The life science industry is one of the most closely regulated sectors of the global economy. We must be grateful for this fact as we all rely on timely, local access to safe and effective medication for our well-being.Clearly this does not only require extensive R&D, but also thorough testing as well as a system of checks and balances. After all, in an industry that generates well over US$ one trillion in annual revenues, there are vast monetary incentives at play.
The result is the regulatory segment of the life science industry. It represents the interaction between national regulatory authorities, such as the US FDA on the one hand, and thousands of enterprises active in the production of pharmaceuticals, biotech solutions, medical devices, veterinary medication and active pharmaceutical ingredients on the other hand. At the heart of the regulatory life science industry, lies product marketing authorization, as applied for by industry and granted or rejected by regulatory authorities.
The complexity of this process, if seen on a global scale, is enormous both on a qualitative and quantitative level: A regulatory application for a drug may consist of tens of thousands of pages, outlining comprehensive administrative and prescription information, product summaries, quality documentation as well as the corresponding non-clinical and clinical trial studies.
If one is to gauge the regulatory activity volume of a top 30 pharmaceuticals company, one needs to multiply a portfolio of hundreds of drugs with the number of relevant export markets where regional authorities will review individually as well as the different types of submission requirements. The latter will vary according to the product life cycle on the one hand and regional requirements on the other hand. The result is that millions of regulatory processes need to be managed by finite resources, in order to get sometimes life-saving medications to market. Time is critical, not only because a patented blockbuster drug which is not on the market, may represent an opportunity cost of millions per day, but more importantly because lives may literally be at stake.
In this digital age, it is therefore hard to believe, that there are still vans full of paper, driving from industrial headquarters to regulatory authorities, delivering regulatory submissions. Besides the above mentioned human and opportunity cost, the environmental footprint as well as downsides in regard to review and storage efficiency are considerable. On the upside, worldwide standardization of regulatory processes, as driven by organizations such as the International Conference on Harmonization (ICH), have allowed e-regulatory solution providers such as the LORENZ Life Sciences Group, to support the regulatory segment of the life science industry in generating considerable efficiency increases through submission management software systems. The US, Canada, the EU, Japan and Switzerland spearheaded the introduction of the eCTD (electronic Common Technical Document) format and regions such as the GCC (Gulf Cooperation Council), Australia, New Zealand and South Africa, are in the process of following suit.
Many companies within India’s vibrant life science industry have also invested into in-house eCTD solutions, as a pre-requisite for gaining product access to mature markets, where eCTD submissions are increasingly becoming a requirement. The question remains why India has not joined the eCTD evolution. This is clearly not due to organizational inertia: India’s Central Drugs Standard Control Organization’s (CDSCO) track record between 2009 and 2013 has been impressive: The agency strengthened both its manpower and infrastructure substantially. WHO audits in 2009 and 2012 confirmed the positive development of the CDSCO.
The answer may therefore lie in considerations regarding the structure of the Indian life sciences market. Besides successful multi-nationals, such as Dr. Reddy’s, Akorn or Cipla, India contains several thousand small- to mid-sized companies, who may find it challenging to invest in full-fledged enterprise submission management software. LORENZ Life Sciences has therefore designed docuBridge® ONE, an eCTD solution specifically geared towards the small and medium-sized players with few regulatory associates. The product is currently designed for submissions to the US, EU and Canadian markets, but if the Indian regulator were ever to introduce an Indian eCTD version, docuBridge® ONE would be sufficiently affordable for the entire market to go electronic. As the product is available via online download, this could literally happen overnight.
(The author is ,VP Corporate Development, LORENZ Life Sciences Group)