Drug License in Assam
Drug License in Assam
India holds a place of remarkable distinction in the realms of drug business. The country is reported to be the world’s largest provider of generic drugs. In addition to it, the Indian pharmaceutical sector caters to more than 50% of the global demand for various vaccines. A business of such magnitude and significance needs to be operated with proper guidelines and structure, substantiating the need for a regulation. In India, the provisions pertaining to drug control and administration is provided for in the Drugs and Cosmetics Act of India, 1940 among other pertinent State and Central regulations. This article seeks to explore the facets connected with drug license in Assam.
Emphasizing the Need
The Drugs and Establishment Act of 1940 establishes that no drug business can be operated in India without obtaining a license for this purpose. These regulations are applicable to allopathic, homeopathic, ayurvedic or unani drugs.
The manufacturers or sellers of a drug will be held accountable for any harm caused by its consumption or utilization. This proves that unregistered or illegal conduct of trade is detrimental not only to the health and welfare of the citizens (which holds more importance than the latter) but also to the life of the business as the law-books doesn’t include any lenient provisions for these defaults.
Administration of Drug in India
The administration of drugs in the country is vested with both the State and Central administration. The Central Drugs Control Organization (CDSCO) administers the control mechanisms throughout India. In the State of Assam, it is being handled by the State Drugs Control Administration in coordination with the former entity.
Appointment of Pharmacist
The regulations concerning recruitment state that the medicines in a registered retail outlet must be handled by a qualified pharmacist; whereas a wholesale drug store requires a graduate with one year of experience or undergraduate with four years of experience.
Layout Specifications
A pharmacy business, which is a wholesale or retail one, must be undertaken in a premise which has a carpet area of at least 10 square meters. A retail and wholesale pharmacy requires an area of 15 square meters.
Storage Facilities
The medicines to be traded must be maintained at a clean, ventilated and cool storage facility, given that a few of them require low-temperature freezing zone for its sustenance. This makes the facility of a refrigerator and air-conditioner a must for obtaining licenses in India.
Documents Required
Following are the list of documents required for the procurement of licenses prior to the establishment of the business:
For Selling, Storing, or Exhibiting Drugs (wholesale)
- Treasury Challan of Rs. 3,000.
- Appointment and joining letter of the recruited pharmacist with two passport size photographs.
- No Objection Certificate (NOC) for the Stockiest ship with valid GMP certificate of a modern medicine manufacturing unit.
- Certificate of educational qualification.
- Proof of availability of cold storage facility.
- A sketch of the layout.
- Proof of ownership of the premises or tenancy agreement.
- Proof of the constitution of the firm.
- Proof of address of the applicant.
- Proof of identity of the applicant.
- Memorandum or Articles of Association (if applicable).
The applicant or person-in-charge of such premises should be a registered pharmacist or someone who is experienced in dealing with drugs for four years in case of matriculation or equivalent examination or one year of experience with the trade of wholesale drugs in case of a degree-holder. The degree so obtained by the person must be from a recognized university.
For Selling, Storing, or Exhibiting Drugs (retail)
- Treasury Challan of Rs. 3000.
- Registration or renewal certificate of the registered pharmacist, as prescribed under section 32(2) of Assam Pharmacy Council.
- Appointment/joining letter of the pharmacist.
- Consent letter of the pharmacist with two copies of the passport size photograph.
- Court affidavit of the registered pharmacist and the applicant,
- Certificate of educational qualification of the applicant and the person-in-charge.
- Proof of availability of cold storage facility.
- Approved premises of the layout.
- Proof of ownership of the premises or tenancy agreement.
- Proof of the constitution of the firm.
- Proof of residential address.
- Proof of identity of the applicant.
For Selling, Storing, or Exhibiting Drugs Specified in Schedule X (Wholesaler)
- Treasury Challan of Rs. 500.
- Appointment and joining letter of the recruited pharmacist with two passport size photographs.
- No Objection Certificate (NOC) for the Stockiest ship with valid GMP certificate of a modern medicine manufacturing unit.
- Certificate of educational qualification.
- Proof of availability of cold storage facility.
- A sketch of the layout.
- Proof of ownership of the premises or tenancy agreement.
- Proof of the constitution of the firm.
- Proof of address of the applicant.
