DRUG LICENCE

Medical advancement has been the main factor in keeping human life and healing serious diseases all through time. Medicine is the only weapon of humanity to fight against sickness. But as specialized drugs can be used to treat a specific disease, drugs are not as widely consumed as chocolate. Anyway, before taking any medicine, it is better to have a qualified doctor who can give you advice as to the way, time, and the exact drug to be used for the treatment of the disease. Otherwise, this may result in negative effects. The Indian government passed the “Drugs and Cosmetics Act of 1940” which is the law that provides all the rules for the manufacturing, import, and distribution.

Drug License Details

The Central Drugs Standard Control Organization (CDSCO) is the main government agency responsible for implementing and enforcing the “Drugs and Cosmetics Act”. It is responsible for:

New Drug approval
Clinical trial provisions
Drug standards formulation
Drug quality control monitoring
License issuing for the manufacture and distribution

The Ministry of Health and Family Welfare introduced the Cosmetic Rules, 2020, in December 2020. It made it compulsory to get the import permission of Cosmetics into India.

Definition of Drugs

A drug is a chemical substance, most of the time having a well-defined structure, that produces a biological effect when it is given to a living organism.

Drug License Details

In accordance with the Drugs and Cosmetic Act, the Central Medications Standard Control Organization (CDSCO) is responsible for drug approval, clinical trials, the formulation of drug standards, drug quality control, and so on.

The Health and Family Welfare Ministry announced the Cosmetic Rules 2020 in December 2020, which requires a permission letter to be allowed to produce imports of cosmetics into India.

"Drugs Licence" - A drug is a chemical substance, most of the time having a well-defined structure, that produces a biological effect when it is given to a living organism.

Authority to Issue Drug License

The State Drugs Standards Control Organization (SDSCO), along with the CDSCO, is the authority to issue licenses to business entities dealing with drugs at the state level. If a business is involved in drug sales at more than one location, a license should be obtained for each location.

Types of Drug Licenses

Drug Sales License
- Retail Drug License – The one which is given to the stores that sell the drugs directly to the users, i.e. the drug stores that sell the drugs to the consumers.
- Wholesale Drug License –is the license held by the enterprise which is engaged in wholesale distribution of drugs or the stockists/franchisees' appointment.
Drug Manufacturing License
A drug/cosmetic manufacturing (allopathic, ayurvedic, and unani included) company is d a license from the state authority.
Import License
An importer, who brings drugs or cosmetics from other countries to India, needs to acquire an import license. Importers have to make sure that their production sites and products are registered.
Loan Drug License
Applicants are allowed to use the production facilities of a different license holder and are issued this type of license.
Multiple Drug License
When a company runs in different states, it needs several licenses, one for each location, and that company needs a multiple drug license certification.

Drug License Documents

The list of required documents for the drug license application include
Applicant's details Covering Letter Application Form in the prescribed format
Copy of the Challan (Fees Payment)
Blueprint/site plan/layout of the premises
Ownership proof or rental agreement
Declaration form in the prescribed format
Equipment and Machinery List
Affidavit stating that the proprietor/partners/directors have never been convicted
Details of the technical staff including their qualification, experience, and approval certificates