ArticleJournal of pharmacy & bioallied sciences2013
Clinical research regulation in India-history, development, initiatives, challenges and controversies: Still long way to go.
Article in Journal of pharmacy & bioallied sciences, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 43 citations in OpenAlex.
- Empowering self-care through patient education in heart failure patients: A multimodal approach comprising of P-PILs, videos, and personalized advice.Journal of education and health promotion · 2024Article
- Exploring the antecedents of AI adoption for effective HRM practices in the Indian pharmaceutical sector.Frontiers in pharmacology · 2023Article
- Biosimilars in Oncology: Latest Trends and Regulatory Status.Pharmaceutics · 2022Review
- A cross-sectional questionnaire based study to assess and compare knowledge of drug schedules amongst healthcare professionals in a medical college.Medical journal, Armed Forces India · 2022Article
- The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region.Children (Basel, Switzerland) · 2022Review
- Evolution of Mesenchymal Stem Cell Therapy as an Advanced Therapeutic Medicinal Product (ATMP)-An Indian Perspective.Bioengineering (Basel, Switzerland) · 2022Review
- Regulatory requirements for clinical trials in India: What academicians need to know.Indian journal of anaesthesia · 2017Article
- Industry-sponsored clinical research outside high-income countries: an empirical analysis of registered clinical trials from 2006 to 2013.Health research policy and systems · 2015Article
- Regulatory and clinical considerations for biosimilar oncology drugs.The Lancet. Oncology · 2014Review
- Ensuring that informed consent is really an informed consent: Role of videography.Perspectives in clinical research · 2014Article
- Stay calm and register your trial… its time.Journal of anaesthesiology, clinical pharmacologyArticle
- Knowledge and perception regarding clinical trials among doctors of government medical colleges: A questionnaire-based study.Perspectives in clinical researchArticle
- Clinical trials in oncology: Has India come of age?Indian journal of medical and paediatric oncology : official journal of Indian Society of Medical & Paediatric OncologyArticle
- Medical writing on an accelerated path in India.Perspectives in clinical researchReview
- Embracing Medication Needs of Patients based on Ethical, Dietary, and Religious Preferences.American journal of lifestyle medicineReview
- Accreditation - A solution for problems or a fresh problem?Perspectives in clinical researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The Central Drugs Standard Control Organisation and its chairman Drug Controller general of India are bequeathed to protect the citizens from the marketing of unsafe medication. The startling findings, of the 59(th)report of the Parliamentary Standing Committee on Health and Family Welfare, have uncovered the lax standards followed by the regulatory authorities in India. The growing clinical research after the product patents rights for the pharmaceutical industries as per the trade related aspects of intellectual property rights agreement and adverse drug reaction monitoring of the marketed drugs have raised many ethical and regulatory issues regarding the promotion of new drugs in Indian markets. Many controversial group of medicines; unauthorised and irrational FDCs not relevant to India's medical needs, are available which are not sold in any of the countries with matured regulatory bodies. It becomes vital to understand the history, growth and evolution of the regulatory aspects of drugs which are handled by multiple Ministries and Departments of the Government of India. Although amendment to Schedule Y, registration of Contract Research Organisations, registration of Clinical Trials, Speeding up review process, Pharmacovigilance (PhV) programme for India and Inspection of clinical trial sites have been started by the various regulatory agencies. However due to casual approach in marketing approval for sale of the drugs, the unethical steps taken by some pharmaceutical companies and medical practitioners has reiterated the need to get appropriate understanding of present regulation of drugs and clinical research especially regarding the practical rules and regulations.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.