Interview Session with Lathalu Krishnamoorthy, the Quality Manager of ICM Pharma Pte Ltd
What current issues are impacting your industry?
With rapid emergence of Generics, the competition levels are deepening year after year, not just at formulations level, but into the Active Pharmaceutical Ingredients [API] as it has a direct bearing on finished product costs. While stringent regulatory standards govern the pharmaceutical industry as a whole, in recent years, the API industry is also getting higher on the radar. While this is a welcome move, it is more like a wake-up call for those API manufacturers who were more centric towards the active component, who shall have to focus more on the stringent needs such as impurity profiling, characterization that may need further processing steps etc.
Most of formulators are not truly vertically back ward integrated & have to rely on external API supplies. Any impact faced by the API producer during audits, shall have diverging impact on formulators. Firstly, it is a lengthy and costly process to validate and approve each API source. Any hiccup in API supply might lead not just to instant stock out situations, but also risk market recalls. If the project involved the tender contracts of finished formulations, it often results in penalties and risk of being black listed. It is strongly advisable to the generic formulator industry to lay extra caution towards quality compliance and supply competence of their API source, besides their own internal risk assessment and pricing strategies during such business opportunities.
What are the current developments in the cleaning validation protocol for cosmetic products?
It is imperative that cosmetics are gaining prominence in health care industry with its potential increase in regulatory oversights. In the past, cosmetics were treated as beautifying products but now cosmetics are considered to have an interactive role with the skin which has a pharmacological impact and the Companies who manufacture, import and sell cosmetic products are directly responsible for the safety of the products. Some countries like Malaysia insist for registration of cosmetic products to emulate countries like Vietnam instead of just listing based on ingredients.
Cleaning validation is a well-established process in the Pharma industry. No re-inventing the wheel, the logical flow essentially remains the same in cosmetics also. Protocols are designed to ensure avoidance of cross contamination from the previous product, removal of traces of cleaning products used in cleaning process and making sure the equipment and environment is free from microbial contamination.
Growing emphasis is laid on steroidal preparations and cosmetics that have ingredients of biological origin.
What is the biggest challenge you are facing in your function?
The interruption in any material supply triggers the needs to do a risk mitigation of adding additional API and key excipient sources. Each change, be it from material aspect or machine aspect, often results in a need to do complete development study that may include Validations, Stability, variation approval processes. Would term this more as a positive / welcome challenge, and yes, is a cost and time intensive phase for the formulators. However this is a critical need so as to ensure safety and efficacy of the medicine that is consumed. Opportunistic players shall perhaps slowly get phased out, there by leaving the seriously committed companies to survive and grow in the highly competitive healthcare sector.
Your views on regulatory and compliance matters that are important to adhere
One thing good about regulatory standards is that it is never ending and always evolving. Manufacturing companies of both the ingredients and fully formulated products in each country are being challenged and impacted with responding to its ever-changing regulatory environment.
Just like Quality comes at a Cost, so do the factors related to regulatory and Compliance. Manufacturing firms across the globe are compelled to alter their Compliance practices to conform to changes in the regulations. Especially allergic reaction of any product on a particular person, can trigger and out roar, social media blast, damage to the reputation etc.
Firms can use their stringent policies on “Regulatory & Compliance” & records of implementation there-of as a tool to circumvent such situations. For instance, cosmetic manufacturers must place greater emphasis on the on the safety of their personal care product ingredients, inspection of facilities and records, and development of good manufacturing practices.
As a precaution, Companies that sell cosmetics must assess which specific standards apply to its products and what it must do to ensure that it is fully compliant with global existing and emerging regulations.
Finally, approval to market and sell in a particular country. It is interesting to see that, some countries have made it mandatory to make a Technical Data pack and file with Government Health authorities for product registrations.
What are the new investment trends in the industry?
With a thinning up of the NCE pipeline (New Chemical Entity), focus is now more on the biotech NBE (New Biological entity] products. Mono clonal antibodies and several other such pharmacologically significant products do have their patent protection era. However, post the patent protection phase, alternatives known as “Biosimilars” are making vast inroads. Quite extensive investments are seen in both research and production centers of this sector. Investments into “In-Licensing” deals have greatly enhanced to synergize partnership by and between technical strong companies synergizing with the strengths of commercially strong companies in the market. This is helping to bridge the geographical distances and get closer to the market through such strategic collaborations.
How should governments adjust their regulatory priorities to attract more investment?
To attract more investments into local soil, some preference and prioritization to local produce could be an attractive option besides the encouraging schemes to exports. Supply contracts towards the procurement projects, can have some share allotted to the local industry, be it as a secondary vendor BUT with assured parity in QUALITY.
Where in the industry do you see growth opportunities?
Along-side of BIOTECH based drug formulations which have growth opportunities, we do see that in case of the conventional generics, the future shall lay more on the “Innovative Drug Formulations” For instance, Soft gel formulations with modified / extended release, acid resistant enteric coated products, are making inroads in place of the old conventional tablets and capsules for some ever-green molecules. Product life cycle management through value based formulation designing is gaining prominence. While pure generics continue to offer opportunities in the institutional sector, the “Branded Generics” shall continue to offer growth in the private sector. This is more predominant in case of MNCs that are moving into generic space leveraging their corporate brand equity.
What do you wish to take away from this year’s ISPE Conference?
Getting an opportunity to gain insights and deeper knowledge from experts in understanding the trends and developments across the globe will give a paradigm shift in the knowledge base at the regional level. Most of the time, it’s not what is happening around us, it’s what is happening across the industry globally makes the change management lot more efficient.
Your message to the industry about ISPE conference
ISPE is undoubtedly a one stop centre for excellence that brings together the industry and the regulators, conducting highly efficient and effective workshops attracting the best of the talents from the industry. I think ISPE conferences are beyond the business initiatives that sincerely work towards enhancing the knowledge level of health care industry. Learning and sharing, all under one roof, with a sense of fulfilment is a nice feel and a professional value add. I request the industry to continue to support such conferences through active participation. Though we work for a organization, it reminds all of us that we are serving the “Industry”, the Health care industry.
ICM Pharma Pte Ltd
Don’t miss your chance to hear from Lathalu Krishnamoorthy at the upcoming ISPE Conference & Exhibition happening from 21-23 August 2019. She will be a speaker in the session of Cleaning Validation for Cosmetic Products on Day 2 of the Conference.
This year, ISPE has been given a major upgrade with a stellar lineup of regional and international speakers; with up to 6 conference tracks to choose from, along with 2 workshops and new activities from 21-23 August 2019 at Suntec Singapore.
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