Govt in talks with various mkts to accept Indian drug norms

India is nudging semi-regulated markets like Myanmar and Kenya to accept its drug standards, instead of the US or British norms, a move aimed at helping many Indian drug makers to save cost on upgrading to international standards.

“We are in talks with various semi-regulated markets in Association of Southeast Asian Nations region, Africa and South Asian Association for Regional Cooperation countries to accept Indian Pharmacopoeia instead of British Pharmacopoeia or the US Pharmacopoeia,” Pharmaceuticals Export Promotion Council of India (Pharmexcil) director general P V Appaji said. To shore up support for this, Pharmexcil has invited 10-15 regulatory heads from various nations to participate in the Indian Pharmaceutical Congress at Mysuru next month, he added. “We are already in talks with representatives from Ghana, Kenya and Myanmar regarding the issue,” Appaji said.

“We are telling these markets the Indian drug standards are also at par with the USP or BP. If they accept, both Indian drug industry as well as these countries would benefit.” The move would help many firms, which are solely following IP, to save on time, packaging and other costs needed to adopt BP or USP.

"If they accept then these markets would be able to get drugs from the stock meant for Indian market, leading to saving in terms of cost and time. Also they could avail of certain life saving drugs well in time", Appaji said.

Currently, Indian Pharmacopoeia (IP) is only followed in the Indian market.

"It won't be an easy task (making these countries accept IP). We will have to instill confidence in them by inviting them to our manufacturing facilities, show them our standards.

Moreover, Indian embassies would have to follow up so that we get desired results", Appaji said.

India exported drugs worth over USD 15 billion last fiscal.