Indian Pharmaceutical Industry - Main Hurdles

Main hurdles in Indian Pharmaceutical Industry

During the recent years, there has been serious concerns among US businesses and lawmakers over IP in India where Clinical Trials, Infrastructure and Policies are the biggest hurdles in driving research and development in Indian Health care Sector. While both global and Indian industry leaders opine that India's intellectual property (IP) situation needs to be addressed and clarified, they have highlighted that in fact clinical trials, infrastructure and policy are the biggest obstacles for India to meet its potential of driving R&D innovation at scale. 

Recent reports from 'Crossing the Next Horizon: Will India play a Meaningful Role in Global Biopharma Innovation?'. lays out the myths and facts about the biopharma innovation in India. The findings would help senior management of biopharma companies fine tune their R&D strategy and help leverage India's pockets of R&D strengths.

According to excerpts of the report, many global R&D heads and CEOs emphasise the need for Indian companies to shift from 'deals' that offer only cost arbitrage to alliances that focus on innovation, quality and service. The report notes that emerging markets such as India can play a significant role in collaborations, providing not only more cost effective innovation, but access to new talent, technologies and assets to fill currently dry pipelines. 

The Indian healthcare sector has tripled in size in the last decade from USD 23 billion in 2002 to USD 70 billion today, but India continues to lag peer countries in spending, outcomes, health manpower and infrastructure, it said. Within healthcare, the Indian pharma market has also shown strong growth from USD 6 billion in 2005 to USD 18 billion today and is expected to grow to USD 45 billion by 2020.

Discussions with several global and Indian industry leaders indicate a widespread acknowledgement of India's potential for R&D innovation and while the fundamental drivers of the 'India advantage' exist, the opportunity has not played out as expected.

India holds a vast and largely under-tapped pool of drug innovation resources and capabilities. 

While the report recommends that the Indian government fix and clarify relevant policies and regulations around clinical trials and IP; focus cross-border and cross-entity collaboration on building talent and infrastructure across clinical trials, PI training and basic research. These strategic partnership not only enhance to overcome the hurdles of healthcare sector in India but also improve the quality of life.

Greater use of electronic medical records could help pharma companies cut recruitment times for trials and reduce development costs.

Main Outcomes:

1. Use of patient data collected by healthcare systems can identify potential clinical trial participants more quickly and with better precision than traditional procedures.

Example: Dr Eriksson (pictured), a former senior director at Merck & Co, noted that a recent study by Parexel managed to knock 12 months off the estimated 24 month recruitment time.

2. Such efficiency has the potential to cut down research costs tremendously, with the price of getting a drug to market now well over the oft-quoted $1bn figure.

3. The use of electronic medical records – the medical history of a patient kept in a digital format – to support clinical trials has been encouraged by other prominent figures in healthcare, especially in the UK, which, in the NHS, has a healthcare system that covers the entire country.

4. Establishing EMR will attract new clinical studies across UK. 

5. Also, how use of this data can help, saying that researchers had the ability to use electronic medical records to accurately isolate a specific cohort of patients with a certain condition, and then run this cohort against patient profiles – such as demographic, age, gender, etc – to have representativeness in clinical trials.

6. Being a crucial development, said Dr Eriksson, considering that between 50 and 65 per cent of potential clinical trial participants fail at the screening stage because they are found not to meet one of the study's crtieria.

7. Ease of Market Access.

8. This protocol can then be used to run a report to find out where relevant patients are being treated and what patients are being treated by physicians registered as investigators, while electronic medical records can then be used to demonstrate suitable patients to investigators.

Drawbacks: 

One of the greatest burdens in using electronic medical records is uptake and compatibility among healthcare systems, which varies between different countries.

Alternates: 

This is changing, however, according to Dr Eriksson, who said that countries are now following the route of South Korea and Turkey who became the first two countries in the world to have a healthcare system with 100 per cent electronic medical records that are connected to each other and managed by a central office.

The situation is also improving in the US, where uptake has increased since President Barack Obama introduced an order that all healthcare providers need an electronic medical record system by 2014.

