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India’s current law for regulating drugs, medical devices and cosmetics is outdated and inadequate. It does not address the challenges and opportunities of the 21st century, such as patient safety, innovation, research and development, and global standards. That is why the government has proposed a new bill to replace the old one. Here are some of the key features and benefits of the new bill.
How patient safety and quality assurance are related to health outcomes
The new bill aims to ensure that the drugs, medical devices and cosmetics available in the market are safe, effective and of high quality. It proposes to establish a Central Drugs Authority (CDA) as the apex body for regulating these products. The CDA will have the power to grant or revoke licenses, inspect manufacturing facilities, conduct post-marketing surveillance, recall defective products, impose penalties and take legal action against violators. The bill also empowers the CDA to set standards and guidelines for these products, based on the best practices and evidence from around the world.
The bill also introduces a risk-based approach for regulating these products, depending on their potential impact on human health. For instance, the bill classifies medical devices into four categories, from low-risk to high-risk, and prescribes different levels of scrutiny and approval for each category. Similarly, the bill categorizes drugs into new drugs, generic drugs, and biosimilars, and defines the requirements and procedures for their clinical trials, registration, and marketing.
Innovation and research and development
The new bill recognizes the need to foster innovation and research and development in the pharmaceutical and medical device sectors. It proposes to create a separate division within the CDA for promoting and facilitating these activities. The division will provide incentives, exemptions, fast-track approvals, and regulatory support to the innovators and researchers. The bill also proposes to establish a National Innovation Fund to provide financial assistance to the start-ups and entrepreneurs in these sectors.
The bill also aims to create an enabling environment for conducting clinical trials and research in India. It proposes to simplify the process of obtaining ethical clearance, informed consent, and compensation for the trial participants. It also proposes to protect the intellectual property rights of the innovators and researchers, and to encourage the voluntary disclosure of the trial data and results.
Global standards and competitiveness
The new bill aims to align India’s regulatory framework with the global standards and norms. It proposes to adopt the internationally accepted definitions, classifications, and nomenclatures for drugs, medical devices and cosmetics. It also proposes to harmonize the requirements and procedures for clinical trials, registration, labeling, and advertising of these products. The bill also envisages to enhance the cooperation and coordination with the foreign regulators and agencies, and to participate in the international harmonization initiatives. The bill hopes to boost India’s competitiveness and credibility in the global market, and to attract more foreign investment and collaboration in these sectors.
The bill also aims to make the good manufacturing practices (GMP) the compulsory quality criterion for the production of drugs, medical devices and cosmetics in India. GMP is a quality assurance system that ensures that products are consistently made and monitored according to quality specifications. It helps to reduce the hazards involved in any pharmaceutical production that cannot be detected by testing the final product. The bill also suggests to create a National Accreditation Board for verifying the adherence of the manufacturers to the GMP standards.
