FARMA

FARMA

FARMA

The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for pharmaceuticals and medical devices, functioning under the Ministry of Health & Family Welfare, Government of India. CDSCO is responsible for regulating the safety, efficacy, and quality of drugs, pharmaceuticals, vaccines, biologicals, and medical devices in India, ensuring protection of public health.

Key Functions of CDSCO

  1. Regulatory Approvals
    • Approves New Drugs, Investigational New Drugs (INDs), clinical trials, and imported drugs before marketing.
    • Grants licenses for manufacturing, sale, and distribution of drugs and medical devices.
  2. Quality Control & Standards
    • Establishes standards for drugs, pharmaceuticals, biologicals, and medical devices.
    • Oversees compliance with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
  3. Clinical Trials & Pharmacovigilance
    • Approves and monitors clinical trials of new drugs and medical devices.
    • Conducts adverse drug reaction (ADR) monitoring through the Pharmacovigilance Programme of India (PvPI).
  4. Licensing & Compliance
    • Issues manufacturing licenses, import licenses, and marketing authorization.
    • Monitors post-market surveillance, recalls, and enforcement actions against sub-standard or spurious drugs.
  5. Regulation of Medical Devices
    • Classifies and regulates medical devices under notified categories.
    • Ensures safety, quality, and efficacy of devices like diagnostics, implants, and therapeutic equipment.
  6. Coordination & Policy Implementation
    • Acts as the central authority coordinating with State Drug Controllers for uniform enforcement.
    • Advises the government on drug policy, regulatory standards, and legislative amendments.

Professional Significance

CDSCO ensures regulatory compliance, quality assurance, and public safety in the pharmaceutical and medical device sector. Approval and licensing from CDSCO are mandatory for market access, domestic manufacturing, and import of drugs and medical devices. Professional adherence to CDSCO norms helps organizations avoid legal penalties, product recalls, and reputational risks while ensuring safe and effective healthcare products for consumers.

Medical Devices License

A Medical Devices License in India is a statutory authorization issued under the Drugs and Cosmetics Act, 1940 and Medical Device Rules, 2017, by the Central Drugs Standard Control Organization (CDSCO). It is mandatory for manufacturing, importing, or marketing medical devices in India, ensuring safety, quality, and regulatory compliance.

Types of Medical Devices Licenses

  1. Manufacturing License
    • Required for domestic manufacturers producing medical devices.
    • Issued by CDSCO for Class A and B devices (low-to-moderate risk) at the State Level, and Class C and D devices (moderate-to-high risk) at the Central Level.
    • Compliance with Good Manufacturing Practices (GMP) and quality management systems is mandatory.
  2. Import License
    • Mandatory for foreign manufacturers or importers intending to bring medical devices into India.
    • Issued by CDSCO at the Central Level after verifying the manufacturer’s credentials, product testing, and compliance with relevant standards.
  3. Registration of Medical Devices
    • Certain Class A and B devices require registration rather than licensing, as notified by CDSCO.

Key Compliance Requirements

  • Adherence to Medical Device Rules, 2017 and relevant Indian Standards (IS/ISO).
  • Proper labeling, packaging, and instructions for use.
  • Maintenance of quality management systems (ISO 13485 or equivalent).
  • Periodic audits, inspections, and post-market surveillance.
  • Reporting of adverse events or device-related issues.

Professional Significance

Obtaining a Medical Devices License ensures legal authorization to manufacture, import, and market devices, compliance with safety and quality standards, and protection of patient health and public safety. Non-compliance may lead to penalties, product recalls, or legal action.

Professionally, the license is essential for companies in diagnostics, implants, surgical instruments, monitoring devices, consumables, and therapeutic equipment, enabling market access, credibility, and regulatory alignment in India

Drug License

A Drug License in India is a mandatory statutory authorization issued under the Drugs and Cosmetics Act, 1940 and Rules, 1945. It allows a business or individual to manufacture, sell, distribute, or stock drugs and pharmaceuticals in India. The license ensures compliance with quality, safety, and regulatory standards, protecting public health.

Types of Drug Licenses

  1. Manufacturing License
    • Required to manufacture drugs or pharmaceuticals.
    • Issued by the State Licensing Authority for small-scale drugs and by CDSCO (Central Level) for certain categories like New Drugs.
    • Manufacturers must comply with Good Manufacturing Practices (GMP).
  2. Wholesale License
    • Allows the holder to purchase and sell drugs in bulk to retailers, hospitals, or institutions.
    • Issued by the State Licensing Authority after verifying storage and handling facilities.
  3. Retail License (Retail Sale of Drugs)
    • Permits a pharmacy or chemist to sell drugs directly to consumers.
    • Requires a qualified pharmacist to be in charge.
  4. Import License
    • Required to import drugs into India.
    • Issued by CDSCO (Central Licensing Authority).

Key Compliance Requirements

  • Storage of drugs in accordance with temperature, humidity, and light regulations.
  • Maintenance of records for procurement, sale, and stock.
  • Adherence to labeling, packaging, and expiry date regulations.
  • Implementation of Good Distribution Practices (GDP) for wholesale or retail operations.
  • Periodic inspections by licensing authorities to ensure compliance.

Professional Significance

A Drug License ensures legal authorization to operate, compliance with drug safety and quality norms, and protection of public health. Non-compliance can result in penalties, license suspension, product confiscation, or legal action.

Professionally, obtaining and maintaining a Drug License is critical for pharmaceutical companies, distributors, hospitals, clinics, and pharmacies to operate lawfully and maintain credibility in India’s regulated healthcare sector.

