Pharma cos may get a breather on trials

Health Ministry trying to accommodate companies’ view on clinical trials, says Azad

Bangalore February 6, 2014: As the clamour to ease regulations regarding clinical trials grows in India, the Health Ministry has said it is trying to find a way to take into consideration the concerns of biotechnology companies, while implementing regulations to protect the subjects of clinical trials in India.

“Having gone through the observations made by the Supreme Court, the NGOs and the Parliamentarians, I think we have done our bit, at the ministry level. But at the same time I think we will have to accommodate the viewpoint of the industry as well,” said Ghulam Nabi Azad, Minister of Health and Family Welfare, Government of India, said in Bangalore on Wednesday.  With rules being set to protect the life and medical condition of the trial subject in India, it is now mandatory for companies conducting clinical trials to reveal the contract between the subject and the company to the Drugs Controller General of India (under the rules of the Drugs and Cosmetics Act, 1940). It is also mandatory for an audio-visual recording of consent by the subject to participate in the trial.

“The pharma industry feels that the regulations placed on them are too difficult to abide by. But there have also been complaints from the other side,” Azad said. Some health activists have argued that many global players in the pharmaceutical sector were coming to India to conduct their clinical trials as the lack of strict regulations in the country made it easier for them to circumvent any death or injury to humans from the trials. When the matter was taken to Court, the Supreme Court laid down stringent guidelines making companies liable for the death or injury caused to any human trial subject.

“While we’re happy that the new dispensation is in the interest of the country and the interest of the patient, we should also see that innovation also finds a way in India and the whole industry should not fall short of holding clinical trials,” Azad said. “Biocon too had to go outside India to undertake clinical trials,” he noted, speaking at the sidelines of an event organised by Biocon, India’s largest public-listed biotechnology company. .

“The situation is becoming more and more difficult in India. Several programmes have been stalled and we have also moved the trials offshore, to ensure the work on the development does not stop,” Biocon’s chairperson & managing director, Kiran Mazumdar-Shaw, had said. “We are very concerned that nothing is being done about this problem. These are very serious things and the government is just dragging its feet.”

Not only Biocon, Lupin had also moved some of its clinical trials to the United States and European Union, despite an estimated 10-20 times increase in costs. Cadila Healthcare (Zydus Cadila) is also considering shifting some of its trials to the United States as companies reluctantly embrace higher costs in light of the delay in product development caused by the regulatory constraints in India.

“The industry has to be happy too. We are hearing from the industry that the number of clinical trials being held in the country has dropped by more than half now,” Azad said.  

Azad also mentioned that the Ministry is handling with caution the US FDA’s ban on six facilities of Ranbaxy and Wockhardt on exporting their produce to the United States following alleged inferior manufacturing practices.

“The type and volume (of the exports) and the number of the countries that we are exporting to in the entire globe has caused a lurking fear in the developed countries afraid  that we might take their entire market,” Azad said. “So, when some observation is made in some quarter, we have to go deep into that and handle it cautiously.”  India is touted to be the world’s second-largest manufacturer and leading exporter of generic drugs. -Business Standard