Overview
A manufacturing drug license is issued by the competent authority under the Drugs and Cosmetic Act, 1940. The issued license indicates that the manufacturer is entitled to operate a business involving drugs, medicines, and cosmetics. Thus, a manufacturing drug license is mandatory for such businesses. The license is granted for commercial purposes. The Drugs Controller General of India issues the registration certificate under the Drugs and Cosmetic Act, 1940, and rules are made under it.
What all disclosure has to be made before applying?
The government has issued strict guidelines about drug manufacturing licenses. The drug license signifies that the quality of drugs manufactured is maintained. Under the Drugs and Cosmetic Rules, Form 28 has to be filled to apply for a manufacturing license.
The applicant must disclose the following before applying:
Manufacturing activities undertaken
The layout of the premises
Concise details of the manufacturing process
Specific environmental requirements must be fulfilled
Name and designation of the person who will sign the documents
Product specification
Standards followed by the manufacturer for drug evaluation
Storage method
What are the advantages of obtaining a Manufacturing Drug License?
The advantages of obtaining a manufacturing drug license are as follows:
1. Legal Recognition
Having a manufacturing drug license signifies that the manufacturer has the authority to manufacture such goods. After issuance of the drug license, it provides legal recognition to the manufacturer’s business. In addition, it is illegal to manufacture drugs without a registered license.
2. Proper Regulation
The competent authority keeps a check on the manufacturer having the license. They ensure that the business is regulated properly. This leads to an increase in the trustworthiness of the business.
3. Authenticity
The license works as an authentic proof and helps in the image building of the company. The credibility of the business increases.
4. Consumer Base
The license indicates that the business follows strict guidelines in manufacturing drugs. Having a proper license gives confidence to the consumers. This increases the consumer base of the business.
What Documents are required for Manufacturing Drug License?
The essential documents required for manufacturing drug license are as follows:
Covering letter of the business
Authorization letter
Form 27 of the Drugs and Cosmetic Rules filled properly
Identification and address proof of the applicant
Constitutional documents of the business
Approved Manufacturing Premises layout
Complete disclosure of technical staff
Site master file
Device master file
Specific environmental requirements
Medical devices details
Disclosure of standards followed by the company for product evaluation
ISO Certificate
Full Quality Assurance Certificate
Additional documents which may be required for obtaining the license include a copy of resolutions passed by the Board of Directors, the blueprint of the key plan, and the site plan of the business. The applicant must submit documents to prove his possession or ownership of the property where business is conducted.
What is the Procedure for Issuance of the Manufacturing Drug License?
The procedure for filing the manufacturing drug license is provided below:
1. Attestation of required documents
The applicant must keep all the documents ready and get them attested by the competent authority.
2. Online application
The applicants may visit their state's websites to submit their applications online. After submitting the documents, a processing fee is charged. However, some states don’t have this option available. In that scenario, the applicant has to submit a hard copy of the documents.
3. Payment of fee
The applicant is required to submit the license fees. The license fee is Rs. 6000 and the inspection fee is Rs. 1500.
4. Verification
A drug inspector will visit the premises to verify two things:
To check the submitted documents
To ensure that premises are fit for manufacturing drugs
After the inspection is complete, the drug inspector may call the applicant for an interview.
5. Issuance of license
After all, the documents and premises are checked and the business fulfills the eligibility criteria for granting a certificate. The Drugs Controller General of India will issue the manufacturing drug license to the applicant. A unique registration number is allotted to the applicant and it has to be used for further reference.
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