The United States Pharmacopeia (USP), an official public standards-setting authority for all prescription and over-the-counter medicines and other healthcare products, has been working in India for over 10 years, mostly supporting Indian pharmaceutical manufacturers who want to get into the US market. In an interview to K Rajani Kanth, USP managing director and chief executive officer Roger L Williams shares the organisation's plans including creating a medicines compendium, which could facilitate Indian pharma manufacturers in entering newer export markets, and its proposed new standards for prescription container labels, which would help reduce medication misuse and promote patient understanding. Excerpts:
With India being a huge generic drug market, what are the new initiatives that you are lining up for this country?
Indian manufacturers are critically important for the US market. And, if you think about standards, there are a lot of standards that they have to meet both from USP and FDA. In the US, USP and the National Formulatory are the two official compendia. But the real question is what about the Indian manufacturers who are shipping into all parts of the world? Sometimes, there are no standards that Indian manufacturers can use abroad. Hence, we are trying to create what we call a medicines compendium for them.
In what way will this medicines compendium help Indian pharmaceutical firms?
There are many pharma compendia out there. But at the end of the day, they have got a lot of gaps in public standards. If you look at the medicines that are available across the globe, there are thousands of ingredients and products. And, no pharma compendia can solely cover all these. What we are trying to do with this medicines compendium is to create a sort of focus on the best standards, monographs and reference material, which a manufacturer can use to convince his customers and make good products. This will set a good public standard for them that can be used to ship to countries like Ethiopia, South Africa and Australia ... if the regulators there recognise them (public standards). This will be made freely available and any Indian pharma company can adopt or adapt it ... if they wish.
What is the status of the proposed new standards for prescription container labels?
USP is currently working to standardise the prescription container labels in the US. It is more a matter for the pharmacies. As more patients enter the healthcare system and the nation (US) becomes increasingly diverse, more patients will have difficulty in understanding and using important healthcare information provided to them.
The new standards propose that prescription container labels generated by pharmacies are organised in a patient-centric manner, give explicit instructions (like take 2 tablets in the morning and 2 tablets in the evening instead of take two tablets twice daily), improve readability (black print on white background, large font size and horizontal text only) and include purpose of use (example: for high blood pressure rather than for hypertension). Right now, this is in development in the US. If this can help India, it could be freely used here.
What is your take on the patent infringements or non-compliance issues?
Any company in the US market can get into trouble in terms of good manufacturing practices (GMPs) or affiliated standards. It just happens and people shouldn't think that as a terrible offence. They can always correct themselves in terms of standards, get their contracts and get back to the market.
