The self-regulation society? Consultant challenges manufacturing status quo

14-Oct-2015 - Last updated on 07-Oct-2015 at 09:33 GMT

API suppliers should be allowed to make process improvements without having to seek re-approval says consultant Girish Malhotra, who argues that the current rules create inefficiency and waste.

Under what Malhotra calls “a quite audacious” proposal, suppliers could make manufacturing changes if they can guarantee the ingredients produced are equivalent in terms of quality and therapeutic efficacy to those made using the approved processes. Any deviations would see the drugmaker banned from using the new process for two or three years.

The idea – which will be detailed in a report published at CPhI in Madrid – would replace the long-established requirement that drugmakers seek regulatory clearance for all process changes, no matter how minor, which Malhotra says is outdated and wasteful.

“FDA was created about 100 years ago to ensure product quality is retained and repeated. In early days IP protection was not strong and everyone talked and exchanged notes. For these reasons, getting to the market became a priority rather than having the most optimum process for the product. Thus the inefficient or less than optimum processes were commercialized.

“Quality was assured by repeated testing. There was and still is significant waste” he told in-Pharmatechnologist.com, adding that “as the industry exists, it will live with quality by analysis until hell freezes over.”

While Malhotra acknowledges his suggestion is a new idea for drug manufacturers, he argues that ‘continuous improvement’ has already proved effective in other industries.

Adopting the idea would stimulate the drug industry to “create, innovate, develop and commercialize improved processes” he says.

Self-regulation

But not everyone is convinced that the plan – which amounts to drug industry self-regulation – could work.

A compliance consultant we asked said: “Malhotra is proposing reducing regulatory oversight in favour of self-regulation.”

“Industry has shown that, as a rule, is it mostly unwilling to be bothered with self-regulating itself to the extent needed to ensure quality, and that being the case, regulations are the only thing that stands between consumers and harm,” we were told.

Violation of good manufacturing practices (GMP) is not uncommon, with regulatory organisations regularly sanctioning pharmaceutical firms that break the rules – Sun Pharma, Pan Drugs and Syizera are just three of the recent examples.

The consultant, who asked not to be named, said: “If this is how they [drugmakers] behave under the threat of enforcement - and even after being punished - would you expect them to be better if the threat is removed?

“Regulations are reactive, not proactive: They are usually created in response to a problem. If people were willing to drive safely, there would be no need for speed limits. If drug companies were willing to do the right thing, rather than cut corners and disregard safety of the patients, there would be no need to create all these laws.”