In a bid to help the pharma companies, especially the small and medium scale units, the National Institute of Pharmaceutial Education and Research (NIPER) and Pharmexcil will come together to compile the regulatory requirements of various countries for the benefit of exporters.
A meeting of NIPER and Pharmexcil will be convened soon to begin the process. Both the organisations are also planning to impart training to the SME sectors to adhere to the latest changes in the regulatory norms, sources said.
It may be noted that the constantly changing regulatory stipulations in many countries have been causing concerns to many exporters in the pharma sector. The move by these two premier institutions is likely to solve the problem to a great extent.
"We have been looking for something like a compiled document with the latest changes in the regulatory affairs and it will be a welcome move to get the latest regulatory changes in around the globe,'' said a pharma exporter, explaining the hardships to get the details through official channels.
Unlike the major countries like US, Japan and the European Union, it was all the more difficult to gather details about the lesser known, but developing markets when it comes to the rules prescribed for marketing a product. In America, the US FDA is responsible for the regulatory requirements while the European Medicines Agency (EMEA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) are the respective authorities in their regions. And the laws kept changing regularly too. EU recently introduced, the registration, evaluation, authorisation of chemicals (REACH) is the new EU law under which fine chemicals and drug intermediates are required to be registered for exporting and many of the Indian companies.
Though the establishment of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in an attempt to co-ordinate and synthesize international regulatory requirements tried to mitigate the problem with regard to the three major drug markets, SME players were finding it hard to know about the rest of the markets, it is said.