2013 (12) TMI 1707 - SC - Indian Laws

Summary

Issues Involved:
1. Allegations of malpractices in clinical trials.
2. Compliance with court orders regarding information and affidavits.
3. Strengthening regulation of clinical trials.
4. Approval and monitoring of clinical trials.

Summary:

1. Allegations of Malpractices in Clinical Trials:
The matter alleges malpractices in clinical trials by government and non-government entities as well as independent investigators. The court sought detailed information from the Secretary, Ministry of Health and Family Welfare, and the Central Drugs Standard Control Organisation (CDSCO) on the number of new clinical entities (NCEs) approved, deaths and serious side effects suffered by subjects, and details of compensation paid.

2. Compliance with Court Orders:
The court noted non-compliance with its order dated 8-10-2012, as an affidavit filed by the Deputy Drugs Controller was deemed insufficient. A proper affidavit was directed to be filed within four weeks. The court also recorded the statement of the Additional Solicitor General that clinical trials of new chemical entities would be conducted strictly in accordance with Schedule Y of the Drugs and Cosmetics Rules, 1945, under the direct supervision of the Secretary, Ministry of Health and Family Welfare.

3. Strengthening Regulation of Clinical Trials:
The court was informed about measures taken to strengthen the regulation of clinical trials, including amendments in GSR 53(E), GSR 63(E), and GSR 72(E), which specify procedures for analyzing serious adverse events, conditions for conducting clinical trials, and requirements for Ethics Committee registration. The Drugs and Cosmetics (Amendment) Bill, 2013, containing strict penal provisions, was also introduced. The court directed the Secretary, Ministry of Health, to convene a meeting with Chief Secretaries/Health Secretaries of State Governments and Administrators of Union Territories to discuss the legal framework for clinical trials.

4. Approval and Monitoring of Clinical Trials:
The court reviewed the approval process for clinical trials, noting that 162 approvals were given by the DCGI, with 157 approvals granted before the court's order on 3-1-2013 and 5 approvals after. The court directed that the 157 cases be evaluated by the Technical Committee and the Apex Committee, keeping in view safety and efficacy aspects. For the 5 cases approved after 3-1-2013, the court required audio-visual recording of the informed consent process and preservation of documentation.

Further Proceedings:
The court scheduled further consideration of the matter, including the evaluation of the 157 cases and the suggestions received from various stakeholders, for subsequent dates. Interlocutory applications were also addressed, allowing the Indian Pharmaceutical Alliance to intervene in the case.