Pharmaceutical majors such as Cipla and Sun Pharma have asserted they have not violated any drug approval norms even as Health Ministry has appointed a committee to look into alleged irregularities while clearing new drugs by Central Drugs Standard Control Organisation.
According to the Parliamentary Standing Committee on Health and Family Welfare, headed by Brajesh Pathak, on scrutiny of 39 drugs on which information was available, the committee found shortcomings.
"In the case of 11 drugs phase III clinical trials mandated by rules were not conducted. These drugs are Everolimus (Novartis), Colistimethate (Cipla)...," the panel pointed out while naming a few more companies.
When contacted, a Cipla spokesperson said: "We have followed the procedure as laid down under the Drugs & Cosmetics Act for grant of such licences and there has been no violation".
Cipla said as per the law, it is not mandatory to carry out Phase III trials in India for each and every new drug.
"Both the drugs in question are marketed in a number of countries internationally and have been proven to be life saving. We deny that there has been any collusion with the DCGI," Cipla spokesperson added.
Taking serious note of a Parliamentary panel report, Health and Family Welfare Minister Ghulam Nabi Azad last week constituted a panel of experts to look into alleged irregularities in granting approvals to new drugs.
The panel will submit its report within two months.
"We strongly deny any wrongdoing in this matter. All approvals were sought and received, and protocols followed in compliance with existing regulations," a Sun Pharma spokesperson said.
Drug maker Bayer said it had conducted the mandatory clinical trials for Rivaroxaban for the indication of VTE prophylaxis in India after getting the necessary permission from the Drug Controller General of India (DCGI).
Subsequently, the required data and an application for the indication was submitted to the DCGI. As per practice, the DCGI then seeks advice from experts.
"Our company does not play any role in selecting these experts or evaluating their opinions. This is entirely an internal process of the DCGI. The experts send their opinion letters to the DCGI directly," Bayer said.
The company said it adheres to the requirements of local laws in every country that it operates in.
Commenting on the matter, a Novartis spokesperson said:" At Novartis, we follow one global ethical standard for conducting clinical trials.
"All clinical trials are designed, conducted and reported in accordance with the ethical principals embodied in the Declaration of Helsinki, Good Clinical Practice guidelines and national regulatory requirements," it said.
