The Central Vigilance Commission (CVC) has registered a complaint involving alleged irregularities in granting of permission to a drug company by the Drug Controller General of India (DCGI) for the manufacture and sales of the drug Tadlafil, used to treat pulmonary artery hypertension.
Medical rights activist Anand Rai has alleged in his complaint to the CVC that the drug company (Cipla) obtained the rights to manufacture Tadlafil on the basis of clinical trials conducted at MGM Medical College, Indore and Indira Gandhi Medical College, Shimla.
He has also alleged that the company obtained the permission irregularly in collusion with certain high officials of the DCGI and government doctors in Indore.
The permission to the drug company has cost a loss of Rs. 1,000 crore to the government of Madhya Pradesh and Himachal Pradesh where trials for the drug were conducted.
Citing the case of Indore, Mr. Rai claims that since the trial (CTRI/2009/091/000744) was conducted by a government doctor and was sponsored by the MGM medical college Indore, the rights for manufacture and sale of the drug should have been obtained by the government of M.P.
But the drug company in question and the Principal Investigator “connived with highly placed officials of the DCGI” casuing a “loss of about Rs. 1,000 crore to the government of Madhya Pradesh”.
“The loss of revenue to the governments and to the people of India should be probed by the Comptroller and Auditor General (CAG) in order to bring out the complete truth,” Mr. Rai told The Hindu.
The potential loss figure of Rs. 1,000 crore has been calculated based on the amount involved in a similar deal (between the Eli Lily Pharma company and the United Therapeutics of USA) for the manufacture and commercial rights of the same medicine Tadlafil.
In US, the rights were obtained in the US for a sum of $ 150 million.
A response from Cipla could not be obtained as the company's official contact number was answered by the security personnel who said offices were closed as Saturday was a non-working day.