- Proof of identity of the applicant and the person-in-charge.
- Memorandum/Articles of Association (if applicable).
The applicant or person-in-charge of such premises should be a registered pharmacist or someone who is experienced in dealing with drugs for four years in case of matriculation or equivalent examination or one year of experience with the trade of wholesale drugs in case of a degree-holder. The degree must be obtained from a recognized university.
For Selling, Storing, or Exhibiting Drugs Specified in Schedule X (Retailer)
- Treasury Challan of Rs. 500.
- Registration or renewal certificate of the registered pharmacist, as prescribed under section 32(2) of Assam Pharmacy Council.
- Appointment/joining letter of the pharmacist.
- Consent letter of the pharmacist with two copies of the passport size photograph.
- Court affidavit of the registered pharmacist and the applicant.
- Certificate of educational qualification of the applicant and the person-in-charge.
- Proof of availability of cold storage facility.
- Approved premises of the layout.
- Proof of ownership of the premises or tenancy agreement.
- Proof of the constitution of the firm.
- Proof of residential address.
- Proof of identity of the applicant.
For Selling, Storing, or Exhibiting Drugs (Wholesale)
- Treasury Challan of Rs. 500
- Registration Certificate of the vehicle.
- Driving license of the driver.
- Proof of installation of cold storage facility.
- Experience Certificate of the pharmacist (whose requirements are that of every wholesale pharmacist).
- Certificate of the stockiest with a valid GMP certificate.
- Approved layout premises.
- Proof of ownership of the premises or tenancy agreement. with the proof of the owner.
- Proof of address of the applicant.
- Proof of identity of the applicant.
- Memorandum and Article of Association (if applicable).
For Selling, Storing, or Exhibiting Drugs Homeopathic Medicines (Wholesaler)
- Treasury Challan of Rs. 260.
- No Objection Certificate (NOC) for the Stockiest ship with valid GMP certificate of a homeopathic medicine unit.
- Certificate of educational qualification of the applicant or the person-in-charge.
- Approved layout premises.
- Proof of ownership of the premises or tenancy agreement.
- Proof of the constitution of the firm.
- Proof of address of the applicant.
- Proof of identity of the applicant.
- Memorandum or Articles of Association (if applicable).
The applicant, as well as the person appointed for the trading duties, should possess any of the qualifications specified below:
- He/she must be a registered homeopathic practitioner.
- He/she must have an experience of four years in dealing with Homeopathic medicines after passing a matriculation or equivalent examination.
- He/she must be experienced in the trade of homeopathic medicines for a period of one year after holding a degree in a recognized university.
License to Sell, Stock or Exhibit Homeopathic Medicines (Retailer)
- Treasury Challan of Rs. 260.
- Certificate of educational qualification of the applicant or the person-in-charge.
- Approved layout premises.
- Proof of ownership of the premises or tenancy agreement.
- Proof of the constitution of the firm.
- Proof of address and photo identity of the applicant and the person-in-charge.
- Proof of identity of the applicant.
- Memorandum or Articles of Association (if applicable).
The applicant applying for this license must be a registered Homeopathic practitioner.
Location Specific Registration
A business which has extended its portfolio to more than two states is mandated to avail registration for each of its state of operation. This is because the regulations pertaining to these licenses may have subtle differences among the states.
How to Apply?
The Department has listed out a gamut of licenses which can be applied for. Here, we intend to cover the application for the most basic form of license, i.e., the license to sell and distribute drugs. The rest of the procedures are more or less similar in nature with subtle differences.
Step 1: Login to the Portal
Login to the portal of the State Drugs Control Administration, which administers the provisions connected with licenses in the State.
Step 2: Choose the Department
Choose the department, which in this case would be the Department of Health and Family Welfare.
Step 3: Choose the Form
Select the most relevant form among the options listed out. The application to obtain a license for sale and distribution of drugs must be filled in Form 31.
Step 4: Make an Application
Specify all the mandatory details in the application form.
Step 5: Upload Documents
Upload the scanned copy of the documents in PDF format.
Step 6: Payment and Submission
Remit the required payments and submit the online form, after which the applicant will receive a Unique Application Identification Number (UAIN). The UAIN will act as the user ID of the person for future correspondence.
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