Overview:

India’s medicinal products market is a rapidly growing sector, driven by factors such as an aging population, increasing incidence of chronic diseases, rising disposable income, and the expanding pharmaceutical industry. The market is projected to grow significantly over the next few years, with a compound annual growth rate (CAGR) of around 8.4% from 2021 to 2026.

At Rabt, we understand that navigating the regulatory landscape for medicinal products in Asia can be a challenging and time-consuming process. Each country in Asia has its own unique set of regulations and requirements, and mistakes or oversights in the application dossier can lead to significant delays in the registration process. In India, the Central Drugs Standard Control Organization (CDSCO) is responsible for approving and regulating drugs, including new drugs, investigational drugs, and generic drugs, as well as clinical trials.

Approval Process: The process for obtaining approval for a medicinal product in India involves several steps, including registration with the CDSCO and a separate approval process for new drugs before they can be marketed. Medicinal products are classified into four categories based on their level of risk, with application processing fees ranging from US$1,000 to US$3,000. Clinical trials must be conducted in compliance with the Indian Council of Medical Research guidelines for ethical conduct of research involving human subjects and with approval from the Institutional Ethics Committee.

Import and Export: The CDSCO regulates the import and export of medicinal products, requiring all imported products to be registered before they can be marketed in India. Export of medicinal products requires a no-objection certificate from the CDSCO.

Pharmacovigilance: Pharmacovigilance activities, including monitoring adverse drug reactions and implementing risk management plans, are the responsibility of the CDSCO in India.

Navigating the regulatory requirements and processes involved in bringing medicinal products to market in India can be complex. At Rabt, we can help guide you through this process, ensuring compliance with all regulatory requirements and positioning your product for success in India’s fast-growing pharmaceutical industry.