WHY DRUG LICENSE REGISTRATION

                 DRUG LICENSE REGISTRATION

Drug and Cosmetics Act, 1940

 Drug license is mandatory under the provisions of Drugs & Cosmetics Act; 1940. This act regulates the import, manufacture, distribution and sale of drugs and cosmetics which includes allopathic drugs, homoeopathic drugs and even the Ayurvedic, Siddha or Unani drugs.

Importance of  Drug license

Some of the significance of  drug license is explained in detail below:

·         The  drug license gives the permit to sale, resale, market, manufacture, trade, etc. of drug and cosmetics.

·         Without a drug license, no person can do pharmacy business or even start to associate with any dealings in the state.

·         For ensuring good health our nation through adequately accessing the drugs and medicines, the Drugs & Cosmetics Act of 1940 made it mandatory for obtaining drug license

·         Drug license also ensure that the drug and goods are not misused or abused by any individuals

·         Dealing with drugs and cosmetics without a drug license is a cognizable offence. Every business person in the pharma industry needs to have their drug incense to carry out their day-to-day business work.

·         Drug license contains the rules and regulation for the person who is dealing with drugs and details of the business premise.

Note: To maintain the quality of drugs/medicine and cosmetics is the responsibility of all persons dealing with the process line. If any person consuming a drug or cosmetic suffers any harm from the negligence on the part of the manufacturer or seller, the same is an offence, which is triable as an offence of grievous hurt under IPC. Hence holding drug license is essential.

Who needs Drug Licence?

Drug license is mandatory for dealing with the following type of business in . Any individual, partnership, limited liability company, corporation or business firm located In  and is physically distributing the drugs & cosmetics in the state is required to hold a  drug license.

·         Business with any cosmetics intended to be rubbed, poured, sprinkled, or introduced into the human body or for cleansing, beautifying, promoting attractiveness, or altering the appearance of a Human, must obtain  Drug license.

·         It is mandatory to obtain Drug license to deal with medicines which are used for external or internal use of human beings or animals

·         Manufacturing and distribution drugs/cosmetics applied to the human body to repel insects like mosquitoes need  drug license.

·         Business with substances used for the destruction or insects which cause disease in human beings needs drug license.

·          drug license is essential for dealing with empty gelatine capsule

·         Manufacturing, storage and distribution of medicines used for diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals

Basic Requirement

As per the provision of drug and Cosmetics Act, 1940 to get a  Drug license the following requirements to be met by the applicant

·         Area Recruitment

The minimum area of ten square meters is needed to set up a medical shop or pharmacy, In case store business combination with the retail and wholesale than the minimum area of 15 square meters is required.

·         Storage Facility

It is crucial to have refrigerator and air conditioner on the premises because some drugs such as vaccines, insulin injections are wanted to be stored in the fridge.

·         Technical Staff

v  Sale of drugs can be only carried in the presence of a registered Pharmacist approved by the department who is required throughout the working hours in the retail shop.

v  The wholesale of medicines & drugs can be made either by a registered pharmacist or another competent authority who must be a graduate with one year experience in drugs or in the presence of anyone who has passed SSLC having experience of four years in drugs, specially approved by state drug control department.

 Drug License

Sale License

Sale license will be issued to sell medicines in . The sale license can be further classified into two types.

·         Retail License: It is granted to run and sell drugs or drug products in India.

·         Wholesales License: It is issued to persons or agencies engaged in wholesale of drugs and medicine.

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Application Processing Time

Timeline for grant and renewal of retail sales, wholesale and Drug Manufacturing license is 14 days from the date of application.

Documents Required

Following documents need to be submitted for Obtaining  Drug license.( separate  precise list of  required document with affidavit format/other documents will be provided after confirmation of assignment)

Documents required for Retail Licence like

·         Statutory Application form – 19 for licenses in form (20,21)

·         Residential address proof of proprietor / Partner / Director / Competent Persons / Registered Pharmacist

·         Partnership deed in case of partnership firm or List of Directors downloaded from MCA website signed by Company Secretary / Managing Director

·         In case of the company an Affidavit on Rs.20 stamp paper signed by one of the Directors of the company. I

·         Special declaration by a registered pharmacist on Rs.20 Non-Judicial stamp paper.

·         Self-attested copy of Registered Pharmacist certificate (renewal up to date) affixed with latest photograph and signature of the candidate

·         Plan of the premises is indicating the carpet area (specifying length and breadth in meters and area in square meter) with the signature of building owner and the applicant (Prop/ partners / Authorized signatory / Managing Director) in legal size.

·         Photograph of the building owner with self-attestation

·         Self-attested copy of the document showing the proof of ownership of the building owner for the premises to be licensed such as Encumbrance Certificate or any other legal document showing the present ownership.

Note: Original to be produced to the Drugs Inspector at the time of inspection for endorsement.

Documents required for Wholesale Licence

In addition to the above text an experience certificate of a competent person, need to be produced to get  drug license. The application form for wholesale drug license is form – 19 for licenses in form (20B, 21B).

Verification by Drug Inspector

Drug Inspector (DI) Schedules & Conducts Site Inspection The inspector will verify the following aspects at the time of inspection of the outlet for grant/ renewal of sales licences:

·         Area of the business outlet to verify the compliance with the statutory limit

·         Capabilities to provide proper storage conditions for the drugs/medicines stocked in the premises such as racks, refrigerator (for cold storage drugs)

Drug Inspector (DI) will submit the Inspection Report to the Assistant Director (AD). Assistant Director (AD) will review the Inspection Report and verifies the documents and Information.

Get  Drug License

The applicant can download the approved  drug license from the Drugs Control Administration website.

Note: Once the licence is granted to the business, all such drug license must ensure that all the condition in the drug licence is compiled at all the time during the business. The  drug license needs to be displayed at the prominent place of premises.

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