Regulatory Affairs
Before a drug can be sold, it is necessary to obtain a marketing authorization from the relevant regulator. This stamp of approval confirms that that the drug is of high quality, and is safe and effective. To obtain a marketing authorization, companies submit an application demonstrating that the drug consistently complies with legal and regulatory requirements and that any label claims are supported by robust scientific evidence.
The regulators' evaluation of the report is undertaken by a skilled team of exsperts, including physicians, pharmacists and other scientists. In this way, healthcare professionals and patients can be confident that any drug sold, prescribed or administered as a generic, is a therapeutic equivalence of the original drug and is of the highest quality.
To obtain a marketing authorization for a generic drug, it is necessary to demonstrate that it provides the same quality, efficacy and safety as the reference innovative drug. The application includes information on the composition of the drug and a detailed description of how the active pharmaceutical ingredient and drug product are manufactured and controlled. This ensures that every batch is consistently manufactured to the required quality and is stable when stored at the recommended conditions.
In addition, there is a detailed description of the drug's development, including pharmaceutical, pre-clinical and clinical trials, to ensure that the drug is safe and efficacious. This often involves conducting studies with healthy volunteers, to demonstrate that the generic drug’s rate and extent of biological activity are the same as those of the innovative reference drug.
Obtaining a marketing authorization is, however, only the beginning of the process. Further obligations need to be fulfilled throughout the lifecycle of the drug, namely, monitoring the safety of the drug after launch.
Taj Pharma Group
A dream for new world Anchored in India and committed to its traditional values of leadership with trust, the Taj Pharma Group is spreading its footprint globally through excellence and innovation.
Each operating company in the group develops its international business as an integral element in an overall strategy, depending on the competitive dynamics of the industry in which it operates. For some businesses a focus on the export market remains the priority. For others it is developing a robust presence in domestic markets given growing population of India. And then there are Group companies, a small but growing number, that have global ambitions; additionally, synchronizing these ventures to cater Indian market remains a priority for growth.
Exports from India remain the cornerstone of the Taj Pharma Group’s international business, but different Taj companies are increasingly investing in assets overseas through Greenfield projects (such as in Spain, Germany, Middle East, Africa, Russia, and CIS Countries), joint ventures (in Sri Lanka, UK) and acquisitions.
While individual Taj companies have differing geographical imperatives, the Taj group is focusing on a clutch of priority countries, which are expected to be of strategic importance in the years ahead. The regions are UK, Sri Lanka, the Netherlands, Germany, South Africa, members of the Gulf Cooperation Council, Brazil, Vietnam, Thailand and Taiwan.
Dr. R.K.Singh, Chairman, Taj Pharmaceuticals Limited., sums up the Taj group’s efforts to internationalize its operations thus: “We hope that a several years from now we will spread our wings far beyond India, that we become a global group, operating in many countries, an Indian business conglomerate that is at home in the world, carrying the same sense of trust that we do today." We have already progressed on such efforts by our current presence in more than 40 countries.
