Regulatory Environment

It is important to recognise that the pharmaceutical industry is one of the most regulated industries globally. Be it in research and development of new products and therapies, development of generic products, conduct of toxicity studies on animals, conduct of clinical trials on patients or healthy volunteers (for some generic products), manufacturing and distribution of products - all these aspects are governed by stringent regulatory guidelines. The regulatory oversight has helped the industry broadly standardise its product development pathway, improve safety and efficacy, and improve Good Manufacturing Practices. While regulatory guidelines are quite evolved in the small-molecule category, in many countries the guidelines for biosimilars, stem-cell therapies and gene therapies are still evolving.

The USA, which is the largest market for pharmaceuticals, is also the largest generics market. The introduction of ‘The Drug Price Competition and Patent Term Restoration Act’, better known as the HatchWaxman Act, enacted by the US Congress in 1984, brought about a transformation in the generic pharmaceuticals industry in the USA. Today, about 90 per cent of prescription pharmaceuticals in the USA are generics.

Regulatory oversight, through review of generic dossiers filed for approvals, inspection of clinical and manufacturing facilities and review of post-approval changes, have become increasingly stringent over the years. USFDA has recently notified that, just like the un-notified inspection of pharmaceutical manufacturing facilities in the US that they conduct, they would be conducting similar un-notified inspections of foreign manufacturing facilities too from now on. This forces pharmaceutical companies to be audit ready on a 24X7 basis.

The development data that needs to be submitted at the time of filing application for generic product approvals have also gone up substantially. Today, regulators insist on Design of Experiments-based development to ensure that critical process parameters and their allowable ranges are well defined during product development itself. Process validation requirements too are evolving rapidly. The concept of continuous process validation is now being encouraged to ensure that the manufacturing processes are robust.