In India, obtaining a valid Drug License from the State Authorities (Drugs Control Department) is mandatory for individuals, corporate entities, and partnership firms. This requirement is governed by the Drugs and Cosmetics Act, 1940, and the Rules, 1945.
Basic Pre-requisites for a Drug License:
- Minimum Area: The office or shop must meet the minimum area requirements set by the licensing authority.
- Commercial Premises: The license must be granted for commercial or independent premises, separate from residential areas.
- Cooling Facilities: The premises should be equipped with a refrigerator or air conditioner, as needed.
- Compliance: The premises must adhere to the conditions specified in the license issued by the authority.
- Technical Staff: A registered pharmacist or a qualified individual with relevant experience, approved by the Drug Control Department, must be present at the business premises.
Documents Required:
- Proof of the premises’ address (commercial property documents)
- Details of the technical staff (pharmacist registration or qualifications)
- Evidence of cooling facilities (refrigerator/air conditioner)
- Any other documents required by the State Drugs Control Department
Conditions for Obtaining a Drug License in India
- Minimum Area & Height of Premises:
- A minimum area of 10 square meters is required for starting a medical shop, pharmacy, or wholesale outlet. For combined retail and wholesale operations, the minimum area is 15 square meters. The clear height of the premises must comply with the National Building Code of India, 2005.
- Storage Facility:
- The premises must have appropriate storage facilities, including a refrigerator and air conditioner. Certain drugs, such as vaccines and insulin injections, require refrigeration as per labeling specifications.
- Pharmacist/Competent Technical Staff:
- Manufacturing: A drug manufacturing unit must have technical staff for both manufacturing and testing.
- Wholesale: A registered pharmacist or a competent person with a degree and one year of experience, or an SSL.C pass with four years of experience, must be present.
- Retail: A registered pharmacist approved by the Drug Control Department must be present during all working hours.
- Commercial Premises:
- Drug licenses can only be granted for commercial premises or those independent of residential areas. State drug offices provide specific guidance on this.
- Location-Based License:
- Separate licenses are required for each location where drugs are sold or stocked. Manufacturers also need separate licenses for different locations, even for the same or different drugs.
- License for Each State:
- If a business operates in multiple states, it must obtain a drug license in each state. The license is specific to each location within the state.
- Importer of Drugs or Cosmetics:
- To import drugs or cosmetics, especially those listed under Schedule X, a license must be obtained. This ensures compliance with safety, effectiveness, and quality standards as mandated by the Drugs and Cosmetics Act.
Documents Required for Drug License in India
- Firm’s Constitution:
- For Companies: Memorandum of Association (MOA) and Articles of Association (AOA).
- For Firms/LLPs: Partnership Deed or LLP Agreement.
- Affidavit:
- For Retail & Wholesale licenses: Affidavit from the registered pharmacist or competent person.
- Property Documents:
- Owned Property: Registry Deed/Lease Deed/Power of Attorney (POA).
- Rented Property: Copy of Rent Agreement.
- Company Documents:
- Board Resolution, List of Directors, Certificate of Incorporation.
- Premises Plans:
- Key plan and site plan of the premises (Blueprint).
- Equipment Purchase Proof:
- Invoice copy for refrigerator/air conditioner used in the premises.
- Covering Letter:
- Stating the purpose of the application.
- ID Proof:
- ID proof of Directors/Partners/Proprietor.
- For Manufacturing:
- Affidavit from employer and/or technical staff confirming full-time employment.
- List of Technical Staff including proof of education qualifications, experience certificates, biodata, appointment letters, and three photographs.
- For Retail License:
- Registered Pharmacist’s degree certificate, registration certificate with the State Pharmacy Council, appointment letter, and biodata.
- For Wholesale License:
- Competent person’s degree certificate, experience certificate in medicine, appointment letter, and biodata.
- For Manufacturer:
- Affidavit of Non-Conviction, List of Equipment and Machinery for manufacturing, and List of Equipment provided for testing.
Drug License Registration Process in India: Step-by-Step
- Obtain Login ID and Password:
- Request: Visit the concerned authority and submit a request letter with details of your firm to obtain a user ID and password.
- Complete Online Application:
- Fill Out Form: Accurately enter all required information in the online application form.
- Submit: Ensure that all details are correct before submission. Incomplete applications will result in forfeiture of the fees.
- Upload Documents:
- Scan Documents: Scan all required documents at 100 dpi in black and white.
- Upload: Use your login credentials to upload the scanned documents in the designated section of the online portal.
- Undergo Physical Inspection:
- Prepare: Have all original documents ready for inspection.
- Inspection: Present these documents to the inspector, who may request additional documents relevant to your application.
- Receive Approval or Rejection:
- Notification: After processing, you will receive an SMS about the approval or rejection of your application.
- Print License: For approved applications, print the license or approval from the portal within 3 days using the “Print License” option for new and renewal licenses, or “MISC Approvals” for other types of approvals.
- Handle Change in Constitution:
- Update: If there are changes in the proprietor or partners, it is considered a change in constitution, and a fresh license application will be required.
- Obtain Separate Password for Pharmacists:
- Update Details: Registered pharmacists must also update their details by obtaining a separate password.