New Delhi, Apr 4 (PTI)
Data about patients participating in clinical trials cannot be shared, the Central Information Commission has held while dismissing an RTI plea seeking details of stalled Human Papilloma Virus (HPV) vaccine trials in the country.
The HPV vaccine clinical trials are being investigated by a committee of Drug Controller of India as allegations of ethics violations including on informed consent, safety protocols and other such issues were raised from several quarters, the RTI applicants submitted in their plea.
The Government had allowed "Gardasil" (imported by M/s MSD Pharmaceuticals, Gurgaon) and "Cervarix" (imported by M/s GSK Pharmaceuticals, Mumbai), to undergo phase-III clinical trials in India, before granting permission to import and market authorisation.
The trials were started in Khammam, Andhra Pradesh and Vadodara in Gujarat in association with a US-based non-profit organisation PATH. After four deaths of participants in Gujarat and two deaths in Andhra Pradesh were reported, the Government had stopped the trials.
"The cause of deaths was determined as viral fever, drowning, suicide, severe anaemia with malaria and suspected snake bite. Based on the concerns on these deaths, states have been advised not to carry out any further vaccinations at present," Minister of State for Health S Gandhiselvan had informed Parliament.
The applicants wanted to know details of these trials including the data generated from the studies which was denied to them.
In the case, Information Commissioner Annapurna Dixit had called for comments from parties involved in the clinical trials including NGO Path, GlaxoSmithKline Pharaceuticals and MSD Pharmaceuticals besides Director General Health Services.
All the parties were unanimous that patients data cannot be shared as keeping it private is one of the clauses of the agreement a company enters with the patient.
"The data contains variety of information regarding the pharmaceutical company''s laboratory, pre-clinical and clinical data including product indications, efficacy, tolerability and safety, pharmaco-kineticks, drug interactions, side effects, contra-indications, adverse effects etc. which are data directly related to patients," Dixit held.
She said even the Drug and Cosmetics Act says that in every clinical trials patient related information is to be held in strict confidentiality by the institutions concerned.
She directed not to reveal information pending investigations and held that "upon the final outcome of the inquiry, the DGCI out of the information in its possession shall provide information...severing all and any patient related information as also any information which deals with exclusive intellectual property rights of the pharmaceutical companies." PTI ABS
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