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DRUG License

DRUG License

DRUG License

To conduct business in India’s drug and cosmetic industries, licences are required. The Drugs & Cosmetics Act, 1940, which is applicable to all of India, contains the relevant clauses. The Drugs Control Department was created by an Act that consolidated the regulations pertaining to drugs and cosmetics. The Act was revised in 1964 to include Ayurvedic and Unani medicines. In spite of the fact that a specific business entity can need a different kind of drug licence depending on their line of work, you can call LegalRaasta for advice.

When a business receives a licence, the licence must make sure that all of the conditions of the drug licence are followed at all times while the business is operating. The licencing authorities must be informed of any changes or modifications to the business activity, and all records, registrations, and forms must be maintained in accordance with their instructions.

Drug License Registration is done through LegalDoor.

Required documents Types of DRUG License

1. Constitution of the firm (MOA/AOA)
2. Photo ID proof of proprietor/partner/director
3. Copy of Property paper (If owned property)
4. Copy of Rent agreement (If rented property)
5. Site Plan and key plan of the premises
6. Refrigerator invoice and details
7. Affidavit regarding compliance of MPD 2021 (if premises are located on DDA residential flat/ plot/ building)

Types of Drug Licenses Issued in India

According on the kind of business for which the licence is obtained, the following different types of licences may be issued:

Manufacturing Drug License

Every producer of allopathic, cosmetic, ayurveda, or any other pharmaceuticals or remedies as defined by the Drugs and Cosmetics Act of 1940. This is the state permit that was granted by the particular state administration in which the property is located.

Loan Drug License

the medication maker who is willing to use his brand name to manufacture on property for which a licence has already been granted but does not own his own land.

Import Drug License

Any dealer who imports materials for the production of drugs or is involved in the business of importing narcotics in India shall this license.

FAQ

Yes, you must apply for a licence from the controller of medicines and cosmetics before starting any business dealing in drugs, whether it be allopathic drugs, ayurvedic medicine, homoeopathy, or unani medicine, in order to manufacture, distribute, or sell the drugs.

Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after obtaining a License.

The requirements of a drug licence are as follows:

For businesses selling medications, medicines, or cosmetics, a drug licence is required. The licence must be issued for a commercial location.

The pharmaceutical and cosmetics industries must adhere to all legal and regulatory requirements and restrictions.

The licence must always be visible in the business location.

Yes, any unit operating in any region of India needs a drug licence. For instance, if a drug business operates a unit in two different states, it must get licences for each unit.

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