Healthcare is a public welfare endeavor and all the governments across the countries strive for better healthcare facilities and policies for the citizens. One of the important attributes is to improve market access for various treatments and therapies at affordable costs. As the drug development is a long process once available, its accessibility for patients…

Cryogenics products contain cryogenic liquids that turn into gases under ambient temperatures. The word cryo- means “cold” and –genic means “producing”. Although cryogenic science is under the faculty of physics, it has wide applications in the field of medicine, materials science and electronics. Due to the changes in the state of matter with temperature change, the operations…

Drug development is primarily driven by three factors: quality, efficacy, and safety. The essential quality, nonclinical safety, and efficacy standards that are established through the assessment of a new drug’s clinical efficacy and safety in accordance with ICH guidelines for pharmaceuticals. In this article, we’ll focus on the Multidisciplinary Guidelines developed by the International Council for…

The mainstay of drug development is based on 3 parameters such as quality, efficacy and safety. In the last few blogs, we discussed the important quality and nonclinical safety aspects as per the ICH guidelines. Today we will focus on the efficacy guidelines that are determined by the evaluation of the clinical efficacy and safety…

The People’s Republic of China is a huge pharmaceutical market and big pharma companies have been trying to get into the Chinese market for past few years. Recognising the need for new drugs for the people of China with an opportunity to develop indigenous industry, Chinese government over the years have made several policy changes to accelerate…

A global initiative called the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together powerful regulatory agencies from Europe, Japan, USA, and pharmaceutical companies to create guidelines and discuss the scientific and technical facets of developing pharmaceutical products and registering them. The goal of the ICH is to advance…

Generic drugs are copies of the original branded drugs that are made available in the market once the validity of the patent protection of the branded drugs has expired. Generic drugs are identical to the original branded product as in contains the same active drug component, similar dosage form, potency, mode of administration, and intended…

The manufacturing of pharmaceutical products by a third party is referred to as third-party pharmaceutical manufacturing, often known as contract manufacturing. A pharmaceutical company enters a contract with a specialised manufacturing facility to manufacture pharmaceuticals, medical devices, or other pharmaceutical items on their behalf. This production plan is available for large scale industrial batch sized…

The centre for drug evaluation and research (CDER) is responsible for ensuring availability of safe and effective medicines in the country. CDER is thus entrusted with the responsibility of the public health. CDER is an important office under the United States Food and Drug Administration. The USA drug approval process for the pharmaceutical products includes a…