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The Indian government controls and maintains the standard of drugs sold in India under the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. The government monitors the use of drugs from the time it is first used as raw material for medicinal and commercial purpose until it is manufactured, sold, and distributed, up until the point at which a pharmacist in a retail pharmacy, hospital, or clinic sells it to a patient or consumer.
The government also exercises control over matters such as the import and export of pharmaceuticals, the sale of drugs to minors, the use of drugs on schedule H and X, and other issues that call for careful planning and close observation. Following the Drugs and Cosmetics Act of 1940, the drug governing authority issues the drug license.
The Drugs and Cosmetics Act of 1940 requires all manufacturers, distributors, retailers, sellers, dealers, pharmacists, and importers of drugs, cosmetics, Ayurveda, Siddha, and Unani drugs to get a drug license.
According to the kind of business for which the license is obtained, the following different types of licenses may be issued:
1. Manufacturing Drug License
For every manufacturer of allopathic, cosmetic, Ayurveda, or any other drug or drugs as defined by the Drugs and Cosmetics Act of 1940. This is a state permit that is granted by a particular state’s administration in which the unit is located.
2. Loan Drug License
For drug manufacturer who does not own his own land but is willing to use his brand name to manufacture on a property for which a license has already been granted.
3. Drug Import License
For any dealer who is involved in the business of importing drugs into India or who imports products for the manufacturing of drugs.
4. Multi-Drug Permit
For an organisation with numerous units operating in multiple states.
5. Drug License for Sale
For a company involved in the distribution of a drug in India, whether on a wholesale or retail basis.
6. Drug Dealer License
For wholesalers in pharmaceuticals business. The applicant for a wholesale drug License must meet certain minimal criteria, including:
• A pharmacy degree or diploma
• Minimum one year of drug dealing experience
7. Drug License for Retail
For Retailers selling drug, independent pharmacists, etc.
A drug license is valid for five years unless the drug department suspends and cancels it.
A license may be extended before its expiration date by completing the renewal application and submitting the required documentation and renewal cost. Post this; a new drug license will be issued by the drug controller.
When the unit's location changes, the drug business owner must relinquish the drug license for the previous location and apply for a new license for the new location.
Online drug license verification is possible through the website of the relevant state's drug authority. One must enter the unique drug license number to check the specifics of the drug license on the website.
Document of entity-
• Constitution of the entity,
• Memorandum of association (moa) and articles of association (AOA) of a company
• Partnership deed (for partnership firm)
• LLP agreement (in case of LLP firm)
Document of partner/director/ proprietor-
• Id proof of partner/director/proprietor. ,
• Affidavit in regard to non-conviction of proprietor/partner/director and the firm.
Documents of premises-
• Documents of ownership of property or rental agreement
• NOC (no objection certificate) from the owner of the rented premises.
• Key plan of the premises (proof of availability of storage space as cold storage, refrigerator, etc.)
Other Document-
• Copy of board resolution regarding obtaining of a license.
• Copy of challan as proof of depositing fee.
• The affidavit from the registered pharmacist/competent person.
• Cover letter with name and designation of the applicant
• Declaration form in a prescribed format
• Applicant’s qualification certificate
For a Pharmacist at a Retail Sale-
• Proof of qualification
• Registration from local pharmacy council
• Appointment letter
• For a pharmacist at a wholesale sale:
• Qualification proof
• Work experience certificate
• Appointment letter
For a Pharmacist at a Wholesale Sale-
• Qualification proof
• Work experience certificate
• Appointment letter
A Drug License is important for pharmaceutical companies in India as it allows them to legally manufacture, trade or distribute drugs in India. It also ensures that the drugs being manufactured, traded or distributed are safe and of good quality.
The process of obtaining a Drug License in India can take several weeks, depending on the completeness of the company's application and the specific state FDA department.
Penalties for operating without a Drug License in India can include fines, penalties, and imprisonment.
A separate drug license is required for each category of drugs.
Yes, there is a limit on the number of drugs that can be manufactured or distributed under one license.
Yes, there are specific labeling and packaging requirements for drugs manufactured or distributed under a Drug License in India. These requirements are defined by the state FDA department.
Yes, there are specific storage and transportation requirements for drugs manufactured or distributed under a Drug License in India. These requirements are defined by the state FDA department.
Yes, it is possible to obtain a Drug License for manufacturing and distribution of scheduled drugs, but the process is more rigorous and requires additional documentation.
Drug License holders are typically inspected annually. If non-compliance is found during an inspection, the FDA may impose penalties or revoke the Drug License.