Detailed Process For Getting Drugs Manufacturing License

To manufacture drugs legally in India, it is mandatory to obtain a manufacturing license under the Drugs and Cosmetics Act, 1940. The process is governed by both State and Central Regulatory Authorities, depending on the nature and category of the drugs.

1.  Identify the Category of License Required

The first step is to determine the type of manufacturing license applicable to your business. This could include licenses for Allopathic Drugs, Ayurvedic, Unani, Siddha, Homeopathic Medicines, Cosmetics, or Medical Devices. Additionally, if the company does not own a manufacturing unit but utilizes another facility, a Loan License may be required.

2.  Establish a GMP-Compliant Manufacturing Facility

The applicant must set up a manufacturing unit that complies with Good Manufacturing Practices (GMP) as outlined in Schedule M of the Drugs and Cosmetics Rules. The infrastructure should have separate areas for manufacturing, packaging, storage, and quality control, with proper ventilation, hygiene, and waste disposal systems. The premises must also include cold storage and equipment suitable for the type of drugs being produced.

3.  Appoint Qualified Technical Personnel

A critical requirement for obtaining the license is the appointment of qualified personnel. This includes a Manufacturing Chemist, who should have a degree in Pharmacy or Pharmaceutical Sciences and relevant industry experience, and an Analytical Chemist, who is responsible for quality control and testing of the products. The qualifications and experience must be documented and submitted with the application.

4.  Gather and Prepare Required Documentation

The applicant must prepare a comprehensive set of documents, which includes:

• Constitution documents (MOA, AOA, partnership deed, LLP agreement)
• Proof of premises ownership or rent agreement along with a No Objection Certificate (NOC) from the property owner
• Site and layout plans of the manufacturing unit
• Details and proof of qualification of technical staff
• List of machinery and manufacturing equipment
• Water testing reports and environmental clearance, if required
• Affidavits regarding non-conviction of the firm and its responsible persons
• GMP compliance declaration

5.  Submit Application to the Licensing Authority

The completed application along with the necessary documents must be submitted to the State Drugs Standard Control Organization (SDSCO) or, in specific cases involving critical drugs or new drug molecules, to the Central Drugs Standard Control Organization (CDSCO). Applications are made in specific forms, such as Form 24 for allopathic drugs or Form 27 for Ayurvedic products.

6.  Inspection by Drugs Licensing Authorities

After submission, the drug inspector from the licensing authority conducts a thorough inspection of the manufacturing premises. The inspection evaluates the infrastructure, hygiene standards, personnel qualifications, and compliance with Schedule M. Any deficiencies must be rectified before the license is approved.

7.  Grant of Drugs Manufacturing License

Upon successful inspection and verification of all submitted documents, the drugs manufacturing license is granted in the prescribed format (e.g., Form 25 for allopathic drugs, Form 28 for other categories). The license remains valid for a period of five years and must be renewed periodically to ensure continued compliance with regulatory requirements.

8.  Post-Licensing Compliance

Once the license is issued, the license holder must ensure ongoing compliance with all regulatory norms. This includes maintaining batch manufacturing records, conducting regular in-house quality checks, submitting periodic returns to the authority, and being prepared for surprise inspections. Any violations or deviations may result in suspension or cancellation of the license.

List of Key Drug License Application Forms in India

Form 24:  Application to manufacture drugs (except those in Schedules C, C (1), and X).

• Form 24 is used to apply for the grant or renewal of a license to manufacture drugs for sale or distribution, excluding those specified in Schedules C, C(1), and X of the Drugs and Cosmetics Rules.
• It is applicable to non-biological, non-narcotic drugs.

Form 24B:  Application for license to repack drugs for sale (excluding Schedules C, C (1), and X).

• Form 24B is used to apply for the grant or renewal of a license to repack bulk drugs into smaller packs for sale or distribution.
• It excludes drugs listed under Schedules C, C (1), and X of the Drugs and Cosmetics Rules.

Form 24C:  Application to manufacture and sell homoeopathic medicines or potentised preparations.

