Association of Biotechnology Led Enterprises (ABLE), which represents the biotech industry, is planning to move the Supreme Court pleading to join as a party in the ongoing case on clinical trials, primarily to share its technical knowledge on the subject.

ABLE, which has sufficient expertise on the matter, wants to join the case and provide scientific information in the interest of the patients community, association president Dr P M Murali informed. “We have people with technical capacity, apart from the latest information in the matter. We consider it as our duty to join the case and share the valuable scientific information for the benefits of the people,” he told Pharmabiz.

A Public Interest Litigation (PIL), filed by NGO Swasthya Adhikar Manch alleging rampant illegal and unethical clinical trials on adults, children and even mentally ill persons in the country, is currently under the consideration of the Supreme Court. The apex court had, in the hearing in January, had rapped the Union Government for its negligence in monitoring the trials. This has prompted the union health ministry to constitute a two tier panel - an apex committee and a technical committee- consisting of senior ministry officials and experts, for supervising clinical trials on new chemical entities in the country.

Dr Murali said ABLE was taking a pro-active stance to support the regulatory system in the country and wanted to work as a bridge between the industry and the Government. It had already joined a case regarding the GM crops in the agriculture sector. “Likewise, we want to play an active role in the clinical trials sector which is very crucial,” he said, on the sidelines of the event to mark the 10th anniversary of ABLE.

The ABLE is also planning to set up a clinical trials committee to create patient awareness and education about clinical trials. It will try to help both the industry and the government with information arising out of clinical trials.

"To ensure smooth operations, we are keen to support the regulatory body in terms of providing training (both class-room and on-site) as well as provide a more neutral platform for exchange of ideas between the regulator and the industry and also maintain a registry of Clinical Research Organisations (CROs), SMOs, ethics committees, Labs and Bio-pharma," Dr Murali said.