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Introduction
The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory authority for drugs,
medical devices, and cosmetics in India, operating under the Ministry of Health and Family Welfare.
Its main objective is to ensure the safety, efficacy, and quality of drugs, cosmetics, and medical devices
that are manufactured, imported, or marketed in India.
History and Establishment:
• The CDSCO was established in 1945 under the Ministry of Health and Family Welfare,
Government of India.
• Its origin was based on the need to regulate the pharmaceutical industry, which was growing
rapidly after India gained independence, to ensure public safety.
Mission:
CDSCO's mission is to regulate and control the quality of drugs, cosmetics, and medical devices,
ensuring public health and safety, and also facilitating innovations in these sectors.

Organizational Structure:
The CDSCO operates under the Ministry of Health and Family Welfare and is organized into several
departments:
• Office of the Drugs Controller General of India (DCGI): The central office located in New Delhi.
• Zonal Offices: These offices are spread across India in different zones (e.g., Mumbai, Chennai,
Kolkata, etc.) to facilitate regulation and ensure that compliance with standards is maintained
at the regional level.
• Sub-Zonal and Port Offices: These offices help monitor imports, exports, and the regulation
of medical devices.

Key Divisions:
1. Drugs and Cosmetics Division: This division deals with all matters related to drugs, medical
devices, and cosmetics.
2. Regulatory Affairs Division: Handles drug approvals, clinical trial permissions, and regulatory
guidelines.
3. Pharmacovigilance Division: Monitors drug safety and adverse drug reactions.
4. Quality Control Division: Ensures the quality of drugs and other medical products in India.
5. Drug Research Division: Focuses on drug research and development, clinical trials, and safety.

Key Functions and Responsibilities:

1. Approval of Drugs and Clinical Trials:
• The CDSCO is responsible for the approval of new drugs, clinical trials, and their
marketing in India.
• Clinical Trials: The organization ensures that clinical trials are conducted ethically and
in accordance with international standards to safeguard public health.
2. Regulation of Drugs and Cosmetics:
• Drug Approval: It approves drugs (including generic, patented, and new chemical
entities) before they are marketed in India.
• Cosmetics and Medical Devices: The CDSCO regulates the safety and efficacy of
medical devices and cosmetics sold in India, including imported products.
• Issues licenses for the manufacture, sale, and distribution of drugs and cosmetics.

NOTES BY MR.S.V. WANKHEDE ASSISTANCE PROFESSOR STYAJEET COLLEGE OF PHARMACY, MEHAKAR

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3. Quality Control and Standards:

• It sets standards for the quality, safety, and efficacy of drugs, medical devices, and
cosmetics in India. The Indian Pharmacopoeia (IP) is a key document in this regard.
• CDSCO coordinates with the National Pharmaceutical Pricing Authority (NPPA) to
regulate pricing and ensure affordable access to medicines.
• It monitors adverse drug reactions (ADRs) and works on pharmacovigilance to protect
public health.

4. Import and Export Control:

• It regulates the import of drugs, medical devices, and cosmetics into India.
• It ensures that imported drugs meet the required quality standards and are not
harmful.
• It also regulates exports of drugs and medical devices from India to other countries.

5. Pharmacovigilance:
• CDSCO maintains a Pharmacovigilance Programme of India (PvPI), which collects,
monitors, and evaluates data related to the safety of medicines used in India. It helps
to detect, assess, and prevent adverse drug reactions (ADRs).

6. Inspection and Licensing:

• The organization inspects manufacturing units to ensure compliance with Good
Manufacturing Practices (GMP).
• It issues licenses for manufacturing, distributing, and selling drugs, including
manufacturing of controlled substances like narcotics and psychotropic drugs.

7. Regulation of Clinical Trials:

• The CDSCO has strict guidelines for conducting clinical trials in India, ensuring that
they meet ethical and scientific standards.
• It reviews and approves trial protocols, and ensures adherence to Good Clinical
Practice (GCP).

