Recent Indian rule on compensation for any injury or death of the subject in a clinical trial, has generated a lot of discussion on its impact on clinical trials in India. The legal process in the compensation rule is based on the causality assessment. However, it ignores the scientific basis of causality assessment. This could have far reaching consequences on (1) science of causality assessment and (2) safety assessment of a new drug under clinical development. There is a need to bring clarity on causality assessment process within the compensation rules to balance the ethical need of human subject protection and the scientific requirements of safety assessment.

Three amendments to the drugs and cosmetics rules were published in quick succession in 2013. These addressed the issues of compensation of injury and death in clinical trials in addition to the role and registration of Ethics Committees. Of the three, the first and the third make an impact on the clinical research activities in India. The second amendment has codified the conduct of clinical trials, putting together rules, which appeared in different sections of Schedule Y. The first amendment deals with the compensation for injuries and deaths taking place during clinical trials while the third deals with registration of Ethics Committees. Despite the long delay in the issue of compensation rules, there appears significant room for improvement. The most problematic are conditions of injury and death in which compensation has to be paid. When compared with other countries, the Indian rules seem unduly harsh on sponsors and are at significant variance with those in UK. The rules are very generous toward subjects and compensation is likely to become an alternative to insurance in terminally ill subjects. The implementation of these rules will make clinical trials in India more expensive and hurt the industry that is already struggling through other handicaps. There is an urgent need to make the the environment more industry friendly to attract more clinical work.

Background: Pharmacovigilance is a useful to assure the safety of medicines and protect consumers from their harmful effects. Healthcare professionals should consider Adverse Drug Reaction (ADR) reporting as part of their professional obligation and participate in the existent pharmacovigilance programs in their countries. In India, the National PV Program was re-launched in July 2010. Objectives: This survey was conducted in order to assess the knowledge, attitude and practice of Indian pharmacists with the aim of exploring the pharmacists' participation in ADR reporting system, identifying the reasons of under reporting and determining the steps that could be adopted to increase reporting rates. Materials and Methods: A cross-sectional survey was carried out among the pharmacists in India using a pretested questionnaire with 33 questions (10 questions on knowledge, 6 on attitude, 7 on practice, 7 on future of ADR reporting in India and 3 on benefits of reporting ADRs.). The study was conducted, over a period of 3 months from May 2012 to July 2012. Results: Out of the 600 participants to whom the survey was administered, a total of 400 were filled. The response rate of the survey was 67%. 95% responders were knowledgeable about ADRs. 90% participants had a positive attitude towards making ADRs reporting mandatory for practicing pharmacists. 87.5% participants were interested in participating in the National Pharmacovigilance program, in India. 47.5% respondents had observed ADRs in their practice, and 37% had reported it to the national pharmacovigilance center. 92% pharmacists believed reporting ADRs immensely helped in providing quality care to patients. Conclusion : The Indian pharmacists have poor knowledge, attitude, and practice (KAP) towards ADR reporting and pharmacovigilance. Pharmacists with higher qualifications such as the pharmacists with a PharmD have better KAP. With additional training on Pharmacovigilance, the Indian Pharmacists working in different sectors can become part of ADR reporting system.

Objective: The objective of this study was to conduct feasibility study of phase III breast and lung cancer clinical trials in India. Materials and Methods: Study synopsis and feasibility questionnaire were mailed to 300 oncologists for each indication. Criteria of selection were enrolment of ≥2 patients per month, frequency of Ethics Committee (EC) meeting ≤4 weeks, dropout rate <20%, adequacy of infrastructure and training of site in good clinical practice (GCP). Descriptive analyses of the data were performed. Results: For both indications, 50/300 (16.7%) sites responded. The median number of patients seen by a site per month for breast and lung cancer was 20 (range 0-300) and 10 (range 0-75), respectively. Median number of eligible patients was 4 (range 0-20) and 3 (range 0-15) per month, for breast and lung cancer respectively. The frequency of EC meeting was ≤4 weeks at 36-56% of sites. All sites were trained in GCP and had adequate infrastructure to conduct the clinical trial. For breast cancer 22 (44%) sites (public 14 [28%]; private 8 [16%)]), and for lung cancer 18 (36%) sites (public 15 [30%], private: 3 [6%]) met the criteria of selection. Conclusion: Preliminary feasibility study would require for confirmation of the important feasibility criteria by in depth discussion during the personal visit to the potential sites.

