A nation’s ability to get medicines and treatments is important to keeping its general health. To make sure that people don’t abuse or misuse these things, access to drugs and medicines must be managed. As a result, the Indian government has created strict laws and rules connected to the creation and sale of drugs. The 1940 Drugs and Cosmetics Act and the regulations made under it include laws related to the production and sale of drugs.
From the moment a drug is used as a raw material throughout production, sale, and distribution until a chemist in a retail pharmacy, hospital, or clinic moves it to a patient or customer, control is kept over the substance. The Drugs and Cosmetics Act of 1940 was amended in 1964 to cover Ayurvedic and Unani medicines. However, depending on their line of work, a particular company organisation may need a different kind of drug licence. This article examines the types of Drug Licenses in India.
What is a Drug License?
A drug license is an authorization provided by regulatory agencies, such as the Central Drugs Standard Control Organization and the State Directorate of Drugs Control in India, enabling individuals or enterprises to participate in activities related to pharmaceuticals and cosmetics. It is required by law for any drugstore or business dealing with drugs.
Types of Drug License
A drug licence is the permission given by the Drug Controller to deal in drugs. Categories of the Licence depend upon the type of business as follows.
1. Sales Drug Licence
- Retail Sale Drug Licence:
The end customer is the one who buys drugs through retail sales. Drug stores can sell medications to various locations, including hospitals, clinics, educational institutions, and study groups. The Drugs and Cosmetics Act states that individuals who sell drugs need to have a drug licence. The Drug Controller Authority of the concerned State grants a store pass. In case any person sells drugs without a Licence, he shall be punished with jail for a term of not less than one year, and it may extend up to 3 years with a fine up to Rs. 5000.
Note: If a store is interested in the drug business in more than one state, a different license is required for each state.
- Wholesale Drug Licence:
A trade pass is given to the company, distributor, or an independent agent who can be an authorized agent for the local or foreign producer. Or we can say that the sales licence is given to the producer and the approved Indian agent. A wholesale Drug Licence is granted by the CDSCO for those who deal in the mass selling of Drugs.
- Restricted Licence for Drugs:
Under Form 20A and 21A, this pass is given to those individuals who want to sell drugs without the guidance of a responsible person.
2. Manufacturing Licence for Drug
A manufacturing licence is granted to manufacturers of Allopathic and Ayurvedic medicines and beauty products by the state government.
- Test Licence – Form -29: This licence is given by the Zonal Office and the State licensing body for testing. Testing and analysis of drugs in small quantities are also provided for the purchase of small amounts of drugs for evaluation, testing, and analysis.
- Post successful clinical trial licence – Form -46, Licence allowed to manufacture for sale of medical products which are new in the market, and a clinical trial has not been done.
- Notified medical products production licence – Form -28, Form – 27. This Licence is granted to the maker of disposable injectable syringes and needles, heart stents, catheters, IVD Devices for HIV, HCV, etc.
3. Loan Drug Licence
According to the Drug and Cosmetic Act, a loan drug license is a license that an authorized body may grant to an applicant who doesn’t have their own manufacturing system but wishes to utilize the manufacturing facilities of a licensee.
4. Import Licence
Under Schedule 10, Drugs & Cosmetics can be brought to India only after getting a Licence. Not only are drugs recorded, but the production unit should also be registered for import reasons.
5. Multi-licence for Drug
This License is for individuals who operate their business in more than one state. Without a multidrug permit, you cannot sell drugs in more than one state.
What is the process for getting a Drug License in India?
- Signing up on the Website: First, individuals need to visit their local state drug licensing body’s website and register by completing the registration form. After that, the candidate has to fill in their information, company details, and contact details to create an OTP.
- Uploading documents: After completing the form, the candidate must share the required documents.
- Payment of Fees: After posting all the papers, the due fees of the form should be submitted, and a challan generated for further processing.
- Securitization of Documents: After submitting the form, the licensing body will review it, and the DCO (District Coordination Officer) of the district will verify the organization to ensure it meets all the requirements. After the proof and inspection of documents, the officer will forward the report to the SDCO of the zone for issuing the License.
- Issuing Drug License: The report of SDCO will be given to the respective State’s Drug License Authority, and if the authority sees no error in the report, then it will issue a Drug License to that person. Generally, it takes 30 days or more for the issue of a Drug license in India, provided the application meets all the requirements.
Key Requirements for Obtaining a Drug License
The key requirements for getting a Drug License in India are as follows:
- Premise Area: Any person who desires to set up a Medical Store or a retail pharmacy must have an area of more than 10 square meters. A more short and straightforward way to write the text is: “For a Retail Cum Wholesale Drug Business, the minimum space requirement is 15 sq mtrs.”
- Storage Facility: An individual must ensure that the location is equipped with proper storage facilities, such as a refrigerator and a cold storage facility, to store drugs.
- Technical and Storage Staff: A Retail Pharmacy Store must have an expert and technical team with complete information regarding their roles and responsibilities. Furthermore, a pharmacist must be qualified to obtain a Drug License. However, it should be noted that for a Wholesale Drug License, the selected staff member must be a graduate with at least 1 year of experience or a student with at least 4 years of experience.
- Inspection of the Premises: Prior to the issue of a Drug License, a Drug Inspector, who has the power, has the right to visit the location for inspection. Further, he shall have the power to check the information provided, measure the premises, and question the capable person.
Documents You Need to Apply for a License
The papers necessary for getting a selling license are:
- The following documents are required, depending on the kind of business organization: an LLP deal for a Limited Liability Partnership (LLP); a partnership contract for a partnership; and a company’s constitution, memorandum of association, and articles of association.
- ID evidence of partner/director/proprietor.
- Papers connected to premises – Copy of ownership papers of property or rental agreement and No Objection Certificate from the owner of the leased premises, as the case may be.
- Site plan of the property.
- Copy of Board resolution authorizing the acquisition of a license.
- Evidence of having enough space for storing items that require cooling, such as a freezer or a fridge.
- A copy of the challan is used as evidence of the depositing fee.
- A stamp statement about the lack of criminal records of the owner/partner/director and the company.
- The affidavit from the registered pharmacist or competent person.
- A cover letter with the name and designation of the applicant
- Applicant’s qualification certificate
For a pharmacist during a retail sale:
- Proof of qualification
- Registration of the local pharmacy council
- Appointment letter
- For a pharmacist at a wholesale sale:
- Proof of qualification
- Experience certificate
- Appointment letter
Conclusion
In conclusion, understanding the different types of drug licenses in India is essential for companies in the pharmaceutical industry. Recapitulating key points, these licenses include Manufacturing, Wholesale, and Retail Drug Licenses, each having specific roles within the business. When filing for a drug license, critical aspects to consider include possessing the necessary educational qualifications as specified in the Drugs and Cosmetics Act of 1940, ensuring ideal locations with suitable cooling facilities, and having a competent staff with relevant experience. Compliance with laws, proper filing of paperwork, and attention to location-specific requirements are essential for a successful drug license application process.
