The Union Health Ministry is reportedly considering new regulations that would allow for the immediate suspension of product licenses for pharmaceutical companies whose drugs fail quality tests conducted by government laboratories.
This proposed overhaul aims to strengthen public health safeguards by ensuring stricter compliance with drug quality standards. According to a report by the Economic Times, the ministry is in active discussions with state drug regulators and key industry stakeholders to finalize the move and a formal notification could be issued soon.
The initiative is driven by the increasing number of drugs being flagged as “Not of Standard Quality” (NSQ) by the Central Drugs Standard Control Organisation (CDSCO). In response, the Drugs Technical Advisory Board (DTAB) the top technical advisory panel under CDSCO has recommended immediate suspension of licenses for any drug declared NSQ, unless the manufacturer submits a satisfactory Corrective and Preventive Action (CAPA) plan.
The DTAB minutes note:
“To protect public health, the license for any drug found to be NSQ should be suspended at once, unless the manufacturer provides a valid CAPA. The license may only be reinstated after a proper root cause analysis and implementation of corrective measures.”
A senior official, speaking anonymously, said the ministry is consulting with state governments and pharma bodies before issuing the final notification.
However, pharmaceutical industry groups have expressed serious concerns about the proposal. The Federation of Pharma Entrepreneurs (FOPE), in its representation, argued that many NSQ incidents result from technical or manufacturing errors not deliberate malpractice.
“NSQ cases often arise due to technical lapses, not intentional violations,” FOPE stated. They also raised doubts about the consistency of test results from different government labs and emphasized the need for compliance with Good Laboratory Practices (GLP).
A pharma association representative pointed out:
“In several cases, samples initially flagged as NSQ were later declared compliant when retested at CDL Kolkata, the appellate laboratory. This raises concerns about the accuracy of government lab testing and the need for greater scrutiny.”
Instead of automatic license suspensions, the industry is calling for improved recall procedures and more rigorous investigations before punitive actions are taken. FOPE warned that without a proper impact analysis, the proposed rule could harm legitimate drug manufacturers, potentially leading to misuse of the system.
“We urge the ministry to carefully assess the consequences. Immediate license suspensions without due process could negatively affect manufacturers who have invested significantly in infrastructure, R&D, and brand-building,” FOPE cautioned.
The government’s next steps are expected to shape a key aspect of India’s pharmaceutical regulatory framework and balance public health priorities with industry realities.