8. Training and Capacity Building:

• The CDSCO provides training to state drug controllers, government officials, and
pharmaceutical companies to maintain regulatory standards.

9. Collaboration with International Bodies:

• CDSCO collaborates with international organizations like the World Health
Organization (WHO), U.S. Food and Drug Administration (FDA), and European
Medicines Agency (EMA) to align with global standards.

10. Drugs Controller General of India (DCGI):

• The head of CDSCO is the Drugs Controller General of India (DCGI), who is responsible
for making decisions related to drug regulation in India. The DCGI oversees the
functioning of the CDSCO and acts as the final authority on drug approval and clinical
trials.

NOTES BY MR.S.V. WANKHEDE ASSISTANCE PROFESSOR STYAJEET COLLEGE OF PHARMACY, MEHAKAR

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India, the State Licensing Authority (SLA) is responsible for regulating and licensing activities related
to drugs and cosmetics within the respective state or union territory. Here's detailed information about
the SLA:

Role and Responsibilities of SLA

1. Drug Licensing:
• Issuance and renewal of licenses for manufacturing, sale, and distribution of drugs and
cosmetics.
• Grant licenses to pharmacies, wholesalers, and manufacturers.

2. Inspection and Monitoring:

• Conduct inspections of manufacturing units, retail, and wholesale outlets to ensure
compliance with laws.
• Check adherence to Drugs and Cosmetics Act, 1940, and Rules, 1945.
3. Quality Control:
• Monitor the quality of drugs and cosmetics sold or manufactured in the state.
• Take action against substandard or spurious products.
4. Legal Action:
• Initiate legal proceedings in cases of violations under the Drugs and Cosmetics Act.
• Coordinate with police and judiciary to prosecute offenders.
5. Awareness and Guidance:
• Provide guidance to applicants regarding the licensing process.
• Conduct awareness programs for professionals and the public on drug laws and safety.
Types of Licenses Issued by SLA
1. Manufacturing License:
• For manufacturing drugs or cosmetics in the state.
2. Sale License:
• Retail Drug License (RDL): For pharmacies and retail shops.
• Wholesale Drug License (WDL): For wholesalers distributing drugs in bulk.
3. Loan License:
• For manufacturing drugs at another party's premises.
4. Import License:
• For importing drugs or cosmetics.

Key Documents Required for Licensing

1. Application form (specific to license type).
2. Affidavit of ownership/partnership or Memorandum of Association (MOA).
3. Proof of registered premises (rent agreement or ownership proof).
4. Pharmacist qualification certificate (for RDL).
5. Site Master File and layout plan (for manufacturing license).
6. Fees as per the schedule.
Application Process
1. Submission of Application:
• Submit the required forms and documents online or offline (depending on the state).
2. Inspection:
• SLA officials inspect the premises to ensure it meets standards.

NOTES BY MR.S.V. WANKHEDE ASSISTANCE PROFESSOR STYAJEET COLLEGE OF PHARMACY, MEHAKAR

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3. Approval:
• Upon successful verification, the license is issued.
4. Renewal:
• Licenses must be renewed periodically, typically every 5 years, with updated
documents.

The Certificate of Pharmaceutical Product (COPP) is an official document issued by a regulatory

authority in accordance with the guidelines of the World Health Organization (WHO). It certifies that
a specific pharmaceutical product is authorized for sale or distribution in the issuing country and is
manufactured according to Good Manufacturing Practices (GMP).

Key Features of COPP:

1. Purpose:
o Facilitates the registration and approval of pharmaceutical products in foreign
markets.
o Acts as evidence of the product's quality, safety, and efficacy.
2. Content of COPP:
o Name of the product.
o Dosage form and composition.
o Manufacturer's details.
o Licensing status in the country of origin.
o Certification of GMP compliance.
3. Issuing Authority:
o In India, the Central Drugs Standard Control Organization (CDSCO) or state drug
regulatory authorities issue the COPP.
4. WHO Certification Scheme:
o The COPP is part of the WHO Certification Scheme, aimed at ensuring the availability
of safe and effective medicines globally.

