Page 174 - CW E-Magazine (17-9-2024)

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from India was banned in the first decreases, India should relook at C1 chemistry and their recent are taken to boost this industry by capabilities and properties. Although that can improve transparency and
half of 2020. establishing large-scale fermentation importance in pharma industry technological interventions. By secondary in nature, their addition collaboration between academia and
facilities. In India, there is need to develop bringing new fermentation strains, leads to significant enhancement in the industry.
Some measures have been taken the chemicals and intermediates for CRISPR technologies and provid- performance of drugs through opti-
to develop new technologies which Incidentally, the API sector has pharma industry using the stable ing special incentives, this industry mum bioavailability, increased disinte- In order to evaluate the best
could enable producers to be price been identifi ed as one of the 18 highly and abundant one carbon molecules can be revived in 2-3 years. There gration, solubility, absorption, etc. approach to a new collaboration, it is
competitive. polluting industries in India by the such as methane, methanol, carbon are specialized laboratories like IM- in the final dosage form. Not only in useful to consider examples of exist-
Pollution Control Board. At present, monoxide, and carbon dioxide. TECH, which could play major role performance, pharmaceutical exci- ing successful partnerships between
The public sector research labora- every time a company intends to Although there are many challenges in these activities. pients also help smooth handling of academia and API manufacturing
tories under the CSIR network have make a change in the product mix, it in the exploitation of the versatile C1 drugs during automated manufactur- industry.
been tasked with the development of needs a fresh approval with the pro- building blocks, it has the potential Interventions for indigenous manu- ing of final formulations.
new, green and cost-effective tech- cess taking as long as four months. to generate various acids, esters, facturing The drive to transfer knowledge
nologies for the production of APIs. And for production or addition of lactones, aromatics, acetic anhydride, Roughly 50% of all APIs imported Good capacity exists in India to and innovation from academia to in-
equipment, it could take eight months ethylene glycol, methyl methacrylate, into India feature on the National List cater to some of the requirements of dustry is increasingly fi erce, but fund-
Adoption of technology as compared or even more – again a deterrent for methyl formate, etc. – all used in the of Essential Medicines (NLEM), sig- domestic formulations market. How- ing restrictions and ongoing miscom-
to global counterparts API manufacturers. pharma industry. nalling the immediate need for self- ever, most of this capacity is aimed munications between the two sides
Since the 1980s, China has in- reliance. Various Task Forces have at fulfilling the requirements of can hamper these attempts. Universi-
vested signifi cantly to improve tech- COVID API Mission by DSIR (CSIR) Future production technologies for pointed towards the importance of re- domestic and non-regulated markets. ties will have to provide strong leaders
nological capabilities, especially in Council of Scientifi c & Industrial bulk and fine chemicals building the API industry for national Those players who are interested in with an understanding of business to
fermentation processes and common Research (CSIR) with other labora- There are several factors beyond security, access to affordable medi- high quality products with bioequiva- negotiate such collaborations, and an
utility programs. India lost large tories has developed 25cost-effective process technology that make manu- cines, and export earnings. Of the 53 lence studies (BCS 2 & 4) still use environment of mutual accountability
volumes of fermentation-based API technologies using locally available facturing APIs viable and attractive. drugs, which were given special impe- imported products. must be nurtured. One of the biggest
business including Pen G and 7-ACA chemicals for the production of APIs Over last few decades pharmaceuti- tus recently by the DoP, 26 could be challenges to academics is fi nding
to China compelled by the availabi- under COVID API Mission and is cal processes have been developed made without any biotechnological Industry-academia engagement the right, trustworthy partner to com-
lity of low-cost energy, cluster-based in the process of transferring the using chemistry in isolation and has interventions. For India, a leader in Collaboration between industry mercialize a technology which may
manufacturing approach and availabi- technologies to industries. neglected the engineering point of organic chemistry and allied areas, and academia can promote innova- have been in development for years.
