How to get a Manufacturing License of Drugs in India?

The company/distributor/independent agent to be an authorized Indian Agent for dealing with local/foreign drugs and cosmetics must have a manufacturing license from the Central Drugs Standard Control Organisations (CDSCO). The application for the manufacturing drug License of medical devices in India is made according to Rule 27 to the State Drug Licensing Authority, CDSCO Zonal/Sub-zonal Office, and Drugs Controller General in India CDSCO (HQ).

Manufacturing of notified medical devices under Central License Approving Authority (CLAA) for sale in India, a manufacturing drug license in form- 28 is required under Drugs and Cosmetics Rules. Rule 76 of Drugs and Cosmetics describe the information/data required for a grant of a manufacturing drug license. Manufacture for sale of Disposable Hypodermic Syringes, Needles, and Disposable Perfusion sets and in-virto Diagnostic Devices are regulated by the concerned State Drug Licensing Authority. 

Manufacturing License for Sales or Distribution of drugs

The Drug license for the manufacture for sale or distribution of drugs (as specified by the Central Government from time to time by notification in Official Gazette) is granted by the Central License Approving Authority (ClAA). For the other drugs, application for grant or for renewal of the license to manufacture for sale or for distribution is required to be made to the licensing authority, which is appointed by the State Government. 

It is also noted that drugs can also be manufactured by obtaining a loan license under the Act and Rules framed. According to Rule 69A of the Rules, a loan license means a license which the licensing authority can issue to an applicant who intends to avail the manufacturing facilities owned by a licensee under the Form 25A. The license to manufacture for sale or distribution of drugs remains valid for a period of 5 years unless sooner suspended or cancelled by the licensing authority.

Manufacturing Licenses and Forms

License Name	Description	Relevant Rule	Licensing Authority	Timeline
Test License For Manufacturing	Form-29 is a license to manufacture drugs for the purpose of Examination Testing and Analysis. The application made in Form-30, and the certificate is valid for one year. The applicant cannot manufacture activity other than examination, testing, and analysis purpose in the proposed manufacturing site.	Rule- 89	DGCI	Usually between three months to six months
Permission to Manufacture Post Successful Clinical Trial	A license in Form-46 is granted when an application is made in Form-44 to allow manufacturing for sale of medical devices that are new in the Indian market without conducting clinical trials.	Rule- 122 B	DGCI	6 months
License to Manufacture Notified Medical Devices	Manufacturing of notified medical devices for sale in India is given In Form-28 with an application made in Form-27. It is required for the manufacturing of Disposable Hypodermic Syringes, Needles, and Disposable Perfusion sets.	Rule 76	For certain specified notified medical devices- DGCI. For other State Drug Licensing Authority.	Usually, three months to six months.
Loan License (Manufacture in a facility owned by third party)	Manufacturing of notified device in the third party site requires a loan license in Form-25 A and Form-28 A. The license is granted by State Authority while other notified devices come under the CDSCO.	Rule- 69A and Rule- 76A	For certain specified notified medical devices- DGCI. For other State Drug Licensing Authority.	Usually, three months to six months.

Manufacture and Import of Drugs

It is a mandate of the Act and Rules framed thereunder that no new drug shall be imported or manufactured for sale unless it is approved by the Licensing Authority (including Fixed-Dose Combination of two or more drugs). The term ‘new drug’ is defined under the Rule 122E of the Rules. It is provided in Rule 122E that a new drug must continue considered to be a new drug for a period of four years from the date of its first sanctioned approval.

(CDSCO) the Central Drugs Standard Control Organisation, is a Licensing Authority for approval of the manufacturing and import of new drugs. Apart from the manufacturing and import of new drugs, any person who intends to import drugs into India, such person requires to obtain a Registration Certificate and Import License from the Licensing Authority in the manner as specified under Part-IV of the Rules. The regulatory compliances are not only restricted to drugs, but they also apply to manufacture sites based overseas, as well.

License to stock, sell, exhibit or offer for sale or distribute the drugs.

Any person or entity who intends to sell stock or distribute drugs, such person or entity is required to obtain the licenses from State Drugs Authorities. Licenses to sell and distribution of drugs are categorized mainly in categories as retail drug license, wholesale drug license, and restricted licenses. There are some conditions attached to every license. Therefore, the license holder has to observe such conditions during the existence of licenses. In case of any failure by the license holder to meet the conditions of licenses, the relevant licensing authority has empowered to suspend or cancel those licenses under the specified Act and Rules. It is important to note that in the event of any change in the constitution of a firm operating under the license, such a firm is required to inform the licensing authority in writing. Such license must be deemed to be valid for a maximum period of three months from the date on which the change takes place.

Read our article:How one can apply for Wholesale Drug License in India?

