Exclusive monographs of 32 new molecules included
In the global arena, there is a growing effort towards harmonisation of regulatory procedures and practices.
Hyderabad, Nov. 13
Drug companies and researchers can look forward to some exciting information in the new edition of the Indian Pharmacopoeia. Exclusive monographs of at least 32 new molecules have been included, which do not find place in any other Pharmacopoeia, said Dr G.N. Singh, Director, IP Commission.
A total of 92 new molecules have been added with details through scientific monographs. Similarly, 30 monographs on anti-retrovirals (ARVs) and insights into medicinal plants and herbs are some of the highlights that would interest the pharma sector, he told at a meeting organised by the Pharmaceuticals Export Promotion Council (Pharmexcil), here recently.
Another major initiative of the IP Commission has been the creation of IP monographs for India developed vaccines. The idea is to get the requisite certification from procuring global institutions like the UNICEF, for Indian products to reach global needs.
Discussions have been taken up with the UNICEF and a Committee that includes Mr Srinivasan of the Indian Immunologicals Ltd (IIL), is looking into the issue.The IP Commission has recently signed an MoU with the US pharmacopoeia. A similar exercise is being pursued with the EU. In the next few months, a large Indian delegation would go to the EU countries to study relevant issues. The objective was to accelerate exports through better acceptance of the Indian IP, Dr Singh said.
Regulatory ProceduresChina was another focus area. Though language problems exist, since the Chinese pharmacopoeia is in their own language, the market and potential for drugs and medicines were huge for the effort. Earlier, the newly appointed Drug Controller of India, Dr M. Venkateswarulu, in his address said every month 3-4 complaints on the quality front were received on Indian exports of pharma products. Some importing countries were also trying to dictate.In the global arena also there was a growing effort towards harmonisation of regulatory procedures and practices. The International Commission for Harmonisation (ICH) is a major initiative in this direction with the US, Japan and the EU ideas converging. However, India is not yet a member in the ICH.
Regulatory NeedsIn this background, Dr Venkateswarulu urged Indian exporters to get conversant with the regulatory needs of the country to which they intend to export products. It was also important to take packaging, especially packaging compatibility seriously, as it can affect quality of product.The other mandatory things were logistics (order to execution time is 45-50 days), labelling procedures and needs and awareness about narcotic and psychotropic drug substance declaration fulfillment of respective countries. As the penalties for non-adherence are very severe, he said.