CDSCO Drug Safety Compliance: Ensuring Pharmaceutical Quality in India

The Central Drugs Standard Control Organisation (CDSCO), under the Directorate General of Health Services in India, plays an important role in ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices in the Indian market. Addressing the challenges posed by substandard and counterfeit products, the CDSCO has established comprehensive guidelines that strengthen drug safety compliance and the regulatory framework for drug and cosmetic surveillance. These guidelines, detailed in Circular No. Enforc-11021(11)/16/2024-eoffice dated 09/02/2024, are essential for public health safety and maintaining the integrity of the pharmaceutical and cosmetic industries in India.

Comprehensive Sampling Plan Development

To ensure the efficacy and safety of pharmaceutical products, CDSCO mandates that each drug inspector collaborates with their controlling authority to develop a sampling plan. These plans are required on a monthly and annual basis, aimed at encompassing the full scope of their respective jurisdictions. Moreover, the annual sampling plans undergo a review at the headquarters to ensure a wide variety of brands and categories are covered, thereby avoiding redundant sampling efforts.

Criteria for Sample Selection

Drug Inspectors will choose samples based on multiple factors that suggest a potential risk to drug quality, including a variety of therapeutic categories, formulations, and manufacturers from a single sales outlet. This process is guided by a non-exhaustive list of indicators:

Reports from citizens and healthcare professionals or efficacy concerns raised through interactions with various stakeholders such as doctors, pharmacists, or through media.
A sampling schedule set by the CDSCO that targets specific drugs during certain months.
Alerts from CDSCO and State Drug Authorities regarding frequently substandard or counterfeit drugs and their points of sale.
Seasonal environmental changes that could affect drug quality, especially relevant for drugs like antimalarials during their peak season.
Price variations in identical products aimed at different market segments.
Drugs sold at significant discounts, which may not align with standard ethical market practices.
High-volume products.
Drugs with low potency or a narrow therapeutic index.
Drugs with tampered labels.
Season-specific products or those sold during health crises.
Input from national health programs like deworming or vaccination initiatives.
Products from newly established manufacturers.
Suspicious labeling or packaging errors, such as spelling mistakes or illegible text.
Poor quality of primary packaging or suspicious packaging.
Products with visible defects.
Products resembling established brands.
Lack of proper sales documentation or discrepancies in product details like batch numbers or expiration dates.
Products typically distributed through specific channels rather than general availability.
Products channeled through unconventional distribution routes.
Inter-State purchases that bypass the regular supply chain.

Inspectors must use these criteria in their six-month sampling plan, ensuring no more than three samples are taken from a single outlet, with any exceptions duly recorded and authorized.

Criteria for Selecting Sampling Locations

Drug Inspectors determine sampling locations using several indicative approaches:

Areas with frequent reports of non-standard quality (NSQ) drugs.
Locations receiving multiple market complaints.
Sites not sampled in over a year by state or central drugs inspectors.
Government Medical Store Depots.
Manufacturing facilities in both private and public sectors.
State and central government hospitals and institutes making local purchases.
Wholesale and retail sales premises.
Outlets operating primarily during morning and evening hours.
Sales outlets near schools and colleges.
Outlets at border areas of districts, states, or countries.
Regions with high disease prevalence relevant to the drugs being targeted.
Locations involving complex manufacturing processes.
Areas where medicine stability is a risk due to local storage, distribution, and usage conditions.
Manufacturers not adhering to Good Manufacturing Practices (GMP).
Complex distribution chains are likely to violate Good Distribution Practices (GDP) and storage standards.

Sample Collection Quantities

The criteria for the number of samples collected are precisely defined under Sections 22 & 23 of the Drugs & Cosmetics Act 1940. Each inspector is required to collect a minimum of 10 samples monthly, including:

- 09 samples of drugs (APIs, excipients, and formulations)

- 01 sample of cosmetics or medical devices

Ensuring Adequate Sample Quantities for Effective Testing

Effective drug quality surveillance requires that sufficient sample quantities are collected for comprehensive laboratory testing, including potential re-testing. The required sample amount varies by product type, including APIs, various formulations (tablets, capsules, liquids, etc.), cosmetics, and medical devices.

Challenges can arise at retail or rural outlets with insufficient product quantities for complete testing. In such cases, priority is given to essential tests like identification and assay to swiftly rule out spurious products. Samples are typically divided into two equal portions: one for analysis and another for legal validation, if needed. Adjustments to testing due to limited quantities are documented and communicated to the relevant authorities, ensuring that critical evaluations proceed despite constraints. Please refer Annexure 1-5 for quantity required for testing of various sample product categories in the Attached PDF.

Adherence to Timelines for Drug Quality Testing

To prevent the circulation of non-standard quality (NSQ) drugs and ensure public safety, the CDSCO stipulates strict timelines for the testing and reporting of drug samples:

- Immediate Sample Dispatch: Drugs Inspectors must send samples to the laboratory on the same day of sampling. If delays occur due to distance or remote locations, samples must reach the lab by the next day.

- Documentation During Sampling: Inspectors are required to collect and document essential details such as the name, address, and purchase invoice from the source during sampling to verify the legitimacy of the drug or cosmetic.

