Drug Recall Law

Context: 

Recently, a multinational pharmaceutical company, published a public notice in newspapers alerting people about a mislabelled batch of medicine that it had inadvertently shipped to the market. 

• While such recalls take place regularly in the U.S., we have never witnessed domestic or foreign pharmaceutical companies recall substandard or mislabelled drugs in India.

Drug Recall Law:

• The law in the USA requires pharmaceutical companies to recall from the market those batches of drugs that have failed to meet quality parameters.
• No such law exists in India that mandates such medicine be removed from the market to this day.
• In 2012, certain recall guidelines were published by the Central Drugs Standard Control Organisation (CDSCO), but they lacked the force of law.

Reasons behind absence of such law:

• Union Health Ministry’s Drug Regulation Section criticized for lack of expertise and prioritizing industry growth over public health.
• India’s drug regulatory structure is highly fragmented, with each state having its own regulator.
• Both the pharmaceutical industry and state drug regulators oppose centralization of regulatory powers.
• Drug regulators believe that mandatory drug recall system will shed light on issues in India’s pharmaceutical industry.

Need of the hour

To create an effective recall mechanism, the responsibility of recalling drugs has to be centralised, with one authority wielding the legal power to hold companies liable for failures to recall drugs from across the country.

News Source: The Hindu