SWASTHYA ADHIKAR MANCH
6, BIJASAN ROAD, OPPOSITE MAHAVIR BAGH, INDORE, MADHYA PRADESH-452005.
The writ petition filed by Swasthya Adhikar Manch came up for hearing today before bench of Supreme Court consisting of Justice R.M Lodha and Justice A.R Dave.
The petitioner, Swasthya Adhikar Manch has filed application for directions regarding investigations of clinical trials of New Chemical Entities (NCEs) without approval as drugs for human use anywhere in the world. Advocate Sanjay Parikh appearing for the petitioner, Swasthya Adhikar Manch drew attention of the court to the illustrative list of all NCEs and 59th report of parliament standing committee dated 8th May 2012, which was submitted to the court. It was pointed out that the parliamentary committee has observed in its report that Indian citizens are being treated as guinea pigs by multinational pharmaceutical industries and the report questioned the role of central and state governments in this matter. In the reply filed by the respondents it became amply clear that states do not have any laws & rules on the subject. Many of the trials are happening without knowledge of the authorities concerned and monitoring & regulatory systems. Union of India in its reply, informed the court that drafting of rules is under process which also indicates that there are lacunae in the existing rules.
It was also pointed out that, apart from Madhya Pradesh, there are other states i.e. Maharastra, Andhra Pradesh, Gujarat & all UTs where illegal & unethical trials are being conducted and they don’t have rules related to Clinical trials.
The court has directed all the States and UTs to provide information related to status of Clinical trials in their states. Court has also asked for independent investigation reports if any carried out by the state within 8 weeks.
After hearing both sides, court has stated following points in its order and asked the Ministry of Health and family welfare and CDSCO (????) to file the reply within 4 weeks .
1) The Ministry of health and Family welfare & CDSCO to provide status of number of New Chemical Entities experimented between Jan. 2005 to 30th June 2012.
2) Besides this number of deaths and instances of serious adverse impacts due to these trials should be provided too.
3) Provide the list of persons to whom compensation was given to those who died during the process and also those who suffered severe adverse impacts in the course of Clinical trials.
The parliamentary standing committee has documented that CDSCO is according primacy to the interests of the drug industry and compromising the consumers interest. The committee observed that giving permission to the drug companies to conduct trial of untested newly patented monopoly drug is being given greater emphasis. These approvals would have adverse impact on health of public at large in India.
The petitioners pointed out how instances of clinical trials, in particular after 2005 Amendment in the Drugs & Cosmetic Rules 1945, using our country as a soft target and the citizens here as guinea pigs. There are no records maintained by the State with regard to deaths which have taken place from January, 2005 to December, 2006. As per available information 2007 to June 2012, 2,374 deaths have taken place in these clinical trials some as young as in their 30’s. Drug companies, investigators employed by drug companies and Ethics Committees have however claimed that only 37 people died during the course of drug trials.
The learned counsel also pointed out that the New Chemical Entities (NCEs) of which the foreign pharmaceutical companies hold the patents conduct trials in different countries but the soft targets are developing countries such as India. The data on side effects and efficacy is generated by Multinational Companies (MNCs) in a country like India at very low cost and without fear of any liability / responsibility. Lured by easy money, free trips to foreign countries, free equipments, hefty payments to doctors and collusion of drug controlling authorities are some of the apparent causes for continuing trials illegally. Constitution of Ethical Committees as private bodies or within a private hospital or a clinic, is another factor which permits unethical risky clinical trials. Therefore, the drug companies (mostly multinational) purely for profits, use the people of our country in clinical trials which are of no benefit to our country.
The court observed that once the parliamentary committee has made an observation and recorded its findings, action should be taken by the Government and they should also bring suitable amendments to the law.
We hope, now that the Supreme Court has taken serious note of the illegal Clinical trials responsible for so many deaths, Central and State Governments will understand the gravity of the situation. We also hope that with the intervention of the Honourable Court the detail status of Clinical trials in the Country will come out in the public domain which will expose the unethical practices of the drug industry as well as the CDSCO and bring under scanner the investigators and other government agencies responsible for the same.
Amulya Nidhi, Chinmay Mishra