At IPA we understand the problems faced by pharma professionals in accessing requisite information in order to comply with the regulatory requirements at home and in the regulated foreign markets. We’ve tried to simplify things for you by assembling the important Indian and international guidelines and regulations in this section.
Resources
- Goa
- Indian Regulations & Guidelines:
- Links to important international guidelines and regulatory bodies
| Directorate of Food and Drugs Administration, Government of Goa (DFDA GOA) | The Directorate of Food and Drugs Administration, Government of Goa was established in November’ 1991 with its office functioning from the building premises at Campal, Panaji – Goa. Thereafter the office premises was shifted and functioned from the Old Goa Medical Complex at Panaji – Goa; until October 2003 and thereafter the Directorate functioned from the Old IPHB Complex at Altinho, Panaji – Goa until February 2014. |
| Directorate of Health Services (DHS GOA) | Directorate of Health Services (DHS) has an important role in the provision and administration of health services and in order to raise the quality, extend accountability and deliver the services fairly, effectively and courteously. |
| National Health Mission Goa (NHM GOA) | The Union Cabinet vide its decision dated 1st May 2013 has approved the launch of National Urban Health Mission (NUHM) as a Sub-mission of an over-arching National Health Mission (NHM), with National Rural Health Mission (NRHM) being the other Sub-mission of National Health Mission.NHM has six financing component |
| Goa State Pollution Control Board (GSPCB) | The Goa State Pollution Control Board is an autonomous statutory organization constituted on 1st July, 1988 under the Water (Prevention & Control of Pollution) Act, 1974. Prior to that, when Goa formed part of the erstwhile Union Territory of Goa, Daman and Diu, the Central Board for the Prevention and Control of Water Pollution was performing the functions of the State Board in Goa. The Central Pollution Control Board at Ponda-Goa had established a Section Office for the purpose. The same arrangement continued |
| Goa Pharmaceutical Manufacturers’ Association (GPMA) | Goa Pharmaceutical Manufacturers’ Association: The GPMA represents the generic pharmaceutical manufacturing industry who have their plants in Goa. A dynamic group of companies which specialize in the production of high quality, affordable generic drugs, fine chemicals and new chemical entities. The industry plays a vital role in Goa as well as India's health care system by providing safe, proven alternatives to more expensive brand name prescription drugs. In addition, our companies are increasingly exporting their products and expanding their presence throughout the world. The Association also helps foster better relations between economies of various countries and Goa and help provide a single point source of information and assistance to set up manufacturing capabilities in the state |
Indian Regulations & Guidelines:
| CDSCO | Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare,Government of India provides general information about drug regulatory requirements in India. |
| NPPA | Drugs (Price Control) Order 1995 and other orders enforced by National Pharmaceutical Pricing Authority (NPPA), Government of India. View the list of drugs under price control here..... |
| PHARMACY COUNCIL OF INDIA | The Pharmacy education and profession in India upto graduate level is regulated by the PCI, a statutory body governed by the provisions of the Pharmacy Act, 1948 passed by the Parliament |
| D & C Act, 1940 | The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in India. |
| Schedule M | Schedule Mof the D&C Act specifies the general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs. |
| Schedule T | Schedule T of the D&C Act prescribes GMP specifications for manufacture of Ayurvedic, Siddha and Unani medicines. |
| Schedule Y | The clinical trials legislative requirements are guided by specifications of Schedule Yof The D&C Act. |
| GCP guidelines | The Ministry of Health, along with Drugs Controller General of India (DCGI) and Indian Council for Medical Research (ICMR)has come out with draft guidelines for research in human subjects. These GCP guidelines are essentially based on Declaration of Helsinki, WHO guidelines and ICH requirements for good clinical practice. |
| The Pharmacy Act,1948 | The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India. |
| The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 | The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 provides to control the advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities. |
| The Narcotic Drugs and Psychotropic Substances Act, 1985 | The Narcotic Drugs and Psychotropic Substances Act, 1985 is an act concerned with control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances. |
| US-FDA | U.S. Food & Drug Administration |
| USP | United States Pharmacopoeia |
| EDQM | European Directorate for the Quality of Medicines. |
