The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to allow immediate suspension of manufacturing licences for medicines found to be Not of Standard Quality (NSQ) on specified critical parameters.
The proposed changes are aimed at strengthening pharmaceutical quality control and improving patient safety by enabling faster regulatory action against substandard medicines.
Under the proposed mechanism, manufacturing licences could be suspended as soon as a government analyst’s report identifies a failure in critical quality requirements. The affected manufacturers would be required to conduct a root cause analysis and implement corrective and preventive actions before their licences could be restored.
The proposed amendments cover critical parameters such as impurities, sterility, active ingredient content and dissolution. These factors are essential in determining the safety, effectiveness and quality of medicines.
The ministry has also proposed a system for sharing laboratory findings with the Central Drugs Standard Control Organisation, state and Union Territory licensing authorities, manufacturers and marketers of the concerned medicines.
The existing process generally involves issuing notices and allowing manufacturers to respond before suspension or cancellation of licences. The proposed framework seeks to reduce delays in regulatory intervention.
The move comes amid continued scrutiny of pharmaceutical quality standards in India. Substandard medicines can pose serious risks to patients, particularly when they are used to treat infections or other serious medical conditions.
According to reported regulatory data, approximately 1.4 lakh drug samples were tested during the financial year 2025-26. Of these, 3,012 samples were classified as Not of Standard Quality, while 283 were declared spurious.
The ministry’s proposal is intended to prevent the continued manufacture and distribution of medicines that fail critical quality standards.
The draft amendments are expected to undergo the prescribed consultation process before final notification.
Source: Ministry of Health and Family Welfare and pharmaceutical regulatory reports.
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