• Types of Drug License

If you are running a pharmaceutical business in India, it is crucial to obtain the necessary drug licenses as per The Drug and Cosmetics Act of 1940. Failure to comply with these regulations can result in hefty fines, legal penalties, and even the closure of your business. Here is a comprehensive list of drug licenses that your business may need to obtain:

Manufacturing License: This license is mandatory for companies that manufacture drugs in India. It is issued by the State Drug Control Authorities or the Central Drugs Standard Control Organization (CDSCO).

Wholesale Drug License: This license is a prerequisite for businesses that engage in the wholesale distribution of drugs within India. The State Drug Control Authorities issue this license.

Retail Drug License: If you operate a retail pharmacy, you need to have a retail drug license issued by the State Drug Control Authorities.

Import License: If you plan to import drugs into India, you need to obtain an import license from the CDSCO.

Export License: If your business involves exporting drugs from India, you need to have an export license issued by the CDSCO.

Loan License: If your business is involved in manufacturing drugs on behalf of another company, you need a loan license issued by the State Drug Control Authorities.

Repackaging License: This license is mandatory for businesses that repackage drugs, and it is issued by the State Drug Control Authorities.

Blood Bank License: If you operate a blood bank in India, you need to obtain a blood bank license issued by the State Drug Control Authorities.

Schedule X Drugs License: If your business manufactures or sells Schedule X drugs, which have a high potential for abuse and addiction, you need a Schedule X drugs license issued by the CDSCO.

Narcotics Drugs and Psychotropic Substances (NDPS) License: If your business is involved in manufacturing or selling narcotics drugs and psychotropic substances, you need an NDPS license issued by the CDSCO.

It's important to note that the name and specific requirements of these licenses may vary depending on the state where your business is located. So, consult the relevant authorities to ensure compliance with the law. Remember that obtaining the necessary drug licenses is crucial for the smooth operation of your business and to avoid any legal issues that may arise.

The following documents are required to get a Drug Licence Certificate in India:

If you are looking to obtain a drug license in India, it is important to be aware of the required documents as per The Drugs and Cosmetics Act, 1940. Ensuring that you have all the necessary documents can help streamline the process and avoid any delays. In this article, we have compiled a comprehensive list of documents required for obtaining a drug license in India.

Application form: A duly filled and signed application form for obtaining a drug license.

Proof of Identity: A self-attested copy of any government-issued identity proof of the applicant (such as PAN card, Aadhaar card, passport, etc.).

Proof of Address: A self-attested copy of any government-issued address proof of the applicant (such as a driving license, voter ID, passport, etc.).

Manufacturing License: In case of a manufacturing license, a copy of the certificate of incorporation or registration of the firm, along with the Memorandum of Association and Articles of Association.

Site Plan and Layout: A detailed site plan and layout of the manufacturing unit, including the location of the plant, the layout of the manufacturing area, the location of the storage area, etc.

Proof of possession of premises: A document showing proof of ownership or possession of the premises where the manufacturing, stocking or sale of drugs is proposed to be conducted.

List of Products: A list of products proposed to be manufactured, sold, stocked or exhibited.

Quality Control Measures: A detailed plan for quality control measures including personnel, equipment, and procedures.

Infrastructure Facilities: A detailed plan of infrastructure facilities including the availability of machinery and equipment, power and water supply, waste disposal system, etc.

Test Reports: Test reports for the raw materials used in the manufacturing process, finished products, and packaging materials.

Appointment of technical staff: A list of technical staff employed or proposed to be employed in the manufacturing process, including their qualifications and experience.

Fee: Payment of requisite fees as per the applicable rules and regulations.

It is important to note that the exact documents required may vary depending on the type of drug license being applied for and the state in which the license is being sought. Therefore, it is recommended to seek legal advice or consult the relevant authorities to ensure all necessary documents are included in the application.

To obtain a drug license in India, you must pay the requisite fees as per the applicable rules and regulations. With this information at hand, you can ensure that your drug license application process runs smoothly, we at India Advocacy will assist you get one step closer to starting your pharmaceutical business.

Overview

If you are looking to start a pharmaceutical business in India, it is crucial to obtain a drug license to ensure compliance with the country's regulatory framework. The Drugs and Cosmetics Act of 1940, regulated by the government, sets the quality standards for the manufacture, sale, distribution, and import of drugs and cosmetics. The act was expanded in 1964 to include Ayurvedic and Unani medicines. Negligence in adhering to these regulations can result in severe punishment.

Depending on the type of business entity, different drug licenses may be necessary. The drug-controlling authority of India, overseen by the Ministry of Health, regulates allopathic, homoeopathic, veterinary medicines, and medical instruments. On the other hand, the Ayush drug control cell, under the Ministry of Ayush, regulates Ayurveda, Unani, Siddha, and herbal products for medicinal and cosmetic use.

To operate your pharmaceutical business legally in India, it is crucial to adhere to the license conditions. By doing so, you can ensure that your business is safe, efficacious, and compliant with Indian laws and regulations. With proper adherence to these guidelines, you can establish a successful pharmaceutical business in India.

