The lack of a drug recall law in India

Source: The post is based on the article “The lack of a drug recall law in India” published in The Hindu on 9^th May 2023.

Syllabus: GS 2 – Governance – Government Policies & Interventions in Various Sectors

Relevance: concerns over drug recall law

News: A multinational pharmaceutical company has recently recalled its drugs by issuing a public notice in newspapers in India, alerting people about a mislabeled batch of the medicine that it had accidentally shipped to the market.

Does India have a drug recall law?

The law in the US requires pharmaceutical companies to recall those drugs batches from the market those have failed to meet quality parameters.

However, India does not have any such law in the present and it has been considering the creation of a mandatory recall law for substandard drugs since 1976.

In 1976, the Drugs Consultative Committee along with the officials from the Central Drugs Standard Control Organisation (CDSCO), discussed the issue of drug recalls.

The issue, drugs being sold in another state while it has been recalled in one state, was discussed.

The need for greater cooperation between various state drug controllers to facilitate better coordination was decided in the meeting.

However, this decision never translated into amending the Drugs and Cosmetics Act to create a legally binding structure to enforce such recalls.

In 2012, certain recall guidelines were published by the CDSCO but they lacked the force of law.

What is the significance of a drug recall law?

Substandard drugs have adverse health consequences which may also lead to deaths of children.

In India, almost every month, dozens of drugs fail random testing in government laboratories and there was also news about Indian drugs failures overseas. These drugs require to be recalled in a transparent manner.

Why is there no drug recall law in India?

First, the Union Health Ministry’s Drug Regulation Section is unprepared to deal with complicated drug regulatory issues. It focuses more on supporting the pharmaceutical industry’s expansion than safeguarding public health.

Second, India has a highly fragmented regulatory structure. Each State has its own drug regulator. This enables pharmaceutical companies to sell drugs in another state where there is no such restriction.

Therefore, to create an effective recall mechanism, the responsibility of recalling drugs must be centralized, with power under one authority.

However, both the pharmaceutical industry and state drug regulators have resisted greater centralisation of regulatory powers.

Third, the drug recall system will bring public attention to the conditions of India’s pharmaceutical industry. Therefore, there has been consistent opposition to such laws.

Must Read: Can a centralized regulation help drug quality?