| FIP | International Pharmaceutical Federation : Representing pharmacy and pharmaceutical sciences The International Pharmaceutical Federation (FIP) is the global body representing pharmacy and pharmaceutical sciences. Through our 144 national organisations, academic institutional members and individual members, we represent over four million pharmacists and pharmaceutical scientists around the world. To support the pharmacy profession Founded in 1912, FIP is a non-governmental organisation with its head office in the Netherlands. Through our partnerships and extensive pharmacy and pharmaceutical sciences network, we work to support the development of the pharmacy profession, through practice and emerging scientific innovations, in order to meet the world’s health care needs and expectations. |
| WHO GENEVA | World Health Organization – Geneva |
| CWP | The Commonwealth encompasses some of the world’s poorest nations. The CPA advances health, promotes wellbeing and improves education for the benefit of the people of the Commonwealth. We support the development of safe and effective systems of medicines management, healthier lifestyles, and the reduction of health inequalities. We achieve this through building strong collaborative networks, partnering with member organizations to improve the quality of pharmacy practice and creating platforms for the dissemination of knowledge about pharmaceutical sciences and professional practice. |
| PHARMACIST | Founded in 1852, APhA is the largest association of pharmacists in the United States, with more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians as members. APhA is the organization whose members are recognized in society as essential in all patient care settings for optimal medication use that improves health, wellness, and quality of life. Through information, education, and advocacy APhA empowers its members to improve medication use and advance patient care. |
| RPHARMS | Royal Pharmaceutical Society - Its mission is to put pharmacy at the forefront of healthcare. Its vision is to become the world leader in the safe and effective use of medicines. Since the Society was founded in 1841 it have championed the profession, and are internationally renowned as publishers of medicines information. Our Royal Charter gives us a unique status in pharmacy. We promote pharmacy in the media and government, lead the way in medicines information, and support pharmacists in their education and development. |
| CPA | Canadian Pharmacists Association |
| WHO (Medicines) | WHO guidelines on medicines policy, intellectual property rights, financing & supply management, quality & safety, selection & rational use of medicines, technical co-operation and traditional medicines. |
| WHO sites | WHO guidelineson all areas relevant to health of people all over. |
| ICH | International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH)guidelines defining quality, safety, efficacy & related aspects for developing and registering new medicinal products in Europe, Japan and the United States |
| OECD | Organization for Economic Collaboration and Developmentincluding 30 member countries covers economic and social issues in areas of health care. |
| EMEA | European Medicines Agency (EMEA), a decentralised body of the European Union headquartered in London, prescribes guidelines for inspections and general reporting and all aspects of human & veterinary medicines in the European Union. |
| US FDA | Regulations, guidelines, notifications, news and communications from US Food and Drug Administration. |
| TGA | Specifications regulating medicines, medical devices, blood, tissues & chemicals, issued by Therapeutic Goods Administration, the Australian regulatory body. |
| South Africa | The department of Health, South Africa. |
| WTO | News, resources, documents and publications of the World Trade Organization (WTO), the global international organization dealing with the rules of trade between nations. |
| Codex Alimentarius | Collection of international food standards and guidelines for processed, semi–processed and raw foods, adopted by the Codex Alimentarius Commission under the Joint FAO / WHO Food Standards Programme. |
| MHRA | News, warnings, information and publications of Medicines and Healthcare products Regulatory Agency (MHRA), responsible for ensuring efficacy and safety of medicines and medical devices in the UK. |
| Health Canada | Advisories, warnings, recalls, reports, publications, activities, legislations and guidelines from Health Canada, the Federal Department responsible for health related issues in Canada. |
| Thai FDA | Thai Food and Drug Administrationlaws and regulations with respect to drugs, food, cosmetics and narcotics. |
| HSA, Singapore | Health Sciences Authority (HSA), the regulatory body of Singapore. |
| DOH, Philippines | The Department of Health, Philippines. |
| Medsafe,New Zealand | Medsafe, New Zealand Medicines and Medical Devices Safety Authority. |
| NPCB, Malaysia | Regulatory information, news and publications of National Pharmaceutical Control Bureau, Malaysia. |
| DGMP, Belgium | Guidelines and useful information to ensure safety, efficacy and quality of medicines, issued by Directorate-General Medicinal Products, Belgium. |
| BfArM, Germany | Licensing and registration guidelines for medicinal products laid down by Federal Institute for Drugs and Medical Devices, Germany |
| SwissMedic | Swiss regulatory agencyfor therapeutic products. |
| MPA, Sweden | Regulatory and surveillance guidelines issued by Medical Products Agency, Sweden. |
| NAFDAC, Nigeria | News, regulations and guidelines issued by The National agency for Food Administration and Control (NAFDAC), Nigeria. |