Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 4, Issue 2, 2017

Pharmaceutical drug discovery and development is an extensive, investment incurring, and unpredictable process that may take 8-12 years to make a drug reaching to market place. Originator companies generally ensure patent rights over the drug molecules discovered and developed by them at an early drug development stage. This is an effort to inhibit other competitor companies from synthesizing, use in manufacture, or sell these molecules at a later stage. This will also allow the originator company to ensure exclusive profit gains if the drug molecule succeeds to become a blockbuster drug. This security on exclusivity is rationalized to allow the originator company to as recuperate investment and realize benefits as the process of discovery and development of new drug needs a lot of investment in people, efforts, time and financial fronts. Through an Abbreviated new drug application (ANDA) process, applicant may get FDA approval for a generic drug without performing full clinical trials if the proposed drug product is bioequivalent to the innovator drug product. USFDA approves the generic drugs if they demonstrate to have the same quality, purity, strength and stability as that of innovator drugs. A paragraph IV certification is submitted by the generic drug applicant in case they wish to market the generic version of the drug before expiry of the originator’s patent rights. Submitting a Paragraph IV certification would mean that generic applicant claims that it is justified to place generic drug early on the market because its drug does not infringe the patent in question or the patent in question is invalid. In case of successful proceedings over the claims the generic drug applicant is rewarded for a ‘Para IV filing’ by granting a marketing exclusivity for 180 days. Exclusivity means that no company is allowed to launch its product during this period. As a result, there is ‘No Competition’ in the market. As the first mover, this helps the generic manufacturer to have an advantage. It can garner a market share. This is a valuable opportunity for generic drug manufacturer to maximize profit margins without any competition. This provision in the act has promoted healthy competition and helped public health sector with drugs becoming available to public at relatively lower prices.

Background: Nutraceuticals are accessible in the form of dietary supplements, nutrients, herbal foods, genetically engineered foods, particular diet, and processed foods in the form of tablets, capsules, granules, and beverages. It provides all the essential requirements such as energy and nutrient supplements to the body, by supplementing a diet. Methods: The study basically involves all the three categories of research methodologies, including analytic, descriptive and historical. It involves secondary data such as various guidelines, rules, and regulations published in scientific reports, books, and journals. Results: Supplements and nutraceutical business sectors are anticipated to accomplish a worldwide size of around 262.9 billion US $ in 2020 at a Compound Annual Growth Rate (CAGR) of 8%. The US nutraceutical market was valued at 50.4 billion US $ in 2010 and grown with a CAGR of 7%. The nutraceutical market in India was priced at 1.4 billion US $ in 2011 and grown up to 3.2 billion US $ in 2016. Conclusion: There has been a continuous growth in the nutraceutical field in the recent years, particularly as a result of the improvement in the regulatory environment of India. Here, with the article, it is discussed, what the nutraceuticals are, what the benefits are, how it is governed, what is the current regulations say and last but not the least, how it helps to strategize regulatory environment of India.

Background: The field of nanotechnology is growing tremendously in vast areas with 13% nano-based products in cosmetic industry. The use of nanomaterials (NMs) in cosmetics formulations for different applications has led to safety concerns globally with aspects related to skin which comes in direct contact and indirectly to the environment with respect to waste management, and is the major issue that needs attention. Objectives: This article will deliberate on the current status of regulatory and safety guidelines for the use of NMs in cosmetics. The need for harmonization globally, by the regulatory authorities and the trend of where it is heading in future towards safety and quality assessment of cosmetics and their ingredients is also highlighted. Discussion: The use of NMs in cosmetics may enhance or inhibit the skin absorption of ingredients. Its use has raised concerns in EU, US, Canada, Japan, etc. The current evidences so far suggest that the NMs used in cosmetic formulations possess no risk to human health particularly skin; rather than they possess the multiple benefits to human health such as protection from the UV radiation which can cause skin cancer. Though few researches have suggested potential risks that have not been confirmed yet. An active debate and discussion regarding the potential risk of NMs in cosmetics has been performed by regulatory agencies and steps are being taken by several regulatory bodies towards harmonization.

Background: Herbal drugs obtained from medicinal plants are used by a majority of the people because of their safety and less side effects, but it is not completely true that herbal products do not have any side effects or toxic effects, they do carry risks. Regulatory authorities of different countries regulate the quality and standard of herbal drugs on the basis of problems associated with them such as herb-drug interaction, side effects, toxicity and adverse effects. The International Drug Monitoring Program of World Health Organization (WHO) has made certain guidelines for herbal drugs evaluation and quality control analysis. The WHO has done various efforts for the improvement of herbal drugs in the context of their safety and efficacy. The herbal drug toxicity arises when the drug is used without proper indications, in large doses, or with other drugs, for longer duration without consultation of a physician, and manufactured appropriately. Objectives: This mini review has been written to discuss the current status of regulatory and quality aspects of herbal drugs. The regulatory guidelines of herbal drugs need to be improved along with the Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP) guidelines. Discussion: In the field of herbal drugs, various parameters/guidelines regarding their safety and efficacy, in manufacturing and selling have been controlled thoroughly by the regulatory authorities. However, improvements should be done w.r.t. rules and regulations of herbal drugs, particularly in the case of collection, cultivation and toxic effects of herbs.

