It's what the doctor ordered

The government’s decision to waive clinical trials for proven drugs may be just what the doctor ordered for millions of patients in India, besides boosting biomedical research in the country. The new rules aim to make local trials redundant for drugs that have not had any adverse effects on patients, with the provision that they should have been marketed for at least two years in countries of the European Union, UK, America, Australia, Canada and Japan.

Health ministry sources indicate that the proposed legislation would enable the introduction of proven medicines in the country in less than a month’s time — unlike the years it usually takes. The Ministry of Health & Family Welfare has reportedly prepared a draft of the new rules, which is now being studied by the law ministry to prepare its legislative version.

The immediate beneficiaries of the new norms will, of course, be patients who are usually forced to wait interminably for advanced medicines to treat life-threatening diseases like diabetes and cancer.

“It is a very good decision,” says Dr Vinod Raina, Executive Director, Fortis Memorial Research Institute in Gurgaon. “It will bring the drugs quicker to the people. Since these drugs have already been tested in advanced countries like the US, UK, and Australia, what’s the point of testing them again? Of course, clinical trials will still be needed for some drugs, but not for those that have already been tested.” Without the new rules, he adds, the drugs would get delayed by another three to four years because of the bureaucracy. “So, it’s a brilliant and bold decision which will cut down a lot of red tape and a lot of expenses.”

The new regulations will also be welcomed by drug manufacturers in the country who will now find it much easier to do business without getting stuck in bureaucratic tangles at every stage of testing new drugs. As R K Vats, additional secretary in the Ministry of Health & Family Welfare, put it: “The new rules will make it easier for the pharma companies to introduce drugs in India which are already in use in well-regulated countries.” The only legal means to evaluate new medicines introduced in India is the Drugs and Cosmetics Act (DCA). But despite several amendments made to the DCA over the years, it has had little impact on the regulatory framework.

Usually, the Indian Council of Medical Research (ICMR) first field-tests a new drug before recommending its suitability to the health ministry. This is done in three phases, with each successive phase involving a larger number of people.

Phase I assesses a drug’s safety in the country of its origin and is carried out over a long period on healthy volunteers. It determines how the drug is absorbed, metabolised and excreted by the human body. Phase II tests the drug’s efficacy and the trials are randomised to provide an objective analysis of its potency. Phase III is carried out over several years on thousands of patients to ascertain the drug’s benefits and possible adverse reactions. The drug can be marketed only if it successfully negotiates this gamut of testing.

While this ensures the safety of new drugs, its downside is that it has resulted in less than 1% of global clinical trials being conducted in India — a country that is home to 16% of the world’s population and accounts for 20% of the world’s diseases. “Clinical trials have fallen dramatically in India in the last 10 years,” says Dr Raina. “Because of corruption and several other factors, they have come down to a trickle now.”

In the mid-2000s, the scene was different as India was seen as a promising destination for conducting clinical trials. A very large patient pool and highly skilled medical personnel gave the country a distinct advantage over countries like China, Russia and Argentina. And the fact that it was more than 50% cheaper to conduct trials in India than in the developed countries pushed India’s share in the global clinical trials up to 5% in 2013.

Safeguarding patients

The bubble burst, however, in 2013 when the Supreme Court stopped all new clinical trials in the wake of allegations of mercenary research causing deaths due to negligence. The court ordered the government to review and revise existing regulations regarding clinical trials, ensure patient safety, and enhance the quantum of compensation due to patients in case a trial goes wrong.

Not surprisingly, clinical trials in India dried up as the stringent regulations forced many multinational majors to pull out their clinical studies from the country. “This was a big set-back for India,” observes Dr Raina. “Because there were also some high quality clinical trials that were doing well in the country earlier and stopping them meant wasting all the technology invested in the trials. With so many obstacles being put in place, India stood to lose out ultimately.”

Although the proposed legislation has more cheerleaders than critics, its fine print should ensure that the rights of trial participants are also protected. After all, the role of patients is crucial to any clinical trial and the absence of adequate regulation to safeguard their rights has been a major reason for clinical research doing so poorly in India.

True, the government has introduced some new measures — such as the requirement for recording the ‘informed consent’ of the participants, or compensating affected participants even if the trial is not directly to blame. But much more needs to be done. Perhaps the government could bring in a full-fledged bill of rights for patients who put up their hands for clinical trials. Only this, along with a new regulatory environment that is friendly towards global stakeholders, can ensure high quality clinical research returns to India sooner rather than later.

(The writer is a New Delhi-based senior journalist)

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