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Jammu and Kashmir Drug License

Jammu and Kashmir Drug License

Jammu and Kashmir Drug License

A drug license is a permit that is granted by the concerned authority under the Drugs and Cosmetic Act, 1940 to run a drug/ medicine or cosmetics business. In India, it is mandatory to obtain a drug license to proceed with such activity. All types of drugs or cosmetics business are covered under the Drugs and Cosmetic Act, 1940 including allopathic, homoeopathic, ayurvedic or Unani drugs. The maintenance of the quality of drugs and cosmetics is the responsibility of the people who are dealing with drugs. In this article, we look at the procedure to obtain a Jammu and Kashmir drug license.

Drug Regulation

Drug Regulatory Affair is a new division developed by the government to protect public health. This is achieved by enabling the safety and efficacy of products in areas like pharmaceuticals, agrochemicals, veterinary medicines, medical devices, pesticides, cosmetics and complementary medicines.

Infrastructure Requirements

The requirement of premises to sell medicines and obtain drug license is as follows.

Minimum Carpet Area

  • For Retail Sale, a minimum of 10 square meters is required.
  • For Wholesale, a minimum of 10 square meters is required.
  • For Retail and wholesale together, a minimum of 15 square meters is required.

Storage Facilities

There should be adequate storage facilities including cupboards with glass doors, racks and refrigerator.

Documents Required for Medical Shop

  • If the premises is owned, then the registered Sale Deed/ Registered GPA/ Conveyance Deed in the name of the owner or in case of unregistered GPA/ unregistered Sale Deed, it should be supported with either the water bill/ electricity bill/ or the property tax receipt. For villages, Khasra Khatauni documents will be accepted.
  • If the building is rented, the registered rent agreement with the rent receipt or in case of an unregistered rent agreement, No Objection Certificate from the owner of the premises. The key plan and site plan of the premises have to be attested by an approved architect or mapmaker of the municipality.

Checklist for Issue of Retail or Whole Sale Drug License

Competent Person/ Pharmacist

All medicines have to be handled by a specialist, therefore there is a requirement of a qualified pharmacist for a retail drug license and for a wholesale drug license, a graduate with 1-year experience or an undergraduate having four years of experience is mandatory.

Area of Pharmacy

To set up a pharmacy, carpet area of a minimum of 10 square meters and if a pharmacy is for both retail and wholesale purpose, a minimum of 15 square meters is required. The premises should have adequate ventilation.

Storage Facility of Drugs

Medicines have to be stored in a clean, ventilated and cool storage facility. This is because some drugs and vaccines have to be stored in a low-temperature freezing zone. Hence, the facility of a refrigerator and air conditioner is required for issuing a drug license in India.

Regulatory Process for Approval of a New Drug in India

The following are the steps that are involved in approving a new drug in India.

Step 1: Submission of Clinical Trials

An application for conducting clinical trials in India has to be furnished including the data of chemistry, the manufacturing control and animal studies to DCGI.

Step 2: Attach the Documents

The date of the trial protocol, investigator’s brochures, and informed consent documents have to be attached.

Step 3: Submission of Application

A copy of the application has to be submitted to the Ethical Committee.

Step 4: Clinical Trials

The clinical trials are performed only after the consent of DCGI and Ethical Committee.

Grant of Drug Sales License

The Drug and Food Control Organization of Jammu and Kashmir sells licenses as per the provisions of Drugs Cosmetics Act, 1940. To sell Allopathic and Homeopathic Drugs, it should be applied in Form 20, 21, 20B, 21B, 20A, 21A, 20C, 20D, 20F, 20G, 20BB, 21BB. There is no license required to sell Ayurvedic Drugs and Cosmetics.

Grant of Retail Sale Drug Licenses

The procedure for granting retail sale drug license is as follows.

Step 1: Obtain the Application

The licensee has to obtain an application for grant of a license to sell, stock, exhibit or offer for sale or to distribute drugs, other than those included in Schedule X has to be made in Form – 19 along with a fee of Rs. 3,000 to the Licensing Authority.

Step 2: Forwarding the Documents

The required documents are forwarded to the concerned area inspector by the Licensing Authority for on spot inspection of the premises.

Step 3: Submission of the Documents

The respective area inspector after inspection of the premises along with the inspection report submits the documents with the inspection report to the Licensing Authority.

Step 4: Issuing the License

The Licensing Authority after hearing the recommendations made by the concerned area inspector for grant of license issues the license to the applicant.

Documents Required

The following are the documents required to obtain a retail drug license.

  • Valid registration certificate that is issued by the President of Jammu and Kashmir Council and named to be as a qualified person on the license.
  • Constitution of the firm/ photo proforma and details of the Qualified person.
  • Documentary evidence of the ownership or occupation on rental or other bases of the premises.
  • Site plan of the premises.
  • Affidavit of the Propertiership and the partnership.
  • Agreement for hiring the qualifies person.
  • Two passport size photographs of the qualified person.
  • Photocopies of academic qualifications and state subject.

Renewal Procedure of Drug Selling License

Given below are the procedures to renew drug selling license.

Step 1: Obtain the Application

The licensee has to obtain Form 19, 19A, 19B, 19AA.

Step 2: Fee Payment

While obtaining the application form, the licensee has to pay the required fee as mentioned in the fee chart.

Step 3: Inspection

The application is surveyed and the premises are inspected by the officials.

Step 4: Grant of License

After inspection, the officials make sure that all the conditions are followed by the licensee. Once that is checked, the officials grant the license.

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