States and the Danger of Poorly Manufactured Drugs (GS Paper 2, Health)
Context:
- The Union government must take immediate action to assist States in addressing the growing concern of poorly manufactured drugs and ensuring the quality of pharmaceuticals sold across India.
Introduction:
- In recent years, India has witnessed several incidents linked to not-of-standard-quality (NSQ) drugs, which have caused significant harm to patients.
- One tragic example is the death of five young mothers in Ballari district, Karnataka, allegedly due to contaminated drugs produced by a pharmaceutical company in West Bengal.
- Such incidents highlight the critical issue of drug quality in India, which is made even more complicated by the decentralized nature of the country's drug regulatory framework.
Unique Nature of India’s Drugs and Cosmetics Act, 1940:
- The Drugs and Cosmetics Act, 1940, a central legislation, creates a complex regulatory environment for pharmaceutical manufacturing in India.
- Under this law, a pharmaceutical company licensed and inspected in one State can sell its products across the entire country.
- This means that a pharmaceutical manufacturer in West Bengal can legally distribute drugs to Karnataka, or any other State, despite being inspected only by the drug inspectors in West Bengal.
- This creates a situation where States have limited control over the quality of drugs manufactured outside their jurisdiction, leaving them vulnerable to poorly manufactured drugs flooding their markets.
- The tragedy in Ballari, Karnataka, serves as a stark reminder of the consequences of such regulatory loopholes.
Licensing and Inspection Responsibilities:
- Under the current system, each State is responsible for the licensing and inspection of pharmaceutical manufacturing units within its borders.
- While this decentralized structure is meant to empower States, it also means that States like Karnataka have limited control over drugs manufactured in other parts of India.
- Even when a drug is proven to be substandard or harmful, a State has no legal recourse to prevent such drugs from entering its market if the drug has been manufactured in a different State.
- Recent data from Karnataka highlights the extent of this issue.
- Out of 894 random drug samples tested over the past three years, 601 samples failed quality testing.
- Most of these failing samples were from manufacturers located outside Karnataka, particularly from States where manufacturing oversight may be less rigorous.
- This statistic underscores the fact that substandard drugs are being sold in Karnataka, but the State lacks the authority to prevent such drugs from reaching local pharmacies.
Information Sharing as a Solution:
Regulatory Tools to Tackle NSQ Drugs:
- The primary regulatory tool available to combat the sale of NSQ drugs is prosecution of the offending pharmaceutical company.
- However, the process of criminal prosecution is notoriously slow, taking years to resolve.
- Meanwhile, the pharmaceutical company can continue selling its products, potentially causing further harm.
- The only real recourse is for drug inspectors in the State where the manufacturing facility is located to cancel or suspend the company’s manufacturing license.
- However, States like Karnataka, which do not have direct jurisdiction over manufacturers in other States, cannot act unilaterally to stop the sale of harmful drugs in their markets.
Need for Urgent Solutions:
- To address these challenges, the Union Health Ministry must take the lead in promoting collaboration and information sharing between States, ensuring that drug regulators have the tools they need to monitor and prevent the spread of substandard drugs across State borders.
- A simple and cost-effective solution to improve drug quality would be to foster greater information sharing between State drug control departments and public procurement agencies.
- At present, drug inspectors in States like Karnataka have no reliable method to verify the track record or history of pharmaceutical manufacturers located outside their State.
- This gap in information-sharing hinders the ability of States to make informed decisions about which manufacturers to allow into their markets.
Centralized Database for Drug Testing Results:
- One potential solution is to establish a centralized database where all drug testing results from central and State drug testing laboratories are stored.
- This would enable drug inspectors and procurement officials in Karnataka and other States to track how often a manufacturer’s drugs fail quality tests.
- If a manufacturer’s drugs consistently fail across multiple States, this would be an important red flag.
- Drug inspectors could then prioritize enforcement actions or procurement decisions based on risk, rather than relying on incomplete or isolated information.
Centralized Inspection and Licensing Information:
- Similarly, making inspection reports and licensing information for pharmaceutical manufacturers across all States available in a centralized database would help procurement agencies like the Karnataka State Medical Supplies Corporation Ltd. (KSMSCL) ensure that they are purchasing drugs from reputable companies.
- Currently, many procurement agencies rely on the claims made by pharmaceutical companies in their tender applications, but they lack an independent way to validate these claims.
- By centralizing inspection and licensing data, State procurement agencies would be able to make more informed and responsible purchasing decisions.
- For example, if a procurement official in Karnataka can easily access information about the inspection and licensing history of a pharmaceutical company, they can avoid purchasing drugs from manufacturers with a poor quality control record.
- This would prevent situations like the Maharashtra scandal, where dubious suppliers sold spurious antibiotics to a public hospital, endangering public health.
Central Register for Blacklisted Manufacturers:
- Another crucial reform would be for the Union Ministry of Health to create a central register that records all pharmaceutical manufacturers blacklisted by different procurement agencies for supplying NSQ drugs.
- This would allow procurement officers to easily check if a supplier has been blacklisted elsewhere, reducing the risk of purchasing drugs from unreliable manufacturers.
- Currently, procurement agencies have no means of verifying if a pharmaceutical company has been blacklisted for poor quality in another State.
- A central register would help weed out these bad actors, improving the overall quality of drugs in the public healthcare system.
States and Legal Powers:
- In addition to improving information sharing and transparency, it is essential to empower States with the legal authority to prevent harmful drugs from entering their markets.
- States should be granted the legal powers to block manufacturers from other States from selling drugs within their borders if they are under investigation for selling NSQ drugs.
- If a drug manufacturer is found to have produced drugs that have caused adverse effects or deaths within a State, that State should have the authority to suspend or ban the sale of that manufacturer’s drugs until the issues are addressed and rectified.
- This reform would allow States to act swiftly and decisively to protect their residents from harmful drugs, even if the manufacturer is based in another part of the country.
- It would also create a deterrent for manufacturers, encouraging them to maintain rigorous quality standards across all States.
Conclusion:
- Given the complexity of the Drugs and Cosmetics Act, 1940, and its impact on drug regulation in India, it is clear that individual States like Karnataka have limited capacity to make systemic changes that could improve drug quality across the country.
- The Union Health Ministry must take the initiative to lead legislative reforms and support measures that improve the quality control and regulation of pharmaceuticals across States.
- Karnataka and other States are ready to support such reforms, which would help ensure that the drugs sold in their markets meet the highest standards of safety and efficacy, ultimately safeguarding public health across the country.
