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A Complete Guide for Getting a Drug License

An Overview of Drug License

Drug License is a permission granted by the authority under the Drugs and Cosmetic Act in order to carry out a business of drugs/medicines or cosmetics. The Drug License is issued by the State Drugs Standard Control Organization or the Central Drug Standard Control Organization.

The drugs are used in the medicines, in a medically defined ratio to cure our health. Drugs come in use on a need basis, to ensure our well-being. However such medicines are manufactured with very restricted and correct amount of the drugs and it does not harm the body.

However, any violation of the medically defined limits may have a very serious effect on the health of the person using it. Therefore it requires to be regulated by the government via imposing stringent law and regulations in the process of manufacturing and distribution of drugs and medicines in India. Once you have Drug License from the government, you can deal with drugs otherwise not.

Drugs License Registration

Drug License registration and everything related to drugs is regulated by the Drugs and Cosmetics Act 1940. The Act regulates every step related to the drugs, from the raw material procurement stage during manufacture to sale including distribution, until it reaches the customer/patient. Drug License is required to be taken for all types of drugs or cosmetics business including Allopathic, Homeopathic, Ayurvedic or Unani drugs etc. The Act even covers the Pharmacist conduct, hospital or a dispensary usage of drugs. The Act covers the Ayurvedic and Unani drugs also in it.

Drugs License for Pharmaceuticals

The requirement of medicines is a never-ending thing which makes pharmacy business as the most ideal business. It does not get affected by the monetary cycles. In recent years, there has been a considerably very high level of developments in the hospitals has also lead to the increasing demand for pharmacies. The pharmacies are set up in hospitals, shopping areas, residential buildings, housing townships; the pharmacies in the residential building are built in form of the firms. E-commerce companies and e-health companies are the main participants due to their market reach with the easy availability of medicines to customers and by providing same-day delivery, cost saving.

Types of Drug License issued

Retail Drug License

It is issued to persons/agencies involved in Standalone/ chemist pharmacy shops

Wholesale Drug License

It is issued to persons/agencies involved in wholesale distribution of drugs

Types of Drug License

There are mainly two kinds of Drug License for drug distribution or sale in India. This License is issued subject to certain conditions attached to premises and competent person who shall be dealing with drugs.

Other types of License are:

  1. Manufacturing License
  2. Loan License
  3. Restricted License for general store basis the type of sale which will be made

Swarit Advisors provides professional assistance in obtaining Drug License in India.

Forms for Drug Licenses for sale and wholesale of drugs

Drugs have various categories and for different categories, the different License is required to be obtained by filing different forms as given below:

FORM 20: For the sale of Allopathic drugs

In case a retailer is willing to obtain Drugs License to sell Allopathic drugs, he/she has to apply by filling FORM 20 for drugs license. Note that Form 20 is to be filed for drugs to be sold by retail other than those specified in Schedule C, C(1) and X (Form-19A).

FORM 20-A: For the sale of Restricted Allopathic drugs

In case a retailer is willing to obtain Drugs License to sell restricted Allopathic drugs, he/she has to apply by filling FORM 20-A for drugs license. Note that Form 20-A is to be filed for drugs to be sold by retail other than those specified in Schedule C, C(1) and X (Form-19A).

FORM-20-B For wholesale of Allopathic drugs

Drug License for wholesale of Allopathic drugs is to be applied in Form 20-B, however not for the categories specified in Sch C, C(1) and X. (Form-19).

Form 20-C – For the sale of Homoeopathic medicines by retail

Fill in Form 20-C in case you are a retailer of Homoeopathic medicines.

Form 21-For Sale of Allopathic drugs specified in Sch C & C (1).

To sell the Allopathic drugs, first apply for Drug License by filing Form 21.

Form 21-B-For wholesale of Allopathic drugs specified in Sch C & C(1).

In order to deal in the wholesale business of Allopathic drugs, obtain a License by filing Form 21-B.

Form 21-A- For the retail sale of restricted Allopathic drugs specified in Schedule C (I).

Obtain Drug License for retail of sale of the restricted Allopathic drugs, which are specified in Schedule C (I).

Form 20-F-For retail sale of drugs specified in Sch. 'X'.

For certain drugs specified in Sch. X of the Act, apply for Drug License in form 20-F.

Form 20-G For wholesale of drugs Specified in Sch. 'X'.

To establish a wholesale business for drugs specified in Sch. X, apply for Drug License in form 20-G.

 

What are the services offered by Swarit Advisors for Drug License?

Our comprehensive range of end-to-end solutions includes following:

  • End to end services for Drug License for importers, manufacturers, sellers, wholesalers
  • We also provide Drug License renewal services.
  • We shall draft the Drug License application, review your business, and shall be responsible for end to end follow up with the Drug License department.
  • We provide regular updates on developments on changes pursuant to the Drugs and Cosmetics Act via your registered mail.
  • Free consultation on the Drug manufacturing plant set up and related matters.

To avail any of the above-stated services, kindly establish contact by posting a query at our site.

Documents required for Drug License: In General

The right documents will save you from any kind of rejections, the documents to be submitted is the most important step in obtaining the Drug License and it includes preparation of key plan and site plan and various Affidavits and declaration pursuant to the applicable rules and regulation of the law.

The following documents would be required along with the application

  • Receipt of the online fee deposit.
  • Site plan and key plan of premises as required in the respective state as per applicable rules.
  • Incorporation proof like Incorporation Certificate.
  • ID proof of proprietor/partner/director as the case may be.
  • A valid affidavit stating about the non-conviction of proprietor/partner/director/ the firm under the Drugs & Cosmetics Act, 1940.
  • An affidavit from the competent person or registered pharmacist.
  • In case of retail sale registered pharmacist
    1. Proof of qualification of the pharmacist
    2. Registration under the Local Pharmacy Council
    3. Appointment letter in this regard
  • For wholesale license competent person:
  1. Proof of qualification of such competent person
  2. Experience certificate of the person dealing into it
  3. Appointment letter of such competent person

This Blog has been contributed by SwaritAdvisors. SwaritAdvisors is a legal & financial services provider with free consultancy. Our services such as: PASARA licenseDrug LicensePPE kit License12a and 80g RegistrationNGO registrationNBFC RegistrationTrade LicenseRERA RegistrationPrivate Limited Company RegistrationNidhi Company RegistrationFSSAI Registration, etc.

 

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