To strengthen the relationship with the chemical industry, we will have to expand our base in India through capacity building and vertical integration, basically decoupling from China. That is where the chemistry development and R&D has to happen, says Prashant Sharma, Chief Technical Officer, Cadila Healthcare Limited.

 

Sharma says “A lot of KSMs that we buy are dependent on advanced intermediates from China and therefore we reduce the steps in our own manufacturing. If the KSM manufacturers invest more in R&D, they would be able to decouple from China and be able to make these advanced intermediates, starting from basic KSMs in India. Setting up capacities in India such as advanced formulations such as sustainable release products end up depending on excipients a lot of which are imported. There is a class of excipients, one from abroad and one made in India and how we harmonize their use in manufacturing in terms of quality and global approval. However, when we talk of decoupling with China, it doesn’t help when we then couple with another country. I would expect that the chemical and excipient industry make use of schemes like PLI to invest in building capacities for this nation. There is a great scope of joint partnership between the chemical and pharma industry to develop vendors."

 

Prashant Sharma along with other pharma industry leaders deliberated on the ways to strengthen correlation between chemical and pharmaceutical industries at the ‘NextGen Chemicals & Petrochemicals Summit 2021’ organized by Indian Chemical News on October 7-8, 2021. The panel discussion titled as ‘‘Strengthening correlation between chemical and pharmaceutical’, was moderated by Pravin Prashant, Editor, Indian Chemical News.

 

“If we look at interlink between the two, pharma is dependent on the chemical industry for many finished products. Among these are active pharma ingredients (APIs), excipients and packaging material for which industry has been depending on imports from China. In the case of packaging material, we have less dependency on China for plastics and aluminum. As far as excipients are concerned, these are vegetable based and animal based and thus less dependent again. In the case of API, we have starting materials, other chemicals and solvents. Earlier most of the KSM used to come from China but a lot of ancillary industry has come up in India in Hyderabad and other regions. There are many small players who have chipped in but then again they are dependent on building block chemicals from China. On solvents, there are suppliers here yet the dependency remains on China. 40 percent of our chemicals come from China and there have been production issues there due to regulatory revamp by the government. The delay in getting the material affects us badly. Since there is a lot of manufacturing in India, we must see how we are dependent on China. Production Linked Incentive (PLI) scheme is encouraging and hopefully we will be able to tap the potential,” says Rajendra Chunodkar, President - Manufacturing Operations, Lupin Limited.

 

As per Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance, there is a significant synergy between chemical and pharma industries. 

 

“We have to go back to basics and see how we can leverage the potential of two industries by together ensuring healthcare security of the nation. We cannot rely on one source of supply as we will be subject to delays and price fluctuations. We have been examining the prices of raw material and APIs for the last 18 months. Be it paracetamol, acetomycin or citric acid, there are tremendous fluctuations in prices due to factors such as high demand, supplier’s ability to fulfill it. Hence, it is fundamental to stability that there has to be a diversified supply chain.”

 

“Another important point is technology and it is not that we don’t have it here in India. We have been equipped with a lot of new technologies since 1990 but in the last 20 years, we gave away the advantage to China as their cost of power and finance is low. The environmental clearance is fast and bureaucratic control is lesser in China. The government has announced the PLI scheme and we are making APIs and many other raw materials in India. We have to think of critical ingredients such as KSM and starting material required in India as unless we don’t bring stability, we can’t bring reliability. The good part is that the government is listening and we have an ongoing dialogue on these issues. Both industry and government are committed towards self-reliance in the pharma sector. Diversified supply chain is important and as a country we are working on it, especially both chemical and pharma need to work together. API security and R&D are integral to enhance the linkages,” adds Jain.

 

“Whether APIs or excipients, these are among the key requirements for development of a formulation or a dossier and not only that but it is a key requirement in the stability and shelf life from batch to batch. That is the connection with the KSM which are the excipients or APIs. If the DMF of the ANDA has to be submitted, it is important that if there is any change in the KSM by the API manufacturer, it has to be accepted by the supplier. Equally important is the large aspect of any change in raw material to be notified to the buyer. It is not just having a quality and a new source but the API manufacturer having the sensitization to know what is going to happen. Whenever it comes to high quality formulations, we always depend upon API manufacturers, be it European or certain Indian companies have taken over the market because of this understanding and depth of knowledge that API is equally important,” says Milan Patel, Joint Managing Director, Troikaa Pharmaceuticals Limited.

 

“Most of the companies, be it chemical or CRAMS, are facing the challenges. I believe the current situation on the supply side, especially the rise in freight charges from China leads to price increase. The dependency in India is very limited and what we try to do is make the raw materials that are imported from China. There are few specified raw materials which we use as a company in our core business. We have a nucleosides business. It is an extremely critical business for us and we are trying to make it in-house. Companies like us can do it but there are many companies which may not be able to do it. If the situation continues, I think the Indian companies must come together to bring technology and government support. With the current dependency on China being more than 60 percent, it would take years to reduce it. Solutions are mostly backward integration as more than 20 APIs we see in the market will soon get off patent. Pharmaceutical companies are manufacturing many of them and it’s the time to work with larger producers and develop KSMs, intermediates, and reagents," says Dr. Hardik Joshipura, Chief Executive Officer, Innovassynth. 

 

“There is a growing trend of combining technologies, specifically for complex APIs where continuous processes are used for hazardous chemicals. Combined with other technologies like chiral compounds, this is not new and we have seen it coming more and more from industry. So, this kind of technology helps in improving the efficiency for API manufacturing. This can also be tried for low temperature cryogenic reactions. Evonik offers upto 200 cubic meter cryogenic reactors at -80 degree Celsius. We also accommodate projects at all stages. This is a need of an hour for many clients as not only does combining technologies reduce the time but also the cost. A lot of time is consumed in process development and this time can be shortened through continuous processing. This processing can be done in a container based system where total exposure to the reactor size is very low and you can actually do this in a loop based function and output can be seen quickly. This can be tested without the need for a pilot and the total cost can be reduced considerably,” says Sudhir Toraskar, Business Director - Sales and Services, South Asia, Evonik.