India updates on manufacture suspension for antifungal therapy

Injection
Injection

India said a suspension on manufacturing of severe fungal infection therapy Liposomal Amphotericin B remains in place for 10 domestic firms with orders out to show improved processes to resume output--though enforcement by state regulators has not been fully confirmed.

In April, the Drug Controller General of India (DGCI) announced a halt to the manufacture of Liposomal Amphotericin B--used in to treat ailments such as meningitis and visceral leishmaniosis--because of increased complaints of potential side effects on kidney and liver function.

The list of manufacturers was not immediately available, but the Economic Times said the operations were spread across 6 states and that the orders were for state regulators to enforce the manufacturing halt.

Whitepaper

Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

"The Central Drugs Standard Control Organization (CDSCO) asked state licensing authorities concerned to suspend the manufacturing licenses of 10 manufacturers of Liposomal Amphotericin B Injection on March 11, 2016," the Minister of State for Health and Family Welfare Shripad Yesso Naik told the lower house of parliament. He added that licenses have not been terminated and the government has "asked the manufacturers to fulfill the conditions and then will restore their production."

He said that 5 states have also suspended licenses, but that Gujarat, a key drug manufacturing center in India, has not responded.

The therapy is sold by several drug companies in India, according to a recent story by the Hindustan Times, which noted Abbott Laboratories ($ABT), Sun Pharmaceutical Industries, Cipla, Panacea Biotech and Bharat Serums all sell it under different brand names, with most buying it from other manufacturers.

In India, the therapy is used to treat a form of leishmaniosis called kala azar (black fever).

- here's the story from the Economic Times

Suggested Articles

Three Samsung execs face up to two years in jail for their roles in destroying data and documents at under-fire affiliate Samsung BioLogics.

Astellas buys gene therapy player Audentes for $3 billion. Keytruda and Opdivo fail to win coverage in China. Hanmi inks I-O deal with Rapt.

It’s a familiar scene in the race onto China’s national reimbursement list: Drugmakers cut prices by an average 60.7% to win coverage.