US Pharmacopeia (USP) head - global verification programmes, V Srini Srinivasan, talks about the collaborative effort with its Indian counterpart as well as the Indian pharmaceutical industry in establishing public standards for medicines that are produced and sold here. He also discusses with B Dasarath Reddy the work of USP’s Hyderabad facility apart from the initiatives they have taken in the area of Medicines Compendium. Excerpts
How significant is the work of US Pharmacopoeia to India and Indian pharmaceutical industry?
We do work with various pharmacopoeias in the world, including the Indian pharmacopoeia. The collaboration with our Indian counterpart is going on for more than a decade. We identify scientific issues that are very relevant, such as new technologies that help evolve drug adulterants, in determining the purity and quality of medicines. We hold scientific conferences and open dialogues. Once we enrich ourself, we use the expertise in formulation of standards for new drugs, exchange scientific people. Scientists from Indian pharmacopoeia come to the US for training. This apart, we also provide medicines compendium standards for free. Our medicines compendium is unique in the sense that it differs from many others in terms of analytical procedures.
This medicine compendium that has been developed so far and that will be developed in future is coming from an expert committee, which consists of Indian scientists. They come from various industries like Aurobindo, Dr Reddy’s and Mylan within the country. Indian Pharmacopoeia's scientific rector is the official liaison for our expert committee. The standards that are published here are coming from Indian experts and the industry. That shows that industry is closely working with us. Companies export drugs to several other countries in Africa and Latin America where there is not much of a regulation due to resource constraints. So, the medicine compendium helps these companies in adopting the standards. This will increase their profits as they export more drugs.
How will the free access being announced by USP to those public standards benefit the people at large?
The compendium is a set of specifications of medicines that would enable manufacturers to produce medicines conforming to those specifications. A specification is defined as a test, test procedure and acceptance criteria. These together constitute specifications that ensure the common masses that the medicines they use are free from impurities and harmful contamination, such as pesticides, toxic metallic impurities like lead. The compendium is for the whole world though we started with India because we have a presence here. There are a lot more drugs in the country for which standards may be required and we will be happy to develop standards for those and make available to our counterpart. Under the norms, any drug that is manufactured and marketed in India must conform to the Indian Pharmacopoeia standards. We have identified 10 drugs for which we published the standards on July 1 and this will be made official on November 24 after completing the public review process. Then they will become the authorised standards available to manufacturers throughout the world.
The identified drugs include anti-malarials, anti-diabetic and other categories of medicines. They are important drugs, which are sold in India and neighbouring counties as well as in Africa. The drug for river blindness, for example, has no standards. There are companies in India, which are making these drugs and exporting to Africa. Now they can use the standards and tell the African people that these conform with prescribed standards. We will be developing more and more standards in various categories.
In your view what are the areas of concern when it comes to quality of drugs?
Presence of pesticides is one such area of concern. For example, Lanolin, which is extracted from sheep wool, is used in shampoos, shoe polish and other ointments. But the pesticide used for killing lice on the bodies of sheep gets into the fatty substance. When we test, sometimes it contains several parts per million particles and sometimes even 5 per cent. Pesticides are not supposed to be present in any medicinal compounds. They are of major concern especially in herbal medicines as they come from plants. Farmers use pesticides. This is a big issue in the pharmaceutical industry.
Compendium describes standards for medicines, tests and procedures to analyse and determine tolerance levels for the presence of pesticides among other impurities and contaminants.
How do you rate the Indian pharmaceutical industry as far as the global standards are concerned?
The Indian pharma industry has come a long way. Indian companies command a lot of respect in various countries including the US. India exports a lot of drugs to the US markets. Outside the US, India has the maximum number of manufacturing units that have been inspected by the US FDA. Indian companies had filed the largest number of Drug Master Files. Hyderabad occupies a unique place in supplying bulk drugs to all over the world. Once in a while, we may come across instances of a company facing a fine by the US FDA, but that can happen anywhere and to big companies also. In China, they sell a lot of Indian drugs manufactured by Dr Reddy's and Mylan. The Indian drug market is huge. Eighty per cent of drugs for the consumption is being provided by the local industry which is very good.
What is your revenue model?
We are the only non-governmental nonprofit private pharmacopoeia in the whole world. On the one hand, we establish public standards and on the other, we also develop reference standards. While the public standards are for free, we sell reference standards, which are provided in very small quantities, sometimes in a few milli or micrograms to be used by manufacturers in determining that their products are in compliance with our standards. We sell the reference standards in 125 countries and more. The income that comes from the sale of reference standards supports what we are doing globally. Roughly about 50 per cent of total revenues comes from overseas sales, that include India too. Public health mission is what drives us. Our motivation to be here and to expand is to provide more help to Indian government, state government and lastly the industry.
The contributions so far made by the USP's Hyderabad facility
We are located in Hyderabad but we serve the whole world from here. Our laboratory in Hyderabad develops reference standards which are sold worldwide. So the city is our second home. Hyderabad facility has collaborated with other collaborative labs in developing several reference standards in the last five years of existence here. Work on medicines compendium has just begun. We will develop reference standard for every monograph standard in the medicine compendium, which will be done here. On September 2, 2011, we are planning a big dedication ceremony in the new USP building where Indian and US Pharmacopoeia will hold joint meetings.