By 2020, I imagine the whole world will be using electronic medical records. Healthcare systems are also becoming more proactive in developing partnerships in clinical development, according to Dr Eriksson, who heads up a department at Parexel that is focused on building alliances between the CRO, industry and healthcare providers.

It is important to have partnership with healthcare and investigator networks to improve the services in the medical industry. 

New CRF in Dublin, Ireland

A €7 million clinical research facility has opened at St James' Hospital in Dublin, Ireland, to carry out early- and late-phase clinical trials across a range of therapeutic categories. The unit is a joint initiative between St James' and Trinity College Dublin, with funding from the Wellcome Trust and Health Research Board of Ireland, and launches with 25 research projects underway or at the planning stage.

These include an EU-funded project to develop a vaccine against hepatitis C in HIV-positive patients, as well as new therapies for oesophageal cancer, diabetes and Alzheimer's disease. This new facility is good news for patients as it will allow the testing of new and innovative therapies, technologies and products and should increase the speed at which these innovations and discoveries enter health care services.

The unit houses a research pharmacy capable of safely compounding cancer drugs and handling novel gene therapies and vaccines, in-patient isolation rooms to nurse patients with infections or compromised immune systems, and a neuropsychology suite that will enable high-quality studies of brain activity and cognition.

The Wellcome Trust provided €7.3 million in funding to construct the CRF, while the HRB has earmarked €5 million to cover operating costs and €8.2 million to fund projects carried out under the banner of the Dublin Centre for Clinical Research (DCCR). The DCCR provides the facilities and trained staff needed to support collaborative clinical research studies across Dublin involving the Trinity College, University College Dublin and Royal College of Surgeons in Ireland (RCSI) medical schools and their associated teaching hospitals.

The facility, placed at the interface between university and hospital, is an early model for the newly announced hospital groupings and academic medical centers. The unit will provide "greater integration between the healthcare agenda and the teaching, training, research and innovation agenda.

Decline in Clinical Trials for Cancer

The fall in the number of clinical trials in India together with blockbuster pipeline drying up from the global pharma majors are seen to seriously impact the access to newer drugs to treat tobacco related cancers. The fewer number of novel drugs is posing to be a huge challenge for oncologists to treat the growing number of cases.

With the stringent norms coming in from global regulatory majors where trial designs mandate use of electronic records, maintenance of total transparency from ethics committee registration, patient recruitment, monitoring of adverse drug reactions and reporting deaths have all resulted in a grinding  halt to novel medicines. There is a serious lack of the newer cancer drugs to treat oral cancer affecting the larynx, pharynx, food pipe, largely attributed to tobacco chewing and smoking, stated the cancer specialist hospitals.

Many patients in the early and late stages of lung, head and neck cancers were agreeable to be part of clinical trials because they did not have to pay for drugs which are expensive. 

Dr. S Krishnamurthy, Professor, Surigcal Oncology at Kidwai Memorial Institute of Oncology (KMIO) expressed that Kidwai was the centre for many of the cancer trials until recently. Also due to government restrictions, there are hardly any human studies being carried out.
As a result we are now forced to prescribe the patients with the existing drugs to treat cancer. Particularly for lung cancer Gemcitabine/cisplatin is among the most widely used regimens. There is also a class of platinum-containing anti-cancer drugs like carboplatin and oxaliplatin which are also popular along with Doxorubicin that is part of a group of chemotherapy drugs.

For the affordable patients, targeted therapies are seen to be the answer to treat cancers affecting the lung, head and neck areas. Currently the most opted commonly used drug is the epidermal growth factor receptor (EGFR) which is known to provide a big relief in terms of symptoms control and also enable patients to lead a somewhat normal life. 

While lung cancer which affects 90 per cent of the smokers is the most difficult to treat and a paucity of clinical trials is affecting patient care. For oral cavity and other tobacco induced cancers, oncologists would prefer to first consider surgery and remove the diseased cells. The second and third options put before the specialists are to go in for radiation and then chemotherapy. But these are known for side-effects. Now with a fall in the number of trails, oncologists are looking at targeted therapies where monoclonal bodies (MAbs) are seen to be an answer.