• Form 24C is an application form required to obtain a license for manufacturing and selling homoeopathic medicines, including potentised preparations.
• This license is essential for any business involved in the commercial production of homoeopathic products.

Form 24D:  Application to manufacture Ayurvedic, Siddha, or Unani drugs.

• Form 24D is the designated application for obtaining a manufacturing license for Ayurvedic, Siddha, or Unani drugs.
• It is mandatory for entities engaged in the commercial production of traditional Indian medicinal formulations.

Form 24E:  Loan license application to manufacture Ayurvedic/Siddha/Unani drugs.

• Form 24E is the application form required to obtain a loan license for the manufacture of Ayurvedic, Siddha, or Unani drugs.
• This form is intended for applicants who do not possess their own manufacturing facilities but wish to utilize an existing licensed manufacturer's premises for production.

Form 24F:  Application to manufacture drugs listed in Schedule X (excluding Schedules C & C (1)).

• Form 24F is the application form for obtaining a license to manufacture drugs listed under Schedule X, excluding those specified in Schedules C and C(1).
• This license is essential for manufacturers involved in the production of controlled substances, which are subject to stringent regulatory controls.

Form 27:  Application to manufacture drugs under Schedules C & C (1) (excluding part XB and Schedule X).

• Form 27 is the form required to obtain a license for the manufacture of drugs listed under Schedules C & C (1), excluding those in part XB and Schedule X.
• It is intended for businesses involved in the production of pharmaceutical products subject to specific regulatory requirements.

Form 27A:  Loan license application for drugs under Schedules C & C (1) (excluding part XB and Schedule X).

• Form 27A serves as the application for obtaining a loan license to manufacture drugs falling under Schedules C & C (1), excluding those in part XB and Schedule X.
• It applies to entities that operate through the facilities of an existing licensed manufacturer.

Form 27B: License to manufacture drugs listed under Schedules C, C (1), and X.

• Form 27B is the prescribed form for obtaining a license to manufacture drugs listed under Schedules C, C(1), and X.
• It is applicable to manufacturers dealing with highly regulated pharmaceutical products, including narcotics and biologicals.

Form 27C: License for operating a Blood Bank for blood processing and component preparation.

• Form 27C is the designated form for obtaining a license to operate a Blood Bank, including the processing of whole blood and preparation of its components.
• It is mandatory for institutions involved in the collection, storage, and distribution of blood and blood products.

Form 27D: License to manufacture Large Volume Parenterals, Sera, Vaccines, or r-DNA derived drugs (excluding Schedule X).

• Form 27D is the prescribed form for obtaining a license to manufacture Large Volume Parenterals, Sera, Vaccines, or recombinant DNA (r-DNA) derived drugs, excluding those listed under Schedule X.
• It is intended for manufacturers involved in producing complex and sterile pharmaceutical products.

Form 27DA3: Loan license to manufacture Large Volume Parenterals, Sera, Vaccines, or r-DNA derived drugs (excluding Schedule X).

• Form 27DA3 is the application form for obtaining a loan license to manufacture Large Volume Parenterals, Sera, Vaccines, or recombinant DNA (r-DNA) derived drugs, excluding those under Schedule X.
• It is meant for entities utilizing licensed third-party manufacturing facilities for the production of these specialized pharmaceutical products.
   

Form 27E: License to manufacture blood products for sale or distribution.

• Form 27E is the prescribed form for obtaining a license to manufacture blood products intended for sale or distribution.
• It is essential for facilities engaged in the processing and commercialization of therapeutic blood derivatives.

Form 30: License to manufacture drugs for examination, test, or analysis purposes.

• Form 30 is the official form for obtaining a license to manufacture drugs exclusively for the purposes of examination, testing, or analysis.
• It is intended for research institutions, laboratories, or manufacturers conducting non-commercial drug evaluations.

Form 44: Permission to import/manufacture new drugs or conduct clinical trials.

• Form 44 is the official form used to obtain permission for the import or manufacture of new drugs, or to conduct clinical trials.
• It is essential for entities involved in introducing new pharmaceutical products or undertaking drug research in India.

For more details, please click Drugs Licensing