With the introduction of most modern testing equipments, the norms for impurity standards for drug substances and products have become more stringent all over the world, says Prof Saranjit Singh from National Institute of Pharmaceutical Education and Research (NIPER).
The noose was tightened further around the industry in the recent past and the regulatory authorities in the West are now implementing standards on genotoxic impurities. As a result of implementing stringent norms, the cost of impurity testing is skyrocketing in India also. The companies would need the latest equipments to conduct the required tests and this would increase the cost of quality assurance and drug production, he said.
Presenting his views on the topic - Emerging trends in regulatory and compendial requirements for testing of impurities in pharmaceuticals - he added that the NIPER, with the financial support of the Government of India, has facilitated latest equipments for impurity tests for Indian companies.
The impurity issue has started knocking on the doors of India too, and the recent incident in which Ranbaxy Laboratories had to voluntarily withdraw 73 million gabapentin tablets from US market is a warning alarm to Indian companies to take precautions to tackle the impurity levels.
Globally, the trend in impurity standards is to follow the guidelines set by the International Conference on Harmonisation (ICH). The standards of European authorities have now become more stringent than that of US, as it has already commenced implementing genotoxicity guideline from January 1, 2007. However, the US regulatory authorities are also on the path of implementing genotoxicity standards and this will harmonise the standards in all the countries that abide by the quality norms of US and Europe.
The World Health Organisation (WHO), the organization which stands for the poor patients in the world, is also planning to improve the impurity standards to decrease the impurity related issues in their drug supply, he said.
The trend is moving towards more complexities. For example, the companies are able to patent the methods of reducing impurity. This will lead to monopoly in manufacturing the drug in that specific impurity standard, Dr Singh added.
In the scientific symposium on the Impurities in Pharmaceuticals - Issue and Challenges, Dr Satinder Ahuja, president, Ahuja Consulting, USA presented his views on guaranteeing drug quality by monitoring impurities in pharmaceuticals. Dr Sandor Gorog, scientific advisor, Gedeon Richter Plc, Hungary, explained the key issues in drug quality control and the safety of drug therapy in regulated countries, while Dr Upendra Quenim, vice president, Quality/Regulatory Affairs, Geltech Pvt Ltd dwelt upon the regulatory aspects for impurity profiling in various countries.