- Early Reporting: The laboratory heads of state and central labs must submit NSQ reports in a prescribed format before the 10th of each month for public disclosure on the CDSCO website.

- Spurious Drug Alerts: Similarly, monthly alerts on spurious drugs must be compiled and uploaded before the 10th of each month to enhance public awareness.

- Utilization of SUGAM Lab Portal: Inspectors should use the SUGAM Lab Portal to manage and forward the necessary documentation and samples effectively.

Monitoring and Database Maintenance

Effective sampling plans rely on meticulous data maintenance and periodic reviews:

- Sampling Data Maintenance: Drugs Inspectors are responsible for recording the number of samples collected, their testing status, and the outcome of these tests, including any NSQ findings.

- Monthly Reporting: Detailed reports on NSQs and actions taken such as drug alerts, product recalls, and legal actions must be documented and reviewed.

- Tracking Spurious Products: A centralized list of retail outlets dealing in spurious products is maintained monthly and shared within the organization for regulatory action and public safety.

- Enhancing Public Awareness: These measures aim to ensure transparency and maintain public trust in the pharmaceutical supply chain by keeping consumers informed about the quality and safety of available drugs.

Strengthening Public Trust with NSQ and Spurious Alerts

NSQ Alerts:

- Compilation and Submission: NSQ reports generated by state and central laboratories are systematically compiled into an Excel sheet, capturing essential details from the test reports. These compiled reports are mandated to be submitted before the 10th of every month.

- Public Disclosure: The aggregated information is subsequently uploaded to the CDSCO website under the Drug/Device/Cosmetic NSQ Alert section. This process is designed to inform the public about the quality of medical products available in the market, enhancing transparency and trust.

Spurious Alerts:

- Documentation and Analysis: Instances where samples are identified as spurious through distribution chain analysis or manufacturer reports are meticulously documented. This documentation, formatted in a designated Excel sheet, includes the Drug Inspector’s report on distribution chain discrepancies and the manufacturer’s insights on distinguishing genuine from spurious products.

- Monthly Compilation: Field offices from state and central drug authorities are responsible for compiling these spurious alerts monthly, ensuring submission preferably before the 10th of each month.

- Public Accessibility: These alerts are made available on the CDSCO website under the Spurious Drug/Device/Cosmetic Alert section, significantly enhancing public vigilance and safety.

This structured reporting mechanism is a strategic approach to disseminate crucial safety information regarding drugs, devices, and cosmetics, aiming to foster a well-informed public and minimize the risks associated with NSQ and spurious products.

Overview of Testing Laboratories for Drugs, Cosmetics, and Medical Devices

Nationwide Testing Infrastructure

India’s regulatory oversight of drugs, cosmetics, and medical devices is supported by a comprehensive network of notified laboratories. These facilities are essential for ensuring product safety and efficacy, with details provided in recurring regulatory updates.

Central and State Testing Facilities

States without their own testing laboratories utilize Central Drugs Testing Laboratories, ensuring that samples from state inspectors are adequately tested. This collaborative approach helps maintain a consistent quality standard across the country.

Focus on Medical Devices

Under the Medical Devices (Amendment) Rules, 2023, “State Medical Devices Testing Laboratory” refers to state-designated labs. Additionally, six Central Medical Device Testing Laboratories (CMDTLs) operate under MDR 2017 to uphold national safety standards for medical devices.

Name of Laboratory	Category of medical device
The National Institute of Biologicals, Noida	In-Vitro Diagnostics for human Immunodeficiency virus, Hepatitis B Surface Antigen and Hepatitis C Virus, Blood Grouping sera, Glucose Test Strip, Fully Automated Analyser Based Glucose Reagent
The Central Drugs Testing Laboratory, Chennai	Condoms
The Central Drugs Laboratory, Kolkata	Surgical Dressings, Surgical Cotton, Surgical Bandages, Disinfectant
The Regional Drugs Testing Laboratory (RDTL), Guwahati	Disposable Hypodermic Syringes, Disposable Hypodermic Needle, Disposable Perfusion Sets, I.V. Cannulae
The Central Drugs Testing Laboratory, Mumbai	IntraUterine Devices (IUD) and Falope Rings
The Regional Drugs Testing Laboratory, Chandigarh	Disposable Hypodermic Syringes, Disposable Hypodermic Needles, Disposable Perfusion Sets, Catheters, I.V. Cannulae, Scalp Vein Set, Ligatures, Sutures, Staplers, Surgical Dressing, Umbilical Tapes.

Conclusion

The Central Drugs Standard Control Organisation (CDSCO) is pivotal in ensuring that all pharmaceutical products in India adhere to the highest safety and efficacy standards. By implementing rigorous sampling and surveillance strategies, CDSCO not only protects public health but also boosts confidence in India’s healthcare products. Morulaa provides support by helping manufacturers and importers understand and adhere to the CDSCO guidelines discussed in this blog. From developing compliant sampling plans to ensuring timely submission of necessary documentation and NSQ alerts, Morulaa’s expertise ensures businesses navigate the regulatory framework effectively, maintaining high standards of product quality and regulatory compliance. For more information on how Morulaa can help you adapt to any regulatory changes, reach out to us at [email protected] or click here to learn more.