Drug License in India Call: 9911404600 Drug License Registration in Delhi, Gurgaon, Noida, Ghaziabad, India - Balaji IP Practice
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Drug License in India

Drug License in India

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Drug and cosmetic industry serve the interest of a larger community, an Act to regulate its manufacture, import, sale, and distribution was passed in the year 1940. The drug license rules under the Drug and Cosmetic Act, 1940 are as follows:

  • • The person who wishes to acquire a drug license must have at least four years of practical experience in the distribution of drugs.
  • • A licensee can only manufacture any drug under the personal supervision of a registered pharmacist.
  • • Further, the retailer of the drug must keep a record in the register at the time of drug supply.
  • • The licensee ought not to sell or stock any drug after its expiry date.
  • • Also, the drugs can be sold to a minor (below 18 years).
  • • The medicine in a retail shop to cure animals should have a tag of “Not for human use, for treatment of animals only.”
  • • Every drug license holder should maintain a purchase record of the drugs sold by retail or intended for sale.
  • • Moreover, the act prohibits a licensee from storing any drugs at his premises which were intended for free sample distribution to a medical profession.
  • • Any medicine prescribed by a registered medical practitioner must be under the inspection of a registered pharmacist before retail supply.
  • • The drugs categorized in Schedule X or Schedule H has a validity of two years. Therefore, it should be supplied to all registered entities like dispensaries, nursing homes, Medical Practitioners and hospitals only in regards to a signed written order.

Note: If you have stored any expired drugs to claim a rebate from the Income Tax, then it will not be considered an offence under the Drug and Cosmetic Act, 1940, unless not intended for sale.

Eligibility for obtaining Drug License

Drug License in India

Drug and Cosmetic Act has set a long list of requirements that every medical aspirant has to fulfil to procure a drug license. Here are the basic needs as per drug rules:

  • • The carpet area of a drugstore should be 10 Sq. and meter for retail or wholesale outlets. Besides, you need to have 15 square meters area for combined wholesale and retail.
  • • Any drugstore or pharmacy must have an air conditioner, sound ventilation system, and refrigerator.
  • • According to the act, a person can only conduct the drug business in the presence of any of these persons:
  • 1. Any Registered Pharmacist under State Pharmacy Council.
  • 2. A graduate with a minimum of 1-year experience in drugs sales and marketing in a reputed pharmacy.
  • 3. An individual with four years of experience in pharma marketing and has passed S.S.L.C.
  • 4. Even a person approved by the department of drug control is eligible.

What Is Included In Our Package ?

Drug License in India

Drafting Documents
Application Filing
Application Processing
Completion of registration

Procedure For Drug License in India

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The Food Safety and Drug Administration Department governs the drug license rules. Therefore, it has enlisted a few simple steps for candidates of pharma business. However, the candidate needs to affix to have authorized documents along with his drug application. Here are the steps to follow:

Fill the Application

the process of filing the drug application is entirely online, wherein the applicant can access it by paying the Government fee. Then, upload a scanned copy of all the documents at the time of applying.

Visit by the Drug Inspector

On receiving the drug application, a drug inspector shall pay a visit to the applicant’s shop. The purpose of his visit is to verify the documents and validate the information provided.

Issue of the Drug License

Once the Drug Inspector completes his interrogation or verifies the correctness of all the documents, then the controller of drugs finally grants the Drug License.

Steps For Getting Drug License

One can file the Drug License application directly with the government. The process is long and requires 60 days to get completed :

Step 1 : Fill the application.

Step 1 : Visit by the Drug Inspector.

Step 1 : Issue of the Drug License.

Frequently Asked Questions

Drug License in India

Only in the recognized Industrial Areas of Delhi.

License to manufacture Cosmetics can be granted only in Industrial areas w.e.f. 01/01/2000.

Licenses in Form 20-A / 21-A are required for the sale of restricted Drugs commonly used as household Remedies.

The applicant firm should have adequate premises of an area of not less than 10 sqr. mtrs. Must be equipped with proper storage facilities for preserving the properties of drugs

The Applicant firm should have adequate premises of an area of not less than 10 sqr. Mtrs. The Competent Person seeking to procure a license should be a Registered Pharmacist /passed Matriculation.

The premises should be of an area of not less than 15 sqr. mtrs.

Licenses for the sale of drugs can be granted in the commercial premises or other premises independent of residence.

Written complaint about doubtful quality of Drugs can be made to the Drugs Control Department, Govt. of Delhi, at 15, Sham Nath Marg, Delhi-54. .

Detailed information about various provisions of the law can be obtained from the Drugs & Cosmetics Act, 1940 & rules there under. .

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