Review Article ISSN: Vinod M. Sonawane et al. / Journal of Pharmacy Research 2010, 3(12),

Transcription

1 Review Article ISSN: Available online through An Overview To Drug Regulatory Authorities Over The World Vinod M. Sonawane* 1, Mrs. Maria Saiffee 1, Aliabbas H. Hawaldar 1, Sagar D. Deshpande 1, Nilesh A. Pawar 1. Department Of Pharmaceutics, Y.B. Chavan College Of Pharmacy, Rauza Bagh, Aurangabad (M.S.) India. Received on: ; Revised on: ; Accepted on: ABSTRACT Today in the world of globalization, there is an ease of transportation and convenience to carry drugs along from one country to another or within the country. In order to have control over the movement of drugs and manufacturing, marketing and other jobs related to drugs need to be regulated. The drugs manufactured at one country may be marketed and utilized to another country. To control these traffic of drugs and other products related to health are under the survillence of respective regulatory authorities in different countries. Here we are taking brief introduction, functioning and other aspects of different drug regulatory authorities over the world. Key words: Regulatory agencies, drug regulation over the world, drug regulatory affairs, regulatory authorities. INTRODUCTION Regulatory affairs in pharmaceutical industry aim at the protection of human health. Regulation promotes various activities so as to ensure safety, efficacy and quality of drugs. It also ensures the appropriateness and accuracy of product information. Before new medicines reach the prescription pad, the appropriate regulatory agencies, which assess their safety and efficacy, must first approve them. The concept of regulation in pharmaceutical industry is not new. Mankind has always felt the need for regulating the production, import, storage, distribution, sale and supply of drugs. The regulations are applied to all drugs from new, innovative to long established products. It also applies to drugs from different sources, regardless of whether they are produced domestically or imported by the public or private sector. Since a long time World Health Organization (WHO), international organizations and many countries are trying to strengthen the regulatory processes at the national and international level. To achieve this, guidelines and adequate norms and standards have been developed continuously. Unfortunately only few developed countries enjoy a well-operated drug regulatory system. Most of the countries have a weak system while in some countries the system is totally lacking. Market circulation of substandard drugs is always a threat to the population. Government support in the form of strong legislation is also required. They should examine their drug legislation and amend it if necessary. Regulatory agencies should be provided with adequate power so as to meet the drug regulatory objectives. The role, responsibilities and duties of the parties involved in drug regulation have to be defined clearly. Provisions for administrative measures and legal sanctions, to be taken in the event that the drug laws and regulations are violated, should be made. Access to pharmaceutical products (drugs and biologicals) requires national drug policies that are part of the overall health policy. Since the purpose of drugs is to diagnose, prevent or treat diseases or ailments in humans, they are products intimately linked with the advances in research and national policies on research and regulation. The pharmaceutical industry, while pursuing an international market, is obliged to comply with national regulations. The scope, nature and practice of drug regulation, including priorities, standards, norms, enforcement strategies, resources available and the rigor of enforcement vary from country to country. However, the goals are generally the same: promotion and protection of public health by ensuring the safety, efficacy and quality of drugs and the appropriateness and accuracy of product information. But an effective drug regulatory body is one that demonstrates results in accordance with the objectives and targets set for it. A drug regulatory body should: 1. Base its decisions on scientific evidences and facts. 2. Provide efficient and timely services. 3. Have a capacity to develop practicable regulatory and enforcement *Corresponding author. Vinod M. Sonawane, Dept. of Pharmaceutics, Y.B.Chavan college of Pharmacy, Rauza Bagh, Aurangabad Maharashtra, India. Tel.: ; (Fax) sonawane.vinod.m@gmail.com strategies (i.e. dynamic). 4. Apply sound management principles. 5. Reach its objectives cost-effectively. 6. Be accountable. 7. Operate to safeguard against corruption and conflict of interest. 8. Most importantly, the process of drug regulation should be transparent. Some drug regulatory authorities world wide Different organizations are working in different countries as drug regulatory authorities at the national and international level. In this review article, an attempt has been made to get an overview of some of the important organizations working worldwide. The World Health Organization (WHO) The World Health Organization or WHO is the United Nations specialized agency for health. It was established on 7th April [1] WHO s objective, as set out in its constitution, is the attainment of the highest possible level of health by all people. Health is defined in WHO s constitution as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. WHO is governed by 192 member states through the World Health Assembly. The health assembly is composed of representatives from WHO s member states. The main tasks of the world health