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Critical condition

Drug majors are shifting clinical trials out of India as lawmakers turn on the heat

They will come to inspect after the horse has bolted from the stable,” grumbles a visibly miffed Kiran Mazumdar-Shaw. The chairman and managing director of Biocon is seated in her tastefully decorated meeting room at the Bengaluru headquarters, where the walls are adorned with paintings by Scottish artist Tom Robertson and bright sunlight pours in through the large windows. The Watson & Creek meeting room is named after the Nobel laureates who discovered DNA; in fact, all meeting rooms at India’s largest biotech firm are named after Nobel Prize winning scientists. This is just another sign that Biocon takes its research seriously, the biggest indicator, of course, being that like most other large Indian pharmas, it is working at breakneck speed to be the first to launch an Indian blockbuster drug. And that explains why Mazumdar-Shaw is unhappy.

Over the past year, regulatory hurdles seem to have thrown cold water all over the industry’s plans, including Biocon. “In our country, regulators have always failed us, be it in aviation, telecom or now, pharma. The regulatory landscape is not thought through in a holistic manner and regulation is often a knee-jerk reaction. Today, regulation has been hijacked by activism,” she says. Mazumdar-Shaw isn’t alone. Most pharma players are loudly expressing their displeasure with restrictions introduced on clinical trials last year, which they claim is stifling innovation and drug discovery in the country and slowing down expansion. What has them so hot under the collar and where does Indian pharma go from here?

Systemic malaise

It all began in January 2013, when the Supreme Court revoked the power of the Drugs Controller General of India (DCGI) to approve clinical trials after finding glaring irregularities in some of the clinical trials approved. Serious lapses had been found in some clinical trials in Madhya Pradesh and in a trial in Andhra Pradesh and Gujarat to evaluate a cervical cancer vaccine. The latter was carried out in 2009 on tribal girls by a US-based NGO Path, which tested cervical cancer vaccines by Merck Sharp & Dohme and GSK, in collaboration with the Indian Council of Medical Research. The trial, which was abandoned in 2010 after the death of seven girls, was held to have violated several norms: in Andhra Pradesh, of the 9,543 consent forms, 1,948 had thumb impressions and 2,

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