How to get Drug Manufacturing License in India?

How to get a Drug Manufacturing License in India? – Wanting to get a license in drug manufacturing? Don’t know how to get registered for drug manufacturing in India? So, this post is for you to help you get familiar with requirements, procedures for the drug manufacturing license in the easiest way. If you want to start a pharma company, independent pharma agent, distributor with the authentic authority to manufacture drugs, or do business with medicines in India then you shall get the license from the Central Drug Standard Control Organization (CDSCO). It has been made compulsory for the pharmaceutical companies, individuals to get licenses under the Drug and Cosmetics Act, 1940 in India.

How to get Drug Manufacturing License in India?

Why Do You Need Drug License?

In case you are dealing with the drugs then one needs to get permission from the government. The wholesale and retail license for drug selling or distribution in India are the two kinds of licenses. With a subject to certain restrictions, conditions related to the place, and the person who shall be dealing with the drugs. For the conduct of sale of drugs in India, one needs to own an appropriate license under the Drugs and Cosmetics Act, 1940. All types of drugs or cosmetics business is covered including Unani drugs( Ayurvedic) or homeopathic, allopathic. The person dealing with the drugs shall be held responsible for maintaining the quality of the medicines. Under the IPC, it is an offense if a person using or consuming any kind of drug or cosmetic undergoes suffering or harm because of the negligence by the seller or the manufacturer. Therefore one must be very careful while dealing with the drugs.

Documents Needed For Drug License

List of documents of the Applicant for Drug License:

The Indian Pharmaceuticals sector ensures security of customer interest. The life of the customer is important. The Government of India had made it necessary for everyone to own a drug license especially the Pharma manufacturers and Pharma Franchise Companies. To apply for licensing , you need to have a list of documents to submit by the company. We have listed the required documents required to apply for license 2020.

  • The Certificate of Incorporation or registration
  • Memorandum of Association and Article of Association or Partnership Deed/LLP Agreement
  • Canceled Cheques and PAN Card
  • Photo, Address Proof of Director and ID
  • Affidavit from Directors
  • Bio-data of Competent person
  • Appointment Letter of Competent Person
  • Qualification and Experience Certificate of CPID, Address Proof, and Photo of a competent person.

Documents of Shareholders/ Directors:

Registered GPA, Registered Sale Deed, Conveyance Deed in the name of the owner if the land is owned.
Unregistered sale Deed / unregistered GPA must be supported with a property tax receipt, water bill, electricity bill.
Khasra Khatauni documents are acceptable in the case of the village.

  • If rented, Registered Rent Agreement with Rent Receipt.
  • In the case of an unregistered rent agreement, the rental agreement must be supported with Electricity Bill/ Property tax receipt.
  • No Objection Certificate from the owner of the premises.
  • Key plan and Site Plan of the premises are duly attested by the approved architect or mapmaker of the municipality.

Drug License in India Registration Process

Step -1: Documentation

Preparation of the site plan and key plan along with various other declarations and affidavits that are needed as per the law is the first and the foremost step that needs to be fulfilled by the individuals obtaining the drug manufacturing license.

Step -2: Filing Application:

After preparing all the documents, these are scanned and upload while filling the application online for drug license. Further after the submission of the forms, the documents are check and analyzed by the inspector.

Step-3: Inspector Visit

In order to verify and cross-check the validity of the documents submitted at the time of application, the same is put up for inspection and thereafter a physical visit to the place is conducted.

Step-4: Granting of the License

Once everything is in order and has been verified then the personal interview is conducted to ensure that the person dealing with the drug is competent enough. Once the verification procedure completes completely, then the drug license is issued by the Drug Controlling Authority in India.


You can apply for a license online or offline directly from the government office. Sanify Healthcare is the best known pharmaceutical company that is certified with ISO, WHO, GMP etc. They are trusted by thousands of people for their quality products ranges in different pharma segments.

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