assembly are to approve the WHO programme and the budget for the following biennium and to decide major policy questions. The drug regulatory programme supports member states in their regulatory work with WHO guidelines and standards. All European countries face new regulatory changes that require international collaboration. Drug regulation in countries of the European Union is covered under the European Union regulatory and legislative framework. Central European countries have organized under the Collaboration Agreement of Drug Regulatory authorities in European Union Associated Countries (CADREAC) agreement to discuss progressive harmonization with European Union regulation. Network Information Services (NIS) regulatory authorities are meeting regularly in the drug net network to discuss improvement of drug regulation. Within QSM, the Quality Assurance and Safety of Medicines (QSM) team is responsible for the development, harmonization and promotion of international standards and for the exchange of information. It provides government and pharmaceutical manufacturers with the means to establish and maintain mechanisms, which ensures the quality, safety and efficacy of pharmaceutical products and their rational use. In collaboration with the United Nations, QSM provides expertise in updating the list of drugs of abuse under the 1961 Single Convention on Narcotic Drugs and the 1971 Convention on Psychotropic Substances. The main activities cover quality assurance of pharmaceuticals, prevention of counterfeit drugs, drug safety, support to drug regulatory authorities and narcotic and psychotropic substances. Agencies Of United States Of America The Pan American Health Organization (PAHO) The Pan American Health Organization is an international public health agency

2 with hundred years of experience. It serves as the specialized organization for health of the inter-american system. It also serves as the regional office for the American World Health Organization and enjoys international recognition as part of the United Nations System. The United States, Europe and Japan formed the international Conference on Harmonization and Technical Requirements for Registration of Pharmaceuticals for human use, which is working toward drug regulatory harmonization. In America there is a need to promote harmonization to facilitate the availability of safe, effective and good quality pharmaceuticals and thereby protect public health. PAHO, in collaboration with the pharmaceutical industry, has held two conferences on drug regulatory harmonization in the region, aimed at facilitating communication and the exchange of information in this area among all interested parties. Food and Drug Administration (FDA) The U. S. Food and Drug Administration is one of the oldest and most respected consumer protection agencies. FDA s mission is to promote and protect the public health by allowing only safe and effective products to reach to the market. It monitors products for continued safety even after they have been brought into use, and also helps the public to get accurate and scientific information needed to improve their health. Every day, every American comes in contact with a host of FDA-regulated products. That includes everyday from the most common food ingredients to complex medical and surgical devices, lifesaving drugs and medical products. In fact, FDA regulated products account for about 25 cents of every dollar spent by the consumer. [2] FDA s regulatory approaches are as varied as the products it regulates. Some products such as new drugs and complex medical devices must be proven safe and effective before companies can put them on the market. The medical products covered by this requirement include: medicines used for the treatment and prevention of diseases, biologics like vaccines, blood products, biotechnology products and gene therapy products. FDA also regulates all medical devices. However, only the most complex new medical devices are reviewed by the agency before marketing. But some products like cosmetics and dietary supplements can be marketed with no prior approval. FDA also protects the public from unnecessary exposure to radiation from electronic products. These include microwave ovens, cell phones, x-ray equipment, lasers, ultrasound and MRI machines, and many other consumer, industrial, and medical products. FDA also regulates drugs and devices used for animals; both pets and animals that produce food. Before manufacturers can market animal drugs (including drugs used in animal feeds), they must get FDA approval by providing proof of their safety and efficacy. Livestock drugs are evaluated for their safety to the environment and to the people who eat the animal products. FDA makes sure that no drug residues remain in these foods. Agencies Of United Kingdom National Institutes for Biological Standards and Control (NIBSC) is a multidisciplinary scientific establishment whose purpose is to safeguard and enhance public health by standardizing and controlling biological substances used in medicines. NIBSC has a leading international role in preparing, evaluating and distributing international biological standards and other biological reference materials. The quality and validity of the control work undertaken at NIBSC is accredited by the United Kingdom Accreditation Service (UKAS) to comply with the international standard BS EN ISO/IEC [3] Medicines and health care products regulatory agency in UK is the executive agency of the department of health protecting and promoting public health and patient safety by ensuring that medicines, health care