The pharmacy profession since its very inspection has been remarkably influencing and in a way governing the healthcare system. It is a noble profession significantly attached with the human health and one cannot imagine of an ideal healthcare environment without considering various aspects related to pharmaceutical sciences.
With the advancement of technology and increased globalisation, it is being felt sincerely that the regulatory aspects must be practiced in the field of pharmacy if we have to create a better healthcare environment. There is no doubt that control would give rise to excellence. In fact, it has been a well-exercised principal of management. The only required thing is that it should be applied judiciously and in an appropriate magnitude. By the term regulation, it should not be inferred that we have to put frequent checks at every stage and phase. This will only hamper and delay the pace of development. Regulation is a reasonably broad term that not only includes controls but also suggests alternatives, options and ways to cope up with the common problems, which may arise during a process.
Before going into details of the impact and significance of regulations on healthcare systems, let us familiarise with the essential components of a good healthcare system.
The essential components of a good healthcare system are:
● Check on quality control
● Adaptation of latest and recent technology
● Continuous interaction with research and development activities
● Better care and look after
● Easy and timely availability of treatment
● Honest implementation of pharmaceutical codes and ethics
● Involvement of pharmacist, which are in immediate contact with patients like hospital and community pharmacist
● Incorporation of drug information centre (DIC) and pharmaceutical services centre (PSC) equipped with latest facilities
● Development and effective usage of innovative and newer drug delivery systems (DDS)
● Applications of principles of personal management and marketing management for patients, which are the ultimate customers
● An effective dialogue between the important trio, i.e., pharmacist, physician and the patient
If we go through minutely across the various components of a better healthcare system, we observe that each component can be made more effective and fruitful if the regulatory aspects are incorporated in them. Pharmacy being the most and prime factor responsible for converting healthcare system into a better one, it is also the most liable to be subjected to the regulatory aspects, particularly in the current and future scenario.
At this point of time, it is quite appropriate to discuss the correlation of regulations and pharmacy in this modern era to generate an ideal healthcare system. The pharmaceutical issues involved in healthcare system are so sensitive in nature that their proper regulation becomes a mandatory requirement if we have to maintain the quality and standard.
Prominent regulatory bodies in pharmacy
There are many regulatory agencies which are playing pivotal role in maintaining the quality and standard in pharmaceutical field in various countries all over the world. Some of those functional bodies are:
● Food & Drug Administration (FDA)
● Medicine & Health Care Regulatory Agency (MHRA)
● Therapeutical Goods Administration (TGA)
● Ministry of Health and Family Welfare
● World Health Organisation (WHO)
● International Organisation for Standardisation (ISO)
● International Conference on Harmonisation (ICH)
FDA: The US Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products and cosmetics.
MHRA: The Medicine & Health Care Regulatory Agency (MHRA) is an executive agency of the department of health with trading fund status operating at UK.
The MHRA's mission is to enhance and safeguard the health of the public by ensuring medicines and medical devices work and are acceptably safe.
TGA: It is a regulatory agency safeguarding public health and safety in Australia by regulating medicines, medical devices, blood and tissues.
Ministry of Health and Family Welfare: Also known as "Swasthya Aur Parivar Kalyan Mantralaya". It is a ministerial department of Government of India. It is responsible for making policies regarding medicines and healthcare system.
WHO: The World Health Organisation is the directing and coordinating authority for health within the United Nations system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends.
ISO: It is an international standard setting body composed of representatives from various national standards organisations. ISO defines itself as a non-governmental organisation. Its ability to set standards that often become law, either through treaties or national standards, makes it more powerful than most non-governmental organisations. In practice, ISO acts as a consortium with strong links to governments.
ICH: The International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in these three regions to discuss scientific and technical aspects of product registration.
Regulatory tools
Various regulatory agencies discussed above operate and enforce their objectives via several regulatory tools to maintain the quality control process in pharmacy profession.
Good manufacturing practice or GMP: It (also referred to as 'current Good Manufacturing Practice or 'cGMP') is a term that is recognised worldwide for the control and management of manufacturing and quality control testing of foods, pharmaceutical products and medical devices promulgated by the US FDA under the authority of the Federal Food, Drug and Cosmetic Act.
Other 'good practice' systems along the same lines as GMP are:
● Good laboratory practice (GLP), for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals)
● Good clinical practice (GCP), for hospitals and clinicians conducting clinical studies on new drugs in humans
● Good distribution practice (GDP), for wholesalers and distributors
● Good regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation
● Corrective and preventive action (CAPA)
● EudraLex
● Food safety
● Good automated manufacturing practice (GAMP)
● Pharmaceutical inspection convention and pharmaceutical inspection co-operation scheme
● Validation (drug manufacture)
● Verification and validation
Evaluation of a good healthcare system
The process of drug discovery and drug development has always been supplemented by the regulations imposed from time to time and at different phases of development. The ultimate purpose of these regulations is to provide a platform where pharmacist can contribute and offer his best to serve the community.
All the regulatory tools may be applied judiciously to different pharmaceutical processes in their own way to get quality results, which in turn can be utilised to provide an ideal treatment to the patient giving prime importance to the safety and efficacy consideration. At any cost, quality and standards have to be safeguarded. Effective patient counselling and furnishing the relevant drug information to the patients are vital means to generate a good healthcare system.
Regulations -Why, when & how
Think of the following situations such as storage and selling of spurious and adulterated drugs by various medical stores owners, production, marketing and distribution of substandard drugs by the drug-manufacturing units, wrong drug information or facts depicted in drug literature, publicity and advertisement about drugs showing exaggerated and unbelievable facts, pharmacy practice by unqualified persons, unsatisfactory and improper patient counselling by pharmacist, non-execution of various pharmacy related acts and illegal clinical trials, which frequently prevail in the existing society.
These situations are quite harmful and de-motivating for the development of a healthy society and may not lead to a good healthcare system for the patients as well as for the healthcare providers. These situations may be avoided by imposing appropriate regulations at appropriate time during the various stages and phases of drug development process and the post scenario. The persons accountable for this have to be very much careful, vigilant and alert with regard to the imposition of regulations.
The government may play a vital and crucial role in it by making its machinery functional and operative so that fruitful results may be obtained. One effective strategy may be the combined application of principles of fields like pharmacy, management and law. The role played by the pharmacist in this regard is inevitable and indispensable. As a pharmacist, he is bound to abide by the pharmaceutical codes and ethics and doing so the pharmacist from all over the world are marching ahead towards the betterment of the society as well as making the healthcare system better and better.
The need of the hour is to give due attention to create a better healthcare environment for the patients as well as the healthcare providers. Pharmacy plays a vital role in deciding the quality of the healthcare system. And in the changing scenario of technological advancement and information technology explosion, it has become mandatory to impose certain regulations effectively at different stages of drug discovery and development. Various pharma regulatory bodies may play a pivotal role in this regard by exercising the different regulatory tools appropriately and judiciously. These regulations can be helpful in the evolution of a better healthcare environment and thus the society may be served in a better way.
(The authors are with D J College of Pharmacy, Niwari Road, Modinagar, UP)