Not of Standard Quality (NSQ) Alert:

The Central Drugs Standards Control Organisation (CDSCO) declared more than 50 drugs, including paracetamol, Pan D, and calcium supplements, as ‘not of standard quality’ in its recent monthly report, raising safety concerns regarding their usage.

A Not of Standard Quality (NSQ) Alert is an official notification issued by regulatory authorities, such as the Central Drugs Standard Control Organization (CDSCO) in India or equivalent agencies in other countries, indicating that a particular batch of pharmaceutical products or drugs has failed to meet specified quality standards. These alerts are critical for ensuring public safety and maintaining the integrity of the pharmaceutical supply chain.

Key Aspects of NSQ Alerts:

1. Quality Testing: Drugs undergo rigorous quality testing to ensure they meet standards for purity, strength, efficacy, and safety. If a batch of drugs fails to meet any of these parameters, it is classified as “Not of Standard Quality.”
2. Reasons for NSQ Classification: A drug can be marked as NSQ for various reasons, including:
   • Contamination (presence of harmful substances)
   • Incorrect labeling (misleading or incorrect information)
   • Poor manufacturing practices (non-compliance with good manufacturing practices, or GMP)
   • Substandard active ingredients (deviation from the required amount of the active pharmaceutical ingredient)
   • Stability issues (loss of potency over time)
3. Issuance of Alerts: Regulatory bodies issue NSQ alerts to inform the public, healthcare providers, and other stakeholders about the affected products. These alerts may include:
   • Name of the drug
   • Batch number
   • Manufacturer details
   • Nature of the defect or reason for the alert
4. Immediate Actions: Upon issuance of an NSQ alert, the regulatory authority may take various actions, such as:
   • Recalling the affected batch from the market or healthcare settings
   • Suspending sales or distribution
   • Conducting further investigations into the cause of the quality failure
   • Imposing penalties on manufacturers for non-compliance
5. Impact on Public Health: NSQ alerts are essential to prevent patients from using substandard or unsafe drugs, which can lead to treatment failure, adverse reactions, or even fatalities in severe cases.
6. Regulatory Follow-Up: Authorities often follow up with manufacturers to ensure corrective measures are implemented. This may include changes in the manufacturing process, enhanced quality control, or stricter supervision.

Examples of NSQ Alerts in Practice:

1. CDSCO’s Role in India: The CDSCO regularly issues NSQ alerts for drugs that fail quality standards. For instance, a particular batch of an antibiotic or pain reliever may be flagged as NSQ if it has inadequate potency or contains contaminants.
2. WHO Medical Product Alerts: The World Health Organization (WHO) also issues medical product alerts for substandard or falsified medicines, particularly in countries where regulatory oversight may be weaker.

Significance of NSQ Alerts:

• Patient Safety: These alerts play a crucial role in safeguarding public health by preventing the use of harmful or ineffective medications.
• Regulatory Compliance: NSQ alerts ensure that pharmaceutical companies adhere to stringent quality control measures and good manufacturing practices.
• Public Trust: They help maintain trust in the healthcare system by ensuring that only safe and effective drugs are available to consumers.
   
• About the Central Drugs Standard Control Organization (CDSCO):
• It is India’s national regulatory body responsible for the approval, regulation, and monitoring of pharmaceutical products, medical devices, and clinical trials.
• It functions under the Ministry of Health and Family Welfare and operates in accordance with the Drugs and Cosmetics Act, 1940, and its associated rules.
• The Drugs Controller General of India (DCGI) heads the CDSCO and oversees its operations.
  

