Over the course of history, medical progress has been essential to ensuring human survival and healing serious illnesses. The only tool available to mankind to combat diseases is medicine. But because a specialised treatment can be used to treat a particular ailment, medicine is not a common consumption like chocolate. A well-educated doctor should be consulted before taking any medication so that he can give advice on how, when, and which specific drug should be used to treat the ailment. If not, this could result in negative side effects. The "Drugs and Cosmetics Act, 1940" is a law created by the Indian government. This law lays out all the rules pertaining to production, import, and distribution.
The Central Medications Standard Control Organization (CDSCO), in accordance with "The Drugs and Cosmetic Act," coordinates the approval of drugs, clinical trials, the establishment of drug standards, drug quality control, etc.
The Cosmetic Rules 2020, which stipulate that a licence is required for the import of cosmetics into India, were published in December 2020 by the Ministry of Health and Family Welfare.
"Drugs" - In pharmacology, a drug is a chemical compound, usually one with a well-known structure, that, when given to a living thing, has a biological impact.
POWER TO ISSUE A DRUG LICENSE
State Drugs Standards Control Organization (SDSCO) - State Authority with CDSCO is in charge of issuing licences to those operating a state-level drug and cosmetics business. A licence is required for each location where the business is located and where drugs are sold or are kept for sale
A Number OF DRUG LICENSES :
The drug controller's authorization to engage in drug dealing is known as a drugs licence. The following licence types depend on the type of business.
1. A drug sales licence
These are the various types of sales licences.
Drug Licence for Retail Sale (Chemist Shop) - Retail sale is the sale of drugs to the final user. Drugs can be sold by retailers to institutions like hospitals, dispensaries, clinics, schools, and research centres. A drugs licence is required by the Drugs and Cosmetic Act for drug retailers and chemist stores. The State's Drug Control Authority also grants a retail licence.
Any person who sells narcotics without a licence faces a minimum one-year sentence in prison, which may be extended to three years, and a fine of up to Rs. 5000.
the fundamental conditions for acquiring a retail drug licence
The applicant's premises should be at least 10 square metres in size.
Throughout business hours, a licenced pharmacist must always be on duty in the establishment.
Air conditioning and a refrigerator should be provided in the space.
Documentation needed to get a retail drug licence :
2.Affidavit of the owner on stamp paper,
3.a certificate of completion of school ID
4.affidavit Evidence of a licenced pharmacist blueprint showing the location of the business
6.Bill for the refrigerator No
7: 5 Images of the owner and pharmacist
2.Whole Sale Drug Licence -
A wholesale licence is given to a business, distributor, or independent agent who may be an official representative of a local or international producer in India. Or, we may say that the manufacturer and the approved Indian representative are the ones who receive the wholesale licence. For those who operate in the wholesale distribution of drugs, the CDSCO issues whole sale drug licences.
1.The applicant's premises should be at least 15 square metres in size.
2.To store the vaccines, insulin injections, sera, and other supplies, the applicant's premises must have an air conditioner and a refrigerator.
3.A licence is given to someone who possesses a pharmacy degree or diploma from an accredited university.
4.A pharmacist must be a graduate with a year of drug dealing experience.
5.The licence must be visible on the property.
The paperwork needed to obtain a wholesale drug licence:
1.of incorporation, MoA or AOA, and, if applicable, Partnership Deed.
2.Evidence of ownership.
3.Including the applicant's name and position within the cover letter.
4.Statement of fees paid for the licence in the specified format.
5.Site map and the building's key plan (Blueprint).
6.The proof of ownership for the property paperwork.
7.Affidavit regarding non-conviction under the 1940 Drugs and Cosmetic Act, signed by. 8.owners, partners, or directors as appropriate.
9.appointment letter for a certified pharmacist appointed to work full-time.
This licence is given to applicants who want to sell drugs without the guidance of a qualified person under Forms 20A and 21A.
2.Drug Manufacturing License
Manufacturers of allopathic, ayurvedic, and cosmetic items are awarded a manufacturing licence by the relevant State government of the manufacturer.
manufacturing licence types:
The Zonal Office and State licencing authority both issue Test Licence for Manufacturing - Form -29 for the purpose of testing. Small-scale drug testing and analysis, as well as permission to import pharmaceuticals in small amounts for inspection, testing, and analysis
Form 46, Post-Successive Clinical Trial Manufacturing Licence, allows manufacturers to produce medical devices for sale that are brand-new to the market without conducting a clinical trial.
Medical device manufacturing licence notification - Form -28 Form -27
The producer of disposable hypodermic needles, cardiac stents, catheters, and IVD devices for HIV, HBsAg, and HCV is granted this licence.
The requirements for obtaining a manufacturing licence:
1.Setting up a plant should be done in accordance with standard schedule M.
2.The factory must be adequately furnished and have space for the machines.
3.The testing center's analysis should be carried out by a highly competent individual.
4.should contain enough testing lab equipment.
5.Arrangements must be made for secure medicine storage.
6.Follow the recommendations for ethical production practises.
3.Import License :
Only after acquiring a licence is it possible to import drugs and cosmetics into India under Schedule X. For importation purposes, not only the pharmaceuticals themselves but also the production facility itself must be registered.
The Drug and Cosmetic Act states that a loan licence is one that a licencing body may grant to an applicant who does not have a manufacturing agreement of their own but plans to use a licensee's production facilities.
Those who apply and who run their business in more than one state are eligible for this licence. You are not allowed to sell drugs in more than one state without a multi-drug licence.
Documentation - The process begins with the documentation because different regions and business types, such as retailers, wholesalers, manufacturers, and importers, have different requirements. Without the proper documentation, an application cannot be submitted, or, to put it another way, a licence cannot be issued.
Application submission - Once all necessary paperwork has been gathered, the Drug Control Authority must receive a full application with all necessary details.
A drug inspector assigned by the authorities performs an inspection of the premises to determine whether the information supplied by the applicant is accurate or not.
Examining the application - A drug inspector will check the application's specifics. The licence will be issued if everything is deemed satisfactory in his eyes. If he asks a question, the applicant must respond within three days.
Grant of Licence - After getting satisfied with the documents, the Drug control department issues the Drug Licence.
30 business days
Licensed is good for five years.
The authorities will renew the licence for the specified amount of time after receiving the necessary paperwork for renewal.
Is it compulsory to get a license to sell Cosmetics?
No, a cosmetic trader does not require a licence from the drug governing authorities. Producers of cosmetics must receive a licence from the pharmacy department, but if they are also manufacturing ayurvedic or herbal cosmetics, they must also seek a licence from AYUSH.
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