Laws_of_Pharmaceuticals_Business

INTRODUCTION The pharmaceutical sector was the second largest sector (after agriculture) in terms of national revenue. According to a working document of International Trade Center (UNCTAD/WTO), Bangladesh market size for pharmaceuticals and natural products was US$ 517 million and the total herbal medicine was about US$ 50 million in 2004. Local companies satisfied 95% of domestic demand with a 10% contribution from multinational companies. The number of companies was subdivided into pharmaceutical units (232), ayurvedic, homeopathic, biochemic units (308), and herbal and unani-related units (295). Employment in the sector was about 75,000. The value of export for essential drugs was US$ 3.1 million and natural ingredients US$ 48 thousand. It exported drugs to over 50 countries in the world, but mainly to Bhutan, Singapore and Yemen. The export market is on a rise each year. On the other hand, Bangladesh imported essential drugs At present situation, being one of the 39 least developed countries, Bangladesh is enjoying the Global Trade Liberalization and Patent Flexibility. Bangladesh does not require respecting trade-related intellectual property rights until 2016. Progressive patent expiration and implementation of trade agreements present promising growth opportunities for pharmaceutical manufacturers in Asia and, are expected to further underline the Asian region’s potential for production. In this context, effective supply chain management, direct access to consumers and reliance on strategic alliances through outsourcing, subcontracting and other forms of linkages and partnerships definitely build comparative advantages. Simplification and harmonization of product registration, as a part of RTAs (Regional Trade Agreements), companies to manufacture drugs in Bangladesh. This will be the start of a new era. The year 2016 will mark the end of TRIP regulations that has allowed Bangladesh to copy world renowned pharmaceutical products at a cheaper price. This competitive advantage is being utilized to the maximum by supporting the pharmaceutical companies to the full. Regulations and Regulatory Agency: The Directorate of Drug Administration (DDA) under the Ministry of Health and Family Welfare is the counterpart of FDA in Bangladesh. It oversees and controls the manufacturing, import, distribution and sale of drugs and all other pharmaceutical services and industries in Bangladesh. The basis of its control over the pharmaceutical sector and services is the following regulations: 1. The Drugs Act, 1940 (as modified up to the 20th September, 1964) 2. The Bengal Drug Rules, 1946 (as amended by the Government of East Bengal up to December 1952). It has been supplemented by several Gazette notifications. • The Drug Policy 0f 1982 • The Drugs (Control) Ordinance, 1982 • The Drug Policy of 2004 • The Drugs (Control) Ordinance, 2004 The Drug Act of 1940 and its rules formed the basis of the country’s drug legislation. Unani, ayurvedic, homeopathic and biochemic medicines were exempted from control under the legislation. The DDA also monitors the quality of marketed drugs through an agency called the Drug Testing Laboratory. Drug Policy of 1982: Following the Drug(Control) Ordinance of 1982, some of the local pharmaceutical companies improved range and quality of their products considerably. The national companies account for more than 65% of the pharmaceutical business in Bangladesh. However, among the top 20 companies of Bangladesh, 6 are multinationals. Almost all the life saving imported products and new innovative molecules are channeled into and marketed in Bangladesh through these companies. Multinational and large national companies generally follow current good manufacturing practices(GMP) including rigorous quality control of their products. National Drug Policy & Ordinance 2004: The Drugs(Control) Ordinance 2004 is based on a new drug policy formulated the same year. The objective was to update the ordinance of 1982 and incorporate new provisions to better align the fast growing pharmaceutical sector to come in terms with the globalization of trade and commerce. During the month of May 2004, the government revised ‘National Drug Policy’ in order to make it more conducive for the foreign investors as well as the local producers planning to promote exports. Drug and Product Registration: Any prospective manufacturer/exporter has to apply in prescribed form for product registration and certifications along with the followings documents: • Name and addresses of the manufacturer • Manufacturing license number • List of drugs • Proposed Maximum Retail Price • Estimated treatment cost (Daily & Full course) • Product Data sheet • Technical Data sheet • Pharmaceutical Data sheet • Toxicological Data sheet • Clinical data sheet • Report on Environmental Impact Assessment / Analysis • Names of the Existing Manufacturers and market size • Bio-data of the Production, Factory and Quality Control Manager. Directorate General of Drug Administration: Directorate General Of Drug Administration (DGDA), National Regulatory Authority for drugs in Bangladesh, was created in 1976 by Government of Bangladesh