In the world of global pharmaceuticals, the regulations and guidelines own a special place. Apart from winnowing the best protocols from the worst ones, they provide a perfect balance to the multiplying pharmaceutical world: both in competitions and economy. Many of the students who came up with this subject in their academic syllabus are often bemoaning about this subject being boring and vast but no one really sees the beauty in it! Why should we be reading the global regulatory affairs in the first place, it’s because the knowledge of the guidelines and the regulations will keep you in the first place in your career.
Why regulatory affairs?
What does a pharmaceutical industry prioritise while producing a new product or a new chemical moiety (NCE)? If we ask this question is asked to any pharmacy aspirant, he/she will surely suggest safety and efficacy as the primitive requirement as well as the assurance of stability and purity are also equally important. But apart from that what is the first priority of any pharmaceutical establishment? You should be honest enough to tell money in here. Each and every plant came to existence with a motive of being a fantastic fundraiser where the propaganda is suggested as a noble social welfare but the background is always about the economic success and stability. In such panorama of growing pharmaceutical ubiquity, a control is essentially required to keep everything in order and that’s what regulatory affairs come into the picture.
Definition
The regulatory affairs can be defined as the interface between the pharmaceutical company and the regulatory agencies across the world. Just imagine what would have happened if there are no such interface present in the world. As pharmaceutical world provide a solid platform for the stable economic growth, we would have seen the unfair and horrendous exploitation of the pharmaceutical field which would have more focused on using the pharma companies only for money with all the possible malpractices.
The basic outline of the interface
Let’s see how we create a certain interface between the regulatory agencies and the pharmaceutical company. Purohit sir defines regulatory agency as the competent government agency which is responsible for ensuring that medicines work and are acceptably safe. He linked the agencies and the companies through the specific departments which are allotted to deal with the regulatory agencies. Pharmaceutical companies categorise the certain departments which are connected with the regulatory agencies. The departments forward the dossier towards the regulatory agencies which is known as dossier filing. The regulatory agencies inspect the dossier and if any shortcomings, they are forwarded as deficiencies to the respective regulatory departments of the pharmaceutical company.
Origin of regulatory affairs in pharmaceutical world
Since the start of the evolution of the synthetic and chemotherapeutic agents, the pharma companies are taken as the ideal investment in the economical world (though with lot of risks). But as people start investing more, they started taking the medicine preparation as a profit oriented industry which resulted in many industrial and medical tragedies in the world. The Bhopal Gas tragedy, Sulphanilamide elixir tragedy, Thalidomide disaster all are some examples and there are many more which are concealed with time. Elixir sulphanilamide when prepared by using diethylene glycol instead of propylene glycol resulted in severe reactions resulting to hundreds of deaths which urged US to forward the Federal Food, Drug and Cosmetic Act in the year 1938. This followed in India too when D&C Act was implemented in 1940. The Thalidomide disaster in the early 1960s resulted in the KAFAUVER HARRIS Amendment in the year 1962. And numbers of amendment and updates are now available with each passing year to make the regulations more precise and stringent as per the present situation.
Objectives of Regulatory Affairs
ü Efficacy
ü Safety
ü Purity
ü Stability
ü Ensure accuracy and appropriateness of the product information
Off the topic: What is the most authentic document in the world?
Ans: The most authentic document is the product label and if you want to examine the formulation and it’s similarities and differences with the standard formulation, inspecting the label and tallying it with the guidelines will be sufficient.
Why different regulations all over the world?
Why there are different regulations all over the world? Why they can’t be compiled to make a single regulations. It’s desire of almost all the students but there are certain factors which are responsible for the variation in the guidelines in different corners of the world.
· Climate(Temperature and humidity)
· Genetic differences
· Cultural segregation of the world
· Socio-economic causes
· Political causes
What roles do the regulatory professionals carry out?
§ Act as liaison with the regulatory agencies
§ Preparation of organized and scientifically valid NDA, ANDA, INDA, MAA, DMF submissions
§ Ensure adherence the compliance with all the applicable cGMP, ICH, GCP, CLP guidelines, regulations and laws.
§ Providing the expertise and regulatory intelligence in translating regulatory requirements into practical workable plans.
§ Advising the company on regulatory affairs
This is the first introduction class given by Dr.R.N.Purohit sir for the Drug and Regulatory Affairs as an elective subject for our Masters in Pharmacy course and this article will be followed by the other lectures summary from him on the coming days.