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Govt in talks with various semi-regulated markets to accept Indian drug norms

30 Nov 2015 Evaluate

With an aim to help Indian drug makers to save cost on upgrading to international standards, India is nudging various semi-regulated markets like Myanmar and Kenya to accept its drug standards, instead of British Pharmacopoeia (BP) or the United States Pharmacopoeia (USP). Pharmaceuticals Export Promotion Council of India (Pharmexcil) Director General PV Appaji has said that “We are in talks with various semi-regulated markets in ASEAN region, Africa and SAARC countries to accept Indian Pharmacopoeia instead of BP or USP”. The move will help many Indian drug makers, which are solely following IP, to save significantly on time, packaging and other costs needed to adopt either BP or USP.

Extending its support to this initiative, Pharmexcil has invited 10-15 drug regulatory heads from various countries to participate in the Indian Pharmaceutical Congress at Mysore next month. Apart from this the council is already in talks with representatives from Ghana, Kenya and Myanmar regarding the issue and has stated them that Indian drug standards are also at par with the USP or BP. It also added that if they accept, both Indian drug industry as well as these countries would be beneficial and these markets would be able to get drugs from the stock meant for Indian market, leading to saving in terms of cost and time and also they could avail of certain life saving drugs well in time.

Pharmacopoeia is a set of standards and quality specifications for ingredients, preparation and dosage forms of medicines manufactured, sold, consumed and exported in a country. Indian Pharmacopoeia Commission (IPC) is an autonomous institution under the Ministry of Health and Family Welfare which sets standards for all drugs that are manufactured, sold and consumed in India. Currently, Indian Pharmacopoeia (IP) is only followed in the Indian market. Last fiscal, India exported drugs worth over $15 billion.

 

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