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Drug Regulations and Licensing in India
Welcome to Satori OCS LLP, your trusted partner in navigating the intricate realm of drug regulatory and licensing in India. As the pharmaceutical landscape continues to evolve, compliance with stringent regulations and securing the necessary licenses are paramount for success in this dynamic industry. Our consultancy services are designed to simplify the complexities, ensuring your pharmaceutical products meet regulatory requirements and gain swift market access. With a team of experienced experts, an in-depth understanding of Indian drug regulations, and a commitment to excellence, we stand ready to guide you through every step of your regulatory journey. Discover how Satori OCS can be your strategic ally, helping you bring safe and effective medicines to the Indian market and contributing to the well-being of countless lives.
What are Pharmaceuticals ?
Pharmaceuticals, also known as drugs or medications, are substances that are designed to prevent, diagnose, treat, or cure diseases or medical conditions in humans or animals. They can be in the form of tablets, capsules, injections, creams, ointments, liquids or other forms, and contain one or more active ingredients that work to achieve their therapeutic effect. Pharmaceuticals are developed through a complex process that involves extensive research and development, testing, clinical trials, regulatory approval, and commercialization. Pharmaceuticals play a crucial role in modern healthcare, and have significantly improved the quality of life for millions of people around the world. The use of pharmaceuticals is highly regulated, with government agencies responsible for evaluating their safety, efficacy, and quality.
Meaning of Drug
Section 3(b) of the Drugs and Cosmetics Act,1940 defines “drug” to include all medicines and devices for the use of human beings or animals internally or externally, and all substances planned to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings, including preparations applied on the human body for the purpose of repelling insects like mosquitoes; it also includes all substances that can be used for the destruction of insects and all components of a drug – like empty gelatin capsules. The definition was amended in 1964, to include Ayurvedic and Unani Drugs.
What is Active Pharmaceutical Ingredient (API) ?
API is the main biologically active component of a pharmaceutical drug that produces the desired therapeutic effect in the body. It is a chemical or biological substance that is responsible for the intended pharmacological effect of a drug product. APIs can be derived from a variety of sources, including natural products, or can be typically synthesized through a complex chemical/ biotechnology process(es) or extracted from natural sources and are purified through a series of chemical and physical processes to meet specific standards for quality, purity, and potency. They are then formulated into the final pharmaceutical product, which can take the form of a tablet, capsule, injection, or other forms. APIs are highly regulated by government agencies to ensure that they meet strict standards for safety, efficacy, quality, purity and potency before they can be used in pharmaceutical products.
Drug Regulations and Regulatory Authorities in India
Drug regulations and licensing in India are governed by following Acts, Rules, and Authorities.
Drugs and Cosmetics Act, 1940
- The Drugs and Cosmetics Act is the primary legislation governing the manufacture, sale, distribution, and import of drugs and cosmetics in India.
- It sets out the regulatory framework for approval, licensing, import, manufacturing, quality control and distribution pharmaceutical products.
- Under this Act, various types of drug licenses are granted to individuals or entities based on the specific activities and functions related to drugs and cosmetics.
Drugs and Cosmetics Rules, 1945
- The Drugs and Cosmetics Rules provide detailed guidelines and procedures for various aspects of drug regulation, including licensing, labeling, and quality control.
Central Drugs Standard Control Organization (CDSCO)
- CDSCO is the apex regulatory authority responsible for the approval, regulation, and control of pharmaceuticals, medical devices, and cosmetics in India. It operates under the Ministry of Health and Family Welfare.
- CDSCO is also involved in the approval of new drugs, clinical trials, import and export of drugs, and setting national drug standards.
- It ensures the safety, efficacy, and quality of drugs and medical products available in the Indian market.
- Drugs Controller General of India (DCGI) is the head of CDSCO.
State Drug Regulatory Authorities/ State Food and Drug Administration (FDA)
- State FDAs/ State Drug Regulatory Authorities are responsible for granting licenses for drug manufacturing, wholesale, and retail, and distribution activities within their jurisdiction.
- These authorities are also responsible for conducting inspections, implementing and enforcing drug regulations within the respective state.
National Pharmaceutical Pricing Authority (NPPA)
- The National Pharmaceutical Pricing Authority (NPPA) is responsible for regulating the prices of essential medicines and monitoring price compliance by pharmaceutical companies.
Central Licensing Approving Authority (CLAA)
- CLAA is responsible for approving licenses for the import of drugs and cosmetics into India.
New Drug Approval
- New drugs and fixed-dose combinations (FDCs) must undergo a rigorous approval process before they can be marketed in India.
