Drugs are not just ordinary consumer products. Therefore, 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 Should Not Be Banned”? Get the original essayPharmaceutical industries are considered highly regulated industries. For execution of rules and regulations and issuing guidelines to regulate the process of drug development, authorization, registration, manufacturing, marketing and labeling of pharmaceutical products and many other things, a regulatory body is present in each country, such as USFDA (USA), MHRA (UK), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa), ANVISA (Brazil), EMEA (European Union), SFDA (China). Added to this are some international regulatory agencies and organizations such as the World Health Organization (WHO), the Pan American Health Organization (PAHO), the World Trade Organization (WTO), the International Conference on Harmonization (ICH), the World Intellectual Property Organization (WIPO) which play an essential role in all aspects of pharmaceutical regulation related to registration, manufacturing, distribution, price control, marketing, research and development and the protection of intellectual property of pharmaceutical products. These organizations ensure the safety, effectiveness and quality of medicines made available to the public. The major challenges for these regulatory bodies are: protecting the public from harmful and suspect drugs, establishing appropriate legalization covering all products with a medicinal claim and all relevant pharmaceutical activities, whether carried out by the public sector or private, to increase globally. regulatory growth to ensure people’s safety. (Geetanjali Sengar*)The main regulatory bodies for drugs and pharmaceuticals in India are: Central Drugs Standards and Control Organization (CDSCO) - It comes under the Directorate of Ministry of Health and Family Welfare . The CDSCO recommends standards and measures to ensure the safety, effectiveness and quality of drugs, cosmetics, diagnostics and devices in the country, regulates market approval of new drugs and standards for clinical trials . It also controls imports of medicines and approves licenses to manufacture the above-mentioned products. National Pharmaceutical Pricing Authority (NPPA) - Established in 1997 under the Department of Chemicals and Petrochemicals. It fixes or revises the prices of wholesale medicines and formulations at judicious intervals; periodically updates the price-controlled list by including and excluding drugs in accordance with guidelines. Drugs Controller General of India (DCGI): It governs matters regarding licensing and quality control matters, marketing authorization is regulated by the Central Drugs Controller of India. State. Drug controllers have the authority to issue licenses for the manufacture of approved drugs and monitor quality control, alongside the CDSCO. A system involving dual regulatory control that exists at the government levelcentral and state. The central regulatory authority carries out approval of new drugs, clinical trials, setting standards, monitoring imported drugs and coordinating the activities of state agencies, while state authorities The government is responsible for licensing and monitoring the manufacture, distribution and sale of medicines and other related products. A huge problem related to different quality of medicines exists in our Indian market. Exported medicines are of better quality, to meet the standards required in the exporting country, while medicines in the local market meet local quality standards set by the regulatory body. Furthermore, the lack of transparency in licensing procedures has led to the flooding of the market with counterfeit and substandard medicines. According to the Mashelkar committee report, almost 30% of the Indian market has been flooded with fake, substandard or counterfeit medicines. To meet global quality standards, proper regulation is necessary on the quality of medicines manufactured in our country. Therefore, some changes are being made to Annex M (which describes GMP-related regulations) that will help improve the quality of medicines. Annex M is revised and advises appropriate pressure differentials in operating areas. Dedicated air handling units with an adequate number of air changes can be used to achieve these pressure differences. This will help eliminate or reduce the risk of cross-contamination between products. Additionally, emphasis on validating cleaning of equipment and processing areas is placed in the revised Annex M each time there is a product change. 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 objective of GMP is to minimize risks with respect to the manufacturing, packaging, testing, labeling, distribution and importation of medicines, cosmetics, medical devices, blood and products blood, food products, etc. These protocols largely concern parameters such as quality, safety, effectiveness and potency of drugs. WHO also gives GMP guidelines to ensure consistency in quality, safety and efficacy standards during the import and export of medicines and related products in different countries. In India, WHO-GMP certification has a validity of two years, which can be granted by both CDSCO and state regulatory authorities after a thorough inspection of the manufacturing premises. The requirements specified in the enhanced Annexure “M” 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 Annexure M compliance compared to units in other states. Besides medicines, special guidelines are given for the manufacture of medical devices. After the case involving unapproved and untested stents on 60 patients at JJ Hospital, and subsequent recommendations made by the Mashelkar committee in 2004, the DCGI formulated a new set of guidelines for the import and manufacture of medical devices in the country in June 2007. The Committee recommended the establishment of a specific medical devices division within the CDSCO to look after the management, approval, certification and.