products and medical equipment need appropriate standards of safety, quality, performance and effectiveness and are used safely. From 1 April 2003, the medicines and healthcare products regulatory agency (MHRA) replace the medical devices agency (MDA) and the medicines control agency (MCA). The MHRA is an executive agency of the department of health with trading fund status. The MHRA (Medicines) s primary objective is to safeguard public health by ensuring that all medicines on the UK market meet appropriate standards of safety, quality and efficacy. Safety aspects cover potential or actual harmful effects; quality relates to development and manufacture; and efficacy is a measure of the beneficial effect of the medicine on patients. This objective is achieved through: 1. A system of licensing before the marketing of medicines; 2. Monitoring of medicines and acting on safety concerns after they have been placed on the market; 3. Checking standards of pharmaceutical manufacture and wholesaling; 4. Enforcement of requirements; 5. Responsibility for medicines control policy; 6. Representing UK pharmaceutical regulatory interests internationally; and 7. Publishing quality standards for drug substances through the British Pharmacopoeia. Agency Of Australia The Australian community expects that medicines and medical devices in the marketplace are safe and of high quality, and of a standard at least equal to that of comparable countries. Regulating medicines Australian manufacturers of all medicines must be licensed under Part 4 of the Therapeutic Goods Act 1989 and their manufacturing processes must comply with the principles of GMP (Good Manufacturing Practice). [4] Medicines assessed as having a higher level of risk (prescription medicines, some nonprescription medicines) are evaluated for quality, safety and efficacy and are registered on the ARTG. Medicines having a lower risk (consumer medicines purchased over the counter such as complementary medicines including vitamins) are assessed for quality and safety. In assessing the level of risk, factors such as the strength of a product, side effects, potential harm through prolonged use, toxicity and the seriousness of the medical condition for which the product is intended to be used, are all taken into account. Once approved for marketing in Australia, medicines are included in the ARTG and can be identified by the AUST R number (for registered medicines) or an AUST L number (listed medicines) that appears on the packaging of the medicine. Regulating medical devices The regulation of medical devices includes the following features: 1. Classifying the medical device based on different levels of risk; 2. Assessing compliance with a set of essential principles for their quality, safety and performance; 3. Implementing appropriate regulatory controls for the manufacturing processes of medical devices; 4. Including the medical device in the ARTG; and 5. Implementing a comprehensive post market vigilance and adverse incident reporting program. Medicines regulation and the TGA The objective of the Therapeutic Goods Act 1989, which came into effect on 15 February 1991, is to provide a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and ensure the quality, safety and performance of medical devices. The Therapeutic Goods Administration (TGA), as part of the Australian Government Department of Health and Ageing, has responsibility for administering the Act. A key focus of the TGA is to ensure that consumers have timely access to medicines. This includes ensuring that the necessary evaluation and assessment procedures are conducted to enable consumers access to the latest treatments available which are safe and of good quality. The regulatory framework within which the TGA operates is based on a risk management approach. It is designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden and minimising the cost of medicines regulation. In undertaking its responsibilities, the TGA has developed a constructive partnership with industry. The result is a regulatory system that allows the public access to safe therapies while contributing to the continued viability of industry by creating confidence in, and acceptance of, Australian therapeutic goods, both at home and overseas. Essentially, any product for which therapeutic claims are made must be either listed or registered in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia. Essentially therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. The ARTG is a computer database of therapeutic goods. Therapeutic goods are divided broadly into two classes - medicines and medical devices. Unless exempt, therapeutic goods must be entered as either registered goods or listed goods before they may be supplied in, or exported from Australia. Information on therapeutic goods is held on the database and in hard copy format. There were approximately 63,400 products on the Australian Register of Therapeutic Goods at March Information held on the database includes: Product name and formulation details. Sponsor and manufacturer details. The Therapeutic Goods Administration (TGA) is a unit of the Australian

