Indian life-sciences companies, comprising the bio-pharma and medical devices companies, have upheld the much awaited US Food and Drug Administration (FDA) regulation on the current good manufacturing practice (cGMP) requirements applicable to combination products that would be enforced from July 22 this year.

The new guidelines is for combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device, and a biological product. This regulation was much-wanted as it would ensure quality production at each stage, according to researchers from Indian Institute of Science and National Centre for Biological Sciences. These institutes have collaborated with industries for the early research and development of combination products like for instance pre-filled drug delivery devices.

According to the US FDA, in a combination product the constituent parts retain their regulatory status as a drug or device, after they are combined. Accordingly, the cGMP requirements that apply to each of the constituent parts continue to become relevant when they are combined to make combination products. However, so far, it has not issued specific regulations clarifying the applicability of the cGMP requirements to combination products. While cGMP regulations are in place for drugs, devices, and biological products, there are currently no regulations that clarify and explain the application of these cGMP requirements when these drugs, devices, and biological products are constituent parts of a combination product.

The FDA published a proposed rule in the Federal Register of September 23, 2009 (74 FR 48423) on current good manufacturing practices for combination products.

The proposed rule addressed cGMP requirements for all combination products. Since the constituent parts, while part of a combination product, are separately manufactured and marketed, they remain separate for purposes of applying the cGMP regulations. Therefore, the proposed rule merely provided that all such constituent parts must be manufactured in accordance with the cGMP requirements that would apply to them if they were not part of a combination product, said the regulatory authority.

The proposed rule reflected Agency recognition that, in most instances, for single-entity and co-packaged combination products, a cGMP operating system that satisfies the regulations applicable to one constituent part will also satisfy most of the cGMP requirements applicable to the other constituent part. In particular, the compliance with either the cGMP regulations for drugs at parts 21 CFR parts 210 and 211 or the quality system (QS) regulation for devices at part 820 which are 21 CFR part 820 will satisfy many, though not all, of the cGMP requirements applicable to both drug and device constituent parts, said the regulatory authority.