Introduction
Drug Licensing is an integral way to maintain the flow of drugs in the industry. The government introduced this license with the intent to ensure that everyone has equal and fair access to medicines and drugs at a reasonable cost. It is used to determine the kind of drugs that exist in the market and it ensures that these drugs are being used only for the purposes that are for the welfare of society such as medicinal purposes.
In India, The Acts & Rules that govern the Drug Licensing are:
Drugs and Cosmetics Act, 1940 and provisions formed under it-
• Drug Price Control Order,2013
• Narcotic Drugs and Psychotropic Substances Act,1985
• Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954
Drug License in Kerala
A drug license in Kerala is used to sell stock and contain the medicines in the state. It maintains the manufacturing and circulation of medicines in the market.
Different categories of Drug Licenses in India
To sell medicines in India, a businessman engaged in pharmaceuticals may apply for a license under the following categories as per their need.
1. Manufacturing License– This license is issued if a party intends to engage in the manufacturing of Drugs.
2. Sale License– This license is issued if a party intends to engage in the sale of drugs. This license is subdivided into two categories –
• Wholesale Drug License
• Retail Drug License
Fees for Drug Licenses in Kerala
Licence fee and an online payment receipt of Rs. 3000
Cover letter with a court fee stamp worth Rs.5/-
This payment can be done through the online portal or an e – e-treasury.
How to submit a Kerala Drug License Application?
1. Get the application form. The forms that fall under the prescribed category are 19, 19A, 19B, and 19AA.
2. Attach the required documents.
3. The concerned authority will inspect the premises.
4. After meeting all the requirements, the applicant can collect the license from the concerned authority
This process approximately takes 28 days to complete.
Drug License Renewal and Validity
In general parlance, a drug license is valid for 05 years subject to compliance with the fixed norms.
A drug license can be revoked subject to the failure of the organisation’s compliance with regulations.
To renew a drug license, the interested party has to make an application under Form 19 B.
Documents Required for a Drug License in Kerala
For a Retail license
1. Application in Form 19/19A/19B/19C
2. Licence fee with an online payment receipt of Rs. 3000/
3. Proof of ownership of premises
4. Pharmacist registration certificate
5. Declaration of the Pharmacist
6. Option request
7. Affidavit in prescribed form
8. Attested copies of documents of the constitution
9. Cover letter with a court fee stamp worth Rs.5/-
10. Proof of identity of the applicant, photograph & Questionnaire
11. In the case of an application made in form 19AA the attested copy of the RC book of the vehicle is to be provided along with the application
12. In the case of application in form 19A, questionnaire, Chalan, affidavit and attested copies of documents, proof of identity etc. are to be provided
For a Wholesale License
1. Application in Form under 19/19B/19C
2. Licence fee with the online payment receipt of Rs. 3000/-
3. Proof of ownership of premises
4. Copy of SSLC/Degree Certificate or pharmacy Registration Certificate
5. Declaration By the Applicant
6. Declaration regarding the maintenance of Cold Chain and supporting documents, if drugs requiring cold storage are intended to be stocked/distributed
7. Affidavit in prescribed format
8. Attested copies of documents of the constitution of the proposed firm
9. Cover letter with a court fee stamp worth Rs.5/-
10. Proof of identity of the applicant, photograph of the applicant & questionnaire
Procedure for obtaining a Drug License in Kerala
1. Register via XLN software to obtain an ID and password. Keep this ID and password handy for future use.
2. The next step involves uploading the required documents into the software
3. After the successful uploading of documents, you can apply E- -submission.
4. After that the process of Inspection occurs, during which you are required to submit the Hard copy of the entire application to the Drugs Inspector.
5. Verification of the documents is done by the concerned Drugs Inspector
6. A Pre-licensing inspection is done by the Concerned Drugs Inspector
7. The process is concluded by the issuance of a drug licence by the Assistant Drugs Controller.
Conclusion
A drug license is used to ensure that only solicited drugs are on the market and people have access to medicines at reasonable costs. There is no black marketing or illicit practice involved in the chain of circulation of medicines.
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