Why are Regulations & Guidelines necessary for Drug Development & Manufacturing?

01 March 2022 | Tuesday | Opinion

Drugs (Medicines) are chemical substances or compounds that are consumed by people to control/cure their health related troubles. Since drugs directly affect the health of a person, therefore, it makes perfect sense that only a certified medical professional (doctor) must prescribe a drug to a patient and also, the drug in question must be safe to be consumed by the patient or health seeker.
"Akhil Pathak , an independent writer who keeps an eye on issues related to health, education, society, global politics and defence. He also follows the geo-strategic matters that are directly or indirectly related to the security framework of India.

"Akhil Pathak , an independent writer who keeps an eye on issues related to health, education, society, global politics and defence. He also follows the geo-strategic matters that are directly or indirectly related to the security framework of India.

What Led To Drug Regulation?

To make sure that a drug product is safe for consumption, it is imperative that the process of drug development and manufacturing must take place under a set of ‘stringent guidelines’ as well as a ‘well defined & properly enforced’ regulatory framework. 


Sadly, it took some very unfortunate incidents to set in motion, some decades long continuously evolving administrative steps, which resulted in the creation of proper drug/medicinal regulatory frameworks that would effectively ensure drug safety.  In 1937, a chemical called Sulfanilamide Elixir was used without any prior testing, resulting in the death of over 100 people in the United States due to Diethylene Glycol poisoning. Consequently, in 1938, The Federal Food, Drug and Cosmetic Act came into existence which mandated that all new drugs must comply with a pre-market notification. It is heartbreaking to know that even today, in countries that have inefficient drug regulatory mechanisms, people die by taking medicines that are contaminated with Diethylene Glycol.   


Another disaster unfolded when a hypnotic/sedative called Thalidomide was introduced in Western Germany in 1956 and was sold in over 46 countries. Between 1958 to 1960, more than 10000 babies were born with certain deformities including Phocomelia due to Thalidomide, simply because the drug was launched without ascertaining its safety. Thereafter, the entire drug regulatory mechanism in the UK was given a complete makeover. In 1963, a Committee on the Safety of Drugs (CSD) was formed in the UK as well as a ‘Voluntary Adverse Drug Reaction Reporting System’ was created in 1964 that was named- the Yellow Card Scheme.


Role of World Health Organisation In Regulating Drugs

WHO is the arm of the United Nations that provides guidance and leaderships on matters relating to global health & well being. WHO conducts extensive health research, defines health standards, assists in making health related policies and offers its technical know-how pertaining to the field of health, to countries worldwide. 


The extremely vital role that WHO plays in the area of drug regulation can be summarised in four steps:


  1. It sets up fundamental standards and issues required guidelines & norms through its Expert Committees.
  2. It supports national level capacity building for drug regulation that helps in effectively carrying out regulatory procedures in compliance with Good Manufacturing Practice (GMP) as well as Good Clinical Practice (GCP).
  3. Ensures the supply of ‘Limited High Public Health Value Essential Medicines’ such as medicines to treat HIV/AIDS and also Vaccines for various vaccination programs on a national scale.
  4. Promotes the exchange of information related to drug regulation by taking steps such as convening the International Conference of Drug Regulatory Authorities (ICDRA) every second year and publishing the proceedings for future references.


USFDA: The Most ‘Powerful & Influential’ Drug Regulator

In order to check and ensure safe drug development & manufacturing, there are multiple regulatory bodies/authorities in the world. The United States Food and Drug Administration which is generally referred to as USFDA or FDA, is a regulatory body that has the maximum influence on the process of drug development and in-turn on drug manufacturing & distribution, all over the globe. This is simply because the US leads in the field of medical research & development. The US has a huge domestic pharmaceutical market and it also supplies/markets numerous pharmaceutical products to a large number of countries, thus making it the global watchdog of the pharma space. 


Although there are multiple other drug regulatory agencies in various countries of the world that essay the same role and that too with ‘great integrity & efficacy’, but since the USFDA’s sphere of influence is the largest, it is a regulatory body that casts a strong & palpable clout when it comes to defining/setting the standards for the global pharmaceutical industry.