3 Government Department of Health and Ageing and is responsible for administering the provisions of the legislation. The TGA carries out a range of assessment and monitoring activities to ensure that all therapeutic goods available in Australia are of an acceptable standard. At the same time, the TGA aims to ensure that the Australian community has access, within a reasonable time, to therapeutic advances. Overall control of medicines is exerted through five main processes: 1. Pre-market evaluation and approval of registered products intended for supply in Australia; 2. Development, maintenance and monitoring of the systems for listing of medicines; 3. Licensing of manufacturers in accordance with international standards of Good Manufacturing Practice; 4. Post-market monitoring, through sampling, adverse event reporting, surveillance activities, 5. response to public inquiries; and 6. The assessment of medicines for export. Agency Of South Africa Over the last thirty years, South Africa has developed a medicines regulatory authority with internationally recognized standing. Over the past five years, it has been transformed in order to improve its performance and regulatory processes. The Medicines Control Council (MCC) is a statutory body that was established in terms of the Medicines and Related Substances Control Act, 101 of 1965, to oversee the regulation of medicines in South Africa. [5] It is appointed by the Minister of Health and its main purpose is to safeguard and protect the public through ensuring that all medicines that are sold and used in South Africa are safe, therapeutically effective and consistently meet acceptable standards of quality. The Council, in considering whether a medicine is suitable for use for its intended purpose, assesses its relative risk against the benefits. The Medicines and Related Substances Control Act 101 of 1965 defines a medicine: As any substance or mixtures of substances used or purporting to be suitable for use of manufacture or sold for use in Diagnosis, treatment, mitigation, modification, or prevention of a disease, or abnormal physical or mental state, or the symptoms thereof in man, or Restoring, correcting, or modifying any somatic or psychic or organic function in man, and includes any veterinary medicine. All medicines for human use are subject to this law, including complementary and complementary biological medicines. Further, all veterinary medicines must be registered in terms of the Act excluding stock remedies registered in terms of Act 36. Agency Of Japan In Japan, pharmaceuticals and medical devices evaluation centre was established on 1 July 1997 to strengthen the governments evaluation capacity for securing safety and preventing harmful side effects of pharmaceuticals. This centre evaluates quality, efficacy and safety of each prescription drugs and medical devices as well as proprietary drugs, quasi-drugs and cosmetics that are purchased directly by the general public. The evaluation process taking, the example of a newly developed drug, is as follows: On accepting the application from an applicant; the ministry for health, labour and welfare, leaves the data reliability survey to the external institution. The evaluation is then conducted from the scientific point of view by an evaluation team of several officials whose backgrounds are from varied fields like pharmaceutical science, medicine, dentistry, veterinary, and bio-statistics to make a report on the drug. The report is then submitted to the Pharmaceutical Affairs and Food Sanitation Council (PAFSC), which is a consultative body of the minister. Based on the CPAP s advice, the ministry finalizes the judge who decides whether the government should approve the manufacture and/or import of the drug. [6] The history of medicine regulation in South Africa So far, more than 20, 000 medicines have been approved. Since the establishment of the Medicines Control Council, more than 220 meetings have been held to decide on the registration of medicines. Applications for more than 11, 800 complementary medicines have been submitted for evaluation by the Complementary Medicines Committee. The South African Pharmacy Council has licensed 300 wholesalers and distributors. These must still be licensed by the Medicines Control Council in terms of the Medicines Act. The Medicines Control Council approves more than 280 clinical trials annually. Medicines regulation in South Africa The Medicines Control Council applies standards laid down by the Medicines and Related Substances Control Act, (Act 101 of 1965) which governs the manufacture, distribution, sale, and marketing of medicines. The prescribing and dispensing of medicines is controlled through the determination of schedules for various medicines and substances. The MCC operates through external experts who are members of Council Committee structures. Most experts evaluate data sets submitted by the pharmaceutical industry for purposes of registration. These evaluators are from various academic institutions, mainly medical and pharmacy schools. The office of the Registrar provides administrative and technical support to Council and its activities. The Registrar is also an executive secretary to Council. The Registrar s office is a Chief Directorate, Medicines Regulatory Affairs, within the Department of Health. There are four Directorates, which are largely responsible for co-ordination and execution of various activities. There is also a Deputy Registrar who performs functions as determined by the Registrar. The staff complement of Medicines Regulatory Affairs includes doctors, pharmacists, veterinarians, other scientists and administrative staff. A certain amount of technical evaluation of generic medicines is performed in-house. It is anticipated that this will increase over time as use of generic medicines increases, in line with government policy of improving access to medicines. The structure of Council and its committees is described below. The skills of Council and its committees are written into law and include expertise in toxicology