Himachal Pradesh Drug License

Drug license is a Government issued permit that a business should possess to carry out activities dealing with drugs and cosmetics. The drug license includes a license for drug manufacturing and drug sale. If the business operation occurs in two or more states or if drugs sold at more than one place, a separate drug license must be acquired. In this article, we look at the online procedure, documents required and other aspects to obtain Himachal Pradesh Drug License for sales and manufacture in detail.

Drugs and Cosmetics Act, 1940

The Drugs and Cosmetic Act, 1940 governs various drug laws under which the licensing of both manufacturing and sale premises of drugs is authorised. Under the act, the license also covers homoeopathic and allopathic medicines. The manufacturer or seller of the drugs or cosmetics is responsible if any person using the product is affected due to the negligence of the same and is considered an offence under the act. Moreover, the act covers the penalty to be imposed on the licensee for non-renewal of the license after its expiry.

Conditions for License

A registered pharmacist should directly and personally supervise any drug made by the licensee.
The licensee should have minimum four years of practical experience in the distribution of drugs.
The retail supply of any drug prescribed by the registered medical practitioner should be under the inspection of a registered pharmacist.
The retail supply of the drug should be recorded in a register at the time of supply.
The drugs mentioned in Schedule H or Schedule X are valid for a period of two years and should be supplied to registered Medical Practitioners, hospitals, dispensaries and nursing homes only on the signed order in writing.
The licensee should maintain the purchase record of the drugs intended for sale or sold by retail.
The licensee should not sell or stock any drug after the expiry date.
The licensee should not store or stock any drugs on his premises that are intended for distribution as a free sample to the medical profession.
The medicine in a retail shop for the treatment of animals should be labelled as “Not for human use _ for treatment of animals only.”

Note: The expired drugs stored to claim a rebate from the income tax will not be considered an offence under the act unless not intended for sale.

Himachal Pradesh Drug License

The drug license is granted for both sale and manufacturing purposes that should comply with the license conditions and must be displayed at the appropriate place of the premises. The application forms, fees and documents required for the grant of fresh license and renewal of a license are same.

Drug Sale License

The drug sale license is issued for both retail as well as the wholesale distribution of drugs in India. The issuance of a license for drug subjects to conditions attached with the competent person who deals with drugs, the area of pharmacy shop and storage facility.

Documents Required

The following documents must be submitted for sale license under Himachal Pradesh drug license.

Form-19 duly filled in by the applicant in original.
Affidavit of the applicant verified by the Notary Public
Copy of the online-generated receipt of the challan
Site and Layout plan of the shop
Proof of possession/ownership of the proposed premises
Id proof of the applicant (Aadhar card, Voters card)
Documents for Registered Pharmacist:

- Affidavit duly attested by Public Notary.
- Copies of educational qualification certificates (Attested)
- Attested copy of registration certificate and its renewal issued by U.P. Pharmacy Council.
- Two photographs per applied license.
- Address proof.
- Appointment letter and joining letter

Documents for the qualified person (for Wholesale license)

- Attested copies of educational qualification certificates
- Experience certificate on the affidavit
- Two photographs per applied license
- Appointment letter and Joining letter if applicable
- Three copies of the plan of proposed premises.

Attested copy of purchase invoice of a refrigerator

Drug Manufacturing License

Every manufacturer of the drug should acquire a proper drug-manufacturing license from the Himachal Pradesh Drug Administration.

Document for the grant/renewal of drugs manufacturing licenses

Application Form-24/24-A and 27/27-A 2.
Affidavit of the applicant duly attested by the Notary
List of the Plant & Machinery installed.
List of the Laboratory Equipments provided.
Valid NOC from the Pollution Control Board
Registration papers of the land in case of owner or Agreement Deed if the premises are rented or leased.
Constitution of the firm.

Documents for the Competent person responsible for manufacturing

Medical fitness certificate after a complete investigation.
Appointment letter of the employee
Joining or acceptance letter of the employee.
Affidavit of the appointed competent person in a prescribed language
Educational qualification certificate
Certificate of approval as manufacturing chemist by the competent drug authority
Original copy of the experience certificate on the letter pad bearing license number of the issuing firm
Passport size Photographs-1 (attested) and 4 (unattested).

Documents related to Competent person for testing

Approval Certificate as an Analytical chemist by the competent drug authority
Section wise and category wise list of the items proposed to be manufactured (Biological and Non-Biological) indicating the following details:
- Reference
- Ingredients,
- Specification and quantity per unit dose
Testing method in case of non-pharmacopoeia drugs and ingredients
Proposed packing presentation and packing material proposed to be used
Site Plan and Location layout of the proposed premises drawn and certified by the competent authority (2- copies)
Medical fitness certificate after a complete investigation.
Appointment letter of the employee
Joining or acceptance letter of the employee.
Affidavit of the appointed competent person in a prescribed language
Educational qualification certificate
Passport size Photographs-1 (attested) and 4 (unattested).

Fees for Himachal Pradesh Drug License

Type of License	Fees for Grant of License
For Wholesale license	Rs. 1500+1500= Rs. 3000.00
For Retail License	Rs. 1500+1500= Rs. 3000.00
For Restricted License	Rs. 500+500= Rs. 1000.00
For Drugs specified in Schedule-X(Wholesale)	Rs. 500
For Drugs specified in Schedule-X(Retail)	Rs. 500

Timeline

The Department has proposed a timeline of 21 days certificate from the date of submission of the online application on the portal to issue the final approval of the certificate.

Application Procedure Himachal Pradesh Drug License

Step 1: Visit the official website for Drug Administration Step 2: Now, create your user account by clicking on “New Log-in and PWD”. After the registration process is done successfully, you will get the credentials to log-in. Step-3: Fill the mandatory details and upload the scanned copy of documents mentioned for the Grantor renewal of Drug License for Retail Step-4: After successful entries of mandatory fields and uploading the scanned documents, make the online payment. Step-5: After payment, finally submit the application to the department.