How to get Drug Manufacturing License in India?

A company/ distributor/independent agent, in order to be an authorized Indian agent to deal with the local/foreign drugs and cosmetic, should have a drug manufacturing license from the Central Drugs Standards Control Organizations. The application for such license is made as per Rule 27 to the State Drug Licensing Authority, Central Drugs Standards Control Organizations^[1] and Drugs Controller General of India.

Drug Manufacturing License for sale and distribution of drugs

Drug license for sale or distribution of drugs is granted by the Central License Approving Authority. In case of other drugs, application for grant or for license renewal to manufacture for sale or for distribution should be made to the licensing authority, appointed by the state government.

Drugs can also be manufactured after obtaining a loan license under the Act and rules framed. As per Rule 69A, a loan license refers to a license which is issued by the licensing authority to an applicant who seeks to avail the manufacturing facilities owned by a licensee under Form 25A. The license to manufacture for sale, or distribution of drugs is valid for 5 years unless suspended or cancelled by the licensing authority. 

Various types of Drug manufacturing licenses and forms

We have discussed some types of manufacturing licenses, and forms in the table made below:

LICENSE NAME	DESCRIPTION	LICENSING AUTHORITY	TIMELINE
Test License for manufacturing	Form-29 is a license for manufacturing drugs for examination and analysis purpose.   The applicant cannot manufacture anything apart from examination, testing and analysis purpose in the manufacturing site proposed.	DGCI	Between 3 to 6 months period
License to manufacture post successful clinical trial	The license is granted under Form 46 when an application is made to permit manufacturing for sale of the medical devices that are new in the market without conducting clinical trials.	DGCI	6 months
License to manufacture notified Medical devices	This is required for the manufacturing of Disposable Hypodermic Syringes, Needles etc.	DGCI and also state drug licensing authority	Between 3 to 6 months period
Loan License	For manufacturing of notified devices in the third party site requires loan license.	DGCI and also state drug licensing authority	Between 3 to 6 months period

Procedure to obtain a Drug manufacturing License

The procedure is as follows:

• The applicant can apply online to the state drugs controller cum licensing authority of the state. The documents should be uploaded and has to be handed over to the inspecting officer or drug control officer.
• The applicant should make an application in the requisite form details of which are given below-
  • Application on Form 24 for non-biological drugs license with a fee of 7500 rupees for 10 items per category and 300 rupees per item for more than 10 products per category.
  • Application in Form 24A for loan drugs manufacturing license for the non-biological drugs according to the prescribed conditions and application for biological drugs to be submitted on  Form 27A;
  • Application on Form 24B for the repacking of license;
  • Application on Form 24C for homeopathic drug license.
• The applicant can submit the application after filling the application to the state drugs controller along with required documents.
• Then the application form would be scrutinized, and then it’s forwarded to the senior drug control officer of concerned zone for inspection of the premises.
• If all conditions are complied with, then the license is granted by the State Drugs Controller, and the applicant is informed via SMS/email. 

Documents required

The following documents are required-

• Blueprint with site plan of the premises;
• Rent receipt or lease deed of the premises;
• Attested copy of partnership deed in case of a partnership firm or MOA and AOA in case of a Limited Firm;
• List of present directors;
• Details of competent technical staff with their educational qualification and registration certificate;
• Attested copies of academic qualification and approval of the technical staff;
• List of the machinery and lab equipment;
• NOC;
• Proof of loan sanction;
• Attested copy of allotment/occupation certificate form;
• Non-conviction affidavit by authorised signatory;
• Resolution of the board of directors about the appointment of the authorised signatory.

Conditions for obtaining a Drug manufacturing license

The following conditions should be noted:

• Factory premises should comply with the standards laid down in Schedule M;
• Premises must have adequate space, machinery, equipment for manufacturing unit;
• Manufacturing and testing of drugs should be conducted under the supervision of full-time competent technical staff;
• There should be adequate staff and laboratory equipment to carry out tests at the testing unit;
• Sufficient arrangements for drugs storage should be ensured;
• Comply with the requirements of Good Manufacturing Practices.

Conclusion

Due diligence should be undertaken by companies and entities before entering into the Pharmaceutical Industry of India. Further, timelines for renewal of license is also crucial. If an application for the renewal of drug manufacturing license is made before its expiry or if the application is made in 6 months of its expiry, the license continues to be in force.

Read our article: Do You Want to Start a Pharmacy Business in India? Obtain Drug License!