New diabetes drug approved without trial

A new drug to combat diabetes, which is administered orally and not injected, was given a marketing approval by the Drugs Controller General of India (DCGI) without being put through the mandatory human clinical trials, highlighting a possible lapse in Indian laws dealing with the testing and approval of drugs.

The drug, Oral Recosulin, which was available in India from 27 January, was originally developed by Canada-based and Nasdaq-listed Generex Biotechnology Corp. and is marketed by Mumbai-based Shreya Life Sciences Pvt. Ltd. India is only one of the two countries where the drug is sold; the other is Ecuador, where it is sold as Oral-Lyn.

“Clinical trials for Oral Recosulin were not conducted in India. But we are currently conducting in India (a) phase IV trial,” said Ram Shelat, director (domestic business) at Shreya Life Sciences in an email.

A phase IV trial is conducted after a drug is given marketing nod to ensure that it doesn’t have any harmful side effects.

While insulin is not a new drug, Oral Recosulin is still classified as one by India’s Drugs and Cosmetics Act (DCA), since the delivery mechanism is new.

“Marketing approval given by the Drugs Controller General, India was unlawful because conventional insulin, instead of being injected, is to be given by spray via mouth. Any change in route of administration makes even an old, approved medicine, a ‘new drug’ as defined in the Drugs and Cosmetics Rules,” said Chandra M. Gulhati, editor of Monthly Index of Medical Specialities, a trade journal.

Repeated calls and emails to DCGI, over several days, remained unanswered.

The drug is being sold in India at Rs2,400 for a single pack. The price was approved by the National Pharmaceutical Pricing Authority in January based on DCGI’s approval, an official at the authority said on condition of anonymity.

Oral Recosulin is currently available in Delhi, Mumbai, Kolkata, Chennai, Hyderabad and Bangalore. It will soon be launched in Ahmedabad, Pune, Jaipur, Lucknow, Bhubaneswar and all other state capitals.

A marketing approval can only be granted once a new drug is proven to be effective and safe on the Indian population after so-called phase III clinical trials in the country.

When asked about the marketing approval being granted without clinical trials in India, Bill Abajian, executive vice-president (worldwide business) at Generex Biotech, said in a phone conversation that it was not possible for him to question the decision of India’s health ministry to approve the drug.

India’s DCA clearly states that an exception can be made only if it is in public interest and based on data available from other countries.

Mint was informed by Shreya Life Sciences that as of date, the only other country where the drug is marketed is Ecuador.

“This Latin American country, with a 14 million total population (less than that of Delhi) does not even have a drug controller,” said Gulhati.

Mint also reviewed the information on worldwide clinical trials put up on the website of Generex, which shows that at the time it received marketing approval for the drug in India, on 25 April, the administration of the drug had not begun in the phase III clinical trials being conducted on 750 patients with Type-1 diabetes across 36 centres located in the US, Canada, Russia, and Eastern Europe; these started in June.

The first result of this ongoing trial was announced on 10 March—42 days after the drug was launched in India.

Since the launch, Shreya Life Sciences has procured orders from nearly 60 doctors for over 100 patients in India, data on its website shows.

Even though Shreya Life Sciences received marketing approval from DCGI in April, Generex Biotech received permission and registration to import the drug for clinical trials in October 2007.

“This kind of (a) product requires a huge trial. I remember we gave them import licence and registration to conduct phase III trial,” said M. Venkateswarlu, the then DCGI.

However, this trial was not conducted in India.

Some doctors are hesitant to prescribe the product, especially after the failure of Pfizer’s inhaled insulin Exubera, launched in 2006 and later withdrawn in 2007, citing poor sales.

Generex, however, denied these apprehensions. “Unlike its failed counterpart, which was inhaled into the lungs, Oral-Lyn is absorbed through the tissue lining of the mouth and using a proprietary liquid formula, and ensures consistent dose-to-dose delivery without dangerous deposits in the lungs. Clinical trials, so far, have found no negative side effects at all, and, in fact, have found that oral insulin acts faster on blood glucose levels than even injected insulin,” the company said in an email.

“Most of this data are preliminary and anecdotal, and do not make a strong case for it. Its safety remains to be demonstrated, especially in view of (the) fiasco of inhaled insulin,” said Anoop Misra, director and head of department of diabetes and metabolic diseases, Fortis Hospitals, who reviewed the published papers.

He has not prescribed the drug to any patient. “Trials were done in Ecuador—again we don’t know much about it. This is an insufficient trial. The side effects are not clear due to inadequate data. We feel they were given a rather hasty permission and I feel very shaky in using it. You have to produce several papers that have been published in a reputed journal. That’s how Exubera was launched,” Misra added.

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