PHARMACOVIGILANCE: ONE OF THE FASTEST GROWING INDUSTRIES:

The Department of Pharmaceutical Technology of Maulana Abul Kalam Azad University of Technology (MAKAUT), West Bengal, India will be organizing a Webinar on "Future Prospects of Pharmacovigilance & Drug Safety" on 11.07.2020. The eminent speakers were: Hon'ble Vice Chancellor of MAKAUT Prof. (Dr.) Saikat Maitra, Mr. Saikat Biswas Global Head-Life Sciences Digital Operations of Wiporo Ltd, Prof. Pranabesh Chakraborty Director-Food, Pharmaceutical and Medical Science  & Technology, MAKAUT, WB. Dr. C. M. Hossain HoD-Department of Pharmaceutical Technology, MAKAUT, WB, coordinated the session. 

Dr. Hossain warmly welcomed the speakers of the webinar and pointed out how important pharmacovigilance is for the new students. He mentioned that this webinar is a platform, where they can have a glimpse of the present scenario of the pharmaceutical industry, specially in the area of pharmacovigilance. 

Mr. Biswas started his deliberation by expressing his gratitude to MAKAUT and sprcially the Hon'ble Vice Chancellor of the University for inviting him in this webinar. He gave a vivid insight to pharmacovigilance and its future prospects. He said, " Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine related problem. It is an organized approach of identifying the hazards associated with pharmaceutical products and minimizing the risk of any harm that may come to the patients. It is very important for every pharmaceutical company to conduct a comprehensive drug safety pharmacovigilance audit and make sure that they comply with the present worldwide laws, regulations and guidelines. In the late 1950s and early 1960s thalidomaide, a drug for treating nausea in pregnant women was administered without any safety assessment. It led to a great tragedy, resulting in the death of 2000 children and approximately 10000 children were born with severe malformities like phocomelia with fin-like hands grown directly on shoulders, stunted or missing limbs, deformed eyes and ears, ingrown genitals and even absence of lungs. This tells us how important pharmacovigilance is. Another instance od such safety assessment negligance was seen in Philippines  recently in 2019. Nearly 600 people, mostly chlidren, who received a dengue vaccine died as a result of which it had to be banned. The FDA declared the recall of Lipitor generic by Ranbaxy as Class II, which signifies a remote chance of severe adverse consequences or death due to the product flaw.Thus, two aspects are very important in Pharmacovigilance: 

• Electronic Data Capture(EDC) and Clinical Data Repository, which is more efficient than paper based data capture.
• Safety Data, which must be analyzed to confirm the clinical significance of a pharmacovigilance signal generated by data mining.

• MedWatch: It is the FDA Safety Information and Adverse Event Reporting Program, the FDA gateway for clinically important safety information and reporting serious problems with human medical products.
• CIOMS (Council for International Organizations of Medical Sciences): This form provides a standardised format for the reporting of suspected adverse reactions to any particular medical product.

There are various services in pharmacovigilance like safety assurance, quality review, MR activity for death and other cases, aggregate reporting etc. All these services offer a vey promising career for the present students. It is one of the fastest growing industries in the field of life sciences. Robust IT solutions and advanced systems can help pharmaceutical companies monitor drug safety during the research, trial and post-launch period. AI can bridge the gap between traditional services and fast paced market expectations.. It has the ability to assimilate large amount of cloud data and correlate with genetics and disease occurance. Automation enables increased labour efficiency by removing clerical tasks in non-value adding processes. Data Analytics tools has increased the speed of signal detection, which essentially seeks information on drug, be it adverse or beneficial.

A few years back paper based clinical studies dominated the industry, while now it has been restricted between a few industries. Day by day everything is becoming electronic. Some comanies have their in-house data base. So technology is taking over and every aspect is getting automated.Pharmacovigilance is becoming more and more dependent on big data technologyto assimilate end to end information as well as ensuring data integrity and security. Cloud technology has started to integrate systems for all stakeholders such as healthcare providers, physicians, consumers, patients and researchers. The industry is interested in cutting short the cycle time of processing a case, drug delivery time etc.Innovation is the key to this and innovation and automation together will drive the industry in future.

Pharmacovigilance Industry is looking for:

• Graduate and PG in Pharmacy/ Lifesciences
• HCPs, Nurses, MBBS Degree Holders, Alternate Medicine Degree Holders
• Qualified, Competent and Committed people
• People with hands on experience 
• People with good Communication skills and right attitude."

Dr. Chakraborty briefly summarized the talk of Mr. Biswas and expressed his gratitude for such a nice illustration. On behalf of the webinar team he expressed his warm and hearty thanks to the Vice Chancellor, who encouraged and inspired through his broad spectrum of thoughts. He also mentioned that MAKAUT, WB will organize 

• 3 months crash course on Pharmacovigilance in collaboration with Wipro
• 1 year course on Pharmacovigilance in collaboration with Wipro
• Course on Pharmaceutical Data Analytics 

The in-house courses offered by the Department of Pharmaceutical Technology, MAKAUT, WB  presently are:

• M.Pharm Pharmacology
• M.Pharm Pharmaceutics

Finally, Vice Chancellor of MAKAUT, WB, Prof.(Dr) Saikat Maitra concluded the session by proposing to arrange several workshop and training programmes by taking advice from the experts. He said that Pharmacovigilance is a fascinating career as this country's public health care system requires more such professionals.