CLINICAL TRIALS
Clinical Trials in India are regulated under the Central Drugs Standard Control Organization (CDSCO) and Drugs and Cosmetics Act, 1940, respectively. Rule 122 DAA of Drugs & Cosmetics Rules, 1945 (“D & C Rules”) defines clinical trials as a “systematic study of new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamics and pharmacokinetic) and/or adverse effects with the objective of determining safety and / or efficacy of the new drug”.
The clinical research market in India is presently valued at a figure of USD 500 million and is projected to reach USD 1 billion by 2016. This market is driven by the availability of a huge genetically diverse population with extremely lower costs when compared to the developed nations. However, the regulatory delays in the clinical trials are harming the prospects of clinical trials in India. The delays and regulatory ambiguity have wrecked innovation as well as growth of the clinical trial industry. After the amendment in January 2013, ineffective regulatory oversight, need for protection for informed consent of vulnerable populations and compensation guidelines for patients for trial related deaths have materialized as chief concerns.
Recently, Biocon has been compelled to move various Indian projects to the US and Europe. The situation only makes the process more cumbersome but also results in a 10-20 times hike in the cost of drug development. In the past two years, companies like Piramal Enterprises and Lupin were also forced to go abroad for conducting clinical trials, due to slow and uncertain approval processes in India with the matter being challenged in court.
FDI POLICY
If India has to ...
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...low when compared to that of the acute therapies but its growth has outperformed the market. With the right support from the government and friendly policies the sector is expected to see a good growth in the near future.
The small and medium enterprises (SMEs) are expected to play a significant role in the growth story of the country's pharma sector as they contribute 35–40 per cent to the industry in terms of production with a turnover of about Rs.35,000 crore (US$ 5.70 billion).
But we have also seen sluggish growth in the recent quarter and that can be attributed to some of the policy changes. To ensure that the sector keeps growing at a healthy rate Indian and foreign companies in the sector have to come up with certain innovative strategies like:
• Venturing into newer markets
• Use of new and improved technology
• Portfolio expansion
• Portfolio Optimization
Third world countries and underdeveloped nations have become the new proverbial Petri dish of experimentation and offer particular conditions which researchers would never be able to find in their home countries. This only serves to highlight the problem that inherently faces all research studies, the ethical debate in regards to the protection and rights of their subjects. Is it feasible to expect the same standards to apply in certain countries where an economical imbalance between what is possible and what is not can be the largest hurdle to overcome? These are key issues examined in the New England Journal of Medicine by author Marcia Angell, M.D., and co-authors Harold Varmus, M.D. and David Satcher, M.D. in their respective articles that consider the ethical standards that should prevail in such circumstances. Should researchers be upheld to universal standards, or are the standards more applicable in a “local” sense, where the conditions and the constraints of the location provide the context for how the principles should be applied?
Regulate the clinical data by enforcing stringent data management practices and mitigate the deviation in data collection and recording. The study protocol will define the source of data collection with Case Report Forms (CRFs), method of storage paper/ electronic and information retained for data archiving. Each subject will be identified with unique ID and Subject Identification Log will be maintained separately from trail analysis documents. The DMS prevents unblinding of specific documents, which protect the privacy and confidentiality of the subject, unless required by the study protocol. Identifiable documents and records will be maintained in accordance with the data retention period as specified in the protocol and the requirement of the regulations and IRB. Any update or changes implemented will be recorded in the revision history of the respective documents. The clinical trial team will be trained on clinical documentation and
Nucleon is a small biotechnology start-up with a very promising potential product (CRP-1), which is also the first product that Nucleon is planning to go into the clinic market. Nucleon has reached to human clinical trials phase with its product and it has no manufacturing facilities that satisfy the guidelines for these clinical trials and testing. Nucleon is on the verge of making a critical choice of manufacturing strategy, which will affect Nucleon’s survival in the intense competition in the long haul. Nucleon management is aware of the facts that they have a limited budget to start with, the financial environment in biotechnology is rapidly changing and establishing the safety and efficacy of products like CRP-1 is complex, time-consuming and expensive; that’s why they want to evaluate risks and rewards of each manufacturing strategy before making their final decision.
In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. 21st century reforms Critical Path Initiative The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. The Initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. Patients' rights to access unapproved drugs
On June 23, 2016, the UK voted to withdraw from the European Union, raising many questions about the future of clinical trials. However, Brexit wasn’t the beginning of the conversation, and it certainly isn’t the end.
Patient consent is the law. Even though the test can provide unsatisfactory results they cannot anticipate the way the drugs will affect the present. This could lead to one patient favoring one treatment over another. The problem that comes from specific informed consent cannot be addressed solely by demanding more rigorous standard for research (Truog et al. 1999).
The pharmaceutical and biotech industries must be free to develop and research life saving medicines and other advancements that will benefit society. If this cannot be done, progress would never be made. People would still be contracting polio a...
trials of investigation medical products. The FDA also has to review and approve in a
Article two entitled “Clinical trials: are they ethical?” is written by Eugene Passamani discusses the importance of randomized clinical trials. Passamani rejects the argument that the physician-patient relationship demands that physicians recommend ...
[6] Kripalani, Majeet & Egnardio, Pete. The Rise Of India. Business Week Online. December 8, 2003. http://www.businessweek.com/magazine/content/03_49/b3861001_mz001.htm
They point out that awareness and understanding of these causes assist companies in avoiding the growth stalls. In addition, the article demonstrates few practices that some companies use to predict and prevent the problem.
There were many key facts and critical issues found in The New England Journal of Medical, Global Health, and the Law. One being what is ethics and how do they play a role in the field of medicine the discussion of how many cases of different epidemics in developing countries that will have inflicted and negative consequences. Policy framework along with legal framework when dealing with health and medicine empirical studies that contribute to discovering a cure many serious and critical health issues were discussed in the journal as well. It talked about how new technology can be analyzed and could possibly help in the medical field. The findings or results of technology that is new and how it is being conducted in the field of law and medicine
India's strategy for development has had many critics. It was pointed out that the emphasis on heavy industry
Qiu, L, Chen, Z-Y, Lu, D-Y, Hu, H & Wang, Y-T 2010, 'Public funding and private investment for R&D : a survey in China’s pharmaceutical industry ', Health Research Policy and Systems, vol. 12, no. 27, pp. 11
The services sector is the key driver of India’s economic growth. The sector contributed around 53.8 % of its Gross Value Added in 2015-2016 and employed 28.6 % of the total population. Net services exports from India grew 14.6% in the