MANUFACTURING DRUG LICENSE
A manufacturing drug license is issued by the competent authority under the Drugs and Cosmetics Act, of 1940. The given license shows that the maker is qualified to work in a business including drugs, drugs, and beauty care products. Consequently, a manufacturing drug license is compulsory for such organizations. The license is allowed for business purposes. The Drugs Controller General of India gives the registration certificate under the Drugs and Cosmetics Act, of 1940, and rules are made under it.
What disclosure must be made before applying?
The government authority has issued severe rules about drug manufacturing licenses. The drug license connotes that the nature of drugs fabricated is kept up. Under the Drugs and Cosmetic Rules, Form 28 must be filled out to apply for a manufacturing license.
The candidate should disclose the accompanying before applying:
- Manufacturing Activities Undertaken
- Product Specification
- Concise Details of The Manufacturing Process
- Storage Method
- Standards Followed by The Manufacturer for Drug Evaluation
- The Layout of The Premises
- Specific Environmental Requirements Must Be Fulfilled
- Name And Designation of The Person Who Will Sign the Documents
CONDITIONS FOR GETTING A DRUG MANUFACTURING LICENSE:
- Factory premises ought to agree with the guidelines set down in Schedule M;
- Premises should have sufficient space, machinery, and equipment for the manufacturing unit;
- Manufacturing and testing of drugs ought to be led under the management of full-time skillful specialized staff;
- There ought to be sufficient staff and research center hardware to complete tests at the testing unit;
- Sufficient arrangements for drugs storage ought to be guaranteed;
- Comply with the requirements of Good Manufacturing Practices.
DOCUMENTA REQUIRED FOR MANUFACTURING LICENSE:
- Covering letter along with payment of application fee
- Self-assessed checklist of documents
- Form 24 & 27
- Product list
- List of excipients
- Similar product
- Draft label
- Methods of analysis
- Additional information form
- Copy of memorandum of articles
- List of directors with their address
PROCESS TO GET DRUG MANUFACTURING LICENSE:
Stage 1: The Candidate needs to apply online to the Drugs Controller –cum- Licensing Authority of the State. The records must be transferred and to be given over to the Investigating Official/Drug Control Official during the examination. The candidate is expected to make an application in the imperative Form. The subtleties of Forms and fundamental expenses are noticed underneath –
- Application on Form 24 for Non-organic drugs producing license with a charge of Rs. 7500 for ten things for each class and Rs. 300 for each thing for more than 10 items for every class and application on Form 27 for manufacturing of biological drugs with an expense of Rs. 7500 for ten things for each classification and Rs. 300 for each thing for things above 10 things for every classification.
- Application on Form 24A for credit drugs producing a license for non-biological drugs according to conditions endorsed and application for advance license of bio-sensible drugs is to be submitted on Form 27A.
- Application on Form 24B for repacking of license with an expense of Rs. 700 up to 10 things for every class and Rs. 100 for everything assuming that the things are more than 10 things.
- Application on Form 24C for Homeopathic manufacturing drug license with a charge of Rs. 300 for mother tincture Rs. 300 for potentized arrangements and Rs. 300 for potentized and Rs. 50 for extra things assuming the things are more than 10.
Candidate has the choice to pay the charge online through Net Banking/Check Card/Visa and can likewise download the challan and can pay the expenses.
Stage 2: The candidate will present an application through web-based mode in the wake of finishing to the State Drugs Controller, i.e., authorizing authority alongside completely required reports. Application Form is investigated, and the application is then sent to the Senior Drugs Control Official of the concerned zone for examination of the premises of the firm. Premises are assessed by the Senior Drugs Control Official of the concerned zone, and the report is sent by Senior Drugs Control Official alongside his proposal to State Drugs Controller.
Stage 3: If all circumstances as recommended by the Act have gone along, the license is granted by State Drugs Controller, and the candidate helps data through SMS/email.