Drug Technical Advisory Committee recommended waiver of clinical trial for 2 cancer drugs

Drug Technical Advisory Committee headed by director general of health services Jagdish Prasad was on 6 November 2014 recommended waiver of clinical trial for 2 cancer drugs, Aflibercept and Trastuzumab emtansine, in public interest.

The committee recommended to sale the medicine without testing on Indian patients. This is permitted to cater to unmet medical needs.

The two medicines-Aflibercept and Trastuzumab emtansine - are used in treatment of metastatic colorectal cancer and metastatic breast cancer respectively.

The move is significant as it comes despite a recent directive from the Supreme Court asking the government to be careful while approving clinical trials as well as new medicines.

While, the law allows waiver of clinical trial in Indian population, only for drugs approved outside India, if there is national emergency, extreme urgency, epidemic, orphan drug or a disease for which there is no therapy.

Although, the committee considered that since both the drugs have been tested in various other countries and found to be effective, these can be allowed for sale in India in public interest.

However, many health experts feel the proposed clinical trial waiver to the two cancer drugs is in violation of rules and can have serious implications for patients.

An expert said that, this is a false and fabricated claim because there are other therapies available for metastatic breast cancer, notably Lapatinib plus Capecitabine. As a matter of fact Trastuzumab emtansine was compared with Lapatinib Plus Capecitabine for efficacy and safety.

Colorectal cancer

Colorectal cancer is one of the lifestyle-related cancers. It is still not much prevalent in India. The incidence of colorectral cancer in India is around 40000 to 50000 every year.

Doctors say it is on rise as people are pursuing a western lifestyle and diet, high in protein and fat, low in fibre and vegetables.

On the other hand, breast cancer is developing into epidemic proportions in India with almost 1.5 lakh new cases being diagnosed every year and close to 70000 women dying of breast cancer, according to Globocan (WHO) Data 2012.