Global leading material sciences company Dow Chemical has worldwide presence including India and continuously it is expanding it. Also being a active member of IPEC it is playing important role in standardising regulation for excipients. Dago Caceres, Global Pharmaceutical Marketing Leader Dow Chemical Company shares the company’s role in IPEC and its Asia pacific plans with Usha Sharma
Tell us about Dow Chemicals’ journey and experience in India?
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| Dago Caceres |
Dow Chemical International is (Dow India) leading material sciences company that connects science with innovation to create sustainable solutions for human progress. Headquartered in Mumbai, Dow India has four manufacturing units and two established Centres of Excellence and sales offices across the country. Dow India is committed to consistent growth through its expertise as a science and technology leader and its experience as a leading chemical company exploring sustainable solutions in areas of health and nutrition, infrastructure, transportation, energy, and consumerism. To mention about our journey in India’s pharma formulation market, Dow Wolff Cellulosic’s Pharma focus is to provide Indian pharma producers’ sustainable and innovative solutions for their formulation needs in the generic and complex generic Indian pharma market. Solutions which bring meaningful advancement to the industry and ultimately contribute to improving patient health; be this through novel drug delivery systems that minimise health risks of patients, or by lowering cost to make medicines more widely accessible. Our customers seek new technologies and designer solutions for a competitive edge. We at Dow are committed to delivering these kinds of tailored solutions to our customers. Methocel Premium VLV is one such solution. It helps to reduce the costs associated with tablet coating, drug layering, and fluid bed granulation during the drug product manufacturing process, without compromising on quality, as per the feedback we have received from the market.
What are the company’s corporate plans for Asia Pacific?
As the generic pharma industry competitive climate becomes more complex, formulation scientists are faced with an ever-increasing challenge to develop solid dosage formulations properly and quickly. Particularly in India, formulation scientists are faced with the formulation strategy problems of Para III and IV drugs; an issue which can be solved by different approaches during pharma product development working with Dow. Our local, scientifically-advanced customer application development centre at Mumbai, supports our customers in the areas of controlled release and immediate release technology. Our three main objectives are customer intimacy ability to respond to customer unmet needs faster with meaningful solutions, support our product offering by closely working with customers on their key projects and align our resources/ expertise with a fast growing economy that has significant expertise in the pharma area. We are committed to discovering new approaches for drug delivery in the region that help our customers create high-value products which brings people healthier lives.
What is Dow Chemicals’ role as a member in the The International Phar-maceutical Excipients Council (IPEC) Federation?
Dow Chemical is a member of IPEC as are many other excipient makers and users. As all other members, our role is to develop, implement, and promote voluntary guidance and other programmes for the pharma companys’ that are designed to ensure excipients and related components in finished drug products meet only the highest appropriate standards for quality, safety, and functionality throughout their manufacturing process.
What are the global issues that IPEC has identified and how will they be tackled by the federation in the future?
IPEC is the premier trade association focused on excipient quality and safety. The IPEC Federation brings together representation from all geographic IPEC groups to determine priorities on which to focus. Some current key areas of focus include metal impurities, atypical visible particles, quality by design, significant change guides and validation. These and other topics like them are tackled through the collaborative effort of committees of excipient makers and users in the development of science and risk-based guidance for the industry.
There was a plan to set up an Indian Chapter of IPEC. Could you please share some details on this development?
India has a presence of both excipient makers and users. Any world geography with such a presence can and should charter an IPEC chapter to enable global visibility of geographic issues where these arise but most importantly to work with makers, users and geographic regulatory entities to globally harmonise requirements for excipient makers and users whenever possible.
Besides the US, which are the other countries where IPEC has its presence?
As far as I know, IPEC has presence in Europe, Japan and China and is working with industry and regulatory entities in emerging geographies such as Brazil and India.
What are the prerequisites for becoming a member of Indian IPEC?
Anyone who has an interest in excipients quality and safety can be a candidate of IPEC member. Excipient makers, users, consultants who work closely with either makers or users, academia, etc. are all members of IPEC organisations around the world.
Do you have any plans for collaboration with Indian regulatory bodies?
Dow works with our customers to assist and provide solutions where possible. Our close involvement with IPEC has increased our ability to assist customers navigate through some regulatory processes. The IPEC trade association would likely collaborate with the Indian regulatory bodies in much the same way as in other countries/ geographies which is to highlight issues and seek science and risk-based solutions with patient safety as the underlying principle.
Indian regulators are making the existing regulations even more stringent. What are your views on this issue?
The ultimate goal of any regulatory authority, excipient maker or user should be to develop science and risk-based industry guidance with the goal of protecting patient safety. However, the ultimate goal of protecting patient safety becomes increasingly difficult when each country or geography develops their own unique regulations. Wherever possible, we should be seeking to harmonise requirements on a global basis and only look to develop local regulatory differences when the globally harmonised approach would not protect patient safety.
Who are your competitors in the domestic market?
Dow participates in the pharma market with multiple areas of solutions; depending on the specific segment we are talking about we have different competitors. In the case of cellulosic derived products, we have both multinational competitors as well as regional ones. We believe that science-driven innovation will give us the edge to continue to be the leader in the markets we compete in. Hence all polymers competing in our addressable market we consider them as our competitor.
