Speciality Chemicals Magazine MAY / JUN 2022 | Page 28

PHARMACEUTICALS

Table 5 - Annual production & hours needed for formulation

Shutdowns could result in temporary drug shortages . Current manufacturing practices will have to be changed and this could take time . All of the necessary equipment and tools are available and in use . Their use will have to configured and practised differently to ensure there are no shortages . Re-learning would be necessary . ^{2 , 12} Another , possibly critical , question could be ‘ Do we have enough trained chemical engineers who could take on the task and meet the posed challenge ?’ If companies adapt different business models and manufacturing methods to meet the environmental challenge , the biggest hurdle would be the regulatory bodies who will demand that every new process or method be ( re- ) approved before it can be commercialised . ¹³ Regulations will also have to be changed . This could take a long time as the regulators do not exactly know what is needed . It is ironic and absurd that the FDA and ICH have been through every means possible in pushing the pharmaceutical industry to change its manufacturing technologies and methods when most people from these institutions have no or minimal experience in developing and commercialising processes . ¹⁴ It is also ironic that none of the changes being demanded address global warming .

Omeprazole Metoprolol Modafinil Current number of API sites 94 29 51 Current number of FDF sites 768 70 338 API production , kg / year / plant 23,234 49,086 6,699 Hrs . for 100,000 Tablets / hour / plant / year .

711 4,067 51

In addition , it is likely the institutions lack understanding of pharma ’ s business strategies and models . Most regulators do not have enough staff familiar with chemistries and manufacturing practices or the business models and the impact of regulations . Regulators have to rely on the information provided by the filing companies , but its acceptance could be difficult . If the efficacy of every manufacturing change has to be demonstrated and approved , it would take long time for the industry to reduce its E-factor emissions . Recently , the Department of Health & Human Services ( HHS ) launched an office to treat climate change as a public health issue . ¹⁵ This is basically a manifestation of FDA ’ s , HHS ’ s and ICH ’ s lack understanding of pharmaceutical manufacturing processes , emissions and their impact on global warming .

Outlook

Current time delays for approval will have to be changed . In addition , the regulatory bodies , considering their current modus operandi , do not have the staff that can react and rationalise manufacturing and approval practices . Producers will have to take the responsibility of making sure that their products meet the established drug performance and quality . If the current practices are not simplified , the approval processes will be extremely disruptive to the supply chain and shortages could result . If pharmaceutical manufacturing , including APIs , biotech drugs and FDFs , wants to participate in reduction of global warming , every organisation involved will have to participate . Regulations and patent laws might have to change . PBMs and every intermediary will have to reconfigure their business practices . Many would raise drug prices . Alternatively , drug distribution through direct marketing to patients might have to be rejuvenated . For pharma producers to achieve their net zero goals , API and biotech manufacturing and their formulation technologies will require re-engineering and alternative application of chemistry and chemical engineering principles . In addition , regulatory conformance and methods would require re-engineering . These tasks will not be easy – and achieving net zero and addressing global warming will be made harder by political and social interference . We need to overcome that so that our future generations will be proud of what we accomplish . •

Girish Malhotra

PRESIDENT

EPCOT INTERNATIONAL k + 1 216 223 8763 J girish @ epcotint . com j www . epcotint . com

28 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981