Bengaluru | 16 Aug, 2016 (3 years, 5 months ago)


Approval s required for Marketing of herbal medicine and patenting it.

We met manufacturer of a herbal medicine which is very effective(for application and not oral) We would like to know the approvals which are required for manufacturing and selling this medicine and also the details for patenting it.
10 Oct, 2017 | 18:14

Yes most definitely.

19 Aug, 2016 | 11:31

(Requirements may vary state to state or area to area)
• Application Form
• Fee Receipt
• Declaration Form
• Required Space: - (For example – In Delhi a minimum of 1200 Sq feet space in conformed industrial area for initial one category.)
• Key Plan (Blue Print)
• Site Plan (Blue Print) as per GMP under schedule T of the Drugs and Cosmetics Act, 1940
• Basis of possession of the premises (Conveyance deed)/ Rent agreement and no objection from the owner (if rented).
• Proof of Constitution of firm.( Certified copy)
• Organizational Chart.
• Letter of Authorized signatory.
• Four technical persons:-
1. One Ayurvedic/ Unani Expert for manufacturing section.
2. One Ayurvedic/ Unani Expert for Quality Assurance.
3. One Botanist/ Pharmacist for Quality Assurance.
4. One Chemist/ Pharmacist for Quality Assurance.
• Biodata, Certificates, Appointment and Consent letter, Affidavit registration Certificate of Technical persons.
• List of formulations with references, Process, Trial reports, Facismile label, Trade mark Affidavit, Product proforma.
• Standard Operating Procedures (SOPs)
• List of necessary Machineries and Equipments.
• Non conviction Affidavit of the firm and Directors/ Partner/ Proprietor under Drugs and Cosmetic Act 1940 and Drugs and Magic Remedies (Objectionable Advertisements) Act 1954.

Inspection team will inspect the premises with regard to:- Location and surroundings, buildings, water supply, disposal of container's cleaning, Stores, raw material, packing material, finished goods store, working space, Health(clothing sanitation and hygiene of workers, medical services, and equipment's, quality control section etc.

A Patent is a monopoly right granted to person who has invented a new and useful article or an improvement of an existing article or a new process of making an article.

• Art, Process, Method or Manner of manufacture;
• Machine, Apparatus or other Articles;
• Substances produced by Manufacturing
• Computer Software which has Technical application to Industry or is used with Hardware
• Product Patent for Food / Chemical / MEDICINES OR DRUGS

• Full name, address & nationality of applicant (s) and inventor (s).
• Specification, provisional / complete drawings, claims and abstract.
• List of countries to claim priority, if any, where the application / applications for the grant of patent has/have been filed, alongwith date and application number.
• Power Of Attorney

• After the grant of patent, every patentee has to maintain the patent by paying renewal fee every year. For first two years, there is no renewal fee. The renewal fee is payable from 3rd year onwards. In case the renewal fee is not paid the patent will be ceased.


Our Firm can handle all the compliances and the Patent. Additionally, we can render complete end to end legal solutions from start to finish.

17 Aug, 2016 | 22:31

Well in order to respond to the regulatory (approval, licensing and best practices) and procedural requirements for patent registration, you should book a slot for meeting. It cannot be answered in brief here.


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