Every citizen in India has the right to obtain medications and pharmaceuticals for their physical and mental health. However, to ensure the safe distribution and sale of drugs, it is mandatory to obtain a drug license. This article aims to provide a comprehensive guide on drug licenses in India, covering the importance of a drug license, different types of licenses, requirements for obtaining a drug license, the regulatory authority, the application process, and also the necessary documents.
Importance of a Drug License:
The primary purpose of a drug license is to prevent the misuse of drugs. Irregular dosage, improper knowledge about their proper application or intake, or addiction can lead to serious consequences. By obtaining a drug license, pharmacists, retailers, and also wholesalers are authorized to sell and deal with medicines in a responsible manner. Any individual or business involved in drug-related activities without a drug license is liable for imprisonment and/or fines.
Types of Drug Licenses:
Manufacturing License:
This license is granted to businesses involved in manufacturing drugs of any kind, including homoeopathic and also ayurvedic medicines.
Sale License:
This license is issued to individuals or stores engaged in selling drugs. It can be further categorized into:
Wholesale License:
This license is provided to drug wholesalers who sell drugs on a large scale to drug retailers.
Retail License:
This license is issued to drug retailers who directly sell drugs to customers, including standalone customers, dispensaries, hospitals, medical colleges, and also research institutes.
Loan License:
This license is granted to companies that utilize the manufacturing unit of another licensed drug manufacturer.
Import License:
This license is issued to dealers involved in importing drugs or raw materials required for drug manufacturing.
Multi-Drug License:
This license is meant for businesses that own pharmaceutical units with the same name operating in multiple states.
Requirements for Obtaining a Drug License:
To obtain a drug license for a medical store in India, certain requirements must be fulfilled:
Pharmacist:
A drug license is issued only to a registered pharmacist. The pharmacist should possess knowledge about the retail business. For a wholesale business, a graduate with at least one year of experience or an undergraduate with four years of relevant experience can apply.
Premises:
A retail medical store must have a minimum area of 10 square meters, while a wholesale medical store should have a minimum area of 15 square meters.
Storage:
Proper storage facilities, including cold storage and refrigerators, must be available in the medical store or manufacturing unit. Medicines that do not require refrigeration should be also stored safely without exposure to sunlight.
Staff:
Hiring experienced personnel with knowledge of handling patients and sick individuals is crucial for a medical store. A graduate with at least one year of experience or an undergraduate with at least four years of experience is preferred.
It’s important to note that a medical store license is region-specific, meaning a license obtained in one state is also only valid for that particular state. The business cannot operate in a different state without obtaining a separate license.
Regulatory Authority for Issuing a Drug License:
The issuance of drug licenses in India is governed by various drug controlling authorities as per the Drugs and Cosmetics Act, 1940. The key authorities include:
State Drugs Standard Control Organisation (SDSCO):
This organization is responsible for issuing licenses related to the manufacture, distribution, and also sale of drugs within the respective state.
Central Drugs Standard Control Organisation (CDSCO):
CDSCO issues licenses for newly manufactured medicines, cosmetics, and clinical trials. It also monitors the quality of imported drugs and collaborates with SDSCO for seamless drug distribution and sales.
State drug enforcement agency and central licence approval agency:
These authorities work together to issue licenses for blood banks and related products such as vaccines and serums.
AYUSH Department:
Dealers selling ayurveda, Unani, Siddha, and homoeopathic medicines and also cosmetics must get licences from AYUSH.
Application Process for a Drug License:
To apply for a drug license, the following steps must be followed:
Visit the Concerned Authority:
Identify the respective drug controlling authority based on the type of pharmaceutical unit you intend to establish. Visit their website or office to initiate the application process, which is also usually done online.
Fill out the Application Form:
Provide accurate details as required in the application form.
Upload Relevant Documents:
Prepare and upload the necessary documents along with the completed application form. Ensure all documents are valid and also up to date.
Inspection by Drug Inspector:
After submitting the application, a drug inspector will visit your premises within 15 days to inspect your setup, storage facilities, staff, and documents.
Grant of License:
Upon successful inspection and verification, you will receive your drug license from the concerned authority.
Documents Required for Obtaining a Drug License:
The following documents are typically required when applying for a drug license:
- Identity proof of proprietor/partner/co-founder/director, etc.
- Address proof of the applicant and other members.
- Educational qualification of the applicant.
- Declaration form.
- Establishment’s constitution documents, such as Memorandum of Association (MOA), Articles of Association (AOA), partnership deed, LLP agreement, etc.
- Ownership or rental agreement for the premises, along with a No Objection Certificate (NOC) from the landlord if applicable.
- Site plan of the premises.
- Proof of availability of storage space.
- Copy of board resolution allowing you to obtain a drug license.
- Copy of fee challan.
- Affidavit from a registered pharmacist.
- Cover letter mentioning the name and designation of the applicant.
- Declaration of the owner, partner, or director’s innocence under the 1940 Drugs and Cosmetics Act.
Additional documents may be required based on whether the license is for a retail or wholesale medical outlet, including qualification certificates, experience certificates, and appointment letters.
Conclusion:
Obtaining a drug license in India is a crucial requirement for anyone involved in the pharmaceutical industry. By following the necessary procedures and fulfilling the prescribed requirements, individuals and businesses can ensure the legal operation of their medical stores, manufacturing units, or distribution centers. It is also essential to adhere to the regulations set forth by the drug controlling authorities and maintain compliance throughout the license validity period. With a valid drug license, you can also proceed confidently with your pharmaceutical business endeavors and contribute to the healthcare ecosystem in India.
Frequently Asked Questions:
01.Can I sell cosmetic products with a drug license?
Yes, by obtaining the appropriate drug license, you can also legally sell cosmetic products.
02. I require a drug license for a franchise medical store?
Yes, every medical enterprise, including franchise stores, requires a drug license. Additionally, you will need state-regulated drug licenses along with the owner’s license.
03.I run a medical store in Mumbai. Can I open one in Chennai too?
Before opening a store in Chennai, you need to obtain a multi-drug license and a state-regulated license from Tamil Nadu to operate legally.
04.How long is a drug license valid?
A drug license is typically valid for five years unless revoked or suspended by the drug controlling authority. It can also be renewed online by filling out the appropriate application form.