The Mutual Recognition Agreements (MRAs) can help the Indian pharma exporters a lot in assuaging regulatory clearances for trading in drugs and other pharmaceutical products. In the area of international commerce, it is difficult for one country to import products from other country, so the Agreement assumes importance, said Dr D Roy, deputy drugs controller general, South Zone.
He was delivering a presentation on 'MRAs -A Growing Opportunity for facilitation of Exports to New regions' at the seminar organized by Pharmexcil.
"The Agreement is helping one country's regulatory agency to collaborate with that of another country in improving the quality of drugs to be traded between them. They can tap every opportunity for exporting and importing their products," he said.
Dr Roy has said that India has the capacity in providing drugs at affordable costs and has huge technical know-how in process chemistry and development of generic products. In the world pharma market, the country occupies a significant position, especially in generics. India's internationally well-known company Ranbaxy is the world's seventh largest generics manufacturer. Along with the exports, the demand of generics in the domestic market is also increasing because of the country's old age population, he asserted.
According to him, for the last two decades the country's pharmaceutical exports have increased substantially and the trend may continue in the coming years. But, he added, there are some other factors, including the areas of energy and transport, which slow down the technical support required to speed up the growth of exports.
He said in 1947, India had maximum one hundred manufacturing units, whereas in 2008 the number of licensed companies has risen to more than 10,000. The country has the best people and Indian products are also considered by others as the best.
The deputy DCGI has pointed out that Good Manufacturing Practice (GMP) is the basic requirement to be considered while assessing a manufacturing Unit as it is one of the requirements of globalization. Some other capabilities the world pharma industry could achieve due to globalization are Drug Master File (DMF), National Pharmacovigilance Programme, Independent Agency for Standards, Effective Market Surveillance, Registration of Foreign Site, Participation in Global Harmonization, etc.
Today, India is capable of conducting clinical trials for a large number of new drugs. Besides, the country can offer to the world pharma market quality generic products, ISM products, new software solutions, process technologies, analysis of clinical data and reports of toxicological and pharmacological studies, he said.