Drug Recall

Drug Recall

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.

What is a Drug recall?
 A drug recall is the process of removing a prescription or over-the-counter drug from the market. A recall may occur if a medication is found to be defective, contaminated, or potentially harmful to the public.

What is need for Drug recall law in India?
 It is crucial for India to have a national Drug Recall Law to guarantee that once a drug is known to be Not of Standard Quality (NSQ), the entire batch is withdrawn from the market. At present, there is no such Law in India to withdraw the entire batch of substandard drugs from the market.
 At most state drug regulators can order a withdrawal of a particular batch from their state but given that India is a common market, it is possible that the same batch is dispersed across multiple states. In such a case, there needs to be a central drug regulator who can execute and coordinate national recall.
 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 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.

Why India doesn’t have a law for drug recall?
 The government’s drug regulatory bodies give more importance to promoting the growth of the pharma industry than restricting their activities. Moreover, they lack expertise in drug regulation (as USA FDA has)
 Both the pharmaceutical industry and state drug regulators have resisted greater centralisation of regulatory powers.
 The Drug Regulation Section of government is not up to the task of tackling complex drug regulatory issues due to a combination of different factors including apathy, lack of expertise in the area, and a greater interest in enabling the growth of the pharmaceutical industry than protecting public health.

Significance of 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.

Way Forward
 The responsibility of recalling drugs needs to be centralized under one authority backed by legal power to hold companies liable for failures to recall drugs and search and seize batches of failed medicine.

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