GMP, cGMP and 21 CFR

GMP means Good Manufacturing Practice. It is a set of guidelines that are prescribed to ensure high quality manufacturing of a drug product or substance which would make the drug- safe for consumption. GMP helps in creating a drug manufacturing work culture where every process is performed by adhering to the highest standards of quality control & quality assurance. GMP came into existence in 1941 in the US and played a crucial role in strengthening the USFDA. However, it was in June 1963 when GMP was enacted in its entirety. The World Health Assembly in 1969, officially recognised GMP but, it was in 1978 when GMP got fully regulated.


GMP applies on various aspects/functionalities that constitute the overall drug manufacturing process. Some categories or processes where GMP focuses are:

  • Manufacturing Premises
  • Equipments or Machinery
  • Training of Personnel Involved
  • Sanitation/Cleanliness
  • Purity of Raw Materials
  • Safe Storage
  • Maintaining Records
  • Proper Packaging
  • Sterility of Products Used
  • End-to- End Quality Checks


‘The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’ or ICH, in its document “Q7”, provides guidance on GMP for manufacturing APIs (Active Pharmaceutical Ingredients). The US government follows the ICH Q7 guidelines and mandates that all API manufacturers must follow that guide in their processes related to API synthesis, production/manufacturing, packaging etc. Apart from the US, there are many other ICH member countries that follow the GMP guidelines such as: 

  • European Union ( a group of 27 countries)
  • Japan
  • Australia
  • Canada
  • Norway


According to the USFDA, a drug product is declared adulterated or not safe to be consumed, if it is not manufactured by adhering to the GMP guidelines. This is the reason why it becomes extremely important to manufacture a drug product only in a GMP certified facility or production unit.


So, now that we have got an idea about GMP, let us look at cGMP.


cGMP simply means current Good Manufacturing Practice. Medical science has evolved by leaps & bounds since the GMP guidelines were first enacted. Various methodologies, practices, processes, equipments, instruments, apparatus etc. that were used/prevalent a few decades back have either changed or have been replaced by those that are much more efficient & technologically advanced. Therefore, it makes perfect sense that the GMP guidelines must evolve accordingly with time to constantly enhance the quality, efficacy & safety of the final drug product and cGMP is the answer to that!


Now, whenever cGMP is discussed, Title 21 of the Code of Federal Regulations (CFR), comes into picture. CFR has 50 titles out of which Title 21 deals with the Food & Drugs sector. 21 CFR can be perceived as a set of cGMP guidelines issued by the US government which are followed by those pharmaceutical companies that intend to get their drug/s approved by the USFDA.


Title 21 is divided into two sections- Part 210 and Part 211.

Part 210

Part 210 consists of the cGMP guidelines for the production area of drugs. It covers the processes related to Manufacturing, Packaging and Storage of Drugs. It is expanded into 3 Sub-Parts which are as follows:

  • Part 210.1: It deals with the Status of Current Good Manufacturing Practices
  • Part 210.2: It deals with the Applicability of Current Good Manufacturing Practices
  • Part 210.3: It contains the Definitions of various Current Good Manufacturing Practices prescribed in Part 210.


Part 211 

Part 211 covers the cGMP guidelines for ‘Finished Pharmaceuticals’. It contains 11 Sub-Parts which are as follows:

  • Sub-Part A: General Provisions
  • Sub-Part B: Organisation & Personnel
  • Sub-Part C: Buildings and Facilities
  • Sub-Part D: Equipments
  • Sub-Part E: Control of Components and Drug Product Containers
  • Sub-Part F: Production and Process Controls
  • Sub-Part G: Packaging and Labelling Control 
  • Sub-Part H: Holding and Distribution
  • Sub-Part I: Laboratory Controls
  • Sub-Part J: Research and Reports
  • Sub-Part K: Returned and Salvaged Drug Products



In the end, we can easily conclude that the sole purpose of drug regulation by means of all the guidelines and rules prescribed by a Drug Regulatory Authority, is to ultimately ensure a safe drug product for the consumer. Therefore, it is incumbent upon all pharmaceutical companies to diligently adhere to all the guidelines laid down by regulatory bodies as well as, sincerely follow the quality & assurance practices to come up with a drug product that would deliver good health & well being to the consumer!

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