Drug License

Introduction

Drug license in Jharkhand 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.

Drug License is permission from a drug authority to handle a drug. For both wholesale and retail, this medicinal product license is granted subject to certain conditions relating to the establishment and the qualifying person. We support pharmacies and pharmaceutical companies in drug product approval.
Drug License is a legal certificate required to conduct business related to the pharmaceutical, drug and cosmetic industries. Bihar State Pharmaceutical Council (regulatory body) issues approval for drugs in Bihar state. This department regulates the manufacture, sale and distribution of medicines in the state of Bihar by enforcing the relevant central and drug laws in the state. In this article, we look at the detailed procedure to get a drug license in the state of Bihar.
The Medicines and Cosmetics Act 1940 provides structured rules to regulate the import/export, manufacture and sale or distribution of pharmaceuticals and cosmetics through licenses and permits. This law guarantees the manufacture, distribution and sale of pharmaceuticals and cosmetics only by qualified employees. Preventing substandard medication, perhaps to maintain a high standard of medical care.

License terms:
A license in the form 20, 20B, 21B, 20F, 20G or 21 to sell, store, display or offer for distribution or sale of any medicinal product may not be granted or renewed to anyone unless the Authority is authorized to issue an authorized license.
A Form 20A or Form 21A license may not be granted to anyone unless the agency authorized to issue the permit is authorized.
Licenses of Form 20C or Form 20D to 4 Homeopathic Medicinal Products may not be granted to anyone unless the agency has the authority to issue such licenses.

The official authorized to grant a drug license under the Drugs and Cosmetics Act 1940 to conduct business related to drugs/medicines or cosmetics. In other words, no one can set up or run a drug or cosmetic business in India without the permission of the relevant authorities. All types of medicine or cosmetic business are included in the Medicines and Cosmetics Act 1940, including allopathic, homeopathic, Ayurvedic or Unana medicines. Maintaining the quality of medicines and cosmetics is the responsibility of all parties involved. Suppose a person who uses or uses a drug or cosmetic suffers a loss due to the negligence of the manufacturer or seller. In this case, it is a crime that is tried under the Criminal Procedure Code as a serious crime of bodily injury. Therefore, it is important to comply with the license terms.

Basic Requirement for obtaining Drug License in Jharkhand

The following are minimum requirements for obtaining drug license or starting a pharmacy in India:

  1. Area: The minimum area of 10 square meter is required to start a medical shop or pharmacy or wholesale outlet. In case, the pharmacy business combines retail and wholesale, a minimum of 15 square meter is required.
  2. Storage Facility: The store must have refrigerator & air conditioner in the premises. According to the labeling specifications certain drugs like vaccines, Sera, Insulin Injections etc., are required to be stored in the refrigerator.
  3. Technical Staff:
  • Wholesale – The sale of drug by wholesale shall be made either in the presence of registered pharmacist or in the presence of a competent person who shall be a graduate with 1 yr experience in dealing in drugs or a person who has passed S.S.L.C with 4y ears experience in dealing in drugs, specially approved by the department of drug control for the purpose.
  • Retail – The sale of drug by retail must be made in the presence of registered pharmacist approved by the department, Registered pharmacist is required throughout the working hours.

Required Documents for obtaining Drug License

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

  • Application form in the prescribed format
  • Covering Letter with the intent of the application signed with name and designation of the applicant
  • Challan of fee deposited for obtaining drug license
  • Declaration form in the format prescribed
  • Key plan(Blue print) for the premises
  • Site plan (Blue print) for the premises
  • Basis of possession of the premises
  • Proof of ownership of the premises, if rented
  • Proof of constitution of the business (Incorporation Certificate / MOA / AOA / Partnership Deed)
  • Affidavit of non conviction of proprietor / partners/ directors under Drugs and Cosmetics Act, 1940
  • Affidavit of registered pharmacist or competent person working full time
  • Appointment letter of registered pharmacist/competent person, if employed person.

FAQs

Qus: 1, What is drug Licence?

Ans: Drug License is permission from the government to deal with drugs. There are two kinds of license, the retail license and wholesale license of for drug distribution or sale in India. This license is issued subject to certain conditions attached to premises and the competent person who shall be dealing with drugs.

Qus: 2, What is Form 20b & 21b?

Ans:  Wholesale License

Wholesalers often purchase large quantities directly from the manufacturer or importer. Wholesale Drug licence is issued in Form 20B and Form 21B, for issuance of these licenses application have to be filled as per drug and cosmetic act 1940 and rules 1945.

Qus: 3, What is a wholesale drug distributor?

Ans: Wholesale drug distributors are a link between manufacturers and pharmacists. Their role is to ensure prescription medications are delivered safely and efficiently every day to thousands of health care practitioners and pharmacies nationwide.

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