Govt plans instant ban on manufacturing of drugs failing key quality tests
Pharma companies could have their drug licenses suspended immediately if quality tests indicate failure. The health ministry's proposed changes aim to protect public health by enforcing swift action on substandard medications. Regulators would tak...
New Delhi: Pharma companies may soon have their licence for a drug suspended immediately if the drug fails key quality tests, as per the proposed changes to the rules, which is seeking to minimise public-health risks through instant withdrawal of the substandard medication.
The health ministry's latest proposals empower regulators to act "immediately" when a drug fails important quality tests, such as those for strength (assay), drug dissolution, related substances, impurities and sterility.
At present, regulators follow a set process that involves sending a show-cause notice before suspending or cancelling a licence.
However, according to the ministry, this may result in a time gap between a drug being declared not of standard quality (NSQ) and action being started.
"During this period, the concerned drug may continue to remain in circulation, posing potential risks to public health and making effective recall more challenging," it said in draft proposals.
To address this, the ministry has proposed that the central licensing approving authority or the state licensing authority can suspend the manufacturing licence of the drug immediately. This, however, can be done once they receive a government analyst's report declaring the drug NSQ on assay, dissolution, related substances, impurities or sterility.
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"These parameters are critical to determining the quality of medicines. The proposed provision aims to ensure that instances of non-compliance involving these specified parameters are met with prompt regulatory action, thereby minimising potential risks to patients," said the draft proposal.
The proposal also makes corrective steps compulsory before a suspension is lifted. The suspension will continue until the manufacturer carries out a root cause analysis, which means finding out why the quality failure happened.
The manufacturer should also put in place corrective and preventive action (CAPA), which means fixing the problem and stopping it from happening again, to the satisfaction of the licensing authority, it said.
