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Permissions for clinical trials delayed, bio pharma firms plan to leave country

The health ministry had put in place a three-tier system to scrutinise applications for trials.

There have been an approximate 17,669 suspect measles cases reported from January 1 to February 22. There have been an approximate 17,669 suspect measles cases reported from January 1 to February 22.

With more than a year’s delay in getting permission for starting Phase 3 of the rotavirus vaccine trial among 7,000 infants, Serum Institute of India is in no mood to ask for the government’s approval for testing other vaccines in clinical trials “Be it dengue or meningitis vaccine, we are now moving out to other countries in Asia,” said Adar Poonawalla, executive director at Serum Institute of India.

At Lupin Pharmaceuticals’ research park in Pune the scene is similar, with scientists fed up due to delay in conducting trials and have already moved out to other countries.

Poonawalla said all clinical trials have been delayed. “Take the rotavirus vaccine for example. It is the leading cause of severe diarrhoea in infants and young children, with more than one lakh under the age of five succumbing to the virus in a year. Once licensed, this indigenous and affordable vaccine will have the potential to reduce the burden of severe rotavirus in the country,” he said.

What has been frustrating for scientists involved in clinical trial related research is the time taken for obtaining approvals. “It has taken more than a year to get approval for conducting Phase 3 of the rotavirus clinical trial among 7,000 infants across five centres in the country,” Poonawalla said.

“We have to test the pneumococcal vaccine and polyvalent meningitis vaccines. If approvals are taking so much time, we might as well move to other centres in Asia,” he added. Serum’s efforts to test a dengue vaccine will also be taken outside the country, he said.

There has been a slowdown in decisions related to clinical trials in the wake of stringent directives from the Supreme Court asking the government and regulatory agencies to take measures to ensure safety of patients participating in clinical trials of new medicines.

Accordingly, the health ministry had put in place a three-tier system to scrutinise applications for trials.

Several bio pharmaceutical firms have been hit as securing approvals has become a time-consuming process under the new drug advisory committee.Dr Dhananjay Bakhle, executive vice-president , medical research (novel drug discovery and development), Lupin pharmaceuticals — that has a research park in Pune —  said: “There has been a great deal of uncertainty about conducting clinical trials in India and we moved to Europe and Japan one and a half years ago.”

“We are trying to develop new chemical entities for various diseases. It is ironical that when India has the capability to conduct global clinical trials, the time taken in permissions has affected the effort,” Bakhle said, citing how the new drug advisory committees directed them to to apply for Phase 1 clinical trial for a bio similar product that had already reached Phase 3.

The application for Phase 3 clinical trial was pending before the Drug Controller General of India much before the SC laid down the stringent guidelines. However, the firm was directed to re-apply for Phase 1 stage of the clinical trial under the new regulations. “We have moved 10-11 such candidates of new chemical entities for trials in Europe, while other studies on bio similar products will also be done in Japan,” Bakhle said.

Dr Urmilla Thatte, head of the Department of Clinical Pharmacology at KEM Hospital, Mumbai, said the scenario was dismal as very few clinical trials are underway in the country.

MR vaccine donated to Philippines

Five million doses of the measles-rubella (MR) vaccine were donated by Serum Institute of India to His Royal Highness, the Prince of Wales’ health charity in UK for Philippines “Following a request from the Prince of Wales, we decided to give five million doses for the mass immunisation campaign for children under five years of age in Philippines as part of the response to super typhoon Yolanda,” said Adar Poonawalla, executive director of Serum Institute of India. There have been an approximate 17,669 suspect measles cases reported from January 1 to February 22.

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