Procedure to obtain Drug Manufacturing License (Fresh)

Stage 1: The Applicant has to apply online to the State Drugs Controller –cum- Licensing Authority of the State^[1]. The documents have to be uploaded and to be handed over to the Inspecting Officer/Drug Control Officer during the inspection. The applicant is required to make an application in the requisite Form. The details of Forms and necessary fees are mention below:-

• Application on Form 24 for Non-biological drugs manufacturing license with a fee of Rs. 7500 for ten items per category and Rs. 300 per item for more than 10 products per category and application on Form 27 for manufacturing of a Biological drugs with a fee of Rs. 7500 for ten items per category and Rs. 300 per item for items more than 10 items per category.
• Application on Form 24A for loan drugs manufacturing license for Non-biological drugs as per conditions prescribed and application for loan license of bio-logical drugs is to be submitted on Form 27A.
• Application on Form 24B for repacking of license with a fee of Rs. 700 up to 10 items per category and Rs. 100 per item if the items are more than 10 items.
• Application on Form 24C for Homeopathic manufacturing drug license with a fee of Rs. 300 for mother tincture Rs. 300 for potentized preparations and Rs. 300 for potentized and Rs. 50 for additional items if the items are more than 10.

User has option to pay the fee online through Net Banking/Debit Card/Credit Card and can also download the challan and can pay the fees.

Stage 2: The applicant shall submit an application through online mode after completing to the State Drugs Controller, i.e., licensing authority along with all required documents. Application form is scrutinized, and the application is then forwarded to the Senior Drugs Control Officer of the concerned zone for inspection of the premises of the firm. Premises are inspected by Senior Drugs Control Officer of the concerned zone, and the report is forwarded by Senior Drugs Control Officer along with his recommendation to State Drugs Controller. 

Stage 3: Grant of Manufacturing drug License – If all conditions as prescribed by the Act have complied, the license is granted by State Drugs Controller, and the applicant gets information through SMS /email.

Documents with Application for Grant of Drug Manufacturing License:-

• Required application form has to be filled Online.
• Blueprint along with site plan of the premises, duly signed by the firm’s Proprietor/partner/Director.
• Rent receipt or lease deed of the premises (original or attested photocopies)
• Attested copy of the partnership deed in case of partnership firm or Memorandum (MOA) and Article of Association (AOA) if it is Limited firm or company duly signed by Directors.
• List of present directors showing their complete name and residential address.
• If there is change in Directors (registration, addition, replacement) as original with their attested photocopy of Form 32 in respect of such outgoing or incoming director.
• Full details of the competent technical staff /registered persons along with copies of their educational qualification, experience, and registration certificates.
• Non-conviction affidavit of approved technical staff as required with academic qualification & approval.
• Attested copies of academic qualification and the approval of technical staff as per conditions prescribed in Drugs and Cosmetics Act, 1940 and Rules, 1945.
• List of the machinery
• List of the lab equipment
• Purchase bills of the machinery and equipments (original or attested photocopies)
• NOC of fire fighting and NOC of pollution control if applicable (original or attested photocopy)
• Proof of load sanction (original or attested photocopy)
• Attested photocopy of allotment/occupation certificate form
• Declaration in the form of affidavit about sleeping/active partner/Director responsible for day to day work and conduct of the company along with declaration as to whether such prop/partner/director has been convicted under Drugs and Cosmetics Act, 1940 and Rules, 1945.
• Resolution of Board of Directors regarding the appointment of authorised signatory.
• Non-conviction affidavit by authorised signatory, if appointed any by the firm.

Procedure for Retention of Drug Manufacturing License

• Government by vide its notification no. GSR-1337 dated 27.10.2017 has removed the word “Renewal” and instead of renewal procedure of license retention by the licensee, “if the licensee deposits a license retention fee before the expiry of a period of every succeeding five years from the date of its issue, unless, it is suspended or cancelled by the Licensing Authority.
• The license retention fee must be equivalent to the respective fee required for the grant of such license, excluding the inspection fee paid for grant of license.
• In case the licensee fails to pay license retention fee on or before the due date, he must be liable to pay license retention fee along with a late fee calculated at the rate of two percent of the license fee for every month or part thereof up to six months, and in event of the non-payment of such fee, the license must be deemed to have been cancelled.
• Licensee at the time of submission of license retention fee must also submit an undertaking that is (a) there is no change in the constitution (b) there is no change in premises (c) there is no change in approved technical staff (d) list of already approved items and required fee which firm intends to retain.
• Validity certificate on receipt of license retention fee must be issued forthwith if full fee in all respect is deposited.

Conclusion

A due diligence is required to be undertaken by every company and entity prior to entering into the Indian Pharmaceutical Industry. It must be ensured whether the prospective drug or formulation (either to be manufactured or imported to India), as qualified as a drug or a new drug since there are different set of rules and procedures for drugs that are prevailing in the Indian market for more than 4 years for new drugs. Timelines for renewal of license plays a significant role. For instance, if an application for the renewal of a drug manufacturing license is made before its expiry or if the application is made within 6 months of its expiry (after payment of additional fees), the license continues to be in force until orders are passed on the application.

Read our article:A Complete Overview on Drug License Rules in India