Private firm suspended for conducting clinical trials on poor women

Anti-cancer drug was given to poor women without their consent

sonal

Sonal Matharu | June 24, 2011



The drugs controller general of India (DCGI) under the health ministry on Friday suspended the approval of a private firm conducting clinical trials in Hyderabad after it was found that the firm is administering anti-cancer drug to poor women in Piduguralla town of Andhra Pradesh without securing their informed consent.

Investigations conducted by the DCGI’s south zone office in Chennai and sub-zonal office in Hyderabad on June 20 and 21, 2011 have confirmed that M/s Axis Clinicals Ltd., Hyderabad, did not follow rules with respect to subject recruitment process, informed consent process, independence of the ethics committee and its review and decision making process.

The investigations were conducted on at the Bio-equivalence study centre of M/s Axis Clinicals Ltd. situated at Serlingampally, Miyapur, Hyderabad. It was found that the company was violating norms specified in schedule Y of the drugs and cosmetics rules for conducting clinical trials.

“The DCGI has therefore suspended the approval of the said firm for conducting all Bio-availability and Bio-equivalence studies at their centres in Miyapur, Hyderabad in public interest,” said a press note from the health ministry.

The office of the DCG(I) has further decided to investigate the working of all Bio-availability and Bio-equivalence study centres in Andhra Pradesh within a period of two months to ensure that such studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines.

M/s Axis Clinicals Ltd., Hyderabad had conducted Bio-equivalence studies on Exemestane tablets in its Serlingampally, Miyapur, Hyderabad centre during the period 27th January 2011 to 15th February 2011.
 

Comments

 

Other News

Who is Eknath Shinde, the auto driver who became CM?

Hailing from Satara district of Maharashtra, Eknath Sambhaji Shinde had to leave his education midway to financially support his family. He worked as an auto rickshaw driver, a lorry driver and also said to have worked in a brewery before he came in contact with Anand Dighe, Shiv Sena’s Thane unit pr

Metro 3 car shed to stay at Aarey, say new CM Shinde

Former Maharashtra chief minister Davendra Fadnavis stunned all at a press conference Thursday and named Eknath Shinde, the rebel MLA from Shiv Sena, as the next chief minister. Though Fadnavis said he would stay out of the government, a few hours later the BJP leadership announced he would be the deputy c

Uddhav Thackeray resigns as chief minister of Maharashtra

Minutes after the Supreme Court ordered a floor test on Wednesday night, Uddhav Thackeray in a televised address resigned as the chief minister of Maharashtra and also as a member of legislative council (MLC). He later drove down to Raj Bhavan and tendered his resignation to the governor Bhagat Singh Koshi

Gig workforce expected to expand to 2.35 crore by 2029-30

The gig economy has arrived in India, as the Covid-19 pandemic has propelled a flexibility of employment. As many as 77 lakh workers were engaged in the gig economy, constituting 2.6% of the non-agricultural workforce or 1.5% of the total workforce in India. The gig workforce is expected to expand to 2.35

How Antyodaya Saral is simplifying everyday life in Haryana

From obtaining an electricity connection to a driver`s licence, ration card, or old-age allowance, delivery of government schemes and services is an aspect of governance that impacts citizens at various points throughout their lives. The Haryana state government provides over 600 such schemes and services.

A blueprint of India’s economic future: From a former RBI governor

From Dependence to Self-Reliance: Mapping India’s Rise as a Global Superpower By Bimal Jalan Rupa Publications, 184 pages, Rs 695 Bimal Jalan, a former governor of the Reserve Bank of India (RBI), has been one of our finest commentators on econom

Visionary Talk: Sanjay Pandey, Mumbai Police Commissioner with Kailashnath Adhikari, MD, Governance Now


Archives

Current Issue

Opinion

Facebook    Twitter    Google Plus    Linkedin    Subscribe Newsletter

Twitter