I understand stability studies are required for product license application, please advice on the duration of study required and how many batches will be required. Is it only accelerated or long term study will also apply.
Response:For manufacturing any Ayurvedic product in India, manufacturer’s require three month case study i.e. clinical trial. Product is distributed to atleast three registered B.A.M.S. doctors (Two must be governmental doctors). They submitted their report regarding product’s. effectiveness against indication’s claimed, potency, stability, side effects if any etc. Above mentioned study is adequate for getting approval for manufacturing of any Ayurvedic Preparation in India. Duration and requirements may vary state to state or timely by Governmental policies.
After approval of these Ayurvedic Doctors, AYUSH department gives permission of manufacturing, sale and promotion of any Ayurvedic Products in India. This process is applicable to all Proprietory and Patented Ayurvedic Products.
In case of Classical Ayurvedic Products e.g. Single herbs, Chawanprash, Ristha, Ashava etc, Manufacturer doesn’t need to take approval from AYUSH department. Ayurvedic manufacturer can manufacturer classical products without any alteration in label and indications as described in Ayurvedic Books.
With above requirements, you will need IEC number ( Import/Export Code Number) for exporting or importing from/to India. This is necessary for all importer or exporter to have IEC. Without IEC, no one can do export/import from/to India. IEC is alloted by Director General of Foreign trade within the jurisdiction office of your firm situates.
For Ayurvedic Products Export approval
All formulations, herbal/Ayurvedic medicines, where the label does not mention any ingredients extracted from prohibited plants shall be freely exportable without the requirement of any certification from any authorities what soever.
On request from processor or exporter, the competent authority shall issue certificate(s) for the export of Ayurvedic, Unani and Siddha products as per the requirement of the importing country. ref: order dated: 16-4-2008, Government of India, Ministry of commerce and Industry.
But you may have to pass one from three type of inspections or certifications:
- Consignment wise inspection for ensuring safety with regard to contaminant such as heavy metals, pesticides, aflatoxins and microbes or
- System approach to include end-product quality as well as implementation of good manufacturing practice (GMP’s) by the processor or
- Safety, quality and efficacy through independent review of dossier submitted by the manufacturer.
Dossier may include following things:
- Name of the drug
- List of all ingredients and their strengths
- Strength and dosage form, Indications if applicable
- Name and strength of each ingredient; in case of a product containing more than one ingredient
- Trade name or proprietary name; if any
- Specification of the medicine, where applicable
- Ayurvedic/Siddha/Unani Medicines
- Total quantity to be exported
- Name and address of the exporter
- Name and address of the manufacturer
- Name and address of consignee
- Country of consignee
- Route of dispatch
- Licence/registration number
- Cost, insurance, freight (CIF) value
- Expected date of dispatch
Procedure For Exporting Ayurvedic Medicines:
- Start a Ayurvedic Company/Firm/Business
- Apply for Import Export Code and Free Trade License
- Search Foreign Customers and Agents (B2B portal may help in this regard)
- Make a Contract with them
- Finalize Rates (Included or excluded with shipping cost, custom clearance and other expenses)
- Finalize payment, shipping method/agent and delivery terms
- Receive Order
- Prepare Invoice (Against PO or Letter of Credit(LC))
- Clear custom procedure (By own or through agent)
- Apply for Shipping bill electronically through Custom Online Software System and obtain shipping bill
- Inspection will be carried out of material, documents etc. Custom officer will send examination report to higher custom officers for approval
- “Let Export Order” will be issued and three shipping bill is generated. One for exporter, one as exchange control copy for submission in Reserve Bank of India through exporter’s bank and one is shipping carrier for exporting country destination.
- In importing country, all clearance will be handled by your customer, agent or any appointed agent.
Things to Give Attention for Exporting From India:
- HTS (HS code) of the product which exporter is going to be export. HTS stands for Harmonized Traffic Schedule. For exporting any product, HTS code has to be mentioned of the product. These code are of international standards and accepted while clearing custom in importing country.
- HSN code: The Harmonized Commodity Description and Coding System, also known as the Harmonized System (HS) of tariff nomenclature is an internationally standardized system of names and numbers to classify traded products.
- ITC code stands for Indian Tariff Code. It is 8 digit level code. The first two digits give the chapter number, Four digits the heading number. The last two digits signify the subheading
- Export of Pharmaceutical and Ayurvedic products is defined under Chapter 30 of schedule 2 in Indian Tariff Code (ITC). ITC is devided in two schedules. Schedule 1 define import requirement where as Schedule 2 defines export requirements.
- LC (Letter of Credit): A letter of Credit is a Bank Guarantee letter issued by Buyers Bank as a proof of payment to the seller that payment will be received on time and for correct amount.
Hope above information was useful to you….
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