Drugs are not just ordinary consumer products, so if they do not have a certain quality, effectiveness and safety they can be dangerous. It is therefore the responsibility of national regulatory authorities to protect the patient from harm. (Lembit Rago, 2014) Say no to plagiarism. Get a tailor-made essay on "Why Violent Video Games Shouldn't Be Banned"? Get an Original EssayPharmaceutical industries are considered highly regulated industries. For carrying out rules and regulations and issuing guidelines to regulate the process of drug development, licensing, registration, manufacturing, marketing and labeling of pharmaceutical products and many other things, each country has a regulatory body, such as USFDA (USA), MHRA (UK), CDSCO (India), HEALTH CANADA (CANADA), MCC (South Africa), ANVISA (Brazil), EMEA (European Union), SFDA (China). Along with these there are some international regulatory agencies and organizations such as World Health Organization (WHO), Pan American Health Organization (PAHO), World Trade Organization (WTO), International Conference on Harmonization ( ICH), the World Intellectual Property Organization (WIPO) which play an essential role in all aspects of pharmaceutical regulation relating to the registration of pharmaceutical products, manufacturing, distribution, price control, marketing, research and development and protection of intellectual property. These bodies work to ensure the safety, effectiveness and quality of medicines available to the public. The main challenges of these regulatory bodies are: to protect the public from harmful and suspect drugs, to establish adequate legalization covering all products with therapeutic indications and all relevant pharmaceutical activities, both carried out by the public and private sectors, to increase regulatory growth worldwide to ensure people's safety. (Geetanjali Sengar*) The major regulatory bodies for drugs and pharmaceutical products in India involve: Central Drug Standards and Control Organization (CDSCO) - This is under the guidance of the Ministry of Health and Family Welfare. CDSCO recommends standards and measures to ensure the safety, effectiveness and quality of drugs, cosmetics, diagnostic tools and devices in the country, regulates market approval of new drugs and clinical trial standards. It also controls drug imports and approves licenses for the manufacturing of the above-mentioned products. National Pharmaceutical Pricing Authority (NPPA) - Established in 1997 under the Department of Chemicals and Petrochemicals. Sets or revises prices of bulk drugs and formulations at judicious intervals; periodically updates the list under price control through the inclusion and exclusion of drugs according to the guidelines. Drugs Controller General of India (DCGI): governs licensing and quality control matters, market clearance is regulated by the Central Drug Controller, State drug controllers have the authority to issue licenses for manufacturing drugs approved and monitor quality control, along with the CDSCO.A system which provides dual regulatory oversight that exists at both central and state government levels. The central regulatory authority carries out the approval of new drugs, clinical trials, setting standards, control over imported drugs and coordination of the activities of state bodies, while state authorities take responsibility for licensing and monitoring theremanufacturing, distribution and sale of drugs and other related products. In our Indian market there is a huge problem related to the different quality of drugs. The exported drugs are of superior quality, to meet the required standards in the exporting country, while the drugs in the local market comply with the local quality standards set by the regulatory body. Also due to the lack of transparency in licensing procedures, the market has been flooded with counterfeit and substandard medicines. According to the Mashelkar Committee report, nearly 30% of the Indian market has been flooded with fake, substandard or counterfeit drugs. To meet global quality standards, proper regulation on the quality of medicines produced in our country is necessary. Therefore, some changes are being made to Schedule M (describing GMP regulations) that will help improve the quality of medicines. The M program is revised which recommends the correct pressure differentials in the operational areas. To obtain these pressure differentials it is possible to use dedicated air handling units with an adequate number of air changes. This will help eliminate or reduce the chances of cross-contamination between products. Additionally, emphasis on validating the cleanliness of equipment and processing areas is given in the revised M schedule whenever a product changeover occurs. The current status should be displayed on the equipment to avoid confusion or contamination, a stability study should be conducted to determine the retest period and expiration date, etc. (Dr. J Ramniwas, 2012) The aim of GMP is to minimize risks with respect to the manufacturing, packaging, testing, labelling, distribution and import of drugs, cosmetics, medical devices, blood and blood products, food products, etc. These protocols largely concern parameters such as quality, safety, efficacy and potency of drugs. WHO also provides GMP-related guidelines to ensure consistency of quality, safety and efficacy standards during the import and export of medicines and related products in different countries. In India, OMS-GMP certification is issued with a validity of two years, which can be granted by both CDSCO and state regulatory authorities after thorough inspection of manufacturing facilities. The requirements specified in the 'M' update for GMP have become mandatory for pharmaceutical units in India. According to the study, units in states like Gujarat, Karnataka, Maharashtra and Andhra Pradesh have achieved a high percentage of Schedule M compliance compared to units in other states. In addition to drugs, special guidelines are provided for the production of medical devices. After the case involving unapproved and untested stents in 60 patients at JJ hospital and subsequent recommendations made by the Mashelkar Committee in 2004, the DCGI has formulated a new set of guidelines for import and manufacturing of medical devices in country in June 2007. The Committee recommended the creation of a specific medical device division within the CDSCO to address the management, approval, certification and quality assurance of all medical devices. Regulation of the quality of organic products is also important. The rules for the production, use, import, export and storage of dangerous microorganisms or genetically modified organisms or cells are laid down by the Ministry of Environment and Forestry under the Environment (Protection) Act of 1986. Under these rules, biological materials are regulated from the research and development phase to their.