Business Accent

Public health needs and ICH guidelines

Dr Sunil Kanvinde talks on the regulations which affect the healthcare needs of countries.

World Health scenario is complex due to diversity in climatic conditions, socio-economic structures, racial factors, history of localised diseases and epidemics. Emergence of HIV and related disease conditions have further added to the woes of the population in economically poor countries. Combating these diseases by regulating the supply of quality medicines with cost optimisation has been the main challenge to the regulatory authorities.

Health needs

Public health needs relate to general health monitoring, long-term therapy for chronic ailments and medication to combat epidemics. The supply of good quality essential drugs is identified as one of the prerequisites for the delivery of healthcare at the International Conference on Primary Health Care in Alma Ata in 1978. Significant efforts have been made by government bodies and social institutions for this cause by funding the treatments, particularly in economically backward countries.

Every government allocates a substantial proportion of its total health budget to essential drugs. This proportion tends to be the greatest in developing countries, where it may exceed 40 percent. Proper utilisation of funds by ensuring supply of essential drugs is, therefore, another important dimension apart from control of health care. For the patient, any drug which is safe, effective and fit for use, is acceptable. Cost factor too drives the acceptability. Thus, the patient links the concept of quality to his needs. A patient cannot analyse or judge the quality of most drugs that he consumes. The responsibility of protecting patient needs, therefore, falls on regulatory bodies that govern the pharmaceutical industry. Regulatory bodies face unique challenges to control quality without hindering drug supplies and protect public health by developing suitable control mechanisms.

Regulations

The regulatory status of any country and its ability to adopt and support technological advancement drives the progress of pharma industry. Regulatory controls should enable the industry to focus on basic research, design and development to ensure quality, fair promotion and availability. The regulatory status may be stagnant for various reasons. Regulations are often based on the needs of a country, perceptions when rules are made, and historic laws which are modified or amended over a period of time. Regulations show wide variations and gaps amongst various countries and this leads to ambiguity in interpretation. Globally, countries have been classified as regulated and less regulated countries. This classification is attributed to the resources available towards the development of standards, which depends on the financial status of the country apart from the willingness and awareness at the political level, FDA and the industry.

Harmonising regulations

In the recent years, the concept of global economy has dissolved trade barriers. Treaties like WTO and TRIPS have forced nations to open their markets and economy to global commerce and trade. Pharmaceutical industry is no exception. Global supply centres are fast emerging with cost optimisation as the primary focus. These centres face hardships due to diversity in product registration processes in various countries. The lack of uniformity and awareness can delay the registration process, and impact the availability of medicines.

Hence, most of the amendments in regulated markets have been directed towards more stringent norms. The gap between regulated and less regulated markets seems to be widening. Many countries therefore feel the necessity to harmonise regulations.

What is the impact of these rapidly evolving guidelines on less regulated countries and its healthcare needs has remained a matter of concern. This commentary covers the concerns that need to be addressed since the primary aim of any regulation must be directed towards protecting public health needs.

The concern must be directed towards economically backward or developing countries which are also facing the onslaught of epidemics and priority diseases like malaria, TB, and HIV/AIDS.

ICH and WHO guidelines

The International Conference on Harmonisation of Technical Requirements for the Registration of Pharma-ceuticals for Human Use (ICH) was established in 1990 as a tripartite venture, representing regulatory bodies and research based industry. ICH since its formation in 1990 has gained momentum in harmonisation efforts by tripartite groups. The process begins with formation of task forces with representation from industry, academics and regulatory bodies. Drafts are open for discussions and comments. Very little differences are seen in acceptance of these guidelines by member states. The generation of guidelines and also its mplementation has been put through well-defined time lines. This approach has not only helped the industry to move faster but has also put restrictions on DRAs to respond to applications by the industry.

ICH also formed global co-operation group, GCG in 1999 to make information on ICH activities available to non-ICH countries. ICH has also made the guidelines available on Internet and lays emphasis on interaction with non-ICH countries. This thrust by ICH countries has led to the belief that guidelines are gold standards that represent international requirements to ensure safety, quality and efficacy. The powerful partnership amongst strongest DRAs and pharma companies is also responsible for imposing and implementing their views.

WHO was formed in 1946 and possesses the mandate to issue standards, yet it has been lacking behind. The first GMP text was published by WHO in 1967-69 and revised in 1975. Expanded GMP guidelines were published in 1992. These are fully consonant with other internationally recognised texts on GMP. GMP guidelines published by WHO need to be adapted to address specific conditions in individual countries.

Developing countries often lack the effective mechanism to implement WHO guidelines and simultaneously ensure that their own needs are addressed. As a result WHO in not able to counterbalance the ICH activities and its growing influence.

Observations

There are many similarities than differences in fundamental directives between ICH and WHO guidelines. And some of these differences are because of the interpretation of requirements by industry and by DRA inspectors. ICH adopts stricter stands on implementation, while WHO accepts flexible interpretation. WHO thus gives option to the applicant submitting the data that is not in conformity with the guidelines and accepts such data if scientifically justifiable. ICH countries undertake a majority of R&D work. The research caters to the needs of their own population and hence, the focus is on lifestyle drugs. It is obvious that very little resources are directed towards drugs for the treatment of priority diseases. This is a serious concern because it shows their lack of interest towards endemic conditions prevailing in the developing world. This also reflects on their commercial approach and interest only in developing molecules for lifestyle diseases. Developing countries and local institutions will have to take the responsibility to combat this situation and protect public health.

ICH guidelines reflect technological thrust due to active participation by technocrats and the scientific community. However, questions are being raised on the need for these high standards and whether they are driven by scientific needs more than patient needs. Further, the pharmaceutical industry in the developing world may not be able to fall in line with these requirements resulting in disqualification. Availability issues can then surface leading to health problems.

Certain specific requirements incorporated in technical specifications have also raised concerns in the industry across the world. Impurity standards of 0.1 percent is one such area. Laying down such standards is clearly felt, particularly in developing countries, as a scientific parameter which may not have relevance to safety and needs. WHO takes a judicious approach towards cost impact arising out of implementation of stringent specifications and specific analytical techniques that require sophisticated instruments. Further, WHO also considers weaknesses of developing countries in procuring sophisticated instruments and accommodates itself to available methodology, where appropriate. That will facilitate the use of International Pharmacopoeia on a global basis.

(The writer is DGM, Production Outsourcing of Novartis India Limited)