India’s Delayed Implementation of Mandatory Drug Recall Law

Context:

Abbot published a public notice in newspapers, alerting people about a mislabelled batch of medicine that it had inadvertently shipped to the market. Such recalls take place regularly in the US but it is uncommon in India for domestic or foreign pharmaceutical companies to recall substandard or mislabelled drugs.

Relevance:

GS II: Government Policies and Interventions

Dimensions of the Article:

1. India’s Struggle for a Mandatory Law
2. Why there is no concrete law in India?
3. Consequences of Delay in Implementing a Mandatory Drug Recall Law in India
4. Way forward

India’s Struggle for a Mandatory Law

• Since 1976, India has been considering the creation of a mandatory recall law for substandard drugs.
• In 1976, the Drugs Consultative Committee (DCC) meeting resolved to enhance cooperation between state drug controllers for recalling and destroying drugs that failed tests.
• However, DCC meetings in 1989, 1996, 1998, 2004, 2007, and 2011 also discussed the issue of recalls, but no changes were made to the Drugs & Cosmetics Act.
• In 2012, the Central Drugs Standard Control Organisation (CDSCO) proposed draft recall guidelines, but the national regulator lacked the power to convert guidelines into binding law.
• The issue of recalls resurfaced in DCC and Drugs Technical Advisory Board meetings in 2016 and 2018-2019, respectively, but India still lacks a recall law, after 46 years of considering the issue.

Why there is no concrete law in India?

• Insufficient resources: The Drug Regulation Section of the Union health ministry is not equipped to tackle complex drug regulatory issues.
• Fragmented regulatory structure: India has a highly fragmented regulatory structure, with each state having its own drug regulator.
• Fear of public attention: India’s drug regulators are aware that a mandatory drug recall system will bring to public attention the poor state of affairs in India’s pharmaceutical industry.
• Lack of accountability: The delay in implementing a recall law exposes the lack of accountability in protecting public health.

Consequences of Delay in Implementing a Mandatory Drug Recall Law in India:

• Failed Drug Testing: Government laboratories report dozens of drugs failing random testing every month.
• Circulation of Substandard Drugs: Absence of a mandatory drug recall law leads to substandard drugs, including those with hazardous consequences for consumers, to be sold in the market.
• Public Health Risk: People, especially children, are exposed to the risk of death or adverse health events due to the delay in the swift removal of substandard drugs from the market.

Way forward

• Implementation of a mandatory drug recall law with effective enforcement to hold pharmaceutical companies accountable for substandard drugs.
• Centralization of responsibility for drug recalls under one authority with legal powers to hold companies liable for failures to recall drugs from across the country and to search and seize batches of failed medicine.
• Streamlining of regulatory processes to reduce approval time and ensure thorough drug testing before entering the market.
• Equipping the Drug Regulation Section of the Union health ministry with the necessary resources, expertise and mandate to tackle complex drug regulatory issues.
• Encouragement of ethical pharmaceutical companies through incentives for compliance with regulatory standards, penalties for non-compliance, and transparency in drug pricing.

-Source: The Hindu