In India, every business must hold a specific license for its operations. The Drug License is a legal authorization from the Government, necessary for businesses dealing with drugs and cosmetics. It is region and location-specific, requiring distinct licenses for operations spanning multiple states or locations. The Drug License encompasses permissions for both drug manufacturing and sales.
A Drug license in India is a compulsory legal requirement for the business who engaged in manufacturing, selling and distributing the drugs in India. Basically, this license is issued by the CDSCO (Central Drug Standard Control Organizations) or state-level authority. This license is not only a license to run a business but essential to ensure quality and safety of pharmaceutical goods. In addition to protecting consumers from harmful or substandard products, the license ensures that drugs sold or manufactured meet legal safety and quality standards. A business can’t legally operate pharmaceutical space without having a valid drug license in India.
What is a Drug License?
Drug License is a legal document granted by the regulatory authority such as CDSCO (Central Drugs Standard Control Organization or state-level authority. Any individual or business wants to manufacture, sell, distribute or import drugs or any pharmaceutical goods mandatory to obtain a drug license in Tamil Nadu. This license determines that the businesses who involve in the pharma industry comply with laws, intend to safeguard public health by assuring that drugs are manufactured, stored and sold as per the specific quality and safety standards.
Purpose of Drug License
- Ensure the quality, safety, and efficacy of drugs manufactured, sold, or distributed in India.
- Prevent the sale of spurious, adulterated, or misbranded drugs that could harm public health.
Regulate the manufacturing, import, export, sale, and distribution of drugs to maintain a safe and ethical pharmaceutical market.
Types of Drug License
There are three types of Drug License, as follow:
- Drug Manufacturing License: This drug license is required for production of pharmaceutical drugs and medicine.
- Wholesale Drug License: For wholesale distribution of pharmaceutical products, wholesale drug license is required.
- Retail Drug License: If someone wants to open or run a chemist shop, they have to obtain a retail drug license.
Documents Required
- Covering letter to the Assistant Director of Drugs Control of the Concerned zone
- Form 19
- Authorization document signed by the authorized signatory
- Declaration form duly signed and filled by the applicant, pharmacist or the competent person.
- Details of premises
- Ownership document of the premises
- Rental agreement of the premises, if applicable
- Plan of the premises signed by the licensed surveyors and the applicant.
- Pharmacist/ competent person’s details
- Pharmacy council registration certificate
- Education qualification certificate
- Experience certificate of the competent person
- Declaration of pharmacist/ competent person
- Applicant details:
- Document relating to the constitution of concerned firm/ Company/ LLP and others.
- If proprietor, a passport size photo , in case Partnership/ LLP- group photo (the file should not exceed 50 KB of size)
- Applicant ID/ address proof
- Legal tenancy affidavit
- Details of Storage Accommodation:
- In case of a change in premises or change in the constitution, enclose the following.
- Original license
- Documents related to change in the constitution like sale deed, reconstitution/dissolution deed,
- Amalgamation court along with board resolution and any other document order if it is a Company.
- Request to cancel the old license of the premises
- If the existing license has obtained through online, then the change of premises/ change in the constitution should be applied through e-Sevai centre only.
- If the license was issued before the launch of the online process then the application should be submitted manually in the concerned zone.
- Purchase bills of A/C and refrigerator along with Working condition/Installation Certificate
- Any other document or particulars to verify the correctness of the particulars submitted by the applicant if required.
Eligibility for obtaining drug license in Tamil Nadu
Premises Requirements:
- Area – Minimum 10 square meters to start a medical shop or pharmacy. For pharmacy businesses who retails and wholesale both require a minimum 15 Square meter.
- Storage Facilities – should have refrigerator, air condition and other requirements if necessary.
Educational Requirements:
- For Retail Drug License – It should be a registered pharmacist or an individual with pharmacy degree must be employed.
- For Wholesale Drug License – The applicant should be registered pharmacist or have a competent person with the necessary qualifications and experience.
Legal Age:
The drug license applicant must be at least 21 years and plus old.
Process for Drug License in Tamil Nadu
Step 1: Create an Account on Government Portal
At the initial stage, you have to create an account on the government portal as per your state, visit its state drug control website or the national portal.
Step 2: Submit Application
Gather all the relevant documents (complete list given above) and enter details such as business type, personal and business details and upload other relevant documents. These documents must be appropriate and accurate, if there are any discrepancies, it can lead to rejections.
Step 3: Pay Applicable Fees
Pay application fee online by the government payment gateway system.
Step 4: Premises Inspection
Once above mentioned stages have been cleared, an inspection will be held where the drug inspector will inspect and examine the premises to assure the compliances with safety and storage requirements are fulfilled or not.
Step 5: Licensing Decision
If you cleared all the criteria and there are no discrepancies in premises the drug licensing authority will grant the license within a stipulated time.
FAQs
Drug License Renewal in Tamil Nadu?
A drug license in Tamil Nadu is typically valid for five years, after which it must be renewed. Renewal requires an updated submission of documents and payment of renewal fees, similar to the initial application process. Renewal should be applied for before the expiration date to avoid penalties.
Regulatory Authority for Issuing a Drug License?
- Central Licensing Authority (CLA): – Issues licenses for manufacturing of certain categories of drugs, such as: – Allopathic drugs (excluding those specified for SLA) – Blood banks – Large volume parenterals – Vaccines – Sera – Antitoxins – Operates under the Central Drugs Standard Control Organization (CDSCO).
- State Licensing Authority (SLA): – Issues licenses for: – Manufacturing of drugs not covered by CLA – Sales (wholesale and retail) – Import – Export – Functions at the state level, with the State Drug Controller as the head.
- Licensing Authority under Drugs and Cosmetics Act, 1940: – An officer appointed by the Central or State Government to exercise powers under the Act.
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