DRUG LICENCE
Medical advancement has been critical to ensuring human life and mending serious ailments throughout history. Medicine is humanity’s exclusive means of combating sickness. However, because a specialised medication might be employed to address a specific ailment, medicine is not as widely consumed as chocolate. Before taking any medication, speak with a well-educated doctor who can advise on how, when, and which exact drug should be used to treat the disease. If not, this could have negative consequences. The Indian government enacted the “Drugs and Cosmetics Act, of 1940.” This law establishes all manufacturing, import, and distribution regulations.
Drug License Details
In line with the “The Drugs and Cosmetic Act”, the Central Drugs Standard Control Organization (CDSCO) oversees:
- Approval of new drugs
- Conduct of clinical trials
- Formulation of drug standards
- Monitoring drug quality control
- Issuing licenses for manufacturing and distribution
In December 2020, the Ministry of Health and Family Welfare introduced the Cosmetic Rules 2020, making it mandatory to obtain permission for the import of cosmetics into India.
Definition of Drugs: A drug is a chemical substance, usually with a well-known structure, that has a biological effect when administered to a living organism.
Drug License Details
In line with the Drugs and Cosmetic Act, the Central Medications Standard Control Organization (CDSCO) manages drug approval, clinical trials, the formulation of drug standards, drug quality control, and so on.
The Ministry of Health and Family Welfare announced the Cosmetic Rules 2020 in December 2020, requiring permission for the import of cosmetics into India.
"Drugs" - A drug is a chemical substance, usually with a well-known structure, that has a biological effect when given to a living species.
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 is required for each location.
Types of Drug Licenses
- Drug Sales License
- Retail Drug License – Issued to chemists who sell drugs directly to customers.
- Wholesale Drug License – Required by entities involved in wholesale drug distribution or appointment of stockists/franchisees.
- Drug Manufacturing License
- Issued to drug/cosmetic manufacturers (including allopathic, ayurvedic, and unani) by the state authority.
- Import License
- Required for importing drugs or cosmetics into India. Importers must ensure their manufacturing site and products are registered.
- Loan Drug License
- Issued to applicants using the manufacturing facilities of another license holder.
- Multiple Drug License
- Required when a business operates in more than one state and needs licenses for each location.
Documents Required for Drug License
- Covering Letter with applicant's details
- 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
- List of Equipment and Machinery
- Affidavit regarding non-conviction of proprietor/partners/directors
- Details of the technical staff including qualification, experience, and approval certificates
Lead Time
For the standard method, 2 working days are needed, whereas the streamlined approach takes about 30 working days.
