In a big blow to foreign multinational companies, the Supreme Court on Monday said no clinical trials should be allowed for new drugs till a mechanism is put in place to monitor them and to protect the lives of people on whom these drugs are tested.
A bench headed by justice RM Lodha asked the Centre to create such a system in consultation with various stakeholders in order to avoid any serious and adverse impact. On its part, the Centre assured the apex court that it will also not allow clinical trials for the 162 drugs it had cleared earlier.
The SC directive comes at a time when foreign drug regulators, including the US Food and Drug Administration, have been issuing form 483s, warning letters and import alerts against Indian drug manufacturers such as Ranbaxy, Wockhardt and Strides Arcolab.
“Considering the kind of deaths that have happened in India over the past few years, a move like this was inevitable.
Indian people cannot be made guinea pigs in the name of clinical trials. If foreign drug regulators insist on complying with current good manufacturing practices by Indian drug manufacturers, the MNC pharma companies should act equally responsibly as well,” said a top industry official, requesting anonymity.
While the Drugs and Cosmetics Act awaits penal provisions, the Centre had earlier informed the Supreme Court that at least 80 people have died due to illegal clinical trials in the last seven years.
In an affidavit submitted to the court as per its directive, the health ministry has said there were 2,644 ‘serious adverse events’ of deaths from clinical trials during 2005-2012. Of these, 80 have been attributed to clinical trials, while the other deaths could be due to terminal illnesses or other life-threatening diseases. Compensation was paid to families of 44 victims till 2011.
According to the ministry, there were around 12,000 incidents of ‘other adverse effects’ in this period, of which 506 directly pertained to clinical trials.
Earlier, serious concerns were raised on the manner in which the American NGO PATH (Programme for Appropriate Technology in Health) set up office in the country and conducted clinical trials for Human Papilloma Virus (HPV) vaccines under the garb of ‘observational project’ by violating all guidelines.
The trials were suspended following deaths of five girls in Andhra Pradesh, and two deaths in Gujarat in 2009-2010 after being administered the HPV vaccine. The vaccines were provided by two pharmaceutical companies – Merck and GlaxoSmithKline – through PATH during studies carried out in collaboration with the Indian Council of Medical Research and the states concerned. The project was reportedly funded by Bill and Melinda Gates Foundation.
The apex court ruling, however, is seen having little impact on the Indian pharma sector since only a handful of players, such as Glenmark, Dr Reddy’s and Cadila, are working on new drug development.
“The strength of Indian pharma companies lies in generics, active pharmaceutical ingredients and formulation, which is a $12 billion export market. Unless something happens to that, there is very little to be worried about. The sector could expect some losses on this account, but that’ll be too small a sum,” said Ranjit Kapadia, senior vice-president, Centrum Broking.
Analysts also said that pharma MNCs may move to other countries for clinical trials if things get difficult in India. “They may consider shifting clinical trials to other countries like Philippines, Bangladesh, or for that matter China,” said a pharma sector analyst.
Life & death
The health ministry said there were 2,644 ‘serious adverse events’ of deaths from clinical trials during 2005-2012
Of these, 80 have been attributed to clinical trials, while the others could be due to terminal illnesses or other life-threatening diseases.