Dr. Sanjay Bajaj – Speaking to Pharma Insider

Name: Dr. Sanjay Bajaj
Designation: Managing Director

Organization/Institution: Select Biosciences India Private Limited

Qualification: M.Pharm, PhD, MBA

Biography:

Dr. Sanjay Bajaj is the Managing Director of Select Biosciences India Pvt. Ltd. He is a graduate in Pharmacy from DIPSAR, Delhi University, postgraduate in Pharmaceutics from UIPS, Panjab University, Chandigarh and doctorate from USCT, GGS Indraprastha University, Delhi and also MBA from IGNOU, Delhi. He is a recipient of IPA Medal for being Delhi University Topper in the year 1989. He has worked in Pharmaceutical companies like Panacea Biotec and Win Medicare. Later, he joined teaching and research and was Professor and Principal in Swami Vivekanand College of Pharmacy, Banur, India. He has developed several novel mathematical tools for their potential application in drug discovery. He has several publications, book chapters and presentations at national and international level. He is a Life member of IPA, APTI, IPGA and IHPA.

Dr. Bajaj is having experience in diverse fields including Academics, Research, Product Management, Sales and Marketing, Consultancy, Administration, HR management and Event management

  1. What is the main advantage of attending a Pharma event?

Pharma Industry is dynamic in terms of technology, knowledge and regulatory requirements. The drug molecules, molecule characteristics, formulations, delivery systems, excipients, analytical instrumentation and methods, stability issues, approval processes and regulatory requirements keep on changing. Therefore, it is important for each and every scientist to keep oneself updated with the latest developments. It is also important to know what the academic scientists are doing because it might give them several new ideas to solve specific problems. Moreover, these events provide excellent networking opportunities with other scientists including overseas scientists which undoubtedly offers several advantages.

  1. Why do you think frequent Pharma Conferences/events must be organized?

Pharmaceutical Industry Scientists perform a lot of activities depending upon their experience and hierarchical level. Similarly, diversity exists between and also within the organizations for example Organization manufacturing for local market and for US/Eurpoe markets etc, small molecules and biologicals, oral solid dosage forms and parenteral products etc. Requirements for scientists of different level& department is mostly different. Therefore, there is a strong need to organize conferences and training courses catering to the needs of each class of scientists. Moreover, the industry is scattered and it may not be possible for all the scientists to attend a conference at a given time and location. Therefore, more focused events should be organized so that there is an opportunity for the scientists to pick and choose the event of their interest while maintaining a balance between their official responsibilities and taking out time for updating their scientific knowledge. Management of Pharmaceutical companies should also keep out some budget for employee development and allow them to go and attend such events, which is ultimately going to benefit their own organization.

  1. Do you think Pharmaceutical industries are lagging behind when compared to other industries in terms of quality?

I do not agree that the pharmaceutical industry is lagging behind other industry in terms of quality. The quality of products has always been of prime concern for the pharmaceutical industry primarily because of statutory requirements laid down in Drugs and Cosmetics Act 1940 and also because of international regulatory organizations like FDA/MHRA/WHO/EMA etc. A very large number of pharmaceutical companies are exporting finished products to various countries after getting due authorization from the regulatory agencies. Most of them have their production facilities approved by FDA and WHO etc. Their existence in the international market is itself a testimony of their quality. Every industry has some defaulters and so is pharmaceutical industry. Some of these defaulters become so because of their carelessness and some other due to their ignorance. In both cases conference and training courses a definite eye openers.

  1. How far do you think, the scientists will be able to implement the points that they have learned during this event?

Learning and Implementation are 2 different steps which complement each other but at the same time are independent of each other. While obtaining and refreshing knowledge can be considered external or additional by an organization, implementation decision is governed by several internal factors where the scientists, who has been trained, may or may not have control. However, an up-to-date and well trained scientist is always an asset to its organization and can play a role whenever required to do so. The points discussed in these conferences are very much implementable and rather are already in use in some pharmaceutical companies. Most of the speakers were senior scientists from pharmaceutical companies and have shared their practical experiences and not theoretical aspects.

  1. Which aspect is more important in the pharmaceutical industry apart from quality?

Quality, Quality and Quality is the single most important thing for pharmaceutical industry. However, more than quality, what a scientist must understand in pharma profession is “Patient Safety”. One needs to understand the impact of his/her work on the health of very large number of people.  If one understands this, Quality becomes secondary. Secondly, integrity is another most important thing for pharmaceutical industry. A scientist working at any level, must maintain highest level of honesty and integrity when it comes to generation of experimental results as well as maintenance and submission of records thereof. We are aware of many such incidents where negligence, deliberate or unintentional, has resulted in loss of human life.

  1. Which new technology you are using in your industry that makes you superior?

We continuously strive to pick up hot topics in pharma and biotech research for organizing conferences and training courses. For example-We are organizing Microfluidics and Lab-on-a-Chip conferences for the last 4 years and now FDA has approved this as an acceptable technology and has allowed microfluidics based point-of-care (POC) devices for use in clinics. Similarly, we are the only company organizing Flow Chemistry related conferences and training courses for the last 5 years which is a part of Continuous Manufacturing, another hot topic.

  1. In today’s scenario as many pharmaceutical start-up companies are growing, do you think there is a risk of quality taking a back step in the manufacturing process?

My personal opinion is that the today’s Start-ups do not pose any risk to quality of pharmaceuticals because any start-up deciding to begin today will be much more aware, technology savy and quality conscious when compared to the older companies with set style and standard procedures. No start-up will be able to survive and grow without taking quality at the vanguard and as a part of primary marketing strategy.

  1. What is your opinion about the statement “generic drugs are as effective as brand-name drugs”?

In my opinion, Generics drugs should be and can be as effective as brand-name drugs. Many generic drugs from some popular companies are claimed and found to be as effective as their own brand-name drugs. However, it is unfortunate for our country that this is not true for all generics. Majority of generics, though confirming to IP standards, are not having same quality and efficacy as the major branded drugs.

  1. How will formulation strategy impact the overall Drug development?

Formulation strategy determines the effectiveness of the drug when administered as well as ensures that the drug remain stable and effective throughout the shelf life of the formulation. Formulation development begins very early during the development of a new drug molecule. Understanding developed during the initial formulation related studies, sets a benchmark for future drug and formulation development. A well investigated drug molecule and carefully crafted formulation strategy are keys to development of quality medicines.

  1. What according to you is the major difficulty in manufacturing soluble or insoluble drugs?

Solubility is an inherent characteristic of a drug molecule. Drug molecule or the salt form or the polymorphic form which finally comes to the market results from all possible iterations during the lead optimization stage. Hence a formulation scientist has to live with the available drug molecule form and its solubility. A formulation to be effective, has to overcome these solubility related challenges which are there with both the soluble as well as insoluble drug molecules. Once an effective and stable formulation is there, scale-up issues are to be resolved before a batch goes in for actual manufacturing. Although it depends upon the individual drug molecule and its dosage form, but in general insoluble drugs are more difficult to formulate when compared to soluble ones.

 

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