India is the world largest producer of generic medicines. These are “me-too” medications originally developed by international pharmaceutical companies, which have had their patents run out.

The growth of its own pharmaceutical sector has ridden on the back of the generic medicine business. India has fine biochemists and fine university science faculties. Thus it is no surprise that one firm is at an advanced stage in the development of an oral insulin dose. As with every new medicine, there are rigorous independent tests to go through. However as and when this new oral insulin reaches the market, the lives of million of diabetics will change. They will no longer have to inject themselves with their daily insulin shot.

The Indian firm responsible, Biocon has been in the process of doing clinical trials. However, it and other innovative biochemistry firms have been caught up in a sweeping ban that has stopped some 160 clinical trials. The Indian Supreme Court has imposed the moratorium after it was claimed that Indian peasants were being used as human guinea pigs by unscrupulous pharmaceutical companies.

Baby and bathwater spring to mind. There is no evidence that Biocon has been breaking strict international guidelines for the testing of its revolutionary new medicine. Indeed, given the likely impact of its discovery, it would be insane to break the rules in anyway. This is because the huge success that will very probably come the company’s way, will attract extremely close attention from rivals, regulators and the media. Yet now its work as the oral insulin is effectively suspended until a committee has reviewed the appropriateness of all the clinical trials currently under way. Were this process likely to be swift and efficient, this would seem an entirely acceptable move. Unfortunately that is not the Indian way. High speed technology has met low speed bureaucracy.

And the Indian authorities should understand that time is of the essence. Biocon has two international rivals who are working on their own oral insulin. They are reportedly at an advanced stage with their own clinical trials. The first pharmaceutical company to market with this product is likely to enjoy a distinct advantage over its competitors, not least because it will benefit from the substantial publicity that will surround the launch. This is one of those few new medicines that will make the world sit up and take notice.

The irony is that this whole investigative process has been triggered by a major act of philanthropy. The Bill and Melinda Gates Foundation was funding a program to develop a vaccine that could be combined with other vaccines to treat cervical cancer. Every year around 72,000 Indian women, most of them young, die of this disease. The scientific work developing the vaccine was being done outside India. However, the clinical trials immunizing young girls, were to be conducted in India. Questions over these trials appear to have unmasked a scandal. It is alleged that the parents of girls selected to be given the vaccine, had little understanding of the consent forms that they were signing. The financial considerations were small and it appears that over and above the monitoring of the girls who had been vaccinated, there was no provision to care for them should they suffer side effects. In all, maintain human rights investigators, the program was flawed and exploitative. Apart from the considerable embarrassment to Microsoft founder Bill Gates and his wife, these allegations have the potential to tarnish the entire Indian pharmaceutical industry, at the very time that it has the potential to launch itself internationally as a new powerhouse of biochemical innovation.

For Biocon the effects of the moratorium on clinical trials could be a disaster. If the allegations are in anyway true, then firm and swift action should be taken by the authorities to stop the exploitation of gullible families who are duped into having their children used as guinea pigs. Such appalling behavior could not be allowed to continue.

Nevertheless the Indian government must look to the wider picture. At stake here are potentially billions of dollars of new income for India. And success will breed more success. The country has proved its abilities in the outsourcing business, where it has made itself a dominant player handling the back office functions of thousands of international companies.

Therefore the committee reviewing these 160 clinical trials must give priority to important Indian discoveries, including Biocon with its oral insulin development. To allow the bureaucratic process to its grind away through what is in fact, a significant number of complex clinical trials, and let India’s oral insulin discovery take its chances, would be an act of madness.