Relevant Amendment in 2020

In 2020, an important amendment was made to the Drug and Cosmetics Act, 1940 regarding the renewal of drug licenses. The amendment allows for the automatic renewal of licenses if the renewal application is submitted before the license expiry date. This change aims to simplify the renewal process and reduce the burden on license holders. With this amendment, license holders can ensure the continuity of their business operations without the hassle of manual renewal processes.

Follow the general instructions listed below while furnishing the digital signature application form:

• The signature of the applicant should be in blue ink only
• The signature of the applicant should be as it is in the Identity Proof
• A photo of the applicant in the application form should be signed by the applicant
• All supporting documents should be attested by either Gazetted Officer / Bank Manager / Post Master
• For proof of attesting officer, either one of the below is mandatory –
• Contact Details of Attesting Officer including the name, designation, office address, and contact number. This should be part of the attestation. If provided separately, it should be attested either by the Applicant or Attesting Officer
• Self-Attested copy of the Organizational Identity card of the Attesting Officer
• Organizational Documents can also be attested by Authorized Signatory. However, if the taxpayer fails to get the Organizational Documents attested by the authorized signatory, an attested copy of the organizational ID card of the authorized signatory is mandatory.

How Digital Signature work

Like handwritten signatures, digital signatures are unique to each signer. The providers of digital signing solutions, such as DocuSign, follow a specific protocol called Public Key Infrastructure (PKI). PKI requires the provider to use a mathematical algorithm to generate two long numbers called keys. One key is public, and one key is private.
When someone electronically signs a document, the signature is created using the signer’s private key, which is always securely kept by the signer. The mathematical algorithm acts as a cypher, creating data matching the signed document, called a hash, and encrypting that data. The resulting encrypted data is the digital signature. The signature is also marked with the time that the document was signed. If the document changes after signing, the digital signature is invalidated.
For instance, suppose that Jane signs a timeshare sale agreement with her private key. The buyer receives the document. A copy of Jane's public key is also sent to the document's purchaser. If the signature is not Jane's or the document has changed since it was signed, the public key will be unable to decrypt it using the cypher that produced the keys. The signature is then invalid. To ensure the integrity of the signature, PKI mandates that keys be generated, carried out, and stored securely. As a result, a reliable Certificate Authority (CA) is typically required. Companies that provide digital signatures, like DocuSign, address the PKI criteria for secure digital signatures.

Different forms of drug license :

• Form 19 This form is used for the grant of renewal of a (License to sell, stock, exhibit or offer for sale, or distribute) drugs apart from those specified in Schedule X..

• Form 19 A Application for renewing or granting a restricted (license to stock, sell, exhibit or offer for sale, or distribute) drugs by retail through dealers who do not engage the services of a qualified person..

• Form 19 B Form 19B This form is used for grant or renewal of a (License to sell, stock, offer for service or exhibit, or distribute) Homoeopathic Medicines..

• Form 19 C Application for renewal/grant of a (license to sell, stock, exhibit or offer for sale, or distribute) drugs specified in Schedule X.

• Form 20 Application for License to sell, stock or exhibit for sale or distribute Drugs by Retail other than the specified under Schedules C, C (1).

• Form 20 A Form 20A Application for restricted (License to sell stock or exhibit or offer for sale, or distribute) drugs by retailers other than those specified under Schedules C, C (1), and X for dealers who do not engage the services of a registered pharmacist.

• Form 20 B Application for (License to sell, stock or exhibit, or offer for sale or distribute) by Wholesale, drugs other than those specified in 2[Schedules C, C (1), and X].

• Form 20 C Application for (License to stock, sell or exhibit or offer for sale, or distribute) Homoeopathic medicines by retailers.

• Form 20 D Application for (License to stock, sell or exhibit, or offer for sale or distribute) Homoeopathic medicines by wholesale.

• Form 20 E Application for certificate of renewal of 2(License to sell, stock or exhibit or offer for sale, or distribute) Homeopathic medicines.

• Form 20 F Application for License to stock, sell or exhibit for sale or distribute retail drugs specified in Schedule X.

• Form 20 G Application for 2(License to stock, sell or exhibit or offer for sale, or distribute) by wholesale drugs specified under Schedule X.

• Form 24 This form is for the grant of a license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X.

• Form 24 A Form 24A This application is for either the grant of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X.

• Form 24 B This form is for the grant of a license to repack for the sale or distribution of drugs other than those specified in Schedule C and C (1) 2[ excluding those specified in Schedule X.]

• Form 24 C Form 24C This is for the grant of a license to manufacture for sale( or for distribution of Homoeopathic medicines or a license to manufacture) potentised preparations from back potencies by licensees holding a license in Form 20-C.

• Form 24 D Application for the grant/renewal of a license to manufacture for sale of Ayurvedic, Siddha or Unani Drugs.

• Form 24 E Application for the renewal or grant of a Loan License to manufacture for sale of Ayurvedic (including Siddha) or Unani Drugs.

• Form 24 F This form is for the grant/renewal of a (license to manufacture for the sale or distribution) of drugs specified in Schedule X and not specified in Schedule C and C (1).

• Form 27 This is for renewal or grant of a (license to manufacture for sale or distribution) of drugs specified in Schedule C and C (1), [excluding those specified in Schedule X and Part XB.]