to plan, investigate, regulate, organize, direct and control activities to ensure that all drugs, vaccines and drug for research, public consumption and exports comply with the laws in force in the country and the recommendations set by WHO or other international organizations, so that drugs are available with the required quality. Mission: To ensure the protection of public health by ensuring, through a system of regulation and control of health, drugs and diagnostics those are available for human use, whether imported or domestically manufactured, for the safety, efficacy and quality requirements. Vision: To consolidate as a National Regulatory Authority for drugs and vaccines, and recognized for its international counterparts, working to accomplish their mission with efficiency and transparency In fulfilling its mission, the functions performed by DGDA are evaluation, registration, inspection, control and surveillance of drugs and vaccines. DGDA defines the general and specific functions of the national control of drugs, which cover all stages of the cycle of drugs and diagnostics for human use, i .e. from research and product development to its post-marketing surveillance. In fulfilling its functions, the DGDA performs services for the industry and population, which may be identified as their external customers: — Manufacturers, marketers and distributors of drugs and vaccines or its domestic and international sales representatives in the country. — People. — Other stakeholders. Some of the services provided are subject to payment by applicants of the same. Rates are stated in the Regulations for the Implementation of the official list prices for technical services productive. The regulation sets out all services and forms of payment if required. DGDA has been proposed to demonstrate its ability to provide services that meet the needs of our internal and external customers by implementing a system of quality management based on compliance with the principles and requirements of international regulations. [pic] Guidance for Industry . Submission of Clinical Trial Application for Evaluating Safety and Efficacy . Requirements for permission of New Drugs Approval . Post approval changes in biological products: Quality safety and Efficacy Documents . Preparation of the Quality Information for Drug Submission for New Drug Approval: Biotechnological/Biological Products DIRECTORATE GENERAL OF DRUG ADMINISTRATION Ministry of Health and Family Welfare, Government of Bangladesh 105-106, Motijheel Commercial Area, Dhaka-1000. Tel:+880-2-9553456, +880-2-9556126, Fax:+880-2-9568166, Email:drugs@citech.net, Website:www.ddabd.org Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy This Guidance has been developed in conformity with Drug Act 1940 and Rules there under of Bangladesh and GCP as per requirements published in WHO Technical Report Series for the purpose of submission of Clinical Trial application. The clinical trial sponsor is required to submit application (As per Prescribed Form of DGDA) for the purpose of conducting clinical trial in Bangladesh and submit documents as per The Drug Act 1940 and Rules there in. All new vaccine and biological products first time produced in Bangladesh from novel seed materials must undergo clinical trials in Bangladesh. The applicability of phase of clinical trials will be decided on case to case basis taking into consideration the technology of production, safety and efficacy of the product based on scientific justification and evaluation. The sponsor is also responsible for implementing and maintaining Quality Assurance system to ensure that the clinical trial is conducted and data generated, documented and reported in compliance with the protocol and Guidelines issued by DGDA on Clinical Trials Supervision as well as all applicable statutory provisions of The Drug Act 1940 and Rules therein. Standard operating procedures should be documented to ensure compliance with GCP, as per WHO guidelines and applicable regulations. Sponsors are required to submit a status report on the clinical trial to the Licensing Authority at the prescribed periodicity. In case of studies prematurely discontinued for any reason including lack of commercial interest in pursuing the new drug application, a summary report should be submitted within 3 months. The summary report should provide a brief description of the study, the number of patients exposed to the drug, dose and duration of exposure, details of adverse drug reactions, if any, and the reason for discontinuation of the study or non-pursuit of the new drug application. Any expected serious adverse event (SAE) occurring during a clinical trial should be communicated promptly (within 24 hours and not more then in 14 calendar days) by the Sponsor to the Licensing Authority and to the other Investigator(s) participating in the study. The manufacturer / sponsor have to submit application on Form Prescribe by DGDA for permission of Clinical Trial under the provisions of The Drug Act 1940 and Rules therein. The requirements in respect of Chemistry and Pharmaceutical information has been elaborated for Biologicals in this document while requirement