In an attempt to improve the quality of service by the pharmacy stores in the state, the Kerala government has decided to issue licences to run pharmacy stores only to qualified pharmacists. At present, any one can obtain a pharmacy license on the condition that the pharmacy store should employ one qualified pharmacist in the shops.
The government decision will come into effect immediately. Under the new system, only qualified pharmacists can apply for running new pharmacy shops in the state. However, the existing pharmacy shops will not be affected by the new system.
State drug controller (in-charge) MP George said that the government has taken a decision in this regard recently. "The state government is seized of the issue of running pharmacy shops without qualified pharmacists. Now, the government at least wanted to ensure that the new pharmacy shops are run properly by the pharmacists only".
The government's efforts in this regard come in the wake of widespread reports that the pharma traders are making mockery of the existing system as most of the time there are no full time pharmacists in the pharmacy shops in the state. As per the existing law, anybody can get a pharmacy license on the condