In a big set back for the drug manufacturers, the Union Health Ministry has proposed immediate suspension of substandard drug manufacturing licences for medicines that fail critical quality parameters. The move is aimed at strengthening drug safety and protecting patients across India.
The proposed amendments to the Drugs Rules, 1945, seek to prevent substandard medicines from continuing to be manufactured and distributed while regulatory proceedings are underway.
Why Has The Government Proposed The Change?
Under the existing rules, suspension or cancellation of drug manufacturing licence generally involves a prescribed regulatory procedure, including issuing a show-cause notice. This can create a delay between a medicine being declared Not of Standard Quality (NSQ) and regulatory action being initiated.
The Centre puts vests powers in the hands of Central Licensing Approving Authority or the concerned State Licensing Authority to immediately suspend the substandard drug manufacturing licences upon receiving a Government Analyst’s report confirming the failure.
The aspects that will be considered include assay, dissolution, related substances, impurities and sterility.
What Does It Mean For Patients
Eventually, patients would be saved from cosuming substandard drugs that enter the market without any quality checks.Particularly those consuming medication on a regular basis for a specific consdition would face a major reveal.
What tests will be done?
An assay test checks whether a medicine contains the required amount of its active ingredient, while a dissolution test determines how effectively the drug releases its active ingredients. Sterility testing is particularly important for medicines that must be free from harmful microorganisms.
When Can A Suspended Licence Be Restored?
Under the proposed amendments, manufacturers will have to conduct a Root Cause Analysis to identify the reason behind the quality failure and implement Corrective and Preventive Action (CAPA).
The licence suspension will continue until the concerned licensing authority verifies that the required corrective measures have been implemented satisfactorily.
The draft amendments have been opened for public consultation, with the government inviting objections and suggestions from stakeholders and members of the public within 30 days.
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