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.
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.
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 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.
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.
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.
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.
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.
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.
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.