Addressing the Issue of Not of Standard Quality (NSQ) Drugs in India

What was the recent incident?

Five young mothers in Ballari district, Karnataka, allegedly died due to contaminated drugs manufactured by a pharmaceutical company in West Bengal.

Challenges with the Current Regulatory Framework

• Fragmented Regulatory Authority: Under the Drugs and Cosmetics Act, 1940, pharmaceutical companies can sell their products across India based on state-level licenses. This means that:
  • A pharmaceutical company licensed in one state can distribute its drugs nationwide without undergoing inspections by other states’ drug regulators.
  • States like Karnataka lack the authority to prevent the sale of substandard drugs manufactured in other states, leading to a flood of NSQ products in their markets.
  • Eg., Data from Karnataka’s drug laboratories shows that out of 894 samples tested over three years, 601 samples (approximately 67%) that failed quality tests originated from manufacturers outside Karnataka. This indicates a significant reliance on external states for drug quality assurance.
• Inefficient Legal Recourse: The primary legal recourse available to state authorities is criminal prosecution against manufacturers of NSQ drugs. However:
  • Criminal cases can take years to resolve, during which time the offending company may continue operations unimpeded.
  • Only the drug inspectors in the home state have the power to suspend or revoke manufacturing licenses, limiting immediate action against harmful products.
• Lack of Information Sharing: There is currently no centralized database for drug testing results or inspection reports, which hampers effective regulatory oversight. The absence of such a system leads to:
  • The difficulty for state inspectors and procurement agencies in verifying the quality and history of pharmaceutical manufacturers outside their jurisdiction.
  • Procurement decisions often rely solely on manufacturers’ claims without independent verification.

Proposed Solutions

• Promoting Information Sharing: Establish a centralised database for:
  • Drug test results from all central and state drug testing laboratories.
  • Inspection reports and licensing details of manufacturers across states.
  • Benefits:
    • Helps drug inspectors and procurement officials track the history of pharmaceutical companies.
    • Enables risk-based enforcement and procurement decisions.
    • Example: Helps avoid scandals like the one in Maharashtra, where spurious antibiotics were sold to a public hospital.
  • Procurement agencies like the Karnataka State Medical Supplies Corporation Ltd. (KSMSCL) could use this database to verify pharmaceutical companies’ antecedents.
• Creating a Blacklist Register: Union Ministry of Health should create a central register of pharmaceutical companies blacklisted for supplying NSQ drugs.
  • Benefits: Helps procurement agencies identify and avoid dealing with unreliable suppliers.
• Empowering States with Regulatory Powers: Allow states to block out-of-state manufacturers under investigation for serious adverse drug events.
  • Manufacturers should prove rectification before resuming sales.
• Amendment: Requires amendment of the Drugs and Cosmetics Act, 1940, which is central legislation.
  • Legislative reform must be initiated by the Union Health Ministry, with Karnataka supporting such measures.

Impact of the Proposed Reforms

• Enhanced public health safety through stricter enforcement.
• Improved decision-making for procurement agencies like KSMSCL.
• Weeding out unreliable pharmaceutical players from the market.
• Ensuring a more robust and transparent regulatory framework for drug manufacturing and distribution in India.

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