Overview of Drug licence in India

Obtaining a drug licence certificate is a significant step for businesses involved in the manufacturing or sale of drugs in India. This process brings a lot of advantages that contribute to the credibility, trustworthiness and growth of the business. Some of them are:

Ensuring Legal Compliance and Avoiding Penalties:

Having a valid drug licence certificate is mandatory to operate legally in the pharmaceutical industry. Engaging in the manufacturing or sale of drugs without the necessary licence is illegal and can lead to severe penalties, fines or even the closure of the business. By obtaining the required drug licence, businesses ensure legal conformity and safeguard themselves from legal repercussions.

Government Monitoring and Enhanced Credibility:

A drug licence certificate enables the government to monitor and regulate the sale of medicines in India. This close oversight establishes your business as credible and trustworthy, as it adheres to the strict guidelines set by the regulatory authorities. It raises trust among consumers and other stakeholders, ultimately benefiting the reputation and growth of the business.

Assurance of Stringent Quality Measures:

A drug licence certificate serves as evidence that your business follows stringent quality measures during the manufacturing process. This assurance is significant in gaining the confidence of consumers in the safety and efficacy of your drugs. It establishes your commitment to delivering high-quality products, which can lead to increased customer loyalty and repeat business.

Ensuring Consumer Safety and Health:

With a valid drug licence, customers can be assured that the medicines and drugs offered by your business are safe and pose no health hazards. This factor plays a pivotal role in consumers' decision-making process when selecting pharmaceutical products. The licence reinforces their trust in your brand and contributes to long-term customer satisfaction. 

Access to Government Tenders and Collaborations:

Having a drug licence certificate makes your business eligible to participate in government tenders and contracts. Many public healthcare programs and institutions require suppliers to possess a valid drug licence. Accessing government opportunities can significantly boost your business prospects and contribute to its success.

The Drug Controlling Authority, also known as the drugs controller, operates under the Drugs and Cosmetics Act and is responsible for issuing various drug licences. These licences ensure the proper regulation and oversight of pharmaceutical products and related activities. These are divided into:

State Drugs Standard Control Organisation (SDSCO)

The State Drugs Standard Control Organisation (SDSCO) is responsible for overseeing drug-related matters within the state. It plays a significant role in issuing licences for the sales, distribution and manufacturing of drugs under the jurisdiction of state authorities. The SDSCO ensures that pharmaceutical activities within the state adhere to the required standards and regulations.

Central Drugs Standard Control Organisation (CDSCO)

The Central Drugs Standard Control Organisation (CDSCO) holds authority at the national level and is entrusted with approving licences for newly developed drugs and clinical trials. Additionally, it regulates the quality of imported drugs and collaborates with the SDSCO to maintain a cohesive drug control mechanism across the country.

State Drug Controlling Authority with Central Licence Approval

This category of authority is responsible for issuing licences for specific activities, such as establishing blood banks and dealing with their components and products, including Vaccines and Sera. These authorities operate at the state level but require approval from the Central Licence Approving Authority to ensure uniformity and compliance with national standards.

Department of Ayush

The Department of Ayush is very significant in traditional and alternative medicine systems, including ayurvedic, Unani, Siddha, homoeopathic and herbal products. This authority issues licences for cosmetic and medical products falling under these categories, ensuring their safety, quality and adherence to relevant regulations.

The following categories of drug licence exist in India:

Manufacturing Licence

To engage in the manufacturing of allopathic, homoeopathic medicines and cosmetics, as well as repacking drugs, a valid Manufacturing Licence is required. However, such licences can only be granted within certain Industrial areas to ensure adherence to proper manufacturing standards and safety protocols. Manufacturing Licences play a significant role in maintaining the quality and safety of pharmaceutical and cosmetic products produced in the country.

Sale Licence

For the legal sale of drugs, businesses must obtain a Sale Licence. This licence is further classified into two categories:

• Retail Drug Licence: This licence is granted to individuals involved in operating chemist shops and retail pharmaceutical outlets.
• Wholesale Drug Licence: Wholesale drug licences are issued to individuals or agencies engaged in the wholesale distribution of drugs.

Loan Licence

A Loan Licence is issued to individuals or businesses seeking to utilise the manufacturing facilities owned by another licencee. This arrangement allows businesses to engage in production without having their manufacturing infrastructure.

The Loan Licence provides an opportunity for smaller businesses or new entrants to the pharmaceutical and cosmetic industry to access manufacturing capabilities without significant investments in setting up their own facilities. This collaboration between the licencor and licencee ensures efficient utilisation of existing resources and encourages growth and innovation within the industry.

Import Licence

A licence is provided to any dealer who imports products for drug production or is in the business of importing drugs into India.

Multi-Drug Licence

A licence awarded to a company that owns pharmacies with the same name in multiple states.

Obtaining a drug licence is significant for businesses involved in the sale and wholesale of drugs. Different types of licences are required for different categories of drugs. Given below are the various forms used for obtaining specific drug licences, categorised based on the types of drugs involved:

Given below are the basic criteria of eligibility for obtaining a driving licence in the country:

Area of Set-Up:

To be eligible for a drug licence, the applicant must have appropriate premises for the distribution and sale of pharmaceutical products. The type of licence, whether retail or wholesale, determines the minimum required area:

• Form 20 or Form 21: Premises must be at least 10 Square Metres.
• Form 20-B or Form 21-B: Premises must be at least 15 Square Metres.

Additionally, the height of the premises must comply with the National Building Code of India, 2005. The applicant needs to ensure that the premises meet these criteria when applying for a drug licence in India through the respective state council.

Storage Facilities:

All pharmacies and drug stores are required to have sufficient storage facilities. These facilities must meet specific requirements, as some drugs and substances require storage at low temperatures. It is essential for the applicant to ensure that proper storage arrangements are available at the premises.

