Indian gov’t probes drug regulator after scathing review

Posted under Bayer, Blog, Central Drugs Standard Control Organization, Companies, Diagnostics, Emerging Markets, Funding, GlaxoSmithKline, india, Medical Devices, Medical Supply, Novartis, Pharmaceuticals, Regulatory, Sanofi, Startups, Universities, Videos by rmcbride

India's drug regulators are ensnared in a scandalous fix. Days after a parliamentary report noted shoddy oversight of approvals, the Indian government has mounted an investigation into the alleged misdeeds. Meanwhile, big names in biopharma have surfaced in the sea of allegations.

As The Wall Street Journal reports, India's ministry said Friday it has created a special group to probe the long list of grievances in the report, with an eye toward repairing the infrastructure in place for approving drugs in the country. If the allegations in the parliamentary review are true, the Indian government believes that laws were broken and drugs arrived in pharmacies without undergoing required clinical studies.

Drugs from several of the largest drug companies--including Bayer, GlaxoSmithKline ($GSK), Novartis ($NVS) and Sanofi ($SNY)--were listed among those that were approved without standard clinical evaluation. Many of the drug manufacturers have professed their innocence after the report cited alleged collusion between pharma groups and India's drug regulator, Central Drugs Standard Control Organization.

- read the WSJ's article (sub. req.)
- see Reuters' report

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Subpar clinical trials probed in India’s review of regulation

Posted under aliskiran, ambrisentan, Blog, Clinical Trials, Companies, Diagnostics, dronedarone, Emerging Markets, Funding, GSK, india, Medical Devices, Medical Supply, Novartis, Pharmaceuticals, Sanofi, Startups, Universities, Videos by rmcbride

Indian lawmakers and patient advocates charge that their regulator rubber-stamped drugs to be sold in the county without required clinical trials. And a parliamentary report heaps blame for poor adherence to trials standards on Big Pharma groups, the national regulator and other stakeholders in a scathing review of approvals in the country.

The investigation probed the approvals of 42 drugs from groups such as the global heavyweights GlaxoSmithKline ($GSK), Novartis ($NVS) and Sanofi ($SNY), finding that certain meds were cleared for the market in India after being banned in developed countries or got approvals without being studied in enough patients, Bloomberg reported. For instance, India's Central Drugs Standard Control Organization approved Sanofi's dronedarone and Novartis' aliskiren based on trials with fewer than 50 patients, allegedly allowing the companies to skirt the minimum 100-patient requirement.

"There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts," the report said, as quoted by Bloomberg. "Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk."

Novartis and GSK, for starters, reacted quickly to the news. Switzerland-based Novartis stated that the company follows the same ethical standards for all of its studies around the world, and has mounted an investigation of its own into regulatory activity in India. In its own defense, GSK got Indian regulators to waive trial requirements for the London-based drugmaker's niche hypertension drug ambrisentan, the London-based drug giant told Bloomberg.

The report is a clear signal that Indian lawmakers and advocates are pushing for tighter control of drug regulation in the country, which has been a rapidly growing market for drug development and pharma sales.

- see Bloomberg's report
- check out Reuters' story

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Biocon hiring 300 scientists for new R&D complex in India

Posted under Biocon, Biologics, Blog, Companies, Diagnostics, Emerging Markets, Funding, india, Kiran Mazumdar-Shaw, Kurt Wuthrich, Medical Devices, Medical Supply, Pharmaceuticals, R&D, Startups, Universities, Videos by john

India's Biocon cut the ribbon on a new biologics R&D complex that will host a multi-disciplinary group of more than 300 scientists developing a new generation of "affordable" biologics. Nobel Laureate Kurt Wuthrich will helm the center, which is billed as the first of its kind in southeast Asia.

Biocon, which has experienced its own setbacks in drug development, has set its sights on expanding its work on novel therapies. Biocon chief Kiran Mazumdar-Shaw (photo), who built the company from scratch, has championed the country's drug development community. And she's been hiring an international group of investigators expert in molecular biology, biologics process sciences, formulation research and preclinical and clinical development. 

"I am enthralled with Biocon's research capabilities which are at par with international standards. I will keenly watch the outcome of innovation from this centre as I see a lot of promise in scientific talent here," said Wuthrich in a statement.

"We aspire to build a center of research excellence that will pursue an innovation-led effort to develop advanced yet affordable solutions for several debilitating diseases," says Mazumdar-Shaw. "It will epitomize Biocon's efforts to galvanize the best talent available both in India and from across the globe, and offer them an intellectually stimulating environment combined with an enabling ecosystem to conduct pathbreaking research for biopharmaceuticals."

- here's the press release

Special Report: Kiran Mazumdar-Shaw - The 25 most influential people in biopharma today

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India Compulsory License: A Times of India Article Says It’s Not Helping the Poor

Posted under access, access to medicine, Bayer, Blog, Companies, compulsory license, cost, Diagnostics, drug cost, Essential Medicine, Funding, india, Indian Patent Office, Intellectual Property, Medical Devices, Medical Supply, Natco, patent, Patently BIOtech, Pharmaceuticals, Public Policy, Sorafenib, Startups, Universities, Videos, World Health Organization by biotechnow@bio.org (Biotechnology Industry Organization)

India recently issued a compulsory license on Bayer’s liver and kidney cancer drug (Sorafenib) with the stated goal of providing access to India’s poor. However, the Times of India recently ran the article Cheap generics drugs no panacea for India’s poorest, quickly dispelling this myth:

“The compulsory license system might not really work because poor people cannot even afford the discounted price,” said G. Balachandhran, former head of the National Pharmaceutical Pricing Authority (NPPA), India’s drug price watchdog regulator.

“Instead of dealing on a case-to-case basis, India needs to have a policy that will bring more and more people under medical cover … We need to increase the health insurance penetration, so that even poor people can afford treatment,” he added.

“Only 15 percent of India’s 1.2 billion population is covered by health insurance, according to business lobby group the Federation of Indian Chambers Commerce & Industry, meaning even at a lower price, Nexavar will be out of reach for many.

“Still, the head of Pfizer, the world’s largest drugmaker, told Reuters on March 12 that there were around 100 million people in India with “wealth equivalent to or greater than the average European or American, who don’t pay for innovation”.

While Natco will profit off someone else’s investment and innovation, it seems the company’s compulsory license gift from Indian regulators will do little to help India’s suffering masses.