With majority of developed nations announcing July as the deadline for switching over to the standards set by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Indian pharmaceutical companies will have to submit all their future drug import applications in the ICH format in these countries. The companies will have to prepare separate product approval applications to suit Indian requirements and that of the developed world.
Even though applications for product registration in ICH format is not required in India, all companies aiming at major export markets like the USA, EU and Japan, will have to be well versed with the new norms if they are to continue their presence in the lucrative export markets. The US, EU and Japan account for about 85% of the world pharmaceutical market.
For companies, which are interested in submitting simultaneous drug approval applications in these countries as well as India, the fresh requirement will bring in an additional burden of preparing two types of applications for product registration. While the Common Technical Document as approved by ICH are going to be mandatory in countries like Japan, European Union, and countries like Canada and Switzerland, it will highly recommended in the USA.
The fresh requirement will turn submissions to foreign regulators, cumbersome. The companies would have to have a totally new approach to comply with all requirements. "The development work should be tailored to suit CTD requirements, technical writing expertise needs to be developed or hired and major technical competencies will be required for eCTD submissions," says Dr S Mukherjee, vice president (Medical), Pfizer Limited.
ICH is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. The objective of such harmonisation is a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.
While Indian regulatory authorities are appreciative of the companies who are going after ICH guidelines, they are apparently not in a hurry to make it mandatory for the entire drug industry of the country.