Technical Staff:

Qualified and technically skilled staff are significant for pharmacy operations. The individuals working in the pharmacy must meet certain educational requirements:

• Bachelor of Pharmacy (B. Pharm) certification is mandatory for all staff members.
• In addition, the pharmacy must have at least one to four years of experience in one of the staff members, depending on the nature of the business (retail or wholesale).

Pharmacist/Competent Individual:

For retail business, the applicant must be a qualified pharmacist whereas for wholesale Business, the individual should be a graduate with one year of experience or an undergraduate with four years of experience.

Given below are the set of documents required for drug licence application:

1. Application and Fee Proof:

• Duly signed application form that has been properly filled out.
• Copy of the Challan or receipt as evidence of fee payment.

2. Identity Proof:

• For proprietorship applicants: Identity proof such as PAN, Voter ID, Driving licence, Passport, etc.

3. Partnership Firm:

• Identity proof of each partner.
• Copy of the partnership deed.

4. Private/Public/OPC Companies:

• Copy of Memorandum of Association (MOA), Articles of Association (AOA) and Certificate of Incorporation (COI).

5. Authorisation and Appointment:

• Certified true copy (CTC) of the Board Resolution authorising the company to apply for the drug licence.
• Appointment letter of the authorised representative.

6. Storage Space Proof:

• Proof of availability of suitable storage space (e.g., cold storage, refrigerator, etc.).

7. Additional Documents for Registered Pharmacists:

• Diploma in pharmacy certificate.
• Registration certificate issued by the pharmacy council.
• Appointment letter from the pharmacy.

8. Affidavit and Education Qualifications:

• Affidavit of pharmacist.
• Educational qualification certificates (e.g., high school, intermediary mark sheets, graduation certificate, post-graduation degree, etc.).

9. Relevant Experience:

• Proof of a minimum of one year of experience in drug sales and marketing from any pharmaceutical company.

10. Premise Layout Plan:

• Plan for the layout of the premise for which the licence is being applied.

11. Minimum Area Requirements:

• For wholesale or retail drug sales: Minimum 10 square metres area.
• For both wholesale and retail drug sales: Minimum 15 square metres area.

12. Electricity and Installation:

• Proof of necessary electricity availability and related installation at the premise.

Given below is the process for applying for a drug licence in India:

Step 1: Visit the Official Website

To initiate the process of obtaining a Drug Licence, visit the official website of the Food Safety and Drug Administration of the concerned state government. Each state has its own dedicated portal for drug licencing, where applicants can find relevant information and access the application forms.

Step 2: Access the State Government Portal

On the state government portal, go to the section specifically related to drug licencing. For instance, if an individual intends to open a drugstore in Uttar Pradesh (UP), they should visit the UP government's official portal for drug licencing, which could be found at http://fsdaup.gov.in/online-licencing.htm.

Step 3: Fill the Online Application Form

Complete the online application form provided on the portal and ensure that all necessary details are accurately filled in. Additionally, gather all the required documents in digital format and upload them as per the specified instructions.

Step 4: Drug Inspector's Visit

On receiving the said application, a Drug Inspector is generally assigned for the purpose of conducting a physical inspection of the said drugstore or shop. The whole intention behind this is to verify the authenticity of details and information given in the application and ensure compliance with the regulatory requirements.

Step 5: Verification of Documents

During the inspection, the Drug Inspector will thoroughly examine all the documents uploaded with the application. These documents generally include proof of identity, educational qualifications of the technical staff, premises details, storage facilities and any other relevant certificates as mandated by the regulatory authority.

Step 6: Issuance of the Drug Licence

Upon successful completion of the inspection and verification process, the Controller of Drugs will issue the Drug Licence. The applicant will receive an official communication regarding the grant of the licence, allowing them to legally carry out pharmaceutical activities as specified in the licence.

Step 7: Compliance and Renewal

Once the Drug Licence is received, the licence holder must have to strictly adhere to all terms and conditions outlined in the licence. The regulatory authorities may perform regular inspections and audits to guarantee that the stated rules are followed.

The production and distribution of drugs and pharmaceuticals in India is closely supervised by the government. Before distributing medications and pharmaceuticals, a company must get a drug licence or a pharmaceutical licence. A pharmacy can begin operations with this licence. As a result, it is significant to obtain this licence for the company as soon as feasible.

The provisions of the Drugs and Cosmetics Act of 1940 control many types of drugs and pharmaceuticals. Homoeopathy, allopathy, ayurveda and Unani medicines are examples of these types of pharmaceuticals. Under the requirements of the pharmaceuticals and Cosmetics Act of 1940, any pharmaceutical supplying pharmaceuticals without an appropriate licence would be responsible. Furthermore, the Indian Penal Code, 1860, would impose severe punishments for this violation.

Startupfino is a company that specialises in offering complete services for drug licences. We can aid with everything from providing advice in the beginning phase to ensuring that you meet all the necessary requirements and also keeping your organisation in good legal standing.

Our services include the below mentioned:

• Obtaining all necessary approvals and assisting in the application process for obtaining a drug licence in India.
• Expert guidance on meeting regulatory requirements and ensuring legal compliance for drug licencing.
• Streamlining the documentation process and assisting in filing the online application for drug licence issuance.
• Comprehensive support in preparing and organising required documents for drug licence applications.
• Facilitating smooth communication with the regulatory authorities to expedite the drug licence approval process.
• Expert consultation on storage facilities and other prerequisites for obtaining a drug licence in India.

By availing our services, entrepreneurs can avoid the negative outcomes of non-followance of rules and compliances. StartupFino works hard to provide services that are prompt and effective, so you can manage your business without any issues and without facing penalties or problems.