The drug licencing process can be difficult, particularly after the pandemic challenges. The stringent regulatory criteria established for granting a drug licence show the seriousness of the complexities associated with its acquisition. The vital regulatory framework overseeing the entire drug licencing lifecycle is the Drugs and Cosmetics Act of 1940. Additionally, it is essential to recognise that a drug licence is specific to a particular location. In this blog, we shall see the documents required for drug licence in India.
Types of Drug Licences
There are different types of drug licences in India, including:
1. Drug Manufacturing Licence
A drug manufacturing licence is issued to entities engaged in the production of pharmaceuticals.
2. Loan Licence
A ‘loan licence’ is a type of licence that the licencing authority may grant to an applicant lacking independent manufacturing facilities. The licencee intends to utilise the manufacturing facilities owned by another licencee, as specified in Form 32.
3. Multi Drug Licence
A multi-drug licence allows entities to manufacture multiple types of drugs under a single licence.
4. Drug Sales Licence
Drug sales licences are granted to entities involved in the distribution and sale of pharmaceutical products. This covers:
- Wholesale Licence
Wholesale licences are issued to businesses engaged in the bulk distribution of medicines.
- Retail Licence
Retail licences are granted to establishments involved in the direct sale of medicines to consumers.
- Restricted Licence (General Stores Selling Medicines)
Restricted licences are applicable to general stores that sell medicines, with specific limitations on their pharmaceutical offerings.
Purpose of Drug Licence
Before going into the documents required for drug licence, let us understand its purpose. Obtaining a drug licence is crucial for a range of entities within the pharmaceutical industry. The Drugs and Cosmetics Act of 1940 serves as the guiding legislation for the issuance of these licences. The primary objective behind the drug licence is to effectively regulate and control the access to medicines and drugs, curbing the potential for abuse or misuse by individuals.
1. Regulation of Drug-Related Businesses:
The drug licence serves as permission for enterprises or individuals to engage in activities related to drugs and cosmetics.
No entity or individual is allowed to operate a business dealing in drugs, medicines, or cosmetics without obtaining a valid drug licence in India.
2. Compliance with Legal Requirements:
Entities must obtain not only a drug licence but also a trade licence and a shop and establishment registration to conduct pharmaceutical business operations.
3. Comprehensive Oversight:
The government extends control to aspects such as the import and export of medicines, sale of drugs to minors, and consumption of schedule H & X drugs, necessitating thorough monitoring and cautious execution.
4. Authority and Granting Process:
The drug licence is granted by the drug controlling authority under the Drugs and Cosmetics Act, 1940, ensuring that businesses adhere to legal and quality standards in the pharmaceutical sector.
Requirements for Obtaining a Drug Licence
To acquire a drug licence, individuals must fulfil several basics alongside the documents required for drug licence. Due to the challenging approval process, especially for those pursuing retail sales licences, strict adherence to all requirements is vital.
1. Space Requirements
- The pharmacy or place of sale for a wholesale unit must meet the requirement of at least 10 square meters.
- If both wholesale and retail operations are conducted by a single unit, the premises must have a minimum area of 15 square meters.
- Adequate ventilation of the premises is essential.
- The height of the premises for drug sales must comply with the National Building Code of India, 2005.
2. Storage Facility for Drugs
- Adequate storage facilities, including refrigerators and air conditioners, must be in place to ensure the proper storage of medications requiring low temperatures. Examples include insulin doses, vaccines, etc.
3. Trained and Qualified Staff
- Before applying for a drug licence, it is mandatory to have competent and qualified personnel on board to manage the operations effectively.
Documents Required for Drug Licence
To apply for a drug licence, certain documents required for drug licence must be submitted along with the application. The fundamental prerequisites for obtaining a drug licence include suitable premises, cooling facilities, and qualified personnel. The primary document required is a completed Form 19, which seeks approval for the sale, stock, exhibition, or distribution of drugs, excluding those listed in Schedule X. The documents required for drug licence in India are:
1. Forms for Specific Situations:
- Form 19: Required for approval to sell, stock, exhibit, or distribute drugs (excluding Schedule X drugs).
- Form 19A: Necessary for dealers intending to sell drugs in a retail setting without the assistance of a qualified individual.
- Form 19B: Required for those stocking, selling, or distributing homeopathic medicines.
- Form 19C: Essential for those intending to sell Schedule X drugs.
2. Additional Documents Required for Drug Licence:
- Challan of Rs. 3,000.
- Affidavit of the proprietor on Rs. 20 stamp paper.
- Self-attested copies of the education certificate and identity proof of the proprietor.
- Affidavit of a registered pharmacist or competent person.
- Self-attested copies of the education certificate and identity proof of the registered pharmacist or competent person.
- Experience certificate of the competent person.
- Blueprint of a plan layout of the proposed premises.
- Electricity bill of the proposed premises.
- Copy of the refrigerator bill.
- Either a rent agreement or ownership document of the premises.
- Covering letter.
- Five photos each of the proprietor and either the registered pharmacist or the competent person.
Final Thoughts
Obtaining a drug licence demands careful attention to the documents required for drug licence, ensuring compliance with regulatory standards. The key document, Form 19, serves as the primary application for approval to engage in various drug-related activities, with specific forms catering to different situations. Essential supplementary documents include a Rs. 3,000 challan, proprietor’s affidavit on a Rs. 20 stamp paper, educational and identity proofs, affidavits of registered pharmacists or competent persons, experience certificates, premises-related documents, and a comprehensive set of photographs. The stringent requirement of documents required for drug licence underscore the gravity of the pharmaceutical industry, emphasising the need for proper infrastructure, qualified personnel, and adherence to legal protocols. This exhaustive documentation process not only safeguards public health by ensuring the integrity of drug distribution but also reflects the regulatory commitment to maintaining high standards within the pharmaceutical sector.
