Indian pharmaceutical firms, after the recent Ranbaxy case, are coming under increased scrutiny from global drug regulators. HT explains the factors that are at play:
Why is Ranbaxy Laboratories in the news?
Last week, the USFDA blacklisted Ranbaxy Laboratories' Mohali plant-the generic drug maker's third factory to face such an import ban.
What does it imply for Ranbaxy?
The US Food and Drug Administrator (USFDA) import alert effectively stopped shipments of 11 medicines produced in the company's Mohali plant, although the regulator did not specify the details on which the alert have been issued.
What has USFDA said?
The US drug regulator said that detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's). India's drug companies, which produce copies of drugs whose patents have expired at a fraction of their price, are facing increasing compliance scrutiny by world's drug regulators.
How does USFDA arrive at such conclusions?
It sends a an FDA Form 483 notifying objectionable conditions which might be in violation of the US FDA's norms, at the conclusion of an inspection.
When is an FDA Form 483* issued?
According to the regulator, an FDA Form 483 is issued to the firm's management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and other related Acts.
FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observations are made when in the investigator's judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.
What is the purpose of the form?
The disclosures made by the regulator say that an FDA Form 483 notifies the company's management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company's senior management. Companies are encouraged to implement corrective action plans expeditiously.
Is the FDA Form 483 intended to be an all-inclusive list of every possible deviation from law and regulation?
No, it's not. The FDA Form 483 is a report which does not include observations of questionable or unknown significance at the time of the inspection. There may be other objectionable conditions that exist at the firm that are not cited on it.
FDA investigators are instructed to note only what they saw during the course of the inspection. Companies are responsible to take corrective action to address the cited objectionable conditions and other related conditions that might exist.
How is the FDA Form 483 shared with the company?
FDA Form 483s are discussed with a company's management at the conclusion of the inspection. Each observation is read and discussed so that there is a full understanding of what the observations are and what they mean.
What are the implications of the FDA Form 483 for agency enforcement and what happens next?
It is considered, along with a written report called Establishment Inspection Report.
*Source: USFDA, FDA Form 483 Frequently Asked Questions