Drug License in Kerala

The Drugs and Cosmetics Act, 1940 lists out the provisions pertaining to Drug License. The provisions for Ayurvedic & Unani drugs were also later brought into the Act. In this article, we look at the procedure for obtaining a drug license in Kerala.

Need for the Regulation

Drug regulation is made by the government to monitor public health and to ensure the safety of medical products such as pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Some of the Legal Enactments to regulate the import, manufacture and sale of drugs include the Drugs and Cosmetics Act 1940, Drugs and Magic Remedies (Objectionable Advertisements) Act 1954, and the Drugs and Cosmetics Rules 1945.

Drug and Cosmetic Business in India

The primary step to start a pharmacy or a drug store is to obtain a drug license from the concerned State Government. The drug and cosmetics industry is working efficiently to develop the healthcare sector in India. This has enabled the drugs and cosmetic business to be a profitable business in India. These businesses are often carried out through a proprietorship or partnership model of business. On the other hand, to make sure that the business is transferable, it is established as an LLP or a Private Limited Company.

Basic Regulations

To sell a drug online, it is mandatory to carry a copy of the medical prescription and the drugs cannot be sold to a minor. Moreover, delivery charges should only be imposed if the customer has agreed for the same during checkout.

Classification of Drug License

Drug licenses can be classified in the following categories.

Manufacturing License

A manufacturing license is necessary to manufacture allopathic or homoeopathic drugs and cosmetics. This license is issued only to the recognized industrial areas of Delhi.

Sale License

A sale license is classified into two types. They are

Retail Drug License
Wholesale Drug License

Loan License

A loan license is issued to manufacturing facilities owned by another licensee.

Separate Business Entity

If a particular pharmacy business is held in two or more states, it is mandatory to obtain a drug license from the respective State Government. Once the license is granted, the licensee must comply with the conditions specified by the authority. If there are any changes or modification made to the business, the owner of the business must report the same to the concerned authority, and all registers; records; and forms should be maintained in the prescribed manner.

Infrastructure Requirements

A minimum of 10 square meters requires to set up a pharmacy or a medical store. If the store runs both retail and wholesale business, then the minimum area of the requirement will be 15 square meters.

Storage Requirements

As a preservation measure, it is mandatory to have a refrigerator and an air conditioner within the storage limits. These electrical appliances are mandatory to preserve certain drugs like vaccines, insulin injections, etc.

Technical Requirements

Offline sales of a drug can be carried out in the presence of a registered pharmacist approved by the department who will be required to make his/her presence in the retail shop throughout the working hours. Drugs sold in a wholesale store has to be carried out in the presence of a registered pharmacist, by a person who is a graduate with one year experience or by a person who has completed SSLC with an experience of four years approved by the drug control department.

Forms

The forms so utilized to grant the licenses for various drugs and cosmetics in Kerala are as follows.

FORM	REQUIREMENT OF THE LICENSE
Form 20	To sell, stock or to exhibit or to offer for sale or to distribute the drugs by retail other than those mentioned in Schedule C, C1 and X.
Form 21	To sell, stock or to exhibit or to offer for sale or to distribute the drugs by retails drugs specified in Schedule C and C1. (excluding those specified in Schedule X)
Form 20B	To sell, stock or to exhibit or to offer for sale or distribute by wholesale drugs other than those mentioned in Schedule C, C1 and X.
Form 21B	To sell, stock or exhibit or to offer for sale or distribute by wholesale drugs specified in Schedule C and C1. (excluding those specified in Schedule X) For fresh/renewal applications of the above licenses apply in form 19).
Form 20A	A restriction to sell, stock or to exhibit for sale or distribute drugs by retail other than those mentioned in Schedule C, C1 and X for dealers who do not engage the services of the qualified person (for fresh/renewal application of the above licenses apply in form 19A).
Form 20BB	To sell, stock or exhibit or to offer for sale by wholesale or distribute drugs other than those mentioned in Schedule C and C1 from a motor vehicle.
Form 21BB	To sell by wholesale or distribute drugs mentioned in Schedule C and C1 from a motor vehicle (for fresh renewal applications of the above licenses apply in form 19AA).
Form 20C	To sell, stock or to exhibit or offer for sale or to distribute Homeopathic Medicines by retails.
Form 20D	To sell, stock or to exhibit or to offer for sale or distribute Homeopathic Medicines by wholesale. For fresh/renewal application of the above license form, apply in Form 19B.
Form 20F	To sell, stock or exhibit or to offer for sale or distribute wholesale drugs specified in Schedule X.
Form 20G	License to sell, stock or to exhibit or to offer for sale or to distribute wholesale drugs specified in Schedule X (for fresh/renewal application of the above license, 19C is prescribed).
Others	Certificate of renewal of a license to sell, stock or exhibit or to offer for sale or distribute drugs in the case of all the above licenses except form 20BB and form 21BB - issued in form 21C and that of 20BB and 21 BB are issued in form 21CC.

Drug License (New Application)

The application procedure to obtain a Drug-Selling License(Fresh) is as follows: Step 1: Obtain the Application Form The licensee has to make an application in the appropriate forms such as form 19, 19A,19B and 19AA. Step 2: Attach the Documents Next, he/she has to attach the documents with the application form. Step 3: Inspection The concerned authority conducts the verification procedures, to examine the premises. Step 4: Grant of License On satisfying all the requirements, the applicant can collect the license from the concerned authority.

Required Documents

Duly filled the application form.
Challan or the fee receipt.
Three copies of the layout plan.
Rent receipt and the purchase documents of the premise.
Partnership-deed, memorandum and article of association, etc.
Details of the staffs and the registered personnel.
Details of the proprietor, partners or the Directors who sign the application, authorized signature (if warranted).
Receipt of the refrigerator and deep freezer.

Renewal of the License

The application procedure helps in renewing or retaining a license. Step 1: Obtain the Application Form The licensee has to make an application in the appropriate form such as Form 19, 19A, 19B, 19AA. Step 2: Attach the Documents Further to it, the applicant has to attach the documents with the application form. Step 3: Inspection The concerned authority conducts verification procedures and examines the premises. Step 4: Grant of License On verifying all the requirements, the concerned authority will grant a license to the applicant.