Manipur Drug License

Drug license is a consent granted by the government to manufacture and sell drugs. Once a drug license is obtained for a business, the licensee has to abide by all the rules and regulations or the license would get cancelled. The records, registration and forms have to be maintained in a genuine way by the Drug License Authority and the Drug License authority has to be informed about the changes and modifications that are made in the business activities. In this article, we look at the procedure for obtaining Manipur drug license.

Need for the License

As per the Drugs and Cosmetics Act 1940, it is mandatory to possess a Drug License in order to carry out a drug and cosmetics business. Under this act, all types of drugs and cosmetics business such as allopathic, homoeopathic, ayurvedic or Unani drugs are covered.

Drug Regulation System

Drug regulation is a system to control and monitor drug usage to protect the health by controlling the safety and effectiveness of these products in areas including veterinary medicines, pharmaceuticals, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Legal authorizations to monitor the Import, Manufacture and Sale of Drugs is mentioned in the Drugs and Cosmetics Act 1940, Drugs and Magic Remedies Act 1954, Drugs and Cosmetics Rules 1945 that are made under the Drug Price Control Order 1995.

Regulatory Process for Approving New Drug in India

An application for conducting clinical trials has to be submitted with the data of chemistry, manufacturing control and animal studies to DCGI. The date for the trial protocol, investigator's brochures and informed consent documents have to be attached. A copy of the said application has to be handed over to the Ethical Committee. The clinical trials will be conducted only after the approval of the DCGI and the Ethical Committee.

Characteristics of Drug License

The basic features of a drug license are listed below:

Necessary for drugs and cosmetics business.
Drug license is granted in commercial premises for the sale of medicines and cosmetics.
Pharmacy business has to abide by all the conditions of the license.
Drug license is displayed at a noticeable place of the premises.

Types of Drug License

Drug licenses are classified into three categories. They are

Manufacturing License
Sale License
Loan License

Manufacturing License

Manufacturing license is required for manufacturing allopathic/ Homeopathic medicines and cosmetics and to repack drugs. This license is issued only in recognized industrial areas.

Sale License

Sale license is required to sell drugs to the customers. This license is further classified as

Retail Drug License
Wholesale Drug License

Loan License

Loan license is issued to an individual who intends to avail the manufacturing facilities owned by another licensee. If a pharmacy business is run in more than two states, then this license has to be obtained in every place where the business is carried on.

Infrastructure Requirements

To establish a medical shop or a pharmacy, a minimum of 10 square meters is required. Store business combination with retail and wholesale, a minimum of 15 square meters is required.

Storage Requirements

It is mandatory to have a refrigerator and an air conditioner on the premises because certain drugs such as vaccines, insulin injections, etc have to be stored in the fridge.

Technical Staff

Online Sale: Online sale of a drug is possible only when there is a registered pharmacist is present who is approved by the concerned department. The pharmacist has to be present throughout the working hours in the retail shop. Wholesale: Wholesale of drugs can be made either by a registered pharmacist or by another person who has to be a graduate with one year experience in drugs or the person has to pass S.S.L.C with four years experience in drugs who is specially approved by the drug control department.

Application Procedure

Given below are the steps to obtain a drug selling license. Step 1: Obtain the Application The applicant has to obtain the required application Form 19, 19A,19B, 19 AA. Step 2: Make the Payment The applicant has to make the prescribed fee to the authority. Step 3: Inspection The concerned officials survey the application and then inspect the premises. Step 4: Grant of License If the applicant has abided by all the regulations, then the authority issues the license.

Required Documents

The following documents have to be possessed by the applicant to obtain a selling drug license.

Duly filled an application form.
Receipt of the fees paid or challan.
3 copies of the layout plan of selling premises.
Documents like the rent receipt, purchase documents or attested copies that shows the lawful possession of the premises.
The documents relating to the constitution of the firm such as the Partnership-deed, memorandum and article of association etc.
Full details of the competent technical staff/ registered people along with copies of their experience, registration and educational qualification certificates.
Full name of the partners or the proprietor.
In the case of public or private limited concerns, the full name of the Directors who signs the application and the authorised signatory has to be provided in the application.
The documents pertaining to the purchase of Refrigerator/Deep freezer (For Vaccines/ Sera).

Renewal Procedure

The license for selling drug is valid only for a certain period of time. Once it is expired, the licensee has to renew the license to continue drug business. Here are the steps to renew a drug license. Step 1: Obtain the Application The applicant has to obtain the required application Form 20, 21, 20B, 21B, 20A, 21A, 20C, 20D, 20F, 20G, 20BB, 21BB. Step 2: Make the Payment The applicant has to make the prescribed fee to the authority. Step 3: Inspection The concerned officials survey the application and then inspect the premises. Step 4: Grant of License If the applicant has abided by all the regulations, then the authority issues the license.

Required Documents

The following are the required documents that have to be possessed to renew a drug license.

Copy of cash receipt or challan for payment of fees.
Copy of the Licence or the previous renewal certificate.
Documents such as rent receipt, purchase documents or attested copies showing lawful possession of the premises.
Full details of the competent technical staff /registered persons along with copies of their educational qualification, experience and registration certificates.