  Key Functions of CDSCO:

  1. Regulation of Pharmaceuticals:
     • CDSCO ensures that drugs and pharmaceuticals marketed in India are safe, effective, and of high quality. It approves new drugs and oversees the import, manufacture, sale, and distribution of medicines.
  2. Clinical Trial Oversight:
     • The organization regulates and monitors clinical trials conducted in India to ensure they meet ethical standards and follow protocols that protect the rights and safety of participants.
  3. Approval of Medical Devices:
     • CDSCO is responsible for the regulation of medical devices in India, including approval for manufacture, import, and sale. The regulation of medical devices has become more stringent in recent years as part of India’s efforts to harmonize with global standards.
  4. Grant of Drug Approvals:
     • The organization grants approval for new drugs, biosimilars, vaccines, and over-the-counter (OTC) medicines. It also issues permissions for marketing authorizations and ensures that drugs are launched based on sound scientific evidence.
  5. Licensing of Drug Manufacturing:
     • CDSCO works with state drug regulatory authorities to grant licenses for drug manufacturing and ensure that manufacturers comply with Good Manufacturing Practices (GMP).
  6. Pharmacovigilance:
     • It monitors the safety of drugs post-marketing through the Pharmacovigilance Program of India (PvPI), aimed at detecting and managing adverse drug reactions and ensuring that unsafe drugs are withdrawn from the market.
  7. Regulation of Imports:
     • CDSCO monitors and controls the import of drugs and cosmetics into India, ensuring that imported products meet quality and safety standards. It issues licenses and inspects imported consignments.
  8. Quality Control of Drugs:
     • Through a network of central and state laboratories, CDSCO ensures that drugs sold in the market meet the required standards of quality, safety, and efficacy. This includes conducting random quality checks and testing for adulteration or substandard products.
  9. Issuing Alerts (e.g., NSQ Alerts):
     • The organization issues Not of Standard Quality (NSQ) alerts for drugs and medical devices that do not meet regulatory standards, ensuring that substandard products are quickly removed from circulation.
  10. International Cooperation:
      • CDSCO collaborates with international organizations such as the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) to harmonize regulatory standards and practices. This helps Indian pharmaceutical products gain approval for international markets.

  Structure of CDSCO:

  • Headquarters in New Delhi: The central office is responsible for formulating national policies, issuing regulations, and coordinating with state drug control authorities.
  • Zonal Offices: CDSCO has six zonal offices located in Mumbai, Chennai, Kolkata, Hyderabad, Ahmedabad, and Ghaziabad, which conduct inspections and oversee regulatory compliance at the regional level.
  • Sub-zonal and Port Offices: These offices monitor manufacturing facilities and ports of entry for imported drugs and medical devices.
  • Central Drug Testing Laboratories: The CDSCO operates several central drug testing labs across India for the quality control of pharmaceuticals and cosmetics.

  Key Initiatives and Programs:

  1. SUGAM Portal: An online portal developed by CDSCO to facilitate the submission of applications for drug approvals, clinical trial registrations, and other regulatory clearances. It enhances transparency and reduces processing times for approvals.
  2. Pharmacovigilance Program of India (PvPI): Established to collect, analyze, and act on data related to adverse drug reactions (ADRs). PvPI strengthens drug safety monitoring in India.
  3. Materiovigilance Program of India (MvPI): A program similar to PvPI but focused on the safety monitoring of medical devices. It helps ensure that medical devices used in healthcare are safe and effective.
  4. Collaborations for Capacity Building: CDSCO works with WHO and other global bodies to enhance regulatory capacity and ensure India’s drug regulatory environment is in line with international standards.

  Challenges Faced by CDSCO:

  1. Regulatory Overload: Given India’s status as one of the largest producers of generic drugs globally, CDSCO faces immense pressure in regulating and monitoring a vast number of pharmaceutical manufacturers and medical device companies.
  2. Harmonization with Global Standards: While CDSCO has made strides in aligning with global regulatory practices, it continues to work on bridging the gap between domestic and international standards, especially for medical devices.
  3. Post-Marketing Surveillance: Though CDSCO has made significant progress in pharmacovigilance, there is still a need for more robust post-market surveillance to detect adverse events associated with drugs and devices