Development of Innovative Standards for the Registration of Drugs in India Based Upon International Norms

Abstract

The regulatory landscape in India can be challenging, with multiple agencies involved in the drug approval and registration process. India is increasingly becoming the preferred destination for foreign pharmaceutical companies due to its vast population, expanding healthcare infrastructure, and rising demand. With a well-established regulatory framework and lower production costs, India offers opportunities for market expansion and access to a diverse patient population, making it an attractive choice for pharmaceutical companies. Drug License is imperative for establishments involved with the manufacturing, distribution, and procurement of the drug. The Registration Process to Obtain Drug License may seem plain and simple on the surface, but it is a lot more complicated in the real-world scenario. India’s pharmaceutical industry ranks third in production volume, growing steadily at about 9.43% annually for nine years. Key segments include generics, over-the-counter medicines, and vaccines. India supplies more than half of the world’s vaccine demand, 40% of the US generic demand, and a quarter of the UK’s medicine supply. With a vast pool of scientists and engineers, India plays a vital role in the global pharmaceutical industry. The regulated market involves those countries where there are defined regulatory requirements set by the regulatory bodies of that country and the emerging market countries are those who still lag behind in putting forward the well-defined regulations for drugs.