The rules notified by the government for compensating clinical trial victims have failed to address the concerns raised by patient groups and health activists.

The National Human Rights Commission (NHRC) on Thursday issued a notice to the Union health secretary on a complaint alleging that three big government hospitals in Delhi conducted illegal clinical drug trials on 3,479 children during the last five years.

The commission’s notice cited illegal clinical trials allegedly conducted on 2,056 children at Safdarjung Hospital, 1,023 children in Kalawati Saran Children’s Hospital and 400 children at Lok Nayak Jai Prakash Hospital.

UPA chairperson Sonia Gandhi will launch a new child health screening and early intervention service at Palghar in Maharashtra’s Thane district on Wednesday.

The initiative, titled Rashtriya Bal Swasthya Karyakram, under the aegis of the National Rural Health Mission (NHRM), aims to provide a comprehensive healthcare package for all children up to 18 years of age. The programme will soon be extended to cover all districts of the country in a phased manner. This ambitious scheme, when implemented, is expected to benefit over 27 crore children.

In a move that will go a long way in ensuring the safety of subjects who participate in clinical trials in India, the government has notified procedures whereby compensation will be awarded in case of death or injury suffered by persons participating in the trials.

Hitherto, there was no rule under the law to provide for compensation in case of serious adverse events or injuries to subjects in clinical trials. The Drug Controller General of India (DCGI), the highest drug regulator, approves the conduct of clinical trials under the Drugs and Cosmetics Rules. But these rules have no procedures or even a mention of compensation to be given in case a participant in a trial suffers injury, disability or death.

The government has finally stepped in to curb the practice of paying variable or no compensation by pharma firms for deaths due to clinical trials. It has notified rules for granting relief in case of Serious Adverse Events like death or injuries.

The grant will depend on categories fixed by the government such as death, severe injury and minor injury. The minimum compensation amount would be notified soon. Recently the Supreme Court had directed the health ministry to monitor all clinical trials after stating that the government was in "deep slumber".

Nestled deep within snow-clad mountains, the people of Takiya Magam talk in whispers. They talk about a disease they know little about. Of the 4,000 inhabitants of this village in south Kashmir, 300 have been found to be suffering from Hepatitis C.

The state Health Department has started screening the villagers and has already taken blood samples of more than 1,300 people. "We have sent the samples to the NCDC (National Centre for Disease Control) for genotyping to find the exact strain," Director, Health, Saleem-ur-Rehman told The Indian Express. "As a precaution, we have decided to test all the villagers, and everyday our team collects more than 100 samples."

“Sixty per cent of cancer patients are actually being treated by non-oncologists”

The Indian Council of Medical Research is evolving standards of care and treatment protocols for 34 common types of cancer. Purvish Parikh, managing trustee, Indian Cancer Care Society, and president, Indian Society of Medical and Paediatric Oncology, said the guidelines for some specific conditions were already available on the ICMR website, and subcommittees were working to define treatment for other conditions.

Some 40 drugs will soon be notified under a new schedule, H1, of Drugs and Cosmetics Act to make it mandatory for chemists to maintain a register of their sales and retain a copy of the prescription. This will be in addition to the schedule H drugs which, too, can't be sold without prescription.

Besides, packs of H1 drugs will carry a prominent warning in red stating that it is dangerous to take these drugs without doctor's prescription. The decision, which Central Drugs and Standards Control Organisation hopes will arrest the rising incidence of resistance to antibiotics in the country, was taken at the 62nd meeting of Drug Technical Advisory Board Wednesday.

Each of the 3 drugs— Dasatinib Trastuzumab & Ixabepilone—costs 1L for a month’s dose

The government has appointed a panel to look into issues related to compulsory licensing of drugs and whether cheaper versions of cancer medicines Trastuzumab, Ixabepilone and Dasatinib can be launched under the provision, a person with knowledge of the development said. According to the person, the health ministry has sent its proposal regarding compulsory licensing for the three drugs to the Department of Industrial Policy and Promotion (DIPP), which in turn has sought the opinion of the department of pharmaceuticals. Srikant Jena, Minister of State for Chemicals and Fertilisers, however, denied having received any note.

Firms, foreign and Indian, reiterate they follow the rules fully earlier, SC had rapped govt for gaps in law and enforcement, including on compensation

Despite courts slamming the authorities over the monitoring of clinical trials in the country, the number of deaths caused by the adverse impact of drugs in these processes has risen. Data from the drug controller’s office, reviewed by Business Standard, show 12 drug-related deaths during clinical trials in the first eight months (till August) of 2012, as against 16 in all of 2011.