Centre mulls waiving off clinical trials on humans for critical drugs
NEW DELHI: In a move to make innovative medicines available for critical diseases like HIV, hepatitis and tuberculosis, the health ministry plans to waive off clinical trials in humans for select drugs which are essential for Indian patients and were approved in developed markets like the US, European Union, Japan, Canada and Australia at least two years ago.
"The recommendations were made by the Ranjit Roy Chowdhary committee some time back. The idea is to take a progressive step in the direction of making essential and innovative medicines available in India at a fast pace," Drugs Controller General of India GN Singh told TOI.
Though such waivers are still approved by the drug regulator on case to case basis, the ministry now plans to bring in legal provisions under the proposed rules for clinical trials. This will enable the regulator set a standard procedure and criteria for approvals.
The health ministry has sent the proposed rules to the law ministry for vetting. Singh said in some cases the clinical trial waiver may even be extended to cancer drugs but only if they are considered essential for treatment of Indian patients and alternatives are unavailable. Companies, however, will also be required to do post marketing trials and submit data in a specified period after the launch. Initially the proposal was to waive off clinical trials for all drugs which are available in these developed markets for at least two years. However, this was met with objections during deliberations by the Drugs and Technical Advisory Board, which usually takes a call on such matters.
Experts part of the board had said some of these medicines may be effective in patients of other countries but may act differently on Indian patients because of genetic make up. "Our objective is to ascertain safety and efficacy of the drug in Indian patients...We will still decide on case to case basis and take a call depending on the need and efficacy of the drug," Singh said.
Hospital issued notice for overcharging says it refunded excess amount to patients
Metro Heart Institute, which was issued a demand notice of Rs 1.27 lakh by the drug regulator on Thursday, denied the charges and claimed that it has already refunded the excess amounts to respective patients. The hospital said the initial bills were generated before the National Pharmaceutical Pricing Authority's (NPPA) notice clarifying that the effective date of implementation of price cap is date of billing and not the date of angioplasty. "However, we refunded the excess amount charged on the products to the respective patients," Dr S S Bansal, managing director of Metro Heart Institute said.