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Very Easy to get DRUG LICENCE

Raanconsultants explains to our clients to start a business in the field of pharmaceuticals. Raan Consultants provide to you the facility for obtaining Drug Licence. We Consult you to get the registration by minimum time. For free consultancy please make a call.

Drug Licence Consultancy

Before starting the manufacturing, trading and retailing of medicines, it is very necessary to obtaining the licence. Because the before ensuring the licence the involvement in medicines can very harmful for human being. The Access in drugs and medicines are essential for ensuring good health of a Nation. The licences of drugs or medicines are very restricts to misuse or abused for individuals. The licences are provided to the Individuals or any business entities who having the degrees and experiences in this field. It has Legal Boundaries of Medical Prescription in India. The Indian Medical Council Act, 1956; The Indian Medical Council Regulations, 2002 (Professional Conduct, Etiquette, and Ethics); The Drugs and Cosmetics Act and Act 1940, and of Rules 1945; The Pharmacy Act 1948 is; The Narcotic Drug & Psychotropic Substance Acts, 1985, and Rules 1987; Drugs (Price Control) Order dpco, 1995; and The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and Rules 1955. And there are various types of licences have issued by the Indian government which are required as per the nature of business.

Procedure for Obtaining the Drug Licence


Drug License Application

The procedure, rules and regulations to apply and obtain the licences in drug license are and Food Safety. It is depend on a state government. So the department would be responsible for processing application and give the grant of drug license.

How to Start a Business in Pharmacy

This is business is very evergreen types in India. The main advantage of this business is that, it is affectless by the economic cycles of any country. The increasing popularity of corporate hospitals and multi-speciality hospitals in India has brought about very much growth to the healthcare and pharmaceutical business in India. This business requires very minimum investment and business space this is trading business and ideal for many Entrepreneurs across India. In this article, we look at the procedure for starting a pharmacy business in India.

Pharmacy License or Drug License

Pharmacy business is total depend on a drug license in anywhere in India. There are two authorities one the Central Drugs Standard Control Organization and second State Drugs Standard Control Organization. They are authorised to issue the drug license in India. Drug license for setting up a pharmacy business is usually under the purview of the State Drugs Standard Control Organization and the list of State Drugs Standard Control Organization can be know simply.

Licence Issue by State Drugs Control Organization

The State Drug Control Organization issues two varieties of licenses in India. After its getting, you'll be able to start the pharmacy business. One is that the Retail Drug License (RDL) issued to run a general chemist shop in villages and towns. the opposite is that the Wholesale Drug License (WDL) issued to persons or agencies engaged within the wholesale of medicine and medicines. In most states, a retail drug license is barely issued to persons who possess a degree or diploma in pharmacy from a recognized institute or university after depositing the requisite fee on account of the very fact that it's a specialized job and only qualified persons can handle it. But the above conditions are relaxed just in case of procuring a Wholesale Drug license (WDL).

Requirement for obtaining Drug License

There are minimum requirements to obtaining the drug license or starting a pharmacy business in India:-

• Area:

The minimum 12 square meters area required to start a pharmacy business or wholesale business. If anyone wants combine the retail and wholesale business, than it is required minimum of 15 square meters area.

•Storage Facility:

The store must have refrigerator in the premises. According to the labelling specifications certain drugs like vaccines, Sera, Insulin Injections etc. Some time it is required air conditioner in premises.

• Technical Staff:

For Wholesale – To obtaining the whole sale licence competent person shall be registered pharmacist or competent person who shall be a graduate with 5 year experience in dealing in drugs, specially approved by the department of drug control for the purpose.
Retail – To obtaining the retail licence competent person must have a registered pharmacist and approved by the concern authority of department, registered pharmacist is required throughout the working hours.

Documents required for obtaining Drug License

The documents required for starting a pharmacy business varies from state to state. However, the following is an indicative list of documents required for obtaining drug license in India.

  1. 1. Application form in the prescribed format
  2. 2. Covering Letter with the intent of the application signed with name and designation of the applicant.
  3. 3. Copy of Resolution in the case of company or Partnership firm
  4. 4. Challan copy of fee deposited for obtaining drug license.
  5. 5. Declaration form in the format prescribed
  6. 6. MAP (Blue print) for the premises
  7. 7. Rent Agreement
  8. 8. Electricity Bill
  9. 9. Proof of constitution of the business (Incorporation Certificate / MOA / AOA / Partnership Deed)
  10. 10. Affidavit of non conviction of proprietor / partners/ directors under Drugs and Cosmetics Act, 1940

There are types of Licences

  1. Retails Licence
  2. Whole Sale Licence
  3. Manufacturing Licence
  4. Loan Licence
  5. Repacking Licence

Manufacturing License Conditions

  1. • Ayurvedic
  2. • Allopathic
  3. • Homeopathic
  4. • Cosmetic
  5. • Repacking
  6. • Blood and Blood products

What is DRUG?