and medicine safety, clinical pharmacology, biotechnology, pharmaceutics, internal medicine, virology, pharmaceutical chemistry, neonatology, pediatrics, immunology, veterinary science, complementary medicines and law. The Council has 11 technical committees, with 146 members from various institutions in the country. These include the Clinical Committee, Pharmaceutical and Analytical Committee, Clinical Trials Committee, Scheduling Committee, Veterinary Committee, Pharmacovigilance Committee, Biological Committee, Complementary Medicines Committee, and African Traditional Medicines Committee. Agency Of Brazil In Brazil, the regulatory authority is Brazilian National Health Vigilance Agency (ANVISA). On December 31, 1998 the Brazilian president signed in a provisional measure 1791, that created ANVISA-Agencia Nacional de Vigilancia Sanitaria (Brazilian national health vigilance agency) and established a new user fee structure for company and product registration. [7] The user fees and new certification rules affect medical devices and equipment, pharmaceuticals, vitamins, and food products, cosmetics, tobacco, and certain sanitation products, which must be registered with ANVISA prior to sale in Brazil. The local representative of the foreign company should be responsible for the registration of the products. In this new capacity, the new agency has enforcement powers including cancellation of operation permits for drugs, foods and medical product manufacturers and distributors. The Brazilian agency was created as a public company under a contract to the health ministry. ANVISA also enforces its regulations on installations, equipment, technologies, environment and procedures involved in all manufacturing phases of the above items production, their disposal and respective residues. Main principle of ANVISA: 1. Knowledge as motor of the action 2. Clinical studies 3. Technical studies 4. Standards and technical regulations Agency Of Ireland In Ireland, the regulatory authority is Irish Medicines Board (IMB). [8] The objective of the Irish Medicines Board is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety and efficacy of medicines available in Ireland and to participate in systems designed to do that throughout the European Union. Before a medicinal product can be authorized for use, an application must be made to the Irish Medicines Board and this must contain all of the necessary data supporting its quality, safety and efficacy. Members of staff of the IMB together with the assistance of the Board s committees and individual experts review the scientific aspects of the application and reach a conclusion on the likely balance of any benefits versus risk of the product before arriving at a decision. Following approval and use of a medicine, the IMB monitors the type and frequency of any reported side effects. It is vital that healthcare professionals report suspected adverse effects and quality defects, since this forms an important part of the Irish Medicines Board s role. In addition, there is a responsibility on the holders of product authorizations to keep the IMB informed of events with potential safety consequences for their products. The Irish Medicines Board

4 also monitors the quality of medicines by conducting inspections at sites of manufacture and distribution of medicines and by random sampling of products both pre and post authorization. The use of medicines for clinical research purposes also falls within the IMB s remit. In the case of veterinary medicines there must likewise be assurance of quality, safety and efficacy but in addition the consequences to human health of the use of medicines in animals must be considered.the Chief Executive is responsible for the day to day activities of the Irish Medicines Board with the assistance of an Executive Committee composed of the heads of the various departments, namely Medical, Veterinary, Pharmacy, Inspections, Finance, Administration and Information Technology. The Irish Medicines Board carries out the following services within Ireland: 1. Licensing of medicinal products for human use 2. Licensing of veterinary products 3. Licensing of wholesalers of human medicines 4. Licensing of manufacturers of human and veterinary medicines 5. Pharmacovigilance & drugs safety monitoring 6. Clinical trial licensing 7. Inspection of wholesale and manufacturing sites Agency Of Canada Health products and food branch (HPFB s) mandate is to take an integrated approach to the management of the risks and benefits related to health products and food by: 1. Minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food and 2. Promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health. Biologics and genetic therapies are responsible for regulation of biological and radiopharmaceutical drugs, blood and blood products, viral and bacterial vaccines, genetic therapeutic products, tissues, organs and xenografts. [9] Office of biotechnology and science provides a focal point for biotechnology across Canada and for science within the health products and food branch. Consumer and public involvement promotes meaningful public and consumer participation in decision making on priorities, policies and programs for the health products and food branch and for other branches with similar regulatory responsibilities. The HPFB Inspectorate is responsible for the management of inspection, investigation, monitoring activities and enforcement strategies related to the fabrication, packaging/labeling, testing, importation, distribution and wholesaling of regulated health products for human and veterinary use. Agency Of Colombia The Instituto Nacional de Vigilancia de Medicamentosy Alimentos (INVIMA), created in 1993 by article 245 of law number 100, is Colombia s drug regulatory authority (DRA). It is an autonomous body, whose head is appointed directly by the country. INVIMA s most important functions include: 1. Controlling the quality and safety of medicines, biological products, foods, cosmetics, medical devices and natural products. 