When is COPP Needed?

• For export registration in countries requiring proof of the product’s quality and regulatory
approval.
• To comply with international regulations during product marketing.

Application Process:
1. Submit an application to the regulatory authority with the required documents, including
manufacturing licenses, product details, and GMP compliance proof.
2. Undergo inspections to verify compliance with GMP standards.
3. Once approved, the COPP is issued.

NOTES BY MR.S.V. WANKHEDE ASSISTANCE PROFESSOR STYAJEET COLLEGE OF PHARMACY, MEHAKAR

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REGULATORY REQUIREMENTS AND APPROVAL

The regulatory requirements and approval procedures for a new drug involve rigorous evaluations of
its safety, efficacy, and quality before it is approved for use. While the specifics may vary by country,
the general process is as follows:

1. Preclinical Development
• Objective: Establish preliminary safety and efficacy in laboratory and animal studies.
• Key Activities:
o Pharmacological studies to assess the drug's mechanism of action.
o Toxicology studies to evaluate safety (acute, sub-acute, chronic).
o Pharmacokinetics and pharmacodynamics studies.
• Outcome: Data package demonstrating safety and potential efficacy to proceed to human
trials.
2. Clinical Trials (Human Studies)
Phase 1:
• Objective: Assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in a
small group of healthy volunteers (20–100 people).
• Key Focus: Maximum tolerated dose and adverse effects.
Phase 2:
• Objective: Explore efficacy in the target patient population (100–300 patients) and further
assess safety.
• Key Focus: Dose-response relationship and optimal dosing.
Phase 3:
• Objective: Confirm efficacy and monitor side effects in a larger patient population (300–3,000
patients).
• Key Focus: Provide statistically significant evidence of the drug’s benefits and risks.

3. Regulatory Submission and Approval

A. Submission of New Drug Application (NDA):
• Dossier Includes:
o Preclinical and clinical trial data.
o Manufacturing process and quality control.
o Labeling information and proposed usage.
B. Regulatory Agencies Review:
• Agencies like USFDA (USA), EMA (EU), CDSCO (India), or MHRA (UK) evaluate the submission.
• They may conduct site inspections to verify compliance with Good Manufacturing Practices
(GMP).
C. Marketing Authorization Approval (MAA):
• If data satisfies the regulatory body, the drug is approved for market launch.

4. Post-Marketing Surveillance (Phase 4)

• Objective: Monitor long-term safety and efficacy in a larger, real-world population.
• Key Focus:
• Reporting adverse drug reactions (ADRs).
• Revising drug labeling as needed.

NOTES BY MR.S.V. WANKHEDE ASSISTANCE PROFESSOR STYAJEET COLLEGE OF PHARMACY, MEHAKAR

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Country-Specific Regulatory Requirements

India (CDSCO):
• Application Forms: Form 44 for new drug approval.
• Ethics Clearance: Must comply with Schedule Y of the Drugs and Cosmetics Rules.
• Clinical Trial Requirements: Obtain approval from the Institutional Ethics Committee and
CDSCO.
• Timeline: Typically 12–18 months for a full review.
USA (FDA):
• Investigational New Drug (IND) Application is required before starting clinical trials.
• After clinical trials, an NDA is submitted.
• Fast-Track and Breakthrough Designations are available for drugs addressing unmet medical
needs.
European Union (EMA):
• Uses the Centralized Procedure for marketing authorization.
• Requires a comprehensive Risk Management Plan (RMP).
Challenges in Approval Procedures
1. Lengthy timelines and high costs.
2. Stringent safety and quality requirements.
3. Regulatory variations between countries.

NOTES BY MR.S.V. WANKHEDE ASSISTANCE PROFESSOR STYAJEET COLLEGE OF PHARMACY, MEHAKAR