacturer In India?
There are various types of ayush license registration being required by the manufacturers in india and are obtained by online mechanism and are highlighted below-
1] Ayush manufacturing license
2] Ayush Loan License
3] Ayush contract manufacturing license or product to product manufacturing license
What is Ayush complete manufacturing license ?
The ayush manufacturing license online mode can be achieved in india when the applicant has a proper plan to manufacture the product and set up a manufacturing unit for it as well as do the marketing of the product
There are certain conditions to be fulfilled by the applicant under ayush act in order to achieve ayush manufacturing license registration -
1] The manufacturing unit being set up should be in an industrial area.
2] There should be a space of 1200 sq ft. For manufacturing one drug only.
3] The GMP certification is compulsory for the manufacturing unit
4] The manufacturing team should include at least 02 pharmacists and 02 ayurvedic experts which is mandatory as per the ayush act otherwise it will be difficult to get aush license registration.
5] There will be regular inspection of premises through drug inspectors.
6] All the type of machinery equipment such as packaging and manufacturing should be available in the premises and in the right condition.
What is Ayush Loan License ?
Under this type , the manufacturing units are not being owned by the applicant who is applying for the ayush license registration.The products being manufactured under this are done through the third party manufacturer.
The loan license should be applied with a GMP certified manufacturer and later on will be issued to the applicant company.The only thing to be done is to obtain approval of the product from the concerned authorities.
There are certain requirements to be fulfilled in order to achieve online ayush license registration and is highlighted below -
1] The manufacturing unit should be available in an industrial area.
2] There should be a minimum 03 rooms available in the manufacturing unit for storage of raw material ,storage of finished product and the last for the office work.
3] One should keep in mind the renewal of loan license to be done timely.
4] There will be a regular visit of a drug inspector on the premises for drug inspection purposes.
5] There is no need for any ayurvedic and pharmacist expert in the premises or team.
What Is Product To Product Manufacturing Or Third Party Manufacturing License ?
Under this type of license , the applicant neither has a license nor has a manufacturing unit available with him.He is involved only in the marketing part of the product and nothing else.
The license used for the work is of the manufacturer and it is a manufacturer job to get the product approval from the concerned authorities.
One can assist the manufacturer by providing the raw material and packaging material otherwise the manufacturer would arrange all by himself.
What are the documentation required for GMP certification and Issue of COPP ?
There are certain documents necessary being required in order to file the application for the gmp certification and issuance of the certificate of pharmaceutical product -
1] All the details of the applicant applying for the ayush license registration is required such as name ,address , telephone , email etc.
2] The copy of the manufacturing license is to be provided.
3] The manufacturing process and manufacturing formula is to be provided
4] The list of approved products is to be provided.
5] The list involving products for which company has already availed copp.
6] The method used for the analysis is to be provided
7] various details such as manufacturing date , expiry date , drug name etc.
8] The herbal products validation report for every 03 batches.
9] The list of technical staff is provided along with the qualification , experience ,approval status.
10] The manufacturing plant layout , HVAC system diagram ,02 years export data
11] According to rule 158B drugs and cosmetic rules,1945 the proof of safety and effectiveness.
12] The certificate of analysis of 03 batches of every product.
What is GMP ( Goods Manufacture Practise ) Certification ?
The GMP stands for ‘’goods manufacturing practice’’ and can be defined as a system under which it focuses that the products are consistently produced and being controlled as per the quality standards guidelines by the WHO.
The certification is done in order to minimize the risk being involved in production of pharmaceuticals. One should note that a good GMP certificate indicates that the company has cleared the concerned pharmaceutical body inspection in that country and can also export the products without any difficulty and has met the standards set up by the WHO for manufacturing of products.
What is process of obtaining Ayush license registration ?
The ayush license registration online can be obtained through the following process being provided below -
1] The first step is to go to the state wise site of ayush by online mode in order to apply for the ayush license registration.
2] The second step involves downloading of the required form , attachments , list of various required documents ,other certificates such as COPP and GMP etc.
3] Applying for the certificate of GMP ad COPP
4] The last step is the submission of the application with all necessary documents to the directorate of the ayush under ministry of ayush.
End Point By BIATConsultant
The Ayush manufacturing license online can be obtained through the process guided above and applicants applying for the ayush license registration should first understand all terms and conditions under the ayush act in order to achieve ayush license registration.
There are various types of license available and the applicant should be clear on the ayush license registration he needs to apply for and understand all the requirements and terms and conditions to be fulfilled in order to achieve the license and thereafter apply for the ayush license registration a sper the prescribed format being guided above.