Pharmabiz
 

Growth with caution, need of the hour

AD Pradeep Kumar & Nandita Vijay Thursday, May 12, 2011, 08:00 Hrs  [IST]

Clinical research has been projected as a major business opportunity for Indian pharmaceutical industry  in the years to come by leading consultancy houses and industry chambers. This could prove to be true considering the current rate of growth of clinical trial activity in India during the last  10   years. More than 100 CROs and pharmaceutical companies are already in this space today and more are coming.

While  according to a  recent Assocham report  India's clinical trials business is expected to reach approximately US $ 1 billion in  2011 having a growth rate of 11 per cent solidifying its status  as one of the world's preferred destinations for clinical trials, a Ficci study had earlier  pointed out that India is one of the fastest growing clinical research destinations with a growth rate that is two and a half times the overall market growth.

Even as  the recession from 2008 mid had  been a major blow to the international companies, this proved to be a unique opportunity for the  Indian clinical research industry to grab  human studies,  pharmacovigilance and data management assignments.

The sound medical expertise, English speaking work force, capability in information technology, large patient pool and  modern hospital infrastructure also helped the growth industry in India. Supporting these capabilities are quick turnaround time and the data management skills.

With a huge opportunity in the medical device and diagnostic trials, stem cell research, biosimilar market and phase 1 studies, Indian clinical research industry is on its way to challenge some of biggest markets, said Dr. K. Sashi Kiran, Managing Director, D2L Pharma Research Solutions in an earlier interaction with Pharmabiz.

“We have seen the scenario changing in the last few years as global economic conditions continue to challenge the drug development enterprises. A rising number of sponsors—large, medium, and small — are looking for new ways to better leverage the performance of their CRO partners while addressing intensifying capacity, quality, and cycle time requirements. The study sites in India has increased for a variety of reasons, including greater access to a high volume of treatment-naïve subjects and well-trained professionals, lower costs, and rising infrastructure levels in emerging markets. The industry has also witnessed tremendous growth in the last two years in areas like CDM, Pharmacovigilance, and central laboratories etc, said”,Shekhar Gupta,Chief Operating Officer,D2L Pharma Research Solutions.

 As per the latest estimates, nearly 1000 trials are currently going on in the country for several chemical and biotech compounds of different international companies. Though clinical research is unavoidable for the development and marketing of new drugs, what is usually ignored by the pharma companies and CROs  is the ethical side of this activity.

By its very nature human trials are highly risky as it involves deaths or serious injuries to the subjects undergoing trials. And  information about deaths and injuries of the subjects during the trials are usually suppressed by CROs and pharma companies.

An immense need has risen to address all aspects of pharmacovigilance to ensure delivering medical advances to patients, quickly and efficiently while protecting public health. The  inordinate delays in getting  approvals for conducting human studies is   also  putting the industry at a serious competitive disadvantage point out some experts in the field..

Thus even as the industry bodies are effusive about the growth prospects of the clinical trials sector of India, it is essential to  fill the lacuna in legal, moral and ethical issues while conducting  trials, which has far-reaching implications on this sector, aver experts.

In order to give a  fillip  to the clinical  trials in the country , the Union Government is keen to  beef up the  infrastructure and  also to identify the key strengths of the manpower in clinical trials. Specific biological infrastructure is being developed and massive investments are coming to  India to establish  national institutes to support the future growth areas.

In his key note address delivered via video at the recent Bangalore India Bio expo, M.K. Bhan, Secretary, Department of Biotechnology, Union Ministry of Science and Technology, said that a ‘Clinical Drug Trial and Support Agency' would be soon  set up to connect medical institutes with industries that are looking to test their drugs. This would include a training academy for principal investigators, 200 of who will be trained in the next five years.

Moreover a lot of autonomous companies are also  coming up in this sector. These include Clinical Development Service Agency  and several  dedicated operations like  regulatory  services, clinical trial support, soon to collect and carry out hospital based studies.

The Drugs Control General of India (DCGI) is also mulling a slew of measures which would  include the overseas inspection of sites, strengthening of infrastructure and hiring of personnel, enforcement of drug sampling, monitoring of clinical trials ethics committee and the sites of human studies and keeping a close watch on the fatal incidents and adverse drug reactions.

On the clinical trials front, Dr. Surinder Singh, DGCI said that India had a long way to go in the field of human studies. Of the one lakh trials carried out globally, US accounted for 52,000 and India conducted only 15,000 studies. There has been a lot of hype that the country is the hub of clinical trials and that its patients were guinea pigs for drug assessment.

In order to create more transparency, monitoring of ethics committee and the trials sites would soon be on the drug regulator’s radar. The violators would warrant action under the Indian Penal Code and Drugs & Cosmetics Act, according to DCGI.

In the meanwhile according to a report,the Union health ministry is planning a set of amendments to the country’s drug rules to make monitoring of drug clinical trials more stringent.

Mandatory registration of institutional ethics committees, empowering drug regulatory officials to inspect clinical trial sites and trial sponsors  are among the changes proposed. It is also planning to  revise the clinical trial consent form to capture the exact socio-economic status of the trial recruits.

The move comes after Parliament’s Committee on Government Assurances headed by the  ex-Union minister, Maneka Gandhi, pulled up the ministry for not maintaining records of the socio-economic status and contact details of clinical trial volunteers.

The committee had found the government was not in a position to say how many of the 671 deaths reported during clinical trials in 2010 had been compensated. Under the panel’s directive, the ministry has already sought clarifications from 44 pharmaceutical companies on the compensation given. Of the 671 deaths that were reported in 2010, the ministry has evidence of just three cases of compensation.

Unlike the current consent form, which does not seek details of the clinical trial volunteers but only ensures - through thumb impression or signature – the person’s willingness to participate in the trial, the new form will seek details of the socio-economic status, occupation, address, etc.