2. Issuing licenses concerning the manufacture of medicines. 3. Issuing marketing authorization. Decree No of 1994 includes a provision for decentralizing or delegating drug registration and licensing of manufacturing plants to district or provincial agencies that have the necessary resources. The law also includes provision to delegate inspection and analysis of drugs to other public institutions such as universities that have been accredited for this purpose by the ministry of health. New drug require evaluation by the ministry s review committee, except when they have been approved into or more of 11 reference countries considered to have well developed regulatory system. Agency Of Switzerland Switzerland although is not a member of the European union (EU) nor the European economic area, it recognizes the CE marking and transposed the EU medical devices. The Swiss Federal Law on Medicinal Products and medical devices (known as the law on therapeutic products) and the revised medical devices ordinance (MDO) came into force on January 1, [10] It lays out the rules for the authorization, production, quality control and market supervision of therapeutic products and for national and international cooperation between the authorities working in the therapeutic products sector. In the case of medicines, the new law enables the formal cantonal regulations to be converted into federal legislation. Henceforth all regulation are legally binding throughout Switzerland and can be enforced by Swissmedic, the Swiss Agency for Therapeutic Products, a governmental agency. The Swiss government, through Swiss medic, is now responsible for all therapeutic products (medicines and medical devices). It is no longer possible for the cantons to grant licenses for medicines unilaterally. Agency Of China In China, the regulatory system for medical devices is relatively new; the law was promulgated in 2000, and key implementing regulatory issues still being developed. China s State Food and Drug Administration (SFDA), is the primary agency responsible for regulating medical devices, and information about current regulations alongwith official forms are posted on SFDA s website in Chinese. [11] Chinese custom authorities and Provincial health bureaus also play significant role in the regulation of medical devices. Prior to registration in China, the USFDA must approve devices manufactured in the US for sale there. The FDA certificate to foreign government must be submitted with the registration application. Chinese labeling requirements require that Chinese language labels be attached to all products, and all these labels must be submitted with the registration application. To be sold in China, medical devices must be registered with health authorities. China issues registration certificates and licenses in the name of device manufacturer, not to the agent or distributor. There are three Chinese agencies that have regulatory roles for imported medical equipment. Depending on the product being exported to China, a company will lead to register with the SFDA, and may be required to receive approval from the Ministry of Health (MoH), or the General Administration of Quality Supervision, Inspection and Quarantine of the People s Republic of China (AQSIQ). Chinese customs requires certificates issued by the Safety Quality Licensing Office (SQLO) for import boiler and pressure vessels of the state administration for technical and quality supervision, in addition to SFDA and AQSIQ certification. CONCLUSION The Pharmaceutical industry is now perhaps the most highly regulated of all industries demanding a high level of information to be submitted to governments before a pharmaceutical product is brought to the market place. Regulatory authorities can be said to be the function responsible for obtaining and maintaining licenses to market medicinal products in as many countries as is necessary. According to the present laws all organizations involved in the development and marketing of medicinal products are legally required to have some form of regulatory support. This could be provided internally or via an external service provider such as a Regulatory Consultancy that provide Regulatory services. ACKNOWLEDGEMENT: The authors would like to acknowledge, to the Padamashree Dr. Mrs. Fatma Rafiq Zakaria, Chairperson, Maulana Azad Education Trust, Dr. Rafiq Zakaria Campus, Aurangabad, Maharashtra and Dr. M. H. Dehghan,Principal of Y.B.Chavan College of Pharmacy, Aurangabad for providing necessary facilities and encouragement. Some websites of drug regulatory authorities world wide [12] Austria: Australia: Belgium: Brazil: Canada: Denmark: European Union: Finland: (English language version) France: Germany: (English language version) Greece: language version)

5 Switzerland: United Kingdom: United States: http;// India: Ireland: Iceland: Italy: Japan: (English language version) Korea: (English language version available) Luxembourg: Netherlands: (English language version) New Zealand: Norway: Portugal: (English language version) South Africa: Spain: Sweden: (English language version) REFERENCES Source of support: Nil, Conflict of interest: None Declared