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 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 A DRUG LICENSE
State Drugs Standards Control Organization (SDSCO) – A state authority that collaborates with CDSCO to issue licences to people operating a state-level drug and cosmetics business. Each location where the business is located and where drugs are sold or held for sale requires a licence.

Several DRUG LICENSES: A drug licence is the drug controller’s licence to engage in drug dealing. The following licence kinds are determined by the nature of the business.

1. A drug sales licence

These are the many sorts of sales licences.

i.  Drug Licence for Retail Selling (Chemist Shop) – The selling of drugs to the final user is referred to as a retail sale. Retailers can sell drugs to institutions such as hospitals, dispensaries, clinics, schools, and research facilities. The Drugs and Cosmetic Act requires drug retailers and chemist businesses to have drug licencing. A retail licence is also granted by the State’s Drug Control Authority.
Anyone who sells narcotics without a licence faces a minimum one-year prison sentence, which can be increased to three years, as well as a fine of up to Rs. 5000.

the main requirements for obtaining a retail drug licence
The applicant’s space must be at least 10 square metres in size.
A licenced pharmacist must always be on duty in the establishment during business hours.
The space should have air conditioning and a refrigerator.
Documentation required for a retail drug licence:

1. Lease Agreement

2. Owner’s affidavit on stamp paper,

3. A school ID completion certificate

4. Affidavit Evidence of a licenced pharmacist plan demonstrating the business’s location

5. Refrigerator bill No.

6: 5 Photographs of the owner and pharmacist

ii. Drug Licence for Whole Sale –

A wholesale licence is granted to a company, distributor, or independent agent in India who is an authorised representative of a local or foreign product. Alternatively, the manufacturer and the authorised Indian representative acquire the wholesale licence. The CDSCO offers wholesale drug licences to persons who work in the wholesale distribution of pharmaceuticals.

Fundamental Requirements for Obtaining a Wholesale Drug License
1. The applicant’s office space must be at least 15 square metres in size.
2. The applicant’s premises must have an air conditioner and a refrigerator to store the immunizations, insulin injections, sera, and other supplies.
3. A pharmacy degree or diploma from an approved university is required to obtain a licence.
4. A chemist must have a bachelor’s degree and one year of drug-dealing experience.
5. The licence must be prominently displayed on the property.

The following documents are required to obtain a wholesale drug licence:

1. of incorporation, Memorandum of Association or AOA, and, if applicable, Partnership Deed.
2. Proof of ownership.
3. Be sure to include the applicant’s name and position in the cover letter.
4. A statement of licence fees paid in the format specified.
5. Site plan and constructing main plan (Blueprint).
6. The property paperwork’s proof of ownership.
7. Signed affidavit indicating non-conviction under the 1940 Drugs and Cosmetic Act. 8. Owners, partners, or directors, as applicable.
9. Appointment letter for a certified chemist hired on a full-time basis.

Drug Licence Restriction
Under Forms 20A and 21A, this permit is granted to applicants who seek to distribute pharmaceuticals without the supervision of a qualified person.

2. Drug Manufacturing Licence

Manufacturers of allopathic, ayurvedic, and cosmetic items are granted a manufacturing licence by the manufacturer’s home state government.

Types of manufacturing licences:

Both the Zonal Office and the State Licensing Authority grant Test Licence for Manufacturing – Form -29 for testing purposes. Drug testing and analysis on a small scale, as well as approval to import medications in small quantities for inspection, testing, and analysis

Form 46, Post-Successive Clinical Trial Manufacturing Licence, allows producers to sell brand-new medical products to the market without first undertaking a clinical trial.
Notification of medical device production licence – Form -28 Form -27
This licence is awarded to the manufacturer of disposable hypodermic needles, cardiac stents, catheters, and IVD devices for HIV, HBsAg, and HCV.

The following are the prerequisites for acquiring a manufacturing licence: 1. The establishment of a plant shall be done in line with standard schedule M.
2. The factory must be suitably outfitted and have machine space.
3. A highly qualified professional should conduct the testing centre’s analysis.
4. There should be ample testing lab equipment.
5. Arrangements for secure medicine storage must be made.
6. Follow the guidelines for ethical manufacturing practices.

3. Import License

 Only after obtaining a licence can pharmaceuticals and cosmetics be imported into India under Schedule X. For importing purposes, not only the drugs but also the manufacturing facility must be registered.

4. Loan Drug Licence

According to the Drug and Cosmetic Act, a loan licence is one that a licencing authority may award to an applicant who does not have a manufacturing agreement but proposes to use a licensee’s production facilities.

5. Multiple drug licences

Applicants who apply and conduct business in more than one state are eligible for this licence. Without a multi-drug licence, you are not permitted to sell drugs in more than one state.

Functional Purpose:

Documentation – Because different locations and business kinds, such as retailers, wholesalers, manufacturers, and importers, have varying requirements, the process begins with documentation. An application or, to put it another way, a licence cannot be issued without the required papers.

Application submission – After gathering all essential papers, the Drug Control Authority must receive a full application with all necessary facts.
A drug inspector assigned by the authorities inspects the premises to determine whether or not the information provided by the applicant is accurate.

Examining the application – A drug inspector will go over the details of the application. If everything is satisfactory in his opinion, the licence will be issued. If he asks a question, the applicant has three days to respond.

Grant of Licence – Once the Drug Control Department is satisfied with the documentation, the Drug Licence is issued.

TIME SCHEDULE:

30 working days

VALIDITY:

The licence is valid for five years.

RENEWAL:

After obtaining the relevant documents for renewal, the authorities will renew the licence for the stated period.

Is it necessary to obtain a licence to sell cosmetics?

No, a cosmetic trader does not need a drug regulatory authority licence. Cosmetic manufacturers must obtain a licencing from the pharmacy department, but if they are also producing ayurvedic or herbal cosmetics, they must also obtain a permit from AYUSH.