Drug license is required to carry out a business related to drugs, medicines, and cosmetics. Under the Drugs and Cosmetic Act, 1940, permission is granted by the concerned government authority. Any business dealing with drugs or cosmetics in India, cannot be operated without an appropriate drug license obtained by the authority as per law and regulations for the conduct of such activity. Scope of Drugs and Cosmetics Act, 1940 covers all types of drugs or cosmetics businesses including allopathic, Ayurveda, homeopathic, and Unani medicines. But a particular business entity require different types of drug license based on the business they are dealing with, Drug license is issued on a location basis. A separate drug license is required to operate in more than two states. If the business is being carried on in different states then it is mandatory to get a drug license in every state. In case the drugs are being sold or stocked for sale at multiple places, a separate application needs to be made to get the license issued by the respective local authority of that particular state accordingly. After the grant of license to the business, all the compliances should be followed and business must ensure that all the regulatory conditions in the drug license are followed every time strictly. Complete records must be maintained as specified by the licensing authorities and keep them informed of all the changes or modifications in the business activities.
The first step towards getting the drug License is the preparation of documents including, preparation of key plan and site plan and various affidavits and declaration as prescribed under law
After preparing and arranging all required documents, the next step is to starts with filling the application following the required guidelines. Complete Assistance is provided to fill details about your wholesale/retail business accurately.
After the application complete in all respect, proceed to file with the state Drug Control Authority. Application for drug license is filed to the Drug Control Department along with other declarations.
After the application is filed, an inspection is done to verify the documents by the Drug Inspector. Complete Assistance is provided to ensure the correctness of applications and premises fitness as per guidelines.
After the Inspection is complete and verifies all information and documents the controller of drugs issues the Drug License. The whole process of approval shall take up to 30 to 45 days by the Authority.
With the constant increase of medical issues and irregularities in recent times, it is necessary for the government to take control of the business dealing with drugs. Any business after obtaining a Drug license can do their business without any fear of being caught.
The government is taking strict measures to control the increasing issues in the medical sector nowadays. Having a drug License while dealing with drugs, it would not have fear in doing business or fear of being caught which will provide ease in doing business.
A business can easily expand into the wholesale market because retailers will not hesitate to work with the business having Drug License. Businesses dealing in the pharmaceutical sector can easily expand their wholesale business as retailers will prefer in dealing with an entity having a license with the concerned authority.
Yes, it is mandatory to apply and obtain a license before starting any kind of drug and medicines business, whether it is related to Allopathic Drugs, Ayurveda, Homeopathy or Unani Medicine, to manufacture, distribute or sell the drugs.
The minimum requirement to apply for a retail license is a registered pharmacist to supervise the business and having a premise of an area of not less than 10 sq. meters, with proper storage facilities for preserving the properties of drugs.
Basic requirements are premises of an area of not less than 10 sq. meters and have a qualified person taking care of business. The Caretaker and in charge of the business should be a Registered Pharmacist or passed Matriculation or equivalent with 4 years� experience or holds a degree with one year�s experience in dealing with Drugs.
Cosmetics manufacture Licence can only be granted in Industrial areas.
It is the license issued to an applicant who does not have his arrangement for the manufacture but who intends to avail of the manufacturing facilities owned by another licensee.
Normally it takes up to 45 t0 60 days in the issue of License.