Drug Manufacturing License in India

Drug Manufacturing License in India


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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Mili Rawat
BALLB(Hons.) from National Law Institute University, Bhopal.

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