US FDA has issued a guidance to the pharma and biotech industry on the circumstances that constitute delaying, denying, limiting, or refusing a drug inspection.

The guidance covers facilities that are subject to inspection under section 704 of the FD&C Act. It defines the types of actions, and circumstances that the regulatory authority considers to delay or prevent inspection for the purposes of section 501(j).

The Indian pharma industry stated that the guidance is of significant relevance in a phase when stringent global regulatory norms are being enforced and the frequent inspections conducted by the international regulatory teams. Some of the drug manufacturing plants in the country inspected between 2011 to 2013 have reported violations in  quality standards with glaring instances of  industry representatives distracting the focus of global enforcement teams during audits and sharing false information. In the wake of these developments, the guidance is apt for the current circumstances.

In its guidance, UDFDA  has stated that the examples used in the guidance are not intended to serve as an exhaustive list, rather, they illustrate the most common situations encountered in preparing and conducting inspections. It does not interpret the four terms describing prohibited behavior: delay, deny, limit, refuse necessarily to be mutually exclusive. Therefore, the behaviors described in the scenarios are instances of more than one type of prohibited behaviour.

The inspection authority under Section 704 of the FD&C Act extends to what is reasonably necessary to achieve the objective of the inspection.  The regulator intends to work with facilities to conduct inspections and procure the information necessary to achieve the objective of the inspection. Therefore facilities required to register under section 510 of the FD&C Act  and  voluntarily register as outsourcing facilities under section 503B of the FD&C Act have to submit certain information to the regulator.

US FDA has called to ensure prompt update of contacts, e-mail information if a change occurs after an annual registration submission. The regulator also  pointed out that delays may occur for many reasons. However, where an owner, operator causes the delay of an inspection, it could be a suspect if drugs are adulterated under section 501(j) of the FD&C Act. Its efforts to schedule pre-announced inspections include communicating to the facility’s point of contact including the unit’s US representative if the production plant is a foreign facility. It  will make adjustments  to inspect based on  local conditions like weather or security situations, holidays and other non-work days.

According to Sunil Attavar, secretary, Karnataka Drugs & Pharmaceuticals Manufacturers Association (KDPMA), the guidance was endorsed as a law in 2012. Companies already  supplying or looking to enter the US market were adhering to the same.  This guidance in a very simple manner defines the circumstances that would constitute delaying or refusing inspection. Now pharma companies will welcome this guidance as it very clearly clarifies the expectations of the FDA. It will ensure that the companies will be prepared accordingly and it will also avoid misunderstandings.

Once a company agrees voluntarily in writing to allow FDA to inspect the premises, it is well within the rights of the regulator to prescribe guidelines to achieve the objectives of inspection,” said  Harish K Jain, treasurer, KDPMA and director, Embiotic Laboratories (P) Ltd.