Background: The dynamic pharmaceutical industry is driven by regulatory authorities viz. Central Drug Standard Control Organization (CDSCO) for India, European Agency for the Evaluation of Medicinal Products (EMEA) for Europe, Therapeutic Products Directorate (TPD) for Canada, Medicines and Healthcare Products Regulatory Agency (MHRA) for UK, Therapeutic Goods Administration (TGA) for Australia, Medicines Control Council (MCC); however the most prominent among the regulatory agency is US Food and Drug Administration (FDA). Discussion: The FDA's effort to protect consumers from health fraud in the form of issuing import alerts or warning letters or 483 are praiseworthy. Because it promotes compliance and helps to ensure quality, safety and efficacy of drugs. In general notifying to an organization with import alerts or warning letters or 483 may not be the most welcomed news, however it should be viewed as a valuable tool. With the awareness of auditing and compliance, now pharmaceuticals are more conscious and thoughtful for regulatory auditing and compliance. Moreover, this kind of mind set, preparedness, and seriousness for audit is helping to make practices and processes more rigorous, and in a broader sense, ultimately human beings are getting benefits of receiving quality embedded drugs. With this article, post-mortem of FDA's currently issued some of the important warning letters for noted Indian pharmaceutical firms has been made, reasons have been segmented and some of the suggestions have also been sighted. Conclusion: The inference of this article can act as a reference for pharmaceutical organisation those who are becoming ready for upcoming audits. Preparedness and seriousness for audit will help to make pharmaceutical industry's practices and processes more rigorous, and ultimately with these, human beings are getting benefits of receiving quality embedded drugs.

Background: “Trial and Clinical” emanate from the Anglo-French trier and from the French cliniqu´e and from the Greek klinike respectively; which denotes to try and to the practice of taking care of the sick at the at the bedside. Discussion: Therefore, a clinical trial is the summation of activities or process of positioning something to a test. It's finally to validate whether said drugs is for the worth of treatment or for prevention and or cure of disease or sickness or not. So any new drug or new medical devices need to pass through several stages of clinical trials along with animal studies before stepping into market primarily to anchor safety, efficacy. Conclusion: This article comprises a brief, however, a revealing basics of clinical trials, such as regulatory feature, procedure and its importance and how it operates with the mark and presence of Codes and Policies for Research Ethics, Good Clinical Practices, Data Safety Monitoring Board and Institutional Review Board. This commentary recapitulates the indispensable facts/findings for scientists/researchers who plan to carry out clinical trials.

Background: Energy drinks have swooped the beverage industry of late, there are not much papers related to the regulatory status of energy drinks in India. This paper aims to look into their regulation in India in comparison to developed nations. Methods: The study was conducted by consulting bibliographic databases such as, academic journals, trade journals, books, market reports, newspaper articles, web pages of relevant regulatory authorities using focused review questions. Results: Thirty nine papers were included in the review which revealed that in comparison to developed nations the regulatory status of energy drinks in India is still in the preliminary stages. Energy drinks marketed in India along with their active ingredients and drinks having non-permissible combinations have also been identified. Conclusion: Although FSSAI (Food Safety and Standards Authority of India) has drafted a proposal for regulating energy drinks but implementation seems to be a distant reality, the government should take stringent actions in order to improve the rising health concerns raised by energy drinks before it’s too little too late.

Background: Medical research is a very costly affair and of prime importance for the expansion of knowledge and discoveries of new medical treatments and cures. As a matter of fact a significant amount of medical research in hospitals is conducted on already stored patient data and often useful in devising better treatment modalities as well as in making policy suggestions. Keeping in view the tragedies in clinical trials such as Nazi experiments, thalidomide tragedy, etc, the ethical considerations in research are being given top priority. Hence it is very important to develop tools that can cut the cost of research without compromising research and medical ethics. Objective: This study was designed to develop a tool to cut research cost in resource compromised research institutions. The tool is a general informed consent form that will take blanket permission from each patient for usage of the data related to him at any specified time by hospital/institution. The study entails to evaluate the acceptance and rejection rate of this concept. Methods: The study was carried out on 1600 OPD patients. A general consent form was introduced at OPD/IPD level with permission from hospital authorities. This was an approach to consent whereby participants agree that they understand the unknown aspects of future use, trust the governance procedures, and express a desire for their samples/medical reports/pathological reports/ medical history etc. to be used for the maximal benefit of the research endeavor. Results: The results of acceptance rate of general consent found that out of 1600 patient only 84 (5.25%) patients said no to give general consent and 94.75% of participants agreed to give the general consent for future research. The acceptance rate was higher in educated patients as compared to uneducated patients. The acceptance rate increased with the qualification. Conclusion: From the study it can be concluded that this general consent form if introduced at OPD level will not only enable research institutions to follow ethical principal but also cut the cost of medical research.

Purpose: The aim of this paper is to look into current regulatory specifications and to collect comparative data of probiotics across the globe for understanding the ambiguities related to these regimes. Ultimately it will provide a platform, to develop harmonized guidelines for assurance of quality, premarketing safety assessment and for framing satisfactory regulatory requirements for future. Methods: The study was carried out by using secondary sources by doing literature survey from journals, market reports, proceedings, books and web pages of relevant regulatory authorities. Information from the recently published sources (indeed official regulations) was used instead of older. For acceptance of probiotics based products with uniform quality, greater safety of patients, with established scientific evidences for holistic therapeutic benefits in treatment of various ailments, drafting of comprehensive regulatory guidelines is the need of the hour. So in this context, already prescribed guidelines from various countries have been collected for common point selection and reviewed critically. Results: The comparative representation clearly shows that all countries have approached probiotic regulations differently. Hence it has been found that there is urgent requirement of internationally accepted definition, well established categorization as well as separate guidelines addressing identification, evaluation, manufacturing, labeling-health claims, approval process and dossier. Conclusion: The most noticeable fact is that not even a single country is obliging all the necessary parameters required for the safe and judicious use of probiotics as foods and pharmaceuticals and hence a harmonized regulatory framework is need of the hour.