- The CDSCO reviews the safety, efficacy, and quality data submitted by the manufacturer.
Clinical Trials
- The conduct of clinical trials in India is regulated by the New Drugs and Clinical Trials Rules, 2019.
- Clinical trials must adhere to ethical and safety standards, and sponsors need to obtain approval from the CDSCO's Drug Controller General of India (DCGI).
Quality Control
- The CDSCO is responsible for ensuring that drugs meet quality standards through inspections and testing.
- The National Institute of Biologicals (NIB) and Central Drugs Laboratory (CDL) are key institutions involved in quality control.
These regulatory authorities work together to ensure the safety, efficacy, and quality of pharmaceuticals in India. It's important for pharmaceutical companies and individuals involved in the drug industry to understand the roles and responsibilities of these authorities and comply with their regulations to operate legally and ethically in the Indian pharmaceutical market.
Types of Drug Licenses Granted under Drugs and Cosmetic Act
These licenses are issued by the State Drug Regulatory Authorities or the Central Drugs Standard Control Organization (CDSCO) depending on the nature of the activity and the jurisdiction.
The following are the different types of drug licenses granted under the Act:
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Manufacturing License
Manufacturing licenses are required for entities engaged in the production or manufacturing of:
- Pharmaceutical Formulation: This license is required by manufacturers who produce pharmaceutical formulations such as tablets, capsules, syrups, creams, etc.
- Bulk Drugs/ Active Pharmaceutical Ingredients (API): Manufacturers producing APIs need this license.
- Cosmetic
- Medical Devices
- Homoeopathic Drug
- Ayurvedic, Siddha, or Unani Drug (for traditional medicines).
- They are issued by the State Drug Regulatory Authorities.
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Wholesale Drug License
- Wholesale drug licenses are necessary for individuals or businesses (wholesalers/ stockiest/ distributors) engaged in the wholesale distribution and sale of pharmaceutical products, including drugs and medical devices or cosmetics.
- Wholesalers purchase drugs from manufacturers and sell them to retailers, hospitals, and other healthcare institutions.
- Wholesale drug licenses are typically granted for specific premises and locations.
- These licenses are issued by the State Drug Regulatory Authorities.
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Retail Drug License
- Retail drug licenses are needed for operating retail pharmacies or drug stores or chemist shops selling drugs (on prescriptions of healthcare professionals or over-the-counter) or cosmetics directly to consumers.
- Retail drug licenses are also location-specific and are granted for specific retail premises.
- These licenses are issued by the State Drug Regulatory Authorities.
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Loan License
- A loan license is granted to a person or company who does not possess their own manufacturing unit but intends to get products (drugs/ cosmetics) manufactured under their brand name by using manufacturing facilities of the licensed manufacturer.
- The entity holding the loan license is responsible for the quality and compliance of the manufactured products.
- The licensing authority may be either the State Drug Regulatory Authority or the CDSCO, depending on the product category.
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Repackaging License
- Repacking licence is granted by the for the purpose of breaking up of drugs (as per the list given by the regulatory authority) from the bulk container into a small package and labeling of each package with a view to its sale and distribution.
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- Import License
- Import licenses are necessary for entities involved in importing drugs, pharmaceuticals, medical devices, and cosmetics into India.
- These licenses are issued by the Central Licensing Approving Authority (CLAA) under Central Drugs Standard Control Organization CDSCO.
- Export License
- Export licenses are required for entities intending to export drugs, pharmaceuticals, medical devices, and cosmetics from India to other countries.
- These licenses are issued by the Central Licensing Approving Authority (CLAA) under Central Drugs Standard Control Organization CDSCO.
- Blood Bank License
- Blood bank licenses are required for entities involved in the collection, storage, and distribution of blood and blood components.
- These licenses are subject to stringent quality and safety standards.
- These licenses are issued by the State Drug Regulatory Authorities.
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- Clinical Trial License
- Clinical trials for new drugs or medical devices must adhere to ethical and safety standards, and sponsors/ entities conduction clinical trials must obtain a clinical trial licence from the Drug Controller General of India (DCGI) under Central Drugs Standard Control Organization (CDSCO).
- The conduct of clinical trials in India is regulated by the New Drugs and Clinical Trials Rules, 2019.
- Narcotic and Psychotropic Substances
License
- These licenses are required for handling, manufacturing, dispensing, procurement, trading/sale, and storage of narcotic drugs and psychotropic substances.
- They are issued by the State Drug Regulatory Authorities (State Drugs Controller) in compliance with the Narcotic Drugs and Psychotropic Substances Act, 1985.
