Management

Timely detection, quicker cure

One of the most preferred healthcare options in US, diagnostic kits, are still to make a mark in Indian healthcare market. Sachin Jagdale analyses

In the current scenario, when the developing world has limited funding for healthcare the need for cost effective and quality diagnostic products in the developing world has become more intense. India is the second most populated country in the world. The one billion population of India is undoubtedly prone to different kinds of diseases but unfortunately healthcare services in India have not yet reached the nook and corner of the country. In the absence of strong infrastructure to tackle the disease burden, poor regulatory environment and lack of clear cut policies, patient suffers. Though Indian healthcare market has the diagnostic products it is still in the nascent stage.

Diagnostic kits for doctors

Diagnostic kits by definition help increase the accuracy level of doctor's prognosis. "Diagnostic kits are seen by doctors as optimised assay reagent sets meant for systematic analysis of any clinical sample. It is believed that these kits are generally manufactured after organised research, under highly regulated conditions and therefore any assay using them is considered to reflect actual clinical status of a patient," says Sachin Purohit, Managing Director, GeneOmbio Technologies.

Purohit finds diagnostic introductions in the market a key for more effective healthcare management. According to him some of the limitations of the prognosis can be avoided with the use of newer and advanced diagnostic kits. He says, "Newer diagnostic tools such as nucleic acid based testing (molecular diagnostic testing) tell a clinician of not only the qualitative status of infection in a patient but also the actual viral load in the infected person. These can be clubbed with therapy and a doctor can analyse from time to time the effect of his therapy; lesser viral load over time means that the therapy is working. Hence according to me, the use of these diagnostic kits positively influences a doctor's opinion as well as treatment regimens."

Dr Dinesh Gupta, Director, Gentech Diagnostics, highlights the importance of diagnostic tests. He says, "In the complex milieu of disease prevalence in developing nations and the fact that diseased population put themselves very frequently for voluntary health-check or screening for scourge like cancers, it is of atmost importance that when clinical prognosis arrive it should be based only on thorough diagnostic procedures. At times, few of them may not be directly linked to disease symptoms. The common serology or microbiology tests do not reveal much and may also be subjective, e.g. microbiological examinations."

Gupta adds, "Pap test is a diagnostic meathod for checking women's genital health. Sadly, if not done with HPV test, it may miss 50 percentage of the disease. In other words, every other diseased or symptomatic woman has a chance of missing lower genital cancer."

According to Balram Parath, Country Manager, Bio Rad Laboratories India, a diagnostic test is one of the most important parameters on the basis of which a patient gets right and timely treatment from a doctor. Treatment without a test is hitting in the dark and treating a patient on gut feeling where a professional is assuming that the patient may or may not respond. Today, many of consumers feel that spending on a diagnostic test is a cost but not doing the test and taking treatment can be more expensive in the long run and can be sometimes more traumatic for patients.

A stitch in time…

"Diagnostic kits are seen by doctors as optimised assay reagent sets meant for systematic analysis of any clinical sample" - Sachin Purohit Managing Director GeneOmbio Technologies

In India there is a higher prevalence of some diseases. India is touted to be the diabetic capital of the world. This is obviously an unfortunate tag. Dominance of AIDS among Indian people is rising alarmingly. Such fear factors, from the health management point of view, have made diagnostic kits crucial for developing nations like India.

"We all know that prevention is better than cure. A stich in time saves nine. Sometimes simply by awareness we can avoid many major disorders/diseases like thalassemia, diabetes, new born metabolic errors, AIDS etc. Today disorder like diabetes is a huge economic burden, thalassemia is heavily taxing both emotionally and financially for a family having a thalassemic child, which can be avoided by a simple screening before marriage for a couple," informs Parath.

Diabetes is a silent killer. Different organs in the body are susceptible to the side effects of diabetes. As India harbours the largest population of diabetic patients, deaths related to diabetes are also higher in India. Timely monitoring of blood glucose levels can keep ill effects of diabetes in check. "Organ failure due to high glucose level in the blood can be avoided if a diabetic patient manages the glucose level properly and is aware about his/her HbA1c level in their blood. The expense in preventive diagnosis and simple awareness can build a healthy nation and saves lot of resources and money on the treatments," opines Parath.

Gupta points out some of the lacunae in our healthcare system. He says, "In the US, the diagnostic industry forms a sizable 22 percent of the healthcare sector. In India, it is less than four percent. This comparison could explain how important it is for us. Any diagnostic procedure used in the US, has to have FDA approval. On similar lines, in China they initiated S-FDA procedure. In India, diagnostic kits are still part of drugs as far as regulation is concerned. We have tremendously misplaced priorities in our healthcare system."

As the clinical diagnosis based treatments are largely pragmatic, misdiagnosis could give rise to wrong treatment. Such condition results into increased cost and in extreme cases climbing mortality rate. Building resistant to conventional drugs is also the outcome of failure of the treatment.
Purohit explains how diagnostic kits can influence operations among doctors and subsequent benefits to the patient. "For any developing country like ours, these diagnostic kits are of great significance. The reasons are certain degree of uniformity in results associated with a kit that assist doctors to interpret and monitor various diseases. Further, these kits also substantially decrease turnaround times which is again associated with better and faster prognosis," says Purohit. He adds, "Given the fact that developing countries lack required number of adequately trained professionals to conduct such important tests, these diagnostic kits provide simplified methods of conducting an assay and interpret it. That in turn promotes wider usage of these assays which finally benefits patients."

