Drug License

Drug License in Haryana

Drug License in Haryana

In India, the provisions for drug license finds its place in the Drugs & Cosmetics Act, 1940. Provisions regulating Ayurvedic and Unani drugs were later included in the revised version of the Act in the year 1964. In this article, we look at the procedure for obtaining drug license in Haryana.

Need for the License

Drug license is a permit issued under the Drugs and Cosmetic Act, 1940 for an individual to form and operate a drugs/medicines/cosmetics business. In simpler terms, no individual can start or progress a business that involves the use of drugs or cosmetics without holding a valid license issued by the Indian Government. The above-mentioned Act is applicable to all types of drugs and cosmetic businesses including the use of allopathic, homoeopathic, ayurvedic or Unani drugs. Nevertheless, the quality of drugs and cosmetics have to be maintained by the people dealing with the said drugs. If a consumer suffers any side effects after consuming a particular drug/ medicine, the seller or the manufacturer of the drug will be held responsible. The concerned person may even have to undergo a trial in the court as per the rules laid by the Indian Penal Code (IPC).

Fundamental Regulations Concerning Drug License

The following are the features of a drug license.

  • A drug license is essential to carry out a drug and cosmetic business.
  • The license is issued for selling a medicine or a cosmetic product in any commercial place.
  • Pharmacy businesses have to abide by the regulations as mentioned in the license.
  • The license has to be displayed at a prominent place of the premises.

Obtaining a Drug License

To obtain a drug license, the licensee has to approach a duty officer in a mail receipt counter of the Drug Control Department and fill the application form. This application has to be submitted to the concerned drug controller. The applicant while submitting the application has to attach all the documents specified under the Drug and Cosmetic rules.

Kinds of License

The Drug Control Organization issues two types of licenses, namely Retail Drug License (RDL) and Wholesale Drug License (WDL).

Retail Drug License (RDL)

The RDL is issued to people holding a degree or diploma in pharmacy from a recognized university. The course has to be pursued by paying the required course fees. This license is used to run a chemist shop or a pharmacy.

Wholesale Drug License (WDL)

The WDL is issued to people operating a wholesale business of drugs and medicines.

Checklist for the Issue of License

Given below is a checklist which must be complied with by the licensee:

Skilled Person/ Pharmacist

All medicines have to be handled by a specialist so as to authorize the distribution of medicines. In order to obtain an RDL, a qualified pharmacist is required; while in case of a WDL, a graduate with at least one year experience or an undergraduate with at least four years of experience must be vested with the affairs of the trade business.

Area of Pharmacy Shop

The carpet area of the pharmacy must be in the length of at least 10 square meters. In case of a retail and wholesale pharmacy, the carpet area should be a minimum of 15 square meters. The premises of trade must have sufficient air supply.

Storage Facility of Drugs

The medicines have to be stored in a clean, ventilated and cool environment since the vaccines require low-temperature freezing zone. Therefore, it is essential to possess a refrigerator and an air conditioner to obtain a drug license.

Classification of Drug License

Drug Licenses are classified into three – Manufacturing License, Sale License and Loan License.

Manufacturing License

Manufacturing license is issued only in recognized industrial areas of Delhi to manufacture allopathic or homoeopathic drugs and cosmetics.

Sale License

Sale license includes The Retail Drug License and Wholesale Drug License.

Loan License

Loan License is issued to people to seek for manufacturing facilities owned by another licensee. If a pharmacy business is operated in more than two states, the licensee has to obtain a drug license in every state where the business is carried on. A separate license is issued for drugs that are sold in more than one place. The licensee has to check for the accuracy of the details that are mentioned in the license. If a business owner makes any changes or modification in the business, it has to be reported to the authority and all the registers, records, and forms have to be declared in the stated manner.

Required Documents

The following are the documents required to apply for a drug license:

  • Duly completed application form.
  • Challan or receipt of the fee paid.
  • Three copies of the layout plan of the premises.
  • Rent receipt and purchase documents of the premises.
  • Partnership deed, memorandum and article of association.
  • Details of competent technical staffs or educational qualification, experience and registration certificates of the registered people.
  • Refrigerator and deep freezer purchase voucher.
  • Affidavit of authorized signatory.
  • Copy of resolution of Board of Directors.

Infrastructure Requirements

  • To establish a retail store, an area of 10 square meters is required.
  • To establish a wholesale store, an area of 10 square meters is required.
  • To establish a retail and a wholesale store together, an area of 15 square meters is required.
  • Adequate storage facilities such as cupboards with glass doors, racks refrigerator, etc, must be a part of the establishment.

Application Procedure

Let’s now understand the application procedure through which the various licenses can be obtained:

To obtain Retail and Wholesale Drug (Fresh)

Step 1: Apply Online

To start with, the applicant has to apply online to the Senior Drug Control Officer of the concerned Licensing Authorities located in various zones.

Step 2: Making Payment

The licensee must remit the fee online through Net Banking/Debit Card/Credit Card. It can also be paid by downloading the form connected with the payment.

Step 3: Verification of the Premises

The premises are thoroughly examined by the DCO of the concerned district to verify all facilities mentioned by the applicant. Once verified, the DCO sends the report along with a recommendation letter to the SDCO of the Zone.

Step 4: Issuing License

If all the requirements are met by the licensee, the SDCO of the concerned licensing authority issues the license. The applicant will be notified of the same through an SMS or Email.

To obtain Drug Manufacturing License (Fresh)

Step 1: Apply Online

The applicant has to make an online application to the State Drugs Controller of the State’s Licensing Authority.

Step 2: Make Payment

The licensee must pay the fee online through Net Banking/Debit Card/Credit Card. It can be paid by downloading the form connected with the payment.

Step 3: Submit the application

The applicant has to submit the application online to the State Drugs Controller with the required documents. The premises are thoroughly examined by the Senior Drug Controller of the concerned district. Once verified, the Senior Drug Controller sends the report along with a recommendation letter to the State Drugs Controller.

Step 4: Issuing License

If all the requirements are met by the licensee, the State Drugs Controller of the concerned licensing authority issues the license. The applicant will be notified of the same through an SMS or Email.

Procedure for Retention of Drug Manufacture/ Selling License

As per  notification no. GSR-1337 dated 27.10.2017, the Government of India has replaced the term ‘Renewal’ with ‘Retention’. As is indicative, drug businesses are required to apply for license retention post the expiry of its terms. The license retention fee does not include the inspection fee paid during the issue of license.

Failing to retain the license would force the licensee to not only pay the license retention fee, but also the late fee that is calculated at the rate of two per cent of the license fee for every month for up to six months. If the license fee is not paid by then, the license stands cancelled.  The validity of the license retention fee will be retained once the payment is made.

The following undertakings have to be made when a licensee remits the license fee:

  • No changes will be made to the Constitution.
  • No changes will be made on the premises.
  • No changes will be enforced on the approved technical staffs.
  • Finally, a specification must be made comprising of the approved aspects and the required fee that the firm intends to retain.

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