Clinical trials in India had suffered set backs a few years ago due to disturbing news in mass media that Indian patients or volunteers were being used as guinea pigs. There were reports of violations of ethics where the subjects had been subjected to unfair treatment due to lack of organization, poor regulatory frame work and guidelines.
However due to reforms that followed, now it is advantageous for conducting clinical trials in India than in many other countries. The fact that clinical trials are expensive and there are lesser number of patients in the therapeutic stream, made the multinational companies to look into India and other developing countries for conducting clinical trials. Hence many clinical trials were out sourced to India and other countries.
A special advantage India has over its peers is that it has a large number of trained health care professionals who can communicate in English. Compared to China, India has a huge number of patients and volunteers who could participate in clinical trials. India has GMP approved labs and major cities are connected by airports through which human bio samples can be quickly transported and are called chain facilities which supported analysis.
Despite having all these natural advantage to host clinical trials in the country, due to lack of organizations and regulatory frame work, it could not be started for several years. Many multinationals who had considered India as a good destination for conducting clinical trial for their products were disappointed.
Realizing the loss of opportunities ,various stake-holders including government of India decided to update and establish the clinical research in India at par with international standards. The government of India made amendments and rules which made the conducting of the clinical trials smooth and transparent.
The amendments in patent laws and establishment of national body ‘The clinical trial registry of India’ made all the clinical trials mandatory for registration. The guidelines for conducting clinical trials were updated and the administrative body was affiliated to CDSCO, New Delhi. The ethics committees were required to register and maintain the proceeding of meeting became a regular legal requirement. The centralization of clinical trials in India was initiated by launching of national data base of clinical trial registry of India.
Following these , the ethical treatment of subjects of clinical trials was made possible by updating guidelines of human ethics committee which is acceptable to international standards. The clinical trials in the country which cannot be done without the approval of human ethics committee was handed over to DCGI/CDSCO. Earlier it was handled by Indian council of medical research.
After streamlining the regulatory infrastructure, industry is now exploring contract research orders from developed economies. Central Drugs Standard Control Organization (CDSCO) in India has issued a number of guidelines to strengthen regulations in India since January 2013.
Schedule Y prescribes requirement and guidelines for permission to import or manufacture new drugs for sale to undertake clinical trials. The recent amendments in schedule Y is for specifying the procedures for payment of compensation to the participants of the clinical trials in cases of severe injury or death under rule No. 122DAB. The rule 122DAC is for specifying various conditions for conduct and inspection of clinical trials. And for specifying the data ,detailed guidelines for regulatory of ethics committee are given in the rule 122DD. In order to bring transparency in conduct of clinical trials, audio video recording of informed consent has been made mandatory. The safety adverse events compensation guidelines has been amended in schedule Y.
DR. Ranjith Roy Choudhary Expert Committee and Parliamentary Standing Committee on Health and Family Welfare in Rajya Sabha both recommended structural change in Indian Council Medical Act. The structural changes were regarding the improvement in quality of medical education in India.
Transparency and accountability are the functioning of medical council in order to reducing the corruption making medical education affordable and also reducing the rural - urban gap in terms of availability of qualified doctors. It is also mandatory now to register a clinical trial which has been given consent by an approved institutional ethics committee in Clinical Trial Registry of India. Responsibility of the principal investigator is to update the status and the stage of ongoing trial in the public domain as soon as possible.
The clinical trial industry in India comprises national and multinational industries. In order to have a bird’s eye view of the industry ,we are discussing a few organizations given below.
Quintile is a multinational clinical trial contract research company. Their offices in Bangalore, Ahmadabad, Mumbai, New Delhi are under the banner of quintiles India. Quintile is in line with FDA, ICH, GCP standards. They do services and project management, clinical trial monitoring, regulatory affairs, drug safety, pharmacovigilance, quality assurance, medical and scientific services.
Pharmaceutical Product Development (PPD) is one of the famous international companies started in 1985 having offices in Gurgaon, Bangalore and Mumbai. The services provided include clinical development services, counselling services, laboratory services, and discovery innovations. Paraxel has offices in Hyderabad, Bangalore, Delhi, Mumbai, Chandigarh and Gurgaon. Their services include early phase services, phase 23 services, peri approval services, post approval services, clinical logistics and counselling services.
Siro Clinpharm company started operations in Mumbai . The corporate headquarters of Siro Clinpharm is located in Thane. The European headquarters of CRO is located in Greece. The company also has its offices in USA and Malaysia. The various services that are being offered by this leading Indian CRO are clinical operations, clinical data management, medical writing, scientific writing, clinical trial supplies, pharmacovigilance, biostatics as well as statistical programming. Therapeutic expertise of Siro Clinpharm includes oncology, C V diseases, endocrinology, respiratory diseases and infectious diseases.
GVK Bio is one of the leading discovery research and development organizations in the Asian continent. Its headquarter is located in Hyderabad. In India the company is operating in Hyderabad, Bangalore, Gurgaon, Mumbai and Ahmadabad. The company is also operating in countries such as USA, Netherlands and Singapore. The services include discovery services, manufacturing services, information and analysis.
CLINIMVENT was established as a contract research organization that is having end-to-end capabilities in the areas of clinical trial and management. This company is located in Mumbai. Various services include clinical trial management, data management, medical writing, quality assurance and GCP training.
Clini RX is head-quartered in India. Various services include regulatory services, site selection, project management monitoring, medical writing, safety surveillance, quality assurance, biometrics and other special services.
ECRON ACUNOVA is a CRO which derives its strength from four expert CROs that are serving Europe, South East Asia as well as India. Services include bio availability services, phase1 to phase 4 clinical trials, clinical data management, biostatistics, medical writing, pharmacovigilance and laboratory services.
The clinical trials in India has picked up and is one of the major employers for young, fresh healthcare interns. Making pharmacovigilance submissions mandatory has made clinical trial industry much more active. Many of the pharma companies have added clinical trial department along with pharmacovigilance as their enhanced activity. The convergence of IT BT has made India a choice destination for conducting clinical trials.
(Authors are faculty, Department of pharmacy practice, SCS College of pharmacy, Harapanahalli)