Drug License

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Drug License


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About Drug License

Licensing is mandatory to do business in Drugs & Cosmetics in India. The provisions for this has been made in Drugs & Cosmetics Act, 1940 which is applicable to whole of India. It is an Act to consolidate all the laws relating to drugs & cosmetics, which established the Drugs Control Department. In 1964, the Act was amended to include Ayurvedic & Unani drugs. However a particular business entity may require different types of drug license based on their business.

Advantages

Government Control

With the rise of medical issues in recent times it is necessary for the government to take a control over those dealing in this sector so any entity if obtains Drug license can do their business without any fear of being caught.

Business Expansion

Entity working in pharma sector can easily expand their wholesale business as no retailer will hesitate in dealing with person who has obtained the license with concerned authority.

Safety

Existing drugs that are either approved or have been shown to be safe in late-stage trials, but have failed to meet end points of their originally-targeted indications, can leverage their inherently reduced development risk into potentially new indications . They can do so if they can be proven to be effective in the new indications and also sufficiently differentiated against standard of care.

When such drugs enter clinical trials, they compete with non-repositioned drugs not in terms of safety, but in terms of efficacy. Since safety accounts for approximately 30% of drug failures in clinical trials, this is a significant development advantage that repositioned drugs enjoy.

Document Required

Constitution of the firm (MOA/AOA)

Photo ID proof of proprietor/partner/director

Copy of Property paper (If owned property)

Copy of Rent agreement (If rented property)

Site Plan and key plan of the premises

Refrigerator invoice and details

Affidavit regarding compliance of MPD 2021 (if premises are located on DDA residential flat/ plot/ building)

Eligibility

Minimum Area Requirement

In case of wholesale outlet or Medical Shop : Minimum area of 10 sq. meter.

In case wholesale+ Retail: Minimum area of 15 sq. meter

Storage Facility

Refrigerator and air-conditioner in the premises is must.

Technical Staff

In case of whole sale business, the sale of Drug shall be made before the registered pharmacist or any graduate having an experience of not less than 1 year in dealing in Drugs or any person who has passed the intermediate level of schooling and having the experience of at least 4 years in dealing in drugs.

Process

User ID and Password

Applicant has to obtain user ID and Password by giving request letter in person with the details of the firm.

documents should be scanned

All the documents should be scanned in 100 dpi and black and white and then should be uploaded using the said ID and Password at space provided for the purpose. All the information is filled precisely for respective application and then e-send the application. The licensing authority may ask for any other specific documents if required.

follow-up

You will then need to follow-up with the government department for an update on your application. In case of rejection of your application for incomplete information, the fees once paid will be forfeited by the government.

government department will take 45-60 working days

The government department will take 45-60 working days to completely review your application and approve the same. Else, you can hire Expert Lawyer for getting the Drug license for you. We get license issued and save our customers from all the government hassles.

Frequently Asked Questions

What are the essential requisites for obtaining a Sales Drugs Licences (retail) for a chemist shop?

The applicant’s shop / premises should have an adequate area of not less than 10 sq. metre, should be equipped with proper storage facilities for preserving the properties of drugs and applicant (Competent Person) must be a Registered pharmacist with Pharmacy Council.

The applicant’s shop/premises should have an adequate area of not less than 10 sq. metre and person in charge (Competent Person) must be a Registered Pharmacist/who has passed Matriculation or its equivalent with four year’s experience in dealing with Drugs or who holds a degree of a recognized university with one year’s experience in dealing with Drugs.

The applicant’s shop / premises should have an adequate area of not less than 15 sq. mtr.

Written complaint about doubtful quality of Drugs can be made to the Drugs Control Department, Govt. of N.C.T. of Delhi, at F-17, Karkardooma, Shahdara, Delhi-32 indicating name and address of the complainant, name and other particulars of the Drug under complaint and nature of complaint.

Various provisions dealing with Drug licenses are given under Drugs & Cosmetics Act, 1940 & rules there under. Information can also be sought in person from the drug inspectors seated in Drugs Control Department.

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