Makers of NSQ drugs may immediately lose their licences: Centre

The Union health ministry is proposing immediate suspension of a manufacturer’s licence when its medicine is declared NSQ for certain serious quality failures. The aim is to stop continued production and distribution before a substandard product can pose further risks to patients and public health.

The suspension would begin after receipt of a government analyst’s report identifying failure in assay, dissolution, related substances, impurities or sterility. This removes the current delay between detecting a quality problem and starting regulatory action. It could also make recalls more effective by preventing additional batches from entering circulation.

The proposal would add an immediate manufacturing-licence suspension clause to the Drugs Rules, 1945. Suspension would not automatically become permanent. It would continue until the manufacturer identifies the root cause, takes suitable corrective action and satisfies the licensing authority that the required quality parameters are met.

“Not of standard quality” means a medicine has not met prescribed quality standards when tested against specified parameters. The article describes NSQ medicines as products that fail requirements important for determining their quality. A government analyst’s report formally declares the product NSQ.

For example, a medicine may be classified NSQ after a test finds a problem with its assay, dissolution, related substances, impurities or sterility. These checks examine whether the product contains the expected medicine, behaves as required, avoids unacceptable chemical contaminants and meets its microbiological quality requirement. The proposal treats these failures as serious enough to prompt immediate action.

NSQ does not describe a voluntary recall or a licence decision by itself under the existing process. The proposed amendment would connect an NSQ report for these parameters to immediate manufacturing-licence suspension. The licence could be restored only after verification and satisfactory corrective measures.

The proposal identifies five critical quality parameters that can lead to immediate suspension of a manufacturing licence. They are assay, dissolution, related substances, impurities and sterility. A government analyst’s report declaring an NSQ result for any of these areas would activate the proposed mechanism.

Each parameter examines a different quality concern. Assay checks the medicine’s stated drug content. Dissolution checks how the product releases its contents under test conditions. Related substances and impurities identify unwanted or potentially harmful chemical components. Sterility checks whether a product that must be sterile meets that requirement. Together, the tests cover important aspects of medicine quality.

The ministry says these parameters are critical for determining quality and protecting patients. Under the proposed amendment, an NSQ finding in one of them could bring immediate suspension, rather than waiting for the existing regulatory process to begin. The change is intended to strengthen compliance and public-health safeguards.

Once suspended under the proposed mechanism, a manufacturer’s licence would remain suspended until the required checks and corrective steps are completed. The suspension would be revoked only after thorough verification concludes that all relevant quality parameters are met. This creates a condition-based route back to production rather than an automatic restoration.

The manufacturer must conduct an effective root cause analysis. That means identifying why the medicine failed its quality test. It must then implement appropriate corrective measures and demonstrate their effectiveness to the satisfaction of the licensing authority. The article does not list a fixed deadline for completing these actions.

This approach links licence restoration to evidence of compliance. It is designed to prevent a manufacturer from resuming production while the underlying quality failure remains unresolved. The proposed amendment therefore combines immediate enforcement with mandatory correction before revocation of the suspension.

Under the existing provisions, authorities generally issue a show-cause notice before suspending or cancelling a manufacturing licence. That prescribed regulatory procedure takes time. The article warns that a gap can arise between the government analyst declaring a medicine NSQ and the start of regulatory action.

During this interval, the manufacturer may continue making or distributing the product, and medicine already supplied may remain in circulation. If the product is substandard, continued availability can pose potential public-health risks. Delay can also make it harder for authorities to identify and retrieve affected medicines effectively.

The proposed amendment is intended to close this gap. It would permit immediate manufacturing-licence suspension when an NSQ report concerns assay, dissolution, related substances, impurities or sterility. The existing process would therefore be supplemented by faster intervention, while corrective measures and verification would still be required before suspension is revoked.

The proposed change to Form 13 would distribute the government analyst’s NSQ report to four kinds of recipients. These are the Drugs Controller General of India, the State or Union Territory licensing authority overseeing the manufacturing site, and the manufacturer and marketer of the drug. The arrangement is meant to ensure timely communication.

For example, the licensing authority responsible for the site could act on the finding, while the manufacturer and marketer receive the same information about the affected medicine. Relevant authorities and companies would therefore have a clearer basis for coordinated regulatory action and possible recall work. The article does not specify a separate recall procedure.

The ministry says sharing the report would strengthen accountability across the manufacturing and marketing chain. It could reduce communication gaps between national and local regulators and the companies involved. Together with immediate suspension, the proposed reporting arrangement is intended to limit continued distribution and support more effective responses to NSQ findings.

Assay measures how much active medicine is present compared with the stated amount. Dissolution measures how the medicine releases its contents under test conditions, which is important for consistent availability to the body. Related substances and impurities measure unwanted chemical components that can arise during manufacture or storage. Sterility tests whether a product required to be sterile is free from viable microbial contamination.

For example, a tablet with an incorrect assay or poor dissolution may not deliver the expected dose in the intended way. Unacceptable impurities may create safety concerns, while failed sterility can be especially serious for products that must be free of microorganisms. These explanations use established pharmaceutical meanings; the article itself does not define each test separately.

The article identifies all five as critical to determining medicine quality. Under the proposal, an NSQ report involving any one of them could trigger immediate licence suspension, followed by root cause analysis, corrective action and verification.