Advances in the field of medicine have significantly impacted the realms of physical and psychological health, but the rampant availability of a utility may also lead to its misuse. This has prompted the Indian Government to regulate the manufacturing and distribution of drugs and medicines in India, leading to the constitution of the Drugs and Cosmetics Act in 1940. The Act provides that the sale, resale, marketing, manufacture and related endeavors of drugs and cosmetics in the country must be pursued by obtaining a drug license. This article deals with the provisions pertaining to drug license in Karnataka.

Need for the Regulation

The domain of medicine is rewarding, yet intricate. Aspects related to import and export of medicines, consumption of schedule H&X drugs, sale of drug to a minor, etc, requires through monitoring and cautious execution. This prompts the need of a license that regulates the provisions pertaining to this sector, which is issued to the respective dealers in accordance with the Drugs and Cosmetics Act of 1940.

Karnataka Drugs Control Department

Incorporated in Mysore, the Karnataka Drugs Control Department is vested with the licensing of manufacturing and sales premises of drugs and cosmetics in the state. It primarily strives to ensure the supply of quality drugs at a price which is statutorily determined. The entity comprises of three wings, namely:

• Enforcement wing
• Educational wing
• Drugs testing laboratory

Types of Licenses Granted

The Drugs Control Department issues the following types of licenses:

• Retail Drug License.
• Wholesale Drug license.
• License to sell drugs under Schedule X.
• Restricted licenses.
• License to sell drugs from motor vehicle.

Infrastructural Specifications

A medical shop or pharmacy can be established in a carpet area of 10 square meters, while a store business blended with the concept of retail and wholesale needs a carpet area of 15 square meters. The premises of trade must include a refrigerator and air conditioner as certain drugs such as vaccines, insulin injections; etc must be stored in the fridge. The medicines must be maintained in a clean, ventilated and cool atmosphere.

Staffing Requirements

The handling of drugs must be designated to a registered pharmacist. A qualified pharmacist may control the trading affairs of a retail store, while a graduate with one year of experience/ an SSLC pass-out with four years of experience may handle that of a wholesale store.

Documents Required for Retail Drug License

• Covering letter.
• Form 19/19C.
• Additional Information Sheet (AIS).
• Challan/acknowledgment of payment.
• A duplicate copy of the sketch of the premises.
• Rental agreement/lease deed.
• Qualified person’s proforma.
• KSPC Registration Certificate (original and duplicate).
• Proof of option and approval (in duplicate).
• An Affidavit of Rs. 20 in stamp paper.
• Invoice of the refrigerator purchased for storage.
• Proprietorship declaration/Partnership Deed/ Memorandum or Articles of Association.
• Proof of address.
• Passport size photograph of the applicant.

Documents Required for Wholesale Drug License

• Covering letter.
• Form 19/19C.
• Additional Information Sheet (AIS).
• Challan/acknowledgment of payment.
• A duplicate copy of the sketch of the premises.
• Rental agreement/lease deed.
• Qualified person’s proforma.
• Qualification Certificate of the competent person.
• Experience Certificate of the competent person.
• An Affidavit of Rs. 20 in stamp paper.
• Invoice of the refrigerator purchased for storage.
• Proprietorship declaration/Partnership Deed/ Memorandum or Articles of Association.
• Proof of address.
• Passport size photograph of the applicant.

Documents Required for Drugs Sold under Schedule X

• Covering letter.
• Form 19/19C.
• Additional Information Sheet (AIS).
• Challan/acknowledgment of payment.
• Copy of licenses issued in Form 20, 21 and/or 20B and 21B.
• An undertaking stating that Schedule X drugs will be maintained discreetly.

Documents Required for Grant of Restricted Licenses in Form 20A and Form 21A

• Covering letter.
• Form 19A.
• Additional Information Sheet (AIS).
• Challan/acknowledgment of payment.
• A duplicate copy of the sketch of the premises.
• Rental agreement/lease deed.
• Proprietorship declaration/Partnership Deed/ Memorandum or Articles of Association.
• Proof of address.
• Passport size photograph of the applicant

Documents Required to Avail Drug Sale License for Motor Vehicle Sales

• Covering letter.
• Form 19AA.
• Challan/Acknowledgment of Payment.
• Attested copy of the RC book of the vehicle which is to be utilized for sales purposes.
• A snap of the license in Form 20B and/21B.
• Proof of identification.
• Proof of address.

Procedure for Availing License

Step 1: Submission of Application

To start with, the applicant needs to submit a statutory application in the specified form found in the portal and remit the fees and the documents specified above. The concerned authority may demand further documents to validate the information provided by the applicants.

Step 2: Scrutiny and Inspection

The documents, after validation, is processed and submitted to the respective Assistant Drugs Controller. He/she may choose to either scrutinize the same along with the premises or forward it to the subordinate Drugs inspector for the same purpose.

Step 3: Issue of License

If the application is not coherent or needs some clarifications, a compliance letter will be issued to the applicant. On the other hand, if the submitted documents and storage facilities are found to be in concurrence with the requirements, the concerned Assistant Drugs Controller and delegated Licensing Authority will grant the license to the applicant.

The applicants will be intimated of the grant through a computerized SMS alert. The license will be addressed to him/her by post.

Distinct Entity

For legal purposes, business operations in a particular state are considered to be distinct from another, despite being a branch of the same entity. Hence, state-specific drug licenses is a given for drug businesses.