Many believe that bioequivalence testing is necessary for only a handful of medications. In reality, it should be the norm for virtually all drugs.
The export of generic pharmaceuticals is one of India’s strengths. But both the government and manufacturers need to do more if they want to continue to stay ahead of China.
The government’s premier policy-formulating agency recently recommended measures to deregulate the pharmaceutical sector and make essential medicines more expensive.
In the absence of a standard drug regulatory mechanism, Indian doctors rely on the reputation of companies who have demonstrated their commitment to quality over time.
M.K. Venu, founding editor of The Wire, in conversation with Leena Menghaney from Doctors Without Borders India.
Between 2011 and 2016, as many as 27 drug manufacturing plants in India got FDA warning letters for data integrity violations.
Many families in China have turned to the increasingly popular, unregulated market of online pharmacies, agents and peer groups for cancer drugs.
The patent also covers the raw materials to make the drugs, which means it would allow the manufacturer to disrupt or stop exports of the raw materials from India.
Renown economist JosephStiglitz specifically called out the government’s crackdown on NGOs as well as their reaction to the February 9 incident at JNU.
At this crucial juncture, acceptance of US demands on IP enforcement will have a distressing effect on the availability of next generation generic medicines from India
Sofosbuvir, a single drug to treat hepatitis C viremia, has been hailed as a “milestone” because of its efficacy. But as two charts show, what could be the point if its cost is prohibitive?