The Food and Drug Control Administration (FDCA) Gujarat and the office of the Drugs Controller General of India (DCGI) has jointly unearthed a major racket that has been indulged in forging "new drug approval letters" for pharmaceutical companies in western India. Based on the FIR filed by the state FDCA and the complaints from DCGI, the Gujarat Police has arrested the prime suspect from Delhi and is zeroing in on other members, it is learnt.

The complaint was filed after Gujarat Commissioner S P Adeshara learnt that 17 out of 18 new drug approvals supposedly issued by the DCGI to seven Gujarat based drug companies found to be forged. The commissioner had decided to cross check the authenticity of these approvals after he felt doubts about the R&D capabilities of the companies who had received the approvals.

Speaking to pharmabiz.com, Adeshara said that the illegal activity came to his notice after he started the practice of going through the list of all new drug manufacturing approvals given by his office.

"It was to update myself on the new drugs approved in the region; I started this practice of vetting all files relating to new drugs approvals. While going through the files, I found that some of the approvals have gone to companies who really don't have the facility to develop such drugs. So it was just out of curiosity that I decided to call for all files relating to manufacturing approvals for new drugs in the last one year. A close observation revealed that they are several such cases where the approval seemed to be a remote possibility. I selected 18 such cases and wrote to the office of DCGI to cross check the authenticity and it was found that 17 of them were forged," he explained.

Since the manufacturing licenses for all these drugs have been issued by the Gujarat FDCA to the companies, the state department began the enquiry with a string of show cause notices. They also filed FIRs with the Police, which led to the arrest of some of the company personnel in the recent months. "The pharmaceutical companies were all having documents to prove that they have received the approvals from the office of the DCGI through their agents in Delhi. They even produced the DD receipt made towards the new drug registration charges to the DCGI. It was then we realized that the pharmaceutical companies were being duped by a Delhi based racket who were into forging such documents", Adeshara informed.

Confirming the development, Ashwini Kumar, DCGI said that his department has been offering all possible assistance to Gujarat FDCA and the state Police to unearth the case.

The issue is likely to open a pandora's box as pharmaceutical companies all over the country are getting their regulatory clearance works done through agents/liaisoning personnel in Delhi. It is quite likely that there are unsuspecting drug companies from other states also who have been getting their work done through the same gang.