Ensuring everyone having fair access to medicine & drug is the fundamental concern of the Indian government. However, the right to sell & manufacture the drugs has to be given with extreme caution. Producing drugs in India is not an easy task since it is subjected to stringent rules and regulations. The Act that governs the manufacturing and selling of the drug in India is the Drugs and Cosmetics Act, 1940. In this write-up, we will unveil the Registration Process to Obtain Drug License.
Categories of Drug license in India
In the view of the definition of “Drug” given under the act, the pharmaceutical companies in the country would require to avail of the following licenses:-
Such Licenses are essentially issued to the entities involved with the manufacturing of drugs, including allopathic/ homeopathy medicines.
License is issued to those entities who wish to engage with the business of drug selling. The sale license is further classified into the 3 categories
- Wholesale Drug License
- Retail Drug License
- Restricted Drugs
A loan license is issued to those entities which outsource the drug manufacturing services to another entity.
Import licenses serve those firms that intend to import certain categories of drugs and medicine from the overseas location.
A multi-drug license is mandated for those business establishments that own pharmacies in several states with the same name.
Prerequisites to be Considered for Availing Drug License
Applicant seeking Drug license must take the following parameter into the account before engaging with the Registration Process to Obtain Drug License.
Pharmacist/ Competent Individual
The pharmacist must carry sufficient qualifications in the case of a retail business. Meanwhile, in the case of a wholesale business, the applicant must be at least a graduate individual with in-hand experience of not less than one year. In case if the applicant is an undergraduate then he/she must have 4 years of experience in the same field.
Space is another crucial prerequisite that has to be taken into the account before applying for a drug license.
- For both retail & wholesale license- 15 meter square.
- In remaining cases- 10 meter square.
The height of the premises where the activities of drug selling is proposed to be conducted should be as per the National Building Code of India, 2005.
The storage facilities is another key parameter that ought to be considered since the majority of the drug is sensitive to a higher temperature and even get expired in case of prolonged exposure.
Application Related to Registration Process to Obtain Drug License
Below we have outlined a detailed guide to avail the drug license from the relevant authority:-
- The applicants must make an online application for the license given their line of business, for which they have a legitimate contact number and valid email ID.
- The next step is to determine whether the document related to the Drug license is updated or not.
- Next, upload the scan copy of the document and the form along with the requested fees.
- After completing the online process, an official will visit the premises (where the business is proposed to be conducted) for the verification of the documents.
- The authority would either accept or reject your candidature for drug license based on the verification of submitted documents and application.
Type of Documents to be Arranged for Obtaining Drug License
Documentation is a vital part of the Registration Process to Obtain Drug License. The applicant seeking a drug license must arrange the following documentation without exception:-
- Constitution of the establishment: – Articles of Association (AOA) and Memorandum of Association (MOA) in case if the entity is registered as a private limited or public limited entity. In case, if the establishment is a partnership-oriented firm or an LLP, then a partnership deed would be required.
- Identification proof of the Director/Partner/Proprietor.
- Documentation related to the establishments- Copy of the document representing the ownership of the property or rental agreement depending
- Documents related to premises – Copy of ownership documents of property or rental agreement depending on the circumstances.
- Detailed Floor plan of the establishments.
- Copy related to the board resolution for availing the drug license.
- A document highlighting the availability of storage space acting as cold storage, refrigerator for preserving the drugs in the controlled environment.
- Copy of challan acting as a proof of depositing fee.
- An affidavit showing the non-indulgence of the partner or director with the criminal activities.
- The affidavit from the competent individual/pharmacist for authenticating the candidature of the applicant.
For a Pharmacist Engaged in the Retail Sale
- Qualification proof
- Registration availed from the local pharmacy council
- Letter of appointment
For a pharmacist engaged in the Wholesale Sale
- Proof of qualification
- Experience certificate
- Appointment letter
Type of Application Forms for Drug license that Serve Different Purposes
|Application for the renewal or issuance of a license to sell out, procure, exhibit, or distribute drugs other than listed under Schedule X.
|Application for issuing or renewing a limited license to sell, procure, sale, or distribute drugs through a retail channel that doesn’t involve the service of a qualified individual.
|Application for license to sell, procure or sale, or distribute Homoeopathic-based Medicines.
|Application related to issuance or renewal of a [license to sell, procure, exhibit or offer for sale, or distribute] drugs mentioned in Schedule X.
|Application for either the issuance or renewal of a license or to manufacture or for distribution of drugs excluding those which are mentioned in [Schedule C, C (1) and X].
|Application for either the issuance or renewal of a loan license for manufacturing or distribution of drugs expects those mentioned in Schedule C, C (1), and X.
|Application related for issuance or renewal of a license serving the purpose of drug repacking for sale or distribution. It doesn’t cover the drug mentioned Schedule C and C (1)
|Application related to the issuance or renewal of a license serving the purpose of manufacturing or distribution of Homoeopathic medicines or a license to produce potentized preparations from the back potencies by licensees having a license in Form 20-C
|Application related to the issuance or renewal of a license which is required for manufacturing or distribution of drugs other than specified in Schedule C and C(1).
|Application for issuance or renewal of a license to manufacture for sale or distribution of drugs specified in Schedule C and C (1) except those mentioned in part XB and Schedule X
Drug License is imperative for establishments involved with the manufacturing, distribution, and procurement of the drug. The Registration Process to Obtain Drug License may seem plain and simple on the surface, but it is a lot more complicated in the real-world scenario.
The rejection rate of the drug license is relatively higher than any other license since it is associated with human life in one way or another. The issuance authority might cancel your request for a license even if it got a negligible disparity. Therefore, the individual must be spot on with the documentation work and meet the remaining prerequisite against the prescribed norms.
Read our article: Purchase of Drug Patents by the Pharmaceutical Companies in India