lity of cheaper raw materials. To view. As a result, highly sub-optimal these will be a ‘low hanging fruit’. tion and growth in technology. A mutual appreciation for the value
provide an additional boost to the Issues, challenges & opportunities processes have been implemented with Industry partnerships are instrumental of an innovation between industry
pharma manufacturing capability, to fill the technology gap some great chemistry approaches. This A detailed analysis of these 26 in advancing research and creating a and academic partners in API manu-
China offers subsidies for effluent makes a process unviable beyond APIs, reveals that more than 50% of skilled workforce. facturing is needed.
treatment plants, loans at low in- Availability of basic chemicals a certain time. It is necessary to KSMs for these APIs are not avail-
terest rate, and tax holidays. As a Fluorine, chlorine, bromine and have a unifi ed and highly networked able in India and are being imported. Collaborations with institutions Policy recommendations
result, China has been able to host iodine form an important group of approach that allows chemistry and For example, for the synthesis of like National Institute of Pharma-
complex multistep manufacturing reactive elements, known as halo- engineering developments to work Dexamethasone and other steroidal ceutical Education and Research Support for adequate infrastructure
plants, which produce APIs in large gens. Chlorine chemistry is essential together all along the process. drugs, KSM like Diosgenin is mostly (NIPER), Council of Scientific and To boost manufacturing of APIs
quantities and at a much larger to the vast majority of top-selling imported. A simple intervention by Industrial Research (CSIR) labs and in the country, it is necessary for
scale than their Indian counterparts. pharmaceuticals. Similarly, fluorine Fermentation technology the government to encourage grow- universities are needed to improve the government to develop adequate
Chinese fermentation tanks have also plays an important role in the India was once very strong in ing of plants which produce Dios- process technologies. infrastructure and come out with in-
5-10 times more capacity than drug industry. In general, four out of fermentation technology. But after genin will be an easy way to acquire centive schemes to encourage more
average Indian tanks. To further 10 drugs require fl uorination. In fact, the Drug Price Control Order self-reliance in cortico-steroid series Academia can play a major role investors. The major issue facing
improve efficiency and reduce idle in recent years, a growing number of (DPCO), which was initiated in 1995 of products. Similarly, encouraging in fostering research in collaboration API manufacturing units in the coun-
capacity, in 2019, China launched blockbuster drugs developed glob- by the government, Indian compa- bulk chemical industries to build with industry. While there are more try today is related to lack of infra-
a new plan to develop 20 ‘shared ally like analgesics, anaesthetics, nies turned to China for imports, capacities around petroleum refine- than 200 academic institutions facili- structure and lack of support from
manufacturing platforms’ by 2022 antibiotics, anticancer agents, anti- as APIs were cheaper there. This ries to produce aromatics will bring tating research, rate of commerciali- the government. Government sup-
through strong innovation capabi- viral drugs and anti-HIV treatments, continued for 15-20 years and now down the cost of some of the essen- zation continues to be lower than port for R&D to reduce the import
lity. These would be turned into etc. contain fluorine atoms because businesses are habituated. tial chemicals. desired. Academia can complement dependency of APIs is very low and
‘key drivers for high-quality growth’ they increase bioactivity of the API, industry’s efforts by focusing on should be enhanced.
by 2025. as well as improve its stability, dis- Due to external factors influenc- Pharmaceutical excipients areas that are relevant from patient
solvability, and bioavailability. ing the supply of essential fermenta- Pharmaceutical excipients are in- servicing point of view which the Revive fermentation technology
As the power and labour cost dis- There are large deposits of fluoride tion products, such as antibiotics, it active substances that are added to industry can eventually commercia- Fermentation skills in India are
advantage between China and India salts in China, compared to India. is imperative that special measures drug formulations to improve various lize. There is a need to create forums almost totally lost, except in the

174 Chemical Weekly September 17, 2024 Chemical Weekly September 17, 2024 175

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