Regulations need clarity, says industry
A clinical trial can sometimes be the only option for a terminally ill patient, for whom death is just a matter of time, say advocates of clinical research.
“It is not unusual for executives of pharmaceutical companies to receive calls from cancer patients or their relatives inquiring about the possibility of participating in an ongoing trial,” says Dr Shoibal Mukherjee of Quintiles, a clinical research organisation.
Mukherjee says that patients who are part of the drug trial process often fare better than for those who are not because of the “focussed attention and meticulous follow-up that clinical trial participants get”.
Business Line was unable to get specific evidence of this.
Suneela Thatte, President of the Indian Society for Clinical Research, concurs with Mukherjee: “For many patients, a clinical trial provides early access to a new treatment and for others, the last hope of a cure. Without trials there can be no new therapies.”
REGULATORY MINEFIELD
The industry says it welcomes stronger laws to protect patients. It is the unclear regulations and delayed approvals that create problems, they say. “Although the regulatory authorities have been taking several steps to create a more robust framework, there is still lack of clarity on many issues,” says Suneela Thatte, President, Indian Society for Clinical Research (ISCR).
Mukherjee says that some of the new regulations still do not touch key areas such as data integrity, fraud and patient privacy, which form the bedrock of the regulations in many countries.
Others complain about the inordinate delays in getting approvals. “There is no doubt that regulations need to get stronger. But along with that, the time factor (for clearing trials) is important,” says Dibyendu Sengupta, Senior Adviser (Life Sciences), at the Confederation of Indian Industry.
SLOW PROCESS
It is estimated that on an average, the approval for a trial takes two or three months, if direct approval is given. However, if a drug is being tested for the first time, applications are sent to a DCGI committee, which can take three to six months to give its opinion, on the basis of which the DCGI may decide to grant approval.
The number of clinical trials cleared by the government has fallen from 500 in 2010 to just 56 this year, as of July. Though trials conducted in India cost 40-60 per cent less, the industry says that just being cheaper is not enough.
The uncertain regulatory environment has led many firms to take their research to other countries, such as Malaysia and Canada, which have speedy approvals. India could lose $150-200 million during the current year alone.
“It is not difficult to replace these (Indian trial) sites in other countries,” says Quintiles’ Mukherjee. “Unfortunately, that means the infrastructure created over the last 18 years will also have to be dismantled just when local companies may need it for new drug-development research after years of selling me-too generic products.”
Dhananjay Bakhle, Executive VP, Medical Research – Novel Drug Discovery & Development, Lupin Limited, says over-regulation can impact prices.
“If Indian companies have to go outside for clinical trials to develop new products, they will spend much more. The price of such a new drug, when introduced in India, will be higher,” says Bakhle.
Thatte says that if the ambiguity in regulations is removed, pharma companies will not mind the extra cost. “Our interest is in ensuring that there is a robust regulatory environment for clinical research, securing the rights and safety of patients. What matters is to have a stable regulatory framework, appropriate governance and monitoring, and better compliance.”