Purpose and Aim: Multi-drug resistance in treatment-experienced human immune deficiency virus (HIV) patients has been a major cause to first line antiretroviral therapy (ART) failure, necessitating a switch to second line therapy. In India, the second line treatment program is still relatively new with little experience and unclear outcomes. It is therefore, critical to assess the clinical, virological and immunological effectiveness and treatment outcome over the 1 ^st year of follow-up in the patients' switched to the second line ART at public sector tertiary care center. Materials and Methods: A prospective, observational study was carried out on HIV positive patients switched on second line ART from January 2010 to December 2010 at ART Centre, Civil Hospital, Ahmedabad. Demographic details, symptoms, adverse drug reactions (ADRs), second line ART regimens, CD4 count, and plasma viral load (PVL) were recorded in a case record form. Patients were followed-up monthly for 12 months. The data was analyzed by t-test, z-test, and Fisher-exact test. Results: Out of 126 patients, 82 received regimen V [zidovudine (ZDV) + lamivudine (3TC) + tenofovir (TDF) + boosted lopinavir (LPV/r)] and 44 received regimen Va [3TC + TDF + LPV/r]. A significant ( P < 0.0001) increase in mean body weight and marked reduction in number of patients (7) categorized as WHO stage III/IV was observed at 12 months of second line ART. Moreover, a significant immune reconstitution with increase in mean CD4 count and viral suppression (PVL < 400 copies/ml) in 103 (82%) patients ( P < 0.0001) was also observed. A total of 83 ADRs were observed in 69 (55%) patients, the most common being dyslipidemia (57) followed by anemia (9). Conclusion: Early treatment outcome with second line ART was good with 82% success rate in treatment experienced HIV patients. Dyslipidemia and anemia were the common ADRs observed.

Aim: An effective clinical trial strategy to ensure patient safety as well as trial quality and efficiency involves an integrated approach, including prospective identification of risk factors, mitigation of the risks through proper study design and execution, and assessment of quality metrics in real-time. Such an integrated quality management plan may also be enhanced by using data-driven techniques to identify risk factors that are most relevant in predicting quality issues associated with a trial. In this paper, we illustrate such an approach using data collected from actual clinical trials. Materials and Methods: Several statistical methods were employed, including the Wilcoxon rank-sum test and logistic regression, to identify the presence of association between risk factors and the occurrence of quality issues, applied to data on quality of clinical trials sponsored by Pfizer. Results: Only a subset of the risk factors had a significant association with quality issues, and included: Whether study used Placebo, whether an agent was a biologic, unusual packaging label, complex dosing, and over 25 planned procedures. Conclusion: Proper implementation of the strategy can help to optimize resource utilization without compromising trial integrity and patient safety.

On November 3 ^rd and 4 ^th , 2012, Manipal Hospital, Bangalore and Association for the Accreditation of Human Research Protection Programs co-hosted a regional conference titled "Practical Solutions to Challenges in Research Ethics." This paper is a synthesis of the major themes of the conference. The authors discuss the current state of the clinical research in India today, need to focus on human research protection programs rather than Ethics Committees or institutional review boards, the factors that influence high-quality research and some practical solutions to improving the quality of research and the protection of research participants.

Healthcare industry is flooded with multitude of drugs, and the list is increasing day by day. Consumption of medications has enormously increased due to life style changes, having safer drugs is the need of the hour. Regulators and other authorities to have a check have put in stringent regulations and pharmacovigilance system in place. Eventhough there has been increase in adverse drug reactions (ADR) reporting in the last decade, causality assessment has been the greater challenge for academicians and even industry. Causality is crucial for risk benefit assessment, particularly when it involves post marketing safety signals. Pharmaceutical companies have put in efforts to have a standardized approach for causality assessment. This article will provide some insight into the approaches for causality assessment from a pharma industry perspective.