Central Idea
- 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.
Recall of Medicines: India story
India has been mulling the creation of a mandatory recall law for substandard drugs since 1976.
- Drugs Consultative Committee (DCC) meeting in 1976: Resolved to have greater cooperation between state drug controllers to recall and destroy drugs that failed tests.
- DCC meetings in 1989, 1996, 1998, 2004, 2007, and 2011: Issue of recalls came up but resulted in no amendments to the Drugs & Cosmetics Act.
- CDSCO proposes draft recall guidelines in 2012: National regulator lacks power to convert guidelines into binding law
- DCC and Drugs Technical Advisory Board meetings in 2016 and 2018-2019: Issue of recalls resurfaces but India still lacks a recall law, 46 years on.
Why there is no concrete law in India?
- Complex drug regulatory issues: The Drug Regulation Section of the Union health ministry is not equipped to tackle complex drug regulatory issues.
- Multiple agencies: India has highly fragmented regulatory structure, with each state having its own drug regulator.
- Exposing the loopholes: 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.
- Evading accountability: The delay in implementing a recall law exposes the lack of accountability and interest in protecting public health.
Consequences of delay
- Drug failure hazard: Dozens of drugs fail random testing in government laboratories every month.
- Substandard quality: The lack of a mandatory recall law means substandard drugs, even those with dangerous consequences for consumers, can circulate in the market.
- Public health crisis: People, including children, are likely dying or suffering from adverse health events because substandard drugs are not swiftly removed from the market.
Reasons behind
The lack of a mandatory recall law in India can be attributed to various factors, including-
- Lack of expertise
- Apathy
- Vested interests in enabling the growth of the pharmaceutical industry.
Way forward
- Implementation of a mandatory drug recall law: The Indian government can take steps to implement a mandatory drug recall law. This law should have teeth to hold pharmaceutical companies accountable for their products.
- Centralization of regulatory powers: To create an effective recall mechanism, the responsibility of recalling drugs has to be centralized, with one authority that has the legal power to hold companies liable for failures to recall drugs from across the country, and further, to also search and seize batches of failed medicine.
- Streamlining of regulatory processes: The Indian government can take steps to streamline regulatory processes to reduce the time taken for approvals and ensure that drugs are tested thoroughly before they enter the market.
- Capacity building of regulatory bodies: The Drug Regulation Section of the Union health ministry should be equipped with the necessary resources, expertise and mandate to tackle complex drug regulatory issues.
- Encouragement of ethical pharmaceutical companies: The Indian government can encourage ethical pharmaceutical companies by providing incentives to companies that comply with regulatory standards, penalizing those that do not, and promoting transparency in drug pricing.