All types of medicines for use in internal or use in external for human body or animals body are coming in drug. And all types of substances intensely used to the diagnose, treatments, mitigation (decreasing) or to give prevention from any disease is called Drug. Drug is also cover disordering in human body or animals body. Drug is use for preparations applied on human body for main/or the purpose of repelling insects like mosquitoes. A drug is introduced as a chemical substance, often known structure, which is managed to a living organism. It able to produces a biological effect in Living Body.

Raanconsultants is also discus that a pharmaceutical drug is also called a medication or medicine, is a chemical substance used to treat, to cure, to prevent, for diagnose a disease and for promote to well-being.Often the drugs are obtained through extraction from pharmaceutical manufacturing plants. Normally drugs are using for a limited duration. And it can be used on a regular basis for chronic disorders prescribed by concern doctor. All substances constant for use as components of drugs including empty gelatine capsules. And such devices constant for internal use in human body or external use. Raanconsultants is also discus that a Drug is also use during the diagnosis, in treatment, in mitigation or to prevent from disease or disorder in human beings or animals.


What is Regulation?

Raanconsultants introducing that the regulate means to control something so that it functions properly Drug Regulatory Affair is a comparatively new profession which is developed by government to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.

Drug Regulatory System In India

Legal Enactments to Regulate Import, Manufacture & Sale of Drugs Drugs and Cosmetics Act, 1940 Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 Drugs and Cosmetics Rules, 1945 made under the Act Drug Price Control Order (DPCO), 1995

Drug Regulatory Structure In India

Connections with the Central Legislative Assembly Ministry of Chemicals & Fertilizers Ministry of Health Ministry of Sci & Tech Ministry of Enviro NPPA National Pharmaceutial Pricing Authority Pricing Regulations Health Secretary DGHS DCGI Drug Controller General of India Govt. Drug Testing Laboratories Approval of New Drug DBT Dept. of Biotechnology Additional Secretary GEAC Genetic Engineering Approval Committee.

Business Registration

Pharmacy business can be operated various types of business. In India the Pharmacy business is based on the store format and also called as Medical Stores. In India, majority of the pharmacy businesses are doing under the category of independent pharmacy operating in the unorganized sector. Now a day’s very slowly the concept of chain pharmacy is coming in towns. It is also known as township pharmacy and catching up in big cities. The pharmacy inside the hospital, chain pharmacy business and township pharmacy business are usually setup under a large corporate entity. It is also regulated by the hospital Authorities. – Mostly a private limited company constitution. The standalone pharmacies are usually setup under a proprietorship or a partnership. However, as LLP registration can now be obtained for just Rs.9000/- through raanconsultants, it is advisable that standalone or independent pharmacy businesses also be started as LLP or Private Limited Company. Setting up a standalone independent pharmacy business in a LLP or Private Limited Company constitution will ensure that the business is transferable, scalable and limits the promoter’s personal liability.

Regulatory Process for Approval of a New Drug in India

First of all an Application submitted to conduct clinical trials in India, It should be along with the data of chemistry, manufacturing control and animal studies to DCGI .The date regarding the trial protocol, investigator's brochures, and informed consent documents should also be attached. One copy of same the application should be submitted to the Ethical Committee. The clinical trials are conducted only after approval of DCGI and Ethical Committee.

Procedure to obtain Drug Selling Licence(Fresh)

Stage First

Application for grant of Selling Licence

Application for grant of Selling Licence


The applicant has to make application in the requisite Form viz Form-19, Form-19A, Form-19B, Form- 19AA details of Forms and pay

Documents to be attached along with the application form:

  1. 1. Requisite Application Form of Drug Licence.
  2. 2. Online or offline Receipt for the fees paid or challan, as the case may be or their attested copies.
  3. 3. Layout plan of selling premises in 2 copies.
  4. 4. Document of rent receipt, purchase documents or its self attested copies premises.
  5. 5. All Docs relating of the firm like Partnership-deed, MOA & AOA etc.
  6. 6. Full particulars of the competent technical staff /registered persons along with copies of their educational qualification, experience and registration certificates.
  7. 7. Full name of the proprietor or the partners, as the case may be shall be provided in the application. In case of private or public limited concerns, full name of the Directors who sign the application and the authorised signatory, if any , shall be provided in the application.
  8. 8. Documents for the purchase of Refrigerator OR freezer to maintain to temperature of For Vaccines.

