This license is required for any person or entity that manufactures drugs in India. The Drugs Controller General of India (DCGI) or the Central Drugs Standard Control Organisation (CDSCO) issued the license.

To obtain a manufacturing drug license, the applicant must meet the following requirements:

• The manufacturing unit must be located in a suitable place. It must have adequate space, plant, and equipment for the manufacturing operations.
• The manufacturing unit must comply with the good practices (GMP) the DCGI prescribes.
• The manufacturing unit must have a competent technical staff, including at least one who is a Pharmacy or Pharmaceutical Chemistry graduate with at least 18 months of practical experience in drug manufacturing.
• The manufacturing unit must have separate arrangements for tests for the drugs’ strength, quality, and purity.

Suppose a single manufacturer has two or more factories situated in different locations for manufacturing the same or different drugs. In that case, each such factory will require a separate license.

Travelling agents of licensed manufacturers and importers of drugs involved in the free distribution of samples of medicines among members of the medical profession, hospitals, dispensaries, and medical institutions or research institutions are not required to obtain a manufacturing drug license.

This license is required for any person or entity that imports drugs into India. The DCGI or CDSCO issues the license.

To obtain an import drug license, the applicant must meet the following requirements:

• The premises where the imported drugs will be stored must be equipped with proper storage accommodations for preserving the properties of the drugs.
• Patent or proprietary medicines must be imported in containers intended for retail sale.
• All consignments of drugs imported must be accompanied by an invoice or other statement containing the name and address of the manufacturer and the name and quantities of the drugs.
• The importer must submit a declaration to the Drugs Controller before importing any drugs not covered under mandatory licensing. The declaration should be signed by or on behalf of the manufacturer or importer.

• This license is required for any person or entity operating in multiple states. If drugs are sold or stocked for sale at more than one place, a separate license is required for each such place.

This license is required for wholesalers and retailers who are engaged in the distribution of drugs.

There are three categories of drug licenses:

• Wholesale drug license: This license is required for wholesalers who sell drugs to retailers.
• Retail drug license: This license is required for retailers who sell drugs to the public.
• Restricted license for general stores: This license is required for general stores that sell a limited range of drugs.

• This license is required for persons who do not have manufacturing facilities but want to manufacture drugs on the premises of another licensed manufacturer. The licensee can then sell the drugs under their brand name.

The loan drug license is valid for one year and can be renewed for subsequent years.

• The applicant must have a valid manufacturing license from the Drugs Controller General of India (DCGI) or the Central Drugs Standard Control Organization (CDSCO).
• The applicant must have a written agreement with the licensed manufacturer that allows them to use their facilities for drug manufacturing.
• The applicant must have a competent technical staff capable of manufacturing drugs per the good manufacturing practices (GMP) prescribed by the DCGI.