NEW DELHI: A medicine that fails critical quality tests could soon trigger immediate suspension of the manufacturer’s licence, under proposed rules aimed at preventing substandard drugs from reaching patients. Health ministry has proposed changes to the drugs rules, 1945, to allow regulators to act without waiting for the existing show-cause notice process.Currently, authorities follow a procedure that includes issuing a show-cause notice before suspending or cancelling a manufacturing licence. This can create a gap during which medicines declared ‘Not of standard quality (NSQ)’ may continue to circulate.Under the proposed amendments, central or state drug licensing authority can immediately suspend manufacturing licence for a drug if a govt analyst’s report finds it deficient in any of five critical parameters: assay, dissolution, related substances, impurities or sterility.These tests determine whether a medicine contains the required amount of active ingredient, releases it properly in the body and is free from harmful impurities or microbial contamination.The suspension will continue until the manufacturer identifies the reason for the quality failure and takes corrective and preventive action. The licence can be restored only after the regulatory authority verifies that the required measures have been implemented.
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The ministry has also proposed a system to ensure that reports of substandard drugs reach the drugs controller general of India (DCGI), the state or UT drug licensing authority concerned, and the manufacturer and marketer. This is intended to speed up regulatory action and fix accountability across the supply chain.The draft amendments have been opened for public consultation.