Need of awareness

"A diagnostic test is one of the most important parameters on the basis of which a patient gets right and timely treatment from a doctor. Treatment without a test is hitting in the dark" - Balram Parath Country Manager Bio Rad Laboratories India

Given that per capita income in India is considerably less and large chunk of the population is still illiterate, are poverty and lack of awareness preventing people from using diagnostic kits? Industry opinion varies. Purohit puts in a balanced opinion. He says, "Diagnostic kits are developed after significant investment of manpower, infrastructure and use of intellectual property. These impact the cost of these kits. Hence in a fund limiting condition their use is less, compared to other developed countries. Awareness is a factor that is required very much as it is the patient who needs to understand and use these kits. It is often found that medical doctors fail to convince patients to undertake certain tests that are 'kit' driven, especially the newer nucleic acid testing (NAT) and pharmacogenomic tests. While one of the reasons is cost, the other is knowledge about the need and advantage of these diagnostic kits."

He finds literacy as one of the important parameters that decides the use of diagnostic kits. "Literacy has a significant role to play in the proper usage of these kits. But I am optimistic that soon these kits will be economical and creation of awareness by diagnostic and pharma companies will pave their way into the domestic market. Big pharma companies hence need to tie-up with diagnostic companies, improve awareness in medical fraternity, which will automatically percolate down to the illiterate patient," opines Purohit. While echoing Purohit's views, Parath opines, "Awareness is the key to avoid many diseases and disorders. Along with the affordability, awareness can lead to increase in preventive diagnosis and save lot of cost on treatment."

Eluding kits

In US there are home diagnostic kits for diseases like AIDS, hepatitis, anemia, fertility, cholesterol levels. However, in India only pregnancy and diabetes kits seem to dominate the market. It will be interesting to see when this trend hits Indian markets.

"The healthcare market in the US is largely insurance-reimbursement supported. In the UK, the NHS takes care of this aspect. A similar trend to appear in India would mean our healthcare insurance sector to gear up to shake up common minds, or our government to initiate a national health scheme which looks very impossible for the sheer size of our population," says Gupta.

The expanding Indian population has huge healthcare requirements. The solution to their healthcare problems could come from their own contributions. Public participation in a programme meant for their own well being will give respite to overstretched government efforts. Gupta opines, "Every family in India should be made to pay a nominal fee from their earnings towards healthcare and bodies like CGHS, ECHS, health care insurance sector should take up the responsibility to enhance considerably the awareness among masses and encourage them to go for a comprehensive health check at least once in three to five years even if they are apparently perfectly healthy."

While explaining the necessity of diagnostic kits Parath insists on the need for a medical professional's advice. According to him Indian market is also catching up very fast towards the point of care and home monitoring testing. This does not mean that the medical professional's consultancy is ruled out. The pregnancy kit and glucose monitoring kit is already a big market in India and going to grow further. Further more, increasing middle class and well informed/aware population is growing in the country, this trend will further grow.

Purohit shares his views with Gupta. Even he thinks that lack of insurance based cover like in US is keeping away Indian patients from quality treatment or facilities. "India is still far away from this culture. Health is still at a lower level of priority in the mindset of an average Indian and issues such as health insurance, health cover are not yet discussed at a serious level in urban India as that of US or western world. Further, literacy is another factor that contributes to decision making of patients in using of these kits and even if decided, their is no medical professional to assist around," informs Purohit. He adds, "The requirement is an extended field extension programme, due advertisement and promotion of the culture of using home diagnostic kits rather than benefits of any single kit has to be done in a concerted manner to evolve the culture of their use in Indian homes. In my opinion India is still 5-10 years away from this culture, assuming that promotional efforts initiate right now."

Costly affair

As far as healthcare is concerned India is divided into two parts, one that provides quality medical care to middle-class Indians and medical tourists, and the other whose residents have limited or no access to quality care. In India many patients die because they cannot spend on medicines. Diagnostic kits are an advanced form of the treatment and no wonder an expensive option for many patients. Cost effective diagnostic kits should become an integral part of healthcare management in India. However, question remains, how to make these kits cost effective?
Purohit feels that diagnostic kits can be made cost effective through investment in high level intellectual property that only has the potential to alter methods and investments without compromising quality. As we know that cost is primarily due to the raw material and also the technology that uses it, cost effectiveness cannot be brought about by mere duplicating of components and processes already in place. It requires research at two levels, viz., formulation and process.

Purohit elaborates on the options that can make diagnostic kits cost effective. He says, "Factors that can lead to cost effectiveness is development of technologies that are less dependent on cold chains for their storage and transportation and further in their dependence on use of expensive infrastructure for use and/or development. Indian companies should focus on R&D and develop cheaper alternatives to imported kits and reagents that otherwise raise the costs."

At the end of the day government is an authorised unit that could change the way healthcare service in India operates. Making diagnostic kits cheap is undoubtedly the prerogative of manufacturers. However; unless the government backs them their efforts will remain futile. Gupta puts it more specifically. He says, "In a nutshell, our government needs to change the outlook towards clinical diagnostic industry as stated above for instance, and in place of levying duties and taxes, should not only exempt but also provide easy subsidies to the industry."

sachin.jagdale@expressindia.com