Corporate & Commercial Law, Licenses Approval & Registration
Things You Must Know Before Applying For Drug License in India

Things You Must Know Before Applying For Drug License in India

WHAT IS A DRUG LICENSE?

Drug license in simple language can be stated as a grant or permission by the governmental authorities to do deal in drugs. It is mandatory to obtain drug license in order to do business in drugs.

WHAT IS A DRUG?

The definition of drug is stated under Section 3(b) of the Drugs and Cosmetics Act, 1940 as:

“drug” includes—

(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;

(ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of[vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;

(iii) all substances intended for use as components of a drug including empty gelatin capsules; and

(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board;

WHY DRUG LICENSE IS MANDATORY?

Drug license has been made mandatory in order to curb the problem of illegal dealing in the business of pharmaceutical drugs and it also include the pharmacist to hold a certificate of Diploma in Pharmacy in order to deal in pharmaceutical drugs and also who have complete knowledge in storage, protection and also safe disposal of drugs in case of its contamination and expiry of the same. Thus, in order to dealing in drugs, one has to mandatorily have a drug license without such person cannot deal in a pharmaceutical drug. In case illegal dealing in drugs are done this will be punishable under Section 18(c) of the Drugs and Cosmetics Act, 1940 which states punishment of one year which may extend to 3 years and with fine which shall not less than Rs.5000/-.

WHAT ARE THE TYPES OF DRUG LICENSES?

There are 5 types of Drug Licenses. They are as follows:

  1. Manufacturing Drug License
  2. Loan Drug license
  3. Import Drug License
  4. Multi License for dealing in drugs
  5. Sale Drug license – Wholesale Drug license & Retail Drug License
Manufacturing Drug License

The manufacturing Drug License is obtained in case of the Company/distributor/proprietor is involved in manufacturing of drugs and must have a manufacturing license from the Central Drug Standard Control Organization [CDSCO]. This includes manufacturing in drugs including of allopathic/homeopathy medicines.

Loan Drug License

This is a type of drug license in the business in drug where the manufacturing unit or facilities is not available to it but uses the manufacturing facilities of another licensee.

Import Drug License

This type of drug License is obtained in respect of importing of drugs from outside of India and deal in such in the Indian market.

Multi-Drug License

This is a drug license in which there are multiple pharmacies in the different States of India under the same name.

Sale Drug License

Wholesale drug license – This type of Drug License is required when the licensee is selling the drugs to other retailers of drugs in order for the same to reach the end consumer.

Retail Drug License – A Retail Drug Licensee in order to sell drugs to the end consumers of the same has to obtain the same. The licensee can sell the same to dispensaries, hospitals, medical units etc.

What Are the Documents Required for Drug License?
  1. Memorandum of Association (MOA) or Article of Association(AOA) in case of Partnership Firm then Partnership Deed, LLP Agreement of Partnership and LLP.
  2. Identity Proof of Partner/Director/Proprietor.
  3. Passport size photographs of the Partner/Director/Proprietor.
  4. Documents in respect to premises: – Copy of property Ownership or Rental Agreement
  5. Site Plan of the property
  6. Copy of Board Resolution in obtaining licensee on behalf of the Company.
  7. Proof of availability of proper storage facility, refrigerator, cold storage etc.
  8. Proof of payment of fees for obtaining the particular drug license.
  9. Affidavit in respect of non-conviction of Proprietor/Partner/Director and also the firm/Company
Documents of Pharmacist
  1. Copy of the Diploma in Pharmacy
  2. Registration Certificate from the Pharmacy Council
  3. Experience Letter (if any).
  4. Affidavit of Pharmacist.
  5. Details of the educational certificate of the pharmacist.
What Is the Procedure for Obtaining Drug License?
  1. Uploading of required form for respective type of drug license along with required documents.
  2. After uploading the form and the documents and the fees for the form is to be paid and challan to be generated in respect to process further.
  3. After the documents are submitted the concerned authority will scrutinize the form submitted, the District Coordination Officer (DOC) of the concerned district will do the supervision of the premises for which drug license is sought.
  4. After the verification and inspection, the DOC will forward the report to the SDCO of the zone for granting the license.
  5. Thereport of the SDCO will be forwarded to the respective state drug license Authority and if the authority finds no discrepancy in the report, then it will issue Drug License to the person.

Generally, it takes around 30 days for the issuance of a Drug License in India.

CONCLUSION

The obtaining of drug license is necessary for dealing in pharmaceutical drugs in India. The process is a little bit lengthy as it requires lots of documents for submission and it should be absolutely authentic documents as it involves the healthcare of the population, thus, it involves strict scrutiny of documents as well as the premises before License is provided to any individual, company or partnership firm.

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