Cosmetic License

A Cosmetic License in India is a statutory authorization required to manufacture, import, sell, or distribute cosmetic products under the Drugs and Cosmetics Act, 1940 and Rules, 1945. The license ensures that cosmetic products are safe, labeled correctly, and compliant with regulatory standards before reaching consumers.

Types of Cosmetic Licenses

  1. Manufacturing License
    • Required for domestic manufacturers producing cosmetic products.
    • Issued by the State Licensing Authority for small-scale or state-level operations and by CDSCO (Central Licensing Authority) for large-scale or specialized products.
    • Manufacturers must comply with Good Manufacturing Practices (GMP) for cosmetics.
  2. Import License
    • Mandatory for importing cosmetics into India.
    • Issued by CDSCO after verifying product formulation, labeling, and safety documentation.
  3. Wholesale / Distribution License (Optional)
    • Allows sale or distribution of cosmetic products in bulk.
    • Typically issued by the State Licensing Authority.

Key Compliance Requirements

  • Products must comply with Indian standards and safety regulations.
  • Correct labeling including ingredients, batch number, manufacturing date, expiry date, and usage instructions.
  • Prohibited or restricted substances should not be used.
  • Maintenance of manufacturing, import, and sale records.
  • Facilities must adhere to hygiene, quality control, and GMP standards.

Professional Significance

A Cosmetic License ensures legal authorization, consumer safety, and regulatory compliance. Non-compliance may lead to fines, product seizure, license cancellation, or legal action.

Professionally, holding a Cosmetic License is essential for manufacturers, importers, distributors, and retailers in the cosmetics industry, helping them maintain brand credibility, market access, and adherence to national standards.

Disinfectant Registration

Disinfectant Registration in India is a statutory process required for manufacturing, importing, or marketing disinfectants under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. Disinfectants are categorized as “Drugs” under the Act, and registration ensures that the products are safe, effective, and compliant with prescribed standards before reaching the market.

Regulatory Authority

  • Central Drugs Standard Control Organization (CDSCO) – Central Licensing Authority
  • State Licensing Authorities – Issue licenses for manufacture or sale at the state level, based on product category and scale of operations

Key Requirements for Disinfectant Registration

  1. Product Composition & Formulation
    • Must comply with Indian Pharmacopoeia (IP) standards or other prescribed regulatory standards for disinfectants.
  2. Safety and Efficacy Data
    • Submission of technical dossiers demonstrating antimicrobial efficacy, toxicity profile, and stability.
  3. Labeling Compliance
    • Proper labeling including active ingredients, concentration, usage instructions, batch number, manufacturing date, and expiry date.
  4. Manufacturing Compliance
    • Facility must follow Good Manufacturing Practices (GMP) and maintain records of production and quality control.
  5. Testing and Documentation
    • Product testing in approved laboratories
    • Submission of required documents to CDSCO or State Licensing Authority for evaluation

Types of Disinfectant Registration

  • Central Registration – For large-scale manufacturers, importers, or products for nationwide distribution
  • State Registration / License – For small or medium-scale manufacturers or distributors operating within a state

Professional Significance

Disinfectant Registration ensures legal authorization, product safety, and regulatory compliance. Non-compliance can lead to penalties, product seizure, license cancellation, or legal action.

 

AYUSH License

An AYUSH License is a statutory authorization required for manufacturing, selling, distributing, or importing Ayurvedic, Yoga, Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH) products in India. It is issued under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, specifically for traditional medicine systems regulated by the Ministry of AYUSH in collaboration with State Licensing Authorities.

Types of AYUSH License

  1. Manufacturing License
    • Mandatory for manufacturing AYUSH drugs or products.
    • Issued by State Licensing Authority for most traditional medicines; certain large-scale units may require Central Licensing.
    • Facilities must comply with Good Manufacturing Practices (GMP) for AYUSH, including proper storage, hygiene, and quality control.
  2. Wholesale / Distribution License
    • Required for trading AYUSH products in bulk.
    • Issued by State Authorities after verifying storage, handling, and record-keeping procedures.
  3. Retail Sale License
    • Permits selling AYUSH products directly to consumers via pharmacies or outlets.
    • Requires qualified personnel to oversee dispensing.
  4. Import License
    • Required to import AYUSH drugs or products.
    • Issued by the Central Licensing Authority (CDSCO / Ministry of AYUSH), ensuring product compliance with Indian standards.

Key Compliance Requirements

  • Compliance with Ayurvedic, Siddha, Unani, or Homoeopathic Pharmacopoeia of India (API, HPI, USP) standards.
  • Proper labeling including ingredients, batch number, manufacturing date, expiry date, and usage instructions.
  • Maintenance of records for manufacturing, procurement, and sale.
  • Adherence to GMP guidelines and regular inspections by authorities.
  • Renewal of license within prescribed timelines to avoid penalties.

Professional Significance

An AYUSH License ensures legal authorization, quality assurance, consumer safety, and regulatory compliance. Non-compliance may lead to penalties, license suspension, product seizure, or legal action.

Professionally, holding an AYUSH License is essential for manufacturers, importers, distributors, and retailers in traditional medicine sectors, providing market credibility, lawful operations, and alignment with Indian standards.

How Shri Consultancies Can Help?

Our dedicated team is here to assist you in navigating the complexities of AGROCHEMICAL  compliance for your business. With our expertise, we ensure a smooth and efficient process, from comprehending regulatory requirements to managing documentation and submissions. Our aim is to simplify the registration process, ultimately saving you valuable time and effort while ensuring compliance.

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