Indian drugs are exported to many countries, but there are some challenges that limit their export to certain countries. Indian drug manufacturing standards and international manufacturing standards differ in several ways. The regulatory framework for drug manufacturing is different in India. International standards of drug manufacturing refer to a set of guidelines and regulations established by international organizations such as the International Council for Harmonisation (ICH), the World Health Organization (WHO), and the International Organization for Standardization (ISO), to ensure the quality, safety, and efficacy of drugs. The level of goods manufacturing practices compliance and the inspection frequency differ between India and developed countries. The process validation requirements are more detailed, and there is a greater emphasis on data collection and analysis. International standards require more detailed documentation, including batch records, protocols, and validation reports. Adhering to international standards of drug manufacturing is important for ensuring that drugs are safe, effective, and of high quality. It also helps to facilitate the import and export of drugs between countries, as countries can rely on each other’s regulatory frameworks to ensure that the drugs being traded meet international standards. Adhering to international standards can help countries to improve their drug manufacturing processes, promote access to new therapies/drugs at the earliest to their populations, and boost their exports of drugs while ensuring the quality of drugs supplied domestically and globally. Though Indian companies follow stringent quality checks yet set of international standards is missing. The result is despite some major breakthroughs in new medicines Indian companies are unable to export the medicines to countries with much more stringent standards. COVID-19 vaccine developed in India is classic example of this. The NITI Aayog, India’s public policy think tank, realised these important aspects and has recommended that Indian standards of drug regulation should be brought up to par with global standards and aligned with the International Council for Harmonisation (ICH) guidelines, in order to promote ease of doing business. The organization has also suggested creating a separate authority to regulate medical devices in India, which is currently being monitored by the Drugs Controller General of India (DCGI). A new Drugs, Medical Devices and Cosmetics Bill, 2023 is also being introduced. The draft bill seeks to replace the existing Drugs and Cosmetics Act of 1940. The intent is to align with ICH guidelines for clinical trials, timeliness of decisions, promoting access of new therapies/drugs at the earliest to the Indian population, and ease of doing business. By adopting global standards, export of drugs will get major boost and assure the quality of drugs supplied domestically and globally, thereby overcoming quality-related issues which recently appeared in Gambia and Uzbekistan. The NITI Aayog has endorsed the newly introduced provision of giving powers to the Central Drugs Standard Control Organisation (CDSCO) to issue manufacturing licenses for drugs and cosmetics, rather than state regulators, as it will ensure uniform and effective implementation of the law and rest all manufacturing duties with the central licensing authority. The sale of drugs, cosmetics, and medical devices will continue to be regulated by the respective State Governmen
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