It is not a rule already in force.

Here, “in force” means officially active and being applied.

That is a proposed change, not a rule already in force.

Here, “in force” means officially active and being applied.

It lists failures involving impurities, sterility, the amount of active ingredient, and dissolution.

Here, “dissolution” means the way a medicine breaks down and releases its active ingredient.

Dissolution means how a medicine releases that ingredient.

Here, “dissolution” means the release of a medicine’s active ingredient.

The ministry says that takes time, so the medicine could remain in circulation while action is pending.

Here, “in circulation” means still available for people to use.

The ministry says that takes time, so the medicine could remain in circulation while action is pending.

Here, “pending” means waiting to happen or be completed.

The manufacturer would need to investigate the root cause: in other words, find what led to the failure.

Here, “root cause” means the original reason the failure happened.

That makes the suspension conditional: it would remain until the investigation and required measures were completed and checked.

Here, “conditional” means the suspension depends on the investigation and required steps being completed and checked.

The proposal would take effect only after final publication in the Official Gazette.

Here, “take effect” means become officially active.

To sum up, India’s draft would allow immediate suspension after certain serious quality failures, with restoration depending on corrective action and regulatory verification.

Here, “verification” means an official check that the corrective action has been completed properly.