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Drug License

Drug License is a permission to take from the government to carrying out the businesses by the people who deals into sale and distribution of drugs related products..

Package Inclusions

  • Application Drafting
  • Review about the Business
  • Application filing
  • End to end follow-up with Department
  • License
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Introduction to Drug License

The Drug License is granting a permission by the component authority under the act of drugs and cosmetics for carrying out the businesses related to pharmaceutical industries that deal with drugs, medications and cosmetics. Without a Drug License no person can do pharmacy business or even start to associate with any dealings. Doing so is a cognizable offence. Hence one must obtain an appropriate Drug License for conducting such activities under the drug and cosmetics act of 1940 under which all types of drugs and cosmetics businesses are covered which includes allopathic drugs, homeopathic drugs and even the Ayurveda or unani drugs.

The quantity of the drugs used and produced and packed in a dose is the responsibility of all the persons involved in the whole line of work. In case any consumer of these products suffers from any unmentioned harm, these persons will be held responsible and answerable to the event and is an offence of grievance which can go under trial under IPC. Hence vigilance is important.

How to do Drug License Registration?

A particular business entity could need different types of Drug License based on their business. In case a business is being operated in more than two states, it will require a Drug License in every state where it is placed and operating. A Drug License is region specific. If the drugs are stocked and sold at more than one place than one needs to put an application, made with regard to each of such places and Drug license should be issued except for migrant vendors.

Once a Drug License is obtained for the business, make sure that the license is compiled at all times with the rules and regulations for Drug License or it could get cancelled. All the records, its registration and forms must be maintained in a specified way by drug License authority and the Drug License authority must be informed of any changes and modifications to the business activities.

Documents for Getting a Drug License

The following is the list of documents that are needed for Drug License.

  • The firm's constitution (AOA/MOA)
  • The photograph identity proof of sole proprietor, partner or their director.
  • The papers of the owned property where the business will be conducted.
  • In case it’s rented property, then the copy of rent agreement will be required.
  • The key plan and the site plan of the respective premises.
  • Drugs storage sometimes need to be in the cold chain, hence the details and invoice of the refrigerator in use.
  • An affidavit with regard to compliance with MPD 2021 and if premises are located on DDA residential flat or building or a plot then their affidavit.
  • An additionally detailed document will be required for a registered pharmacist.
  • Qualification proof in form of degrees and certificates or mark sheets.
  • The certificate of registration with Delhi pharmacy council. Or other state council depending on the region.
  • An appointment letter along with bio data.
  • Any other additional wholesale documents for wholesale Drug License competent person.
  • Any kind of experience certificate.

Conditions for obtaining a Drug License

For obtaining a Drug License, there are certain conditions that applicant will have to follow.

The applicant will have to provide with an independent shop with an adequate amount of area to get permission for retail or wholesale Drug License as per the given details below:-

  • To get a drug license in form 20 or form 21 individually or both, the premises of an area must not be less than 10 square meters.
  • To get a drug license in the form 20-B or 21-B or both, the premises are supposed to be of an area of not less than 15 square meters.
  • The height of the premises where the sales will be conducted must be according to the national building code of India.

If the premises of sales are situated on a DDA allotted land then the Drug License will not be granted but then it can in some cases if it meets the requirements of MPD-2021.

The Drug License is classified by different categories.
These are the –

  • Manufacturing license
  • Loan license
  • Sales license

The sales license is then further divided and classified as the –

  • Retail license
  • Wholesale license
  • Restricted license for general store depending on the kind of sales are done.

The steps for getting a Drug License

You may file for a Drug License application with the government directly, this process shall take as long as 30-60 days as it’s a long process.

Step 1 : The applicant must 1st obtain a user identity and a password by requesting a letter in person, with details of their firm.

Step2 : All of the documents must be then scanned in a 100ppi size and in black and white after that be uploaded using the same identity and password you received at space provided for the purpose.

All information should be precisely filled for the respective application then re-send it. However, the other authority involved in licensing could ask for other documents if needed.

Step 3 : Then you would require a follow up with the government for an update on your application. If the information is incomplete, then it’s rejected, and for this the paid fees will be fortified by the government.

Step 4 : The government Drug License department shall take upto 45 to 60 working days for completing the review of your application and approve it.

Check list for Drug License

The Capital and the proper place of business is a must for every new entity coming into the existence. The same holds true for obtaining the drug license also. There are certain minimum criteria prescribed by the Authority which need to be complied with before applying for the drug license. These are:

1. Area of the pharmacy set-up: In case it is a retail medical shop or a retail pharmacy, a minimum area of 10 square meters is required. If the retail outlet is working in combination with the wholesale one, a minimum area of 15 square meters is mandatory.

2. The Presence of proper storage facility: Certain medicines, most importantly, vaccines are required to be refrigerated while certain other drugs are required to be kept in low-temperature zones. Therefore, the facilities like refrigerators and air conditioners are the per-requisite for a pharmacy business seeking to obtain drug license.

3. Recruitment of technical staff: The presence of a registered pharmacist, having valid certification, is mandatory for every retail form of pharmacy.

However, In the case of a wholesale setup, every sale of a drug shall be supervised by either a registered pharmacist or a graduate with one year of experience in drug dealing or an SSLC passed individual with four years of experience in dealing with drugs.

Time-frame of Obtaining Drug License

According to a recent report stated in "The Times of India", the Drug Regulatory Body has made it mandatory for its officials to attend as well as grant all the licenses, whether retail or wholesale, in the time frame of 30 days, if they fulfill all the required eligibility criteria. The intention is to make the whole process of drug license transparent and user-friendly.




Frequently Asked Questions

Drug licence is the right from the government to deal with drugs. It is permission to a business involved in manufacturing, wholesale, retail and distribution of the pharmaceuticals.

The state government in which the manufacturing activity is done grants the drug licence. In order to get drug license a medical shop must be set up with a minimum area of 10sq.m. Qualified personnel must be there as staff at the shop. Air conditioner and refrigerators are necessary to store medicines.

Form 21C means the licence to sell, stock, exhibit or offer for sale or distribute by retail drugs specified in Schedule C and C1. It is issued to the manufacturer or to any other wants to sell, stock etc.

In order to renew the license fill the application form and provide the necessary documents to be submitted with form. If the application is complete, it will be filed with the drug control department with fees. After verifying the documents fresh certificate shall be issued

The drugs are classified according to the drugs and cosmetic rules, 1945. The schedule C contains various biological products. It includes sera, toxins, antigen, antitoxins etc.

A pharmacist cannot open a clinic to diagnose disease and prescribe medicines. Pharmacy council of India recently notified about this. There is no provision in the Pharmacy practice regulation for pharmacist to practice pharmacy

Opening an independent pharmacy requires high investments. Various investments shall be needed for opening a pharmacy like furniture and fittings which may cost around Rs. 30000, legal paper work may cost approx. Rs. 7000, and many other investments that may cost around Rs. 15000.

A licensed drug means a drug that goes through a strictly monitored process. It involves researching in the lab and testing it through trials. After it goes through all these tests and trials then it shall be granted a licence.

In order to get a drug distribution licence application 19 needs to be submitted with various documents like identity proof, affidavit of registered pharmacist, ownership documents of the premises, etc.

In order to manufacture drugs/products manufacturing licence is required as per drugs and cosmetics act, 1940. The applicant can apply for a drug manufacturing licence online by applying to the state drugs controller cum licensing authority.

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