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- Restricted License
- Issued for specific activities, such as research or analysis of drugs or cosmetics.
- NOC (No Objection Certificate)
- Sometimes required for specific activities like setting up certain facilities.
Navigating Drug Licence in India
Navigating the process of obtaining a drug license in India can be a complex and regulatoryintensive task. The specific steps and requirements can vary depending on the type of license you need, whether it's for manufacturing, wholesale distribution, retail distribution, or other related activities.
Here is a general overview of the steps involved in obtaining a drug license in India:
- Determine the specific type of drug license you need based on your intended pharmaceutical business activities, such as manufacturing, wholesale, retail, distribution, import or export.
- For a Manufacturing License, appoint technical staff (manufacturing chemist-for manufacturing activity and analytical chemist-for analytical activity) having prescribed educational qualification and experience as per the Drugs and Cosmetics Rules, 1945, who will be responsible for compliance with drug regulations.
- For Retail Licenses, appoint a qualified person (registered pharmacist), having prescribed educational qualification and experience as per the Drugs and Cosmetics Rules, 1945, who will be responsible for compliance with drug regulations.
- For Wholesale Licenses, appoint a competent person (pharmacist), having prescribed educational qualification and experience as per the Drugs and Cosmetics Rules, 1945, who will be responsible for compliance with drug regulations.
- Ensure that your Medical Store (Wholesale / Retail) premises complies with the requirements for the type of license you are seeking. This includes having adequate space, storage facilities, and equipment etc as per Schedule N of Drugs and Cosmetics Act and Rules.
- Ensure that your Factory Premises (for Manufacturing Licence) complies with the requirements for the type of license you are seeking. This includes having adequate space, storage facilities, and equipment etc and meeting the Good Manufacturing Practices (GMP) requirements as per Schedule M of Drugs and Cosmetics Act and Rules.
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Prepare Required Documents
- Gather and prepare all necessary documents, which may include:
- Application forms (in the prescribed forms as per the type of licence).
- Proof of premises ownership or lease agreement.
- Blueprints or layout plans of the premises.
- Affidavits and declarations.
- Documents related to the qualifications and appointment of personnel (if required).
- Site master file.
- Drug master file (if applicable).
- Other supporting documents specified by the authorities as per the type of licence.
- Submit the completed application along with all required documents to the relevant State Drug Control Authority or the Central Drugs Standard Control Organization (CDSCO) office, depending on the jurisdiction.
- Pay the prescribed application fee along with the submission of the application specified by the authorities as per type of licence.
- The drug control authority will review your application and documents for completeness and compliance with regulations.
- Depending on the type of license, the drug regulatory authority may conduct an inspection of your premises to ensure compliance with quality, safety and other necessary standards.
- The CDSCO or State-level Authority will review your application and documents. If your application is found to be in compliance, your premises meet the required standard and the inspection is successful, they will grant you the drug license with a unique licence number.
- Keep in mind that drug licenses typically have a validity period (often one to five years).
- Ensure that you renew your drug license as per the prescribed schedule to maintain its validity and to avoid any disruptions in your pharmaceutical operations.
- After obtaining the license, you must continue to comply with the regulations and reporting requirements, including adverse event reporting, pharmacovigilance, quality control, and any other requirements.
- If you need to make changes to your drug operations, such as adding or deleting products, changing premises, or other modifications, you will need to apply for variation or amendment of your license as appropriate.
Please note that this is a general overview, and the specific requirements and procedures can vary based on the state or union territory in India where you intend to operate and the type of drug license you are applying for. Given the complexities of the drug licensing process, it is advisable to seek assistance from regulatory consultants or experts who are well-versed in Indian pharmaceutical regulations.
Are you in need of a drug license for your pharmaceutical business in India? Look no further! We offer a complimentary consultation to guide you through the drug license application process. Our expert team will assist you in understanding the specific requirements, preparing the necessary documents, and ensuring a seamless licensing journey. Take the first step towards compliance and success in the pharmaceutical business by booking your free consultation today. Let us be your trusted partner in obtaining the required drug license in India.
FAQs
Q1. Do imported drugs require registration in India?
Imported drugs require registration with CDSCO. The registration process involves submitting documentation to demonstrate safety, efficacy, and quality
Q2. Are clinical trials required for drug approval in India?
Yes, clinical trials are required for new drugs or significant modifications to existing drugs. They must be conducted following CDSCO guidelines and ethical standards.
Q3. How are drugs classified in India?
Drugs in India are classified into various schedules and categories, including prescription drugs, over-the-counter (OTC) drugs, and controlled substances.The classification determines how they can be sold and dispensed.