While the present consent form allows the volunteer to have his legal representative as a signatory, the new form will limit that option to specified occasions. The move is expected to  minimize the chance of exploiting illiterate patients or volunteers.

The changes will also make ethics committees, investigators and sponsors more responsible. The rights and safety of the clinical trial volunteers would  be assured and they would  get adequate compensation in case of serious adverse reactions through these amendments..

The amendments will also give statutory backing to some administrative reforms already initiated by the office of the DCGI. Registration of ethics committees, clinical trial site inspections, mandatory registration of clinical trials etc will all get legal backing. The responsibility of the sponsors will also be redefined, according to the report

The office of the DCGI will also be constituting a special cell to monitor clinical trials. The proposed amendment will arm drug inspectors with the powers to visit clinical trial sites, sites of the sponsors or even offices of pharmaceutical companies as part of its investigation. It will also provide detailed guidelines on how such investigations should be conducted and what action can be taken in case of proof of misconduct. This could include barring clinical trial investigators from taking up future assignments or suspending the licences of contract research organisations.

Registration of ethics committees is another change expected to make such committee members more accountable. Currently, the law mandates the formation of an ethics committee. However, it does not spell out specific measures needed to ensure the quality of such committees. Since the responsibilities of ethics committees are immense, it is essential that these committees are made accountable.

According to the report the amendments would allow the ministry to specify the requirements of an ethics committee and do periodic monitoring of the functioning of such committees.

At present  clinical trials industry in India accounts for around 40 major players. Of these the leading names are global players like Quintile, PharmaNet, PharmaOlam and  Clin Tech International  to name a few. The well-known Indian names include Ecron AcuNova, Lotus Labs, Clingene part of Biocon Limited, Omnicare, ICON, Vaatsalya, St. John’s Medical College Clincial Trial Centre, Triesta Life Sceicnes part of Health Care Global Enterprises Limited, Siro, Synchron, D2L, SMO India and Infinitus.

As India is scaling new peaks in clinical research , speed has become a crucial factor for the growth of this sector. Pharma companies are looking to hasten the drug development process and CROs are scrambling to have easy access right talent. Karnataka is positioned to offer this going by  the number of medical colleges here. There are also  clinical research training centres  working to groom candidates as industry ready professionals at a faster pace, said  Dr. Ramananda S  Nadig, Chief Executive Officer, Khoday Stem Cell Research & Medical Centre.

Clinical studies are carried out at both government and corporate hospitals. The qualified doctors, trained medical personnel including investigators, research-hospital infrastructure, economies-of-scale and access to recruiting large number of naïve  patients together with the growing disease burden ranging from  arthritis to cancer, diabetes, infectious diseases  and genetic disorders have made the international pharma and biotech companies to look at India. Further, the implementation of electronic medical records (EMRs) by hospitals in the country have also proved as a major attraction for international clinical research organizations (CROs) and multinational companies to come to India to carry out the  human studies, said Dr. Devi Shetty, managing director, Narayana Hrudayalaya.

According to  D A Prasanna, Chairman and Managing Director, in a  span of  five years, over 250 Phase one studies and around 70 late phase studies have been conducted taking the company to top 3 amongst 100 CRO’s in India. This has led to expansion of facilities by the companies in the field.

“For instance, we have expanded  our  Mangalore clinical pharmacology unit facility to  80 beds.

 This  expansion caters to the growing needs of its global clients in pharmaco-kinetic and pharmaco dynamic studies. This takes total bed capacity to 176 units in research centres at Mangalore, Manipal and Bangalore. Drug research involves analysing the activity of the drug in plasma using spectroscopy,” added Prasanna.

Ecron has  stormed into the nordic region after it acquired ‘majority stake of aCROnordic, a CRO specialized in clinical research in nordic countries. The acquisition is the second for the company this year after it bought Jamjuree Innovations Co Ltd. (JJI) in January. “ There has been a recent change in the strategy of sponsors in the healthcare space which has led to increase in core  global presence of preferred provider CROs. The merger of Ecron Acunova  and aCROnordic, which have   local knowledge in their geographies, yields substantial synergy to serve customers.  Further aCROnordic has been our  service provider for five  years and the acquisition has added Rs. 24 crore  to revenue”, said Ecron AcuNova chief.

There is no doubt that India has the capacity and the  expertise to carry out  phase-III and phase-IV human studies. But in order to save cost and time, the Indian regulatory authority would also need to give consent to  conducting phase-I trials immediately, said Dr. Rashmi H Barbhaiya, CEO and managing director, Advinus Therapeutics Ltd.

The availability of the dual expertise has led to international companies look at opening up  pharmacovigilance centres in India. The expertise in information technology and medical science has led to companies like Accenture, TCS and Infosys focus on pharmacovigilance.

 Further, the Government of India  is considering keen to include pharmacovigilance in the syllabus of medical education in India. Unless the adverse drug monitoring knowledge is included into medical education, quality of adverse drug monitoring in India would be a challenge, said Dr YK Gupta, co-ordinator, National Pharmacovigilance Programme and professor-head, department of pharmacology, All India Institute of Medical Sciences (AIMS).

Says  Ilango Ramanujam, Vice President – Clinical & Regulatory Services, TAKE Solutions,"There is a clear trend in drug development towards integrating multiple technology platforms that pharma companies end up with as a result of mergers, acquisitions and changes in ownership of the drug. However, the goal of creating an integrated clinical enterprise cannot be achieved through technology expertise and awareness of industry best practices alone. Our experience has shown that pharma companies need deep clinical data and industry standards expertise, coupled with technology skills to implement a unified global environment for clinical data building, analysis and reporting. "

 
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