Second Stage

Inspection of officer
The application is scrutinized and premises inspected.

Third Stage


Grant of Licence
If all conditions as fulfilled by the act are complied licence is granted.

Download
Application Forms ( 19 ,19A , 19AA ,19B, 19C )

Procedure to Renew Drug Selling Licence

Licenses in Forms 20, 21, 20B, 21B, 20A, 21A, 20C, 20D, 20F, 20G, 20BB, 21BB be renewed.

Stage 1

Application for renewal of Drug Selling Licence

The applicant has to make application in the requisite Form 19, 19A, 19B, 19AA and pay Necessary fees as given in fee chart in

Documents to be enclosed along with application of renewal of licence :-
1. Copy of cash receipt or challan for payment of fees. 2. Xerox copy of Licence /Previous renewal certificate. 3. Documents viz. rent receipt, purchase documents or its attested copies showing lawful possession of the premises. Full particulars of the competent technical staff /registered persons along with copies of their educational qualification, experience and registration certificates.

Stage 2

Inspection The application is scrutinized and premises inspected .

Stage 3

Grant of Licence
If all conditions as prescribed by the act are complied licence is granted

Download
Application Forms (19 ,19A , 19AA ,19B , 19C )

Drug Licenses
Documents required in connection with the allotment of Drug Licence.
1. Copy of Partnership Deed/MOA, in case of partnership Firm/Pvt Ltd /Ltd Company.
2. Blue Print of Key Plan of the location of the premises for which the Drug Licence is required.
3. Blue Print of Site Plan of the location of the premises for which the Drug Licence is required.
4. Address proof of the premises to be registered such as ownership proof /Rent Agreement /Lease Deed/Municipal Tax Receipt along with latest electricity bill or telephone bill or any other document accompanied by NOC from Landlord.
5. Qualification Certificates of Competent Person.
6. Experience Certificate of the competent person from Ex-employer on their Letterhead.
7. 5 Photographs of the Competent Person.
8. ID & Address proofs of all partners/Directors/Proprietor.
9. List of items in which the firm or organization in which firm will deal.
10. Drug Licence Number of the Ex-Employer of Competent Person.


FAQ`S

What is the Jurisdiction of the Drugs Control Deptt?
The Drug Control department deals and solves of any matters and issues to solve through concern states in India.

Where licenses to manufacture Drugs can be granted?
The every types of licenses for manufacturing of Homoeopathic/ Allopathic Drugs and also to Repacking of medicines Drugs can be granted only in the recognized Industrial Areas of Delhi.

Where licenses to Manufacture Cosmetics can be granted?
License to manufacturing of Cosmetics Items can be granted only in Industrial notified areas w.e.f. 01/01/2000.

Which license is required for sale of household medicine?
Licenses Number 20-A / 21-A are enable to requirement for the selling of restricted Drugs commonly used as household Remedies. The selling of this type of drugs, have no requirement of registered pharmacist and written prescription of Doctor.

What are the documents requirements to obtain a Retail Sales shop to Drug Licences for the Chemist shop or Medical Store?
The firm should have adequate premises of minimum area of 12 sqr. Mtrs. And also there should have one refrigerator for proper storage to preserve the properties of drugs. The refrigerator is maintaining the temperature for concern medicines. And required a Registered pharmacist for same.

What are the main requirements for obtaining wholesale Drugs Licenses?
The firm should have adequate premises of minimum area of 12 sqr. Mtrs. And also there should have one refrigerator for proper storage to preserve the properties of drugs. Competent Person who called a Registered Pharmacist / the person who passed the Matriculation(10th)or its equivalent with five year's experience in dealing with Drugs or who holds a degree of a recognized university with one year's experience in dealing with Drugs

What is the minimum area of the premises required for retail cum wholesale licenses?
The minimum area required to obtain both licence is 15 sqr. mtrs.

What should be location of the premises for grant of sale licences?
The place for sale of drugs and obtain the licence is in the commercial premises or other premises should be independent from residence. What is a Loan License?
It is the license issued to an applicant who does not have his own arrangement for manufacture but who intends to avail of the manufacturing facilities owned by another licensee.

Where to make complaint regarding poor quality of Drugs and other type of violations?
The complaint for doubtful quality of Medicines/ Drugs can be done to the Drugs Control Department, of Concern States. A complains shall be indicates the name and address of the Company. And also mention nature of complaint.

Where more information about the various provisions can be obtained?
Detailed information about various provisions of the law can be obtained from the Drugs & Cosmetics Act, 1940 & rules there under which is available in the market. Information can also be sought in person from the duty officer of the department.

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