States and the Danger of Poorly Manufactured Drugs

Source: This post on Issue of Poorly Manufactured Drugs has been created based on States and the danger of poorly manufactured drugs published in The Hindu on 31^st December 2024.

UPSC Syllabus topic:  GS Paper 2: Issues Relating to Development and Management of Social Sector/Services relating to Health, Education, Human Resources.

Context: This article addresses the critical issue of poorly manufactured drugs in India and the systemic challenges that enable the proliferation of such drugs across states. The context revolves around a recent tragic incident in Ballari district, Karnataka, where five young mothers allegedly died due to contaminated drugs produced by a pharmaceutical company based in West Bengal. This case highlights the broader problems within India’s drug regulatory framework, which is governed by the Drugs and Cosmetics Act, 1940.

Why is regulating pharmaceutical companies across States challenging in India?

Under India’s Drugs and Cosmetics Act, 1940:

1. Pharmaceutical companies are licensed and inspected only by drug inspectors in the State where their facilities are located.
2. They can sell their products across the country, leaving States like Karnataka unable to prevent the inflow of substandard drugs from other States.
3. For example, out of 894 samples tested by Karnataka’s drug laboratories in three years, 601 failing samples were from manufacturers outside Karnataka.

What is the current limitation in dealing with substandard drugs from other States?

1. Karnataka’s drug department can only initiate criminal prosecutions, which take time. During ongoing trials:
2. The pharmaceutical company can continue manufacturing and selling drugs.
3. Only inspectors from the company’s home State can suspend or revoke its manufacturing license.

How can information sharing help address this issue?

1. A centralised database of test results from all State and central drug testing laboratories can allow drug inspectors and procurement officials to:
   • Track a company’s drug testing history.
   • Make informed, risk-based decisions during enforcement and procurement.
2. Sharing inspection reports and licensing information across States in a unified database can:
   • Help procurement agencies avoid dubious manufacturers.
   • Prioritise manufacturers from States known for rigorous inspections.

What role can a centralised database play in ensuring drug quality?

1. A database should include:
   • Test and inspection reports from all States.
   • Details of pharmaceutical companies blacklisted for supplying substandard drugs.
2. This would:
   • Prevent procurement agencies from relying solely on company disclosures.
   • Help identify manufacturers with poor track records, improving public health.

Why is blacklisting verification necessary?

1. Procurement agencies currently cannot independently verify if a pharmaceutical company has been blacklisted.
2. A central register by the Union Ministry of Health can resolve this issue, making procurement more reliable.

What legal reforms are needed for individual States?

States should have powers to:

1. Block out-of-State manufacturers from selling drugs during investigations for serious adverse events or deaths caused by their products.
2. Require manufacturers to prove issues have been rectified before resuming sales.

Why can’t States amend the law independently?

1. The Drugs and Cosmetics Act, 1940, is central legislation.
2. Legislative reform must be initiated by the Union Health Ministry. Karnataka supports reforms to enhance drug quality nationwide.

What steps are critical to improving drug quality across India?

1. Create a centralised database of test results, inspection reports, and blacklisted manufacturers.
2. Equip States with legal powers to regulate out-of-State manufacturers during investigations.
3. Drive legislative reforms at the central level to ensure stricter regulation and coordination between States.