Overview of Manufacturing Drug license
Manufacturing Drug License is the license issued by the competent authority under the Drugs and Cosmetic Act, 1940 to operate a business concerning drugs/medicines or cosmetics. The State Licensing Authority is responsible to grant the license such as-
- Drug Sales License,
- Manufacturing Drug License for Ayurvedic, Allopathic, and Cosmetics, etc.
The government has strict rules for granting the Manufacturing and sales of drugs under the Drugs and Cosmetics Act, 1940. The other functions carried out by the authorities are to perform a regular inspection of the premises, drugs manufacturing unit, and to stop malpractices by implementing the Food and Drugs Act. All types of drugs include Ayurvedic, Allopathic, and Cosmetics. The drug license helps the authority monitor and maintain the quality of drugs sold in India.
Manufacturing Drug license
What are the Prerequisites for Obtaining a Manufacturing Drug License?
For manufacturing drugs, a Manufacturing license in Form-28 is required under the Drugs and Cosmetics Rules. Application for Manufacturing Drug license is made in Form 27 to-
Before obtaining the Manufacturing Drug License, an applicant must fulfill the below-mentioned Prerequisites-
- Disclosure of manufacturing activities.
- The Layout of the Premises.
- Brief detail about the Manufacturing process.
- Fulfilling the criteria of Specific Environment Requirements.
- An authorization letter granted by the Indian Agent Firm revealing the name and designation of the concerned person authorized to sign the documents on behalf of the firm.
- Disclosure of the Product Specification and flow chart of the manufacturing process of the device.
- Disclosure of the standards followed by the organization for product evaluation.
- Space requirement and Storage facility.
What are the Benefits of Obtaining the Manufacturing Drug License?
The benefits of obtaining the Manufacturing Drug License are-
A person must file a Manufacturing drug license application as it provides legality to the business and also it is illegal to engage in the manufacturing or sale of drugs in India without obtaining the license.
- Proper Monitoring and Regulation by the Authority
Manufacturing drug license helps the authority in monitoring and regulating the sale of medicines in India that ultimately enhances business credibility and trustworthiness.
- Proof of Authenticity
A Manufacturing Drug license plays a vital role, as it works as a proof of authenticity and builds an image of the company.
- Confidence in the Consumers
A drug license certificate proves to your consumers that the business is following strict quality measures while manufacturing drugs. Also, a valid license proves to the consumers that the medicines and drugs are safe and constitute no health hazards.
What Documents are required for Manufacturing Drug License?
Below-mentioned documents are required for Manufacturing Drug License-
- Covering Letter
- Authorization letter and Duly filed form 27
- Id and address Proof of the Applicants
- Constitutional Documents
- Approved Manufacturing Premises layout
- Full Disclosure of Competent and Regular Technical Staff
- Site Master File and Device Master File
- Specific Environmental Requirements
- Particulars of Medical Devices
- Disclosure of standards followed by the Company for Product evaluation
- ISO Certificate
- Full Quality Assurance Certificate
Apart from the above-mentioned documents, additional documents are required for obtaining the Manufacturing Drug license-
- Copy of Board Resolutions passed by the Board of Directors.
- Key Plan and Site Plan in Blueprint.
Proof of Possession
- Rented- (Rent Receipt & Rent Agreement).
Proof of Ownership
- Property Tax Receipt
- Affidavit of Non-Conviction as per format given in Guideline Booklet.
- Particulars of Technical Staff for manufacturing drugs.
- Particulars of Technical Staff for testing.
- Acceptance of Approved Testing Laboratory for advanced Testing.
What is the Procedure for Filing the Manufacturing Drug License?
The procedure for filing the Manufacturing Drug License is mentioned below-
The very initial step involved in a Manufacturing drug license application is preparing the requisite documents. The applicant will have to obtain all the necessary documents and get them attested by the authorities.
- Visiting the Official Website
Nowadays, the drug license application occurs online, and applicants may visit the official website of their respective state authority to fill out the application form. Once the applicant fills the form and uploads the requisite documents, applicants will have to pay the processing fee for the same.
However, in certain states, applicants will have to take a print of the application submitted online along with the supporting documents and send it to the District Licensing Office.
- Verification by the Authority
A drug inspector will visit the premises to verify the submitted documents and to ensure the premises are suitable for manufacturing drugs. After verification, the Drug inspector might call the applicant for an interview.
- Issue of Drug License
Once verification is complete if the organization clears the guidelines, the Controller of Drugs will issue a drug license for the establishment. Once a registration is done successfully, the applicant will receive a unique Registration Number which they use for further processing and reference.
How Corpbiz Helps its Client in Getting a Manufacturing Drug License?
We at Corpbiz have trained experts to help you throughout the Manufacturing drug license process. Our Experts will guide and assist you in the licensing process and also ensures the timely and effective completion of your work. For any queries related to the Manufacturing Drug license and related drug license, feel free to contact our experienced and trained professionals at Corpbiz. Contact Corpbiz and our team of experienced professionals will provide timely updates about the process and get your job completed.
Corpbiz has a team of professionals with years of experience behind which helps its client by providing various services-
- Proper interaction with government authorities.
- Proper documentation by handling all the paperwork and follow up.
- Realistic expectations.
- Access to reliable professionals and direct communication with the clients to fulfill their legal requirements.
- Ensures continuous interactive process with the government.
Frequently Asked Questions
- Manufacturing License
- Sale License
- Wholesale Drug License
- Retail Drug License
- Restricted Drug License
- Loan License
- Import License
- Multi-drug License
A Restricted Drug license is a license granted to those dealers who do not hold the services of a qualified person and only deal with such classes of drugs whose sales can be affected without a qualified person who do not have fixed place of business.
- Manufacturing Drug License is compulsory for the drugs, medicine, or cosmetics business.
- It shall be permitted for a commercial premise
- It shall comply with the requirement and conditions imposed by law and authorities and shall be displayed all the time in the place of business.
The Drugs Controller General (India) grants the registration certificate vide Gazette notification G.S.R 426(E) under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder.
Form 11 under the Drugs and Cosmetics Act is issued for the import of small quantities of drugs for examination testing or analysis.
- Any individual,
- partnership firm,
- Limited Liability Partnership,
- One Person Company can apply for a Drug license.
A holder can submit the complete application with the following enclosures in the office of the Drug Licensing Authority of your district within 15 days of online registration for renewal in a duly filled Form 19/19A/19AA/19C.
Hand sanitizers are licensed under Drugs and Cosmetics Rules, 1945. The standards of such products must be prescribed in the Second Schedule of Drugs and Cosmetics Act & rules made there under. Further, on March 13, 2020, the central government had notified masks (2ply & 3ply surgical masks, N95 mask) & hand sanitizers under Essential Commodities Act, 1955 in order to regulate their production, quality, distribution and logistics.
A subsequent Drug license implies a medication registered by the Central Licensing Authority for certain cases and preferred to be advertised with changed or new cases including sign, course of organization, measurements, and dose structure.
No manufacturing, processing, packing, or holding of prescription or nonprescription drugs shall be conducted in any personal accommodation.