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India

Latest Headlines

Latest Headlines

Another Indian CRO runs afoul of global authorities over trial errors

The World Health Organization has chided one of India's biggest CROs over mishandling clinical trial results, echoing a data scandal that threatens to tarnish the reputation of the country's biopharma contractors.

Indian court upholds BMS Sprycel patent, but list of challengers grows

Bristol-Myers Squibb has won a court verdict to uphold its patent on Sprycel (dasatinib), fending off a challenge, for now, from India's BDR Pharmaceuticals, which sought a compulsory license to make the drug and sell it at a lower cost domestically. But other challenges abound, including one by little-known Lee Pharma for AstraZeneca's Onglyza.

More trouble for India's CROs as Quest Life Sciences hauled up by WHO in HIV trial

Indian CRO Quest Life Sciences of Chennai saw the results of a clinical trial of HIV drugs rejected by the World Health Organization after an inspection found poor clinical practices on data and bioanalytical procedures that could not be remediated, according to a letter from the Geneva-based United Nations body.

Lupin walks the talk, buys Russian generics maker Biocom

Lupin Pharmaceuticals has made no secret of its intention to grow through acquisitions at home and abroad and last week announced it would make a major buy of Russian generic drug maker ZAO Biocom, placing it in a turbulent but fast-growing market.

Orthopedic implant makers fight India price law scope, but NPPA says the law wins

Price checks by India's National Pharmaceutical Pricing Authority on certain orthopedic implants have once again raised hackles by companies concerned they are being swept up in a law that was not meant for their industry,  Business Standard  reports.  

India's Marksans Pharma buys U.S.-based Time-Cap, a trend in the making?

More than a few analysts and company executives are watching Indian drug companies in expectations of consolidation among smaller players and possibly daring moves by mid-cap and larger at home and abroad.

Some Indian drugmakers see M&A preferable to investing in plant upgrades

Consultants tell Reuters that large Indian companies are heeding the warnings from regulators and investing more in equipment and training. But some small to medium-sized companies are considering whether to pour money into their operations, retreat from high-profit but regulatory-heavy markets like the U.S. and Europe, or cash out.

Troubled India's Wockhardt sees third U.S. drug recall in as many months

India's Wockhardt has voluntarily recalled 85,000 cartons of over-the-counter heartburn treatment famotidine tablets, calling the state of its plans to recover from U.S. FDA import bans on two plants into further question, Business Line said.

Tougher regulations force Indian drugmakers to invest or divest

After more than 5 years of FDA regulatory issues kept Ranbaxy Laboratories from generating the kind of cash it once had, owner Daiichi Sankyo threw in the towel. It recently sold the Indian generics maker at a loss to Sun Pharmaceutical and moved on down the road. Analysts say a tougher regulatory world is, in fact, remaking India's vast drugmaking industry.

India's Gujarat state drugmakers speed up biosimilar race

Drug companies in India's leading industrial state of Gujarat, the base of Prime Minister Narendra Modi, are stepping up efforts to crack the domestic market for biosimilars as well as abroad, Business Standard reports.