Delhi's Drug Regulation Overdose

Roger Bate | 17 May 2012
Wall Street Journal Asia
India's Ministry of Health announced emergency plans last week to prevent irregularities in how the government approves new medicines. The sense of urgency comes after a 78-page parliamentary report which found that officials in India's drug regulator, the Central Drugs Standard Control Organization (CDSCO), colluded with pharmaceutical firms to speed up medicine approvals. Such collusion is a problem, but the risk is that the government will waste energy tackling the wrong disease.

So far the ministry has been short on specifics, saying it will strengthen the CDSCO and streamline its functions. The ministry needed to be seen acting after the parliamentary report, which accused several large pharmaceutical companies, including Germany's Bayer AG, of colluding with the CDSCO. In Bayer's case, the report cited several examples of letters of recommendation in support of rivaroxaban, Bayer's anti-blood-clotting medicine, that were purportedly written by different, independent Indian university experts thousands of miles apart and yet were "word to word identical." Bayer says it had no input in the supporting letters, which were obtained by the CDSCO.

This is all well and good—new products should only be used if their manufacturers demonstrate they work properly and new procedures could help. Collusion is of course unacceptable.

But the bigger problem is the overall regulatory framework India has used to approve foreign-developed drugs. Specifically, New Delhi requires that pharma multinationals conduct in-country clinical trials of their products. As a rule, India does not allow products to be registered quickly, even if they are approved by stringent foreign agencies such as the U.S. Food and Drug Administration (FDA).

The Indian government's rationale for clinical trials is that drugs occasionally cause unexpected problems in different ethnic groups, and so should be tested on all ethnicities before being widely used. But such problems are rare. And probably more importantly, the way most of the clinical trials are being run for drug approval processes would not likely find problems anyway. The parliamentary report discusses in-country trials with far fewer than 50 subjects and undertaken in only two hospitals, making it difficult to unearth anomalies. For example, in the local trial of heart drug Dronedarone, made by French company Sanofi, only 21 people were in the trial.

New Delhi appears prepared to double down on this policy. The existing approval system is unnecessarily onerous and probably costs more lives than it saves. If the Ministry tightens enforcement with new regulations, it will simply worsen the problem.

Products approved by rich nations' regulators go through far more stringent tests than can be managed by India's CDSCO, which suffers from limited resources and understaffing. Indians end up gaining access to new drugs much later than ill consumers in the developed world and all for the sake of a regulatory process that can at best yield only the most insignificant of benefits.

Meanwhile, demanding local clinical trials provides opportunities for graft. Recent corruption scandals have exposed the kind of discretionary power officials have, and some of them now can play favorites and reduce requirements on certain firms.

That is, after all, what the parliamentary report accused the CDSCO of doing. According to the parliamentary report, at least 31 drugs were approved by the CDSCO without adequate local clinical trials. The report says "there is adequate documentary evidence to show that [expert] opinions are written by the invisible hands of drug manufacturers and experts merely oblige by putting their signatures."

All of this also distracts from what the CDSCO should focus on: dangerous drugs in the domestic market. If the regulator simply registered all FDA-approved products, then it could spend time regulating the fake and substandard drugs actually being sold across India.

My research team's work shows that around 5% of the drugs on the Indian market are substandard in some way. The government's own assessments through the 1990s and 2000s concur with our findings. Some of the drugs my team found were total fakes, with no active ingredients, but many were legal products that had been poorly made.

My team's ongoing research shows that several companies in emerging nations, especially Chinese but also Indian ones, take advantage of the focus government agencies place on a drug's approval stage. These companies are quite capable of making good-quality products to win approval, but then seem to lower the quality when they actually sell to the market.

This reduces costs, but may be lethal to some patients, and could build drug resistance in infectious diseases. India has one of the worst problems with antibiotic resistance in the world, partly due to the substandard drugs on sale there.

The corner-cutting is probably not accidental, because quality problems are greater in countries that don't invest in detecting poor-quality products. Nations with weak drug regulators, like Ethiopia or Angola, have far more substandard drugs than nations like Brazil or Thailand, where more post-market surveys are carried out.

Sadly, producers know that sloppy procedures will not be spotted in some markets, and so inferior products sometimes get dumped there. India is somewhere in the middle: It has great companies making top-notch products and some competent regulators, but it also has some lazy producers who would rather pay a bribe than make a good product.

This suggests that post-market surveillance should be prioritized in an emerging country like India. It's a better use of the government's time than worrying about whether Western companies have filled out all their paperwork correctly.