New Delhi: The drugs controller general of India (DCGI) has revoked the permission granted to Mumbai-based Shreya Life Sciences Pvt. Ltd to import anti-diabetes drug Oral Recosulin, made by Canada-based Generex Biotechnology Corp., after a Mint investigation revealed that the product had been given marketing approval in India without any local human clinical trials being conducted as required by the country’s drug laws.
A letter to this effect, issued by DCGI on 26 March with a copy to drug controllers at ports across the country, has been reviewed by Mint. In the letter, the drugs controller has asked Shreya to provide details of the quantity of the drug imported and, in case these were being used for a post-marketing study or a sort of clinical trial after the product has been launched, the status of this study.
Also See Tough Treatment (PDF)
DCGI has also suspended sale of the drug and launched an investigation into the marketing approval granted to both Generex and Shreya.
When contacted, Ram Shelat, director (domestic business), Shreya Life Sciences declined comment, saying only that the company is reviewing the paper.
Also Read New diabetes drug approved without trial
The company had received permission to import 10 million packs of Oral Recosulin, each of which was being sold in India for Rs2,400. Oral Recosulin is insulin that is administered locally and not injected. It is categorized as a new drug in India because it uses a new delivery mechanism.
The Drugs and Cosmetic Act of India makes it mandatory for a new drug undergo so called phase III human clinical trials in India before being approved for marketing here. An exception can be made only if it is in public interest and based on data available from other countries.
“The company can no longer import this product into India and whatever has been imported has been put on hold with immediate effect. This means that packs of the product can’t be distributed in the market any more and what is already available has to be withdrawn,” said a senior health ministry official familiar with the issue who spoke on condition of anonymity.
He added that DCGI would investigate the matter and then decide if the company should be allowed to go ahead with the post-marketing study or if the permission to import the drug should be cancelled and it be asked to conduct a clinical trial.
The import permission was granted in 2007 to Generex Biotechnology, and later transferred to Shreya Life Sciences. It was restricted to 10 million packs. Usually, such import permissions have no restrictions on quantity of the drug being imported. Shreya, however, was to conduct the post-marketing study and submit a report to the regulator.
“Now this permission will further be acted upon after the DCGI receives and studies the post-marketing data submitted by the company,” said the same official.
On 26 March, Mint had reported that the marketing approval given for Oral Recosulin by DCGI highlighted a lapse in the regulatory mechanism as no clinical trials were conducted in India before the drug was launched.
Before it was granted approval in India, this anti-diabetes drug was being sold only in one other country, Ecuador, which has no drugs regulator.