India: The Pharmacy of the World Where Fixed Dose Combination Drugs Go Unregulated

[marmar]

India: The Pharmacy of the World Where Fixed Dose Combination Drugs Go Unregulated

Tuesday, 21 July 2015 00:00
By Patricia McGettigan, The Conversation | News Analysis


India has been called the pharmacy of the world. Many generic drugs are made there and much of its drug production is exported internationally. Thousands of fixed dose combination (FDC) drugs – where two or more drugs are combined in a set ratio in a single dose form, usually a tablet or capsule – are formulated, made and sold within India.

Many FDCs are safe and effective. They are used in situations where both the drug combination and the doses needed are standardised and stable, for example, in the treatment of HIV, for Parkinson's disease and in contraceptive pills.

However, in a study investigating these drugs in India, we found thousands of FDCs on the market made up of formulations never approved for marketing by the national regulator, the Central Drugs Standard Control Organisation, and that were likely to be more harmful than beneficial to patients.

As two pharmacologists in India, writing in response to our study put it:

One can find any crazy drug combination which could give nightmares to any doctor who has some understanding of the concept of the rational use of medicine. It is simply beyond comprehension of any rationalist. Even antimicrobials are being combined weirdly, which is a grave challenge for crusaders against antimicrobial resistance.

FDCs in India

Considered an innovation of India's national pharmaceutical industry, FDCs are promoted extensively and used in huge numbers within the country. These drugs are mostly available through wholesalers, pharmacies (not necessarily with a prescription), dispensing doctors, but some are used in hospitals too. .................(more)

http://www.truth-out.org/news/item/31985-india-the-pharmacy-of-the-world-where-fixed-dose-combination-drugs-go-unregulated

[djean111]

1. I am afraid that thngs like this will be used to justify choking off the supply of affordable

generic drugs in total. Pharma wants the world to be just like the USA - either you can afford the drugs or the health insurance, or you die.