India proposes immediate suspension of drug manufacturing licences over quality failures

India has proposed rules requiring regulators to immediately suspend manufacturing licences for medicines that fail specified quality standards in government testing, tightening oversight of one of the world’s biggest pharmaceutical industries.

The rules would apply if government testing finds that a drug fails quality standards for impurities, sterility or assay, which measures the amount of active ingredient, or dissolution, which assesses how the drug releases that ingredient.

Existing rules require regulators to issue a show-cause notice before suspending or cancelling a licence, while the draft mandates immediate suspension for specified quality failures.

The health ministry said on Wednesday that existing due-process requirements can create a time lag between a drug being declared “not of standard quality”, or NSQ, and regulatory action. During that period, the drug could remain in circulation, posing potential public-health risks and making an effective recall more difficult.

Licence restoration subject to corrective action

The licence would remain suspended until the manufacturer conducts an effective root-cause analysis and implements corrective and preventive action, or CAPA, to the regulator’s satisfaction. It could be restored only after regulators verify that those measures have been implemented.

The draft proposal, dated October 28 but published on Wednesday, strengthens the consequences of failed quality tests in a country where regulators regularly identify batches of medicines that do not meet prescribed standards.

Drug quality concerns under increased scrutiny

India’s drug quality standards have come under increased scrutiny at home and overseas in recent years after locally made cough syrups were linked to the deaths of children in India and countries including Gambia and Uzbekistan.

Reuters reported last week that the regulator had ordered the country’s largest drugmaker by revenue, Sun Pharmaceutical Industries, to stop manufacturing, selling and distributing ophthalmic products made at its Assam facility after finding failures in its quality management system.

The Central Drugs Standard Control Organisation, or CDSCO, publishes monthly alerts identifying drug samples declared “not of standard quality” by central and state laboratories.

India also has guidelines covering recalls of quality-defective drugs, including products deemed not of standard quality.

Regulators to seek investigation reports

The proposal would also allow the central licensing authority to seek manufacturers’ investigation reports, root-cause analyses and corrective measures, as well as details of action taken by state regulators.

Government analysts’ reports would be sent to the Drugs Controller General of India, the relevant state or union territory regulator, and the manufacturer and marketer named on the label.

The government will consider comments submitted within 30 days. The rules would take effect upon final publication in the Official Gazette.