for conduction of Clinical trial and other requirements remains the same as per Drug Act 1940 and Rules there in and relevant WHO TRS. Guidance for Industry Requirements for permission of New Drug Approval: The manufacturer / sponsor have to submit application on Prescribe form of DGDA for permission of New Drugs Approval under the provisions of The Drugs ( control) ordinance 1982. As the Form is an application for grant of permission to import or manufacture a new drug or to undertake Clinical Trial the DGDA prescribes information to be submitted for New Drugs Approval (Market Authorization) of Biological in the following format to simplify and harmonize the submission requirements. The requirements in respect of Chemistry and Pharmaceutical information has been elaborated while requirement for non clinical and Clinical trial requirements remains the same as per relevant WHO-TRS. The document design is as per the International submission requirements of Common Technical Document (CTD) and has five Modules. Module I : Administrative/Legal Information Module II : Summaries Module III : Quality Information (Chemical, Pharmaceutical and Biological) Module IV : Non-Clinical Information Module V : Clinical Information Post approval changes in Biological Products: Quality, Safety and Efficacy Documents Objectives a. To assist with the classification of changes made to biological products that have received an approval. b. To provide sponsors with recommendations on the data to support a change which would be considered sufficient to allow a determination ofthe impact of the change on the quality of the approved products as it relates to safety, efficacy and/or effective use of the products. This guidance document applies to sponsors intending to make changes to biologics products that have received an approval to market the products. This would include an emphasis on applying a science-based and risk-based approach to the pharmaceutical and biological products quality assessment of these products. As such, the guidance documents were needed on the information to support quality changes to new biological products which apply a modernized, science-based, and risk-based approach to this area. Preparation of the Quality Information for Drug Submission for New Drug Approval: • DRUG SUBSTANCE (NAME, MANUFACTURER) • DRUG PRODUCT (NAME, DOSAGE FORM) • Controls of Critical Steps and Intermediates (name, dosage form) • Control of Excipients (name, dosage form) • Control of Drug Product (name, dosage form) • Facilities and Equipment (name, manufacturer) • Safety Evaluation Adventitious Agents (name, dosage form, manufacturer) Quality Manual: The System of Quality Management by DGDA is based on the realities and needs of the organization, so as to lay the groundwork for greater credibility in their decisions, greater strength and stability of its functions and a systematic planning, monitoring and improving the quality of processes, as well as the higher levels of efficiency and effectiveness. The DGDA in its development process, influencing its internal environment to improving the organizational structure (Annex 1) and the interrelationships between processes, the establishment of policies and objectives and defining new strategies. Objective and Scope of Quality Manual This document aims to establish and describe the quality system requirements based on international standard Quality Management – Requirements. The scope of quality management involves the processes of realization of services of DGDA: — Receipt and delivery procedures — Register — Pharmaceutical Inspection — Release — Authorization of clinical trials — Monitoring Post — Analytical control The services offered meet the functions to be developed by drug regulatory authorities in any country, so they are already designed and are controlled by specific indicators previously established by international agencies. Conclusion Bangladesh is still far away from the early stage of drug development, for example, the process of drug discovery and development. The local manufacturers focus on known compounds and produce drug products of various dosage forms under different brand names. With the exception of reputed multinationals and big national companies, these drug substances are reformulated to manufacturability, in many cases, with compromised quality, safety and efficacy. The state of R&D is poor in nature and perhaps at its infancy. This is an area that requires immediate attention. Goodwill and investment by the manufacturers and policies and guidelines by the regulatory body are required to improve the current status. Biopharmaceutical development such as bioavailability, bioequivalence and clinical trials, is almost non-existent as part of the development process except for a few industries, mainly multinationals. Beximco, Square, Novartis, Roche and a few other companies are investing in the R&D to get approval certification from oversees regulatory agencies with stringent compliance requirement. References: 1. http://www.bapainfo.org/html/documents/1519.pdf 2. http://www.ddabd.org/download/Guidance%20for%20Industry.pdf 3. http://www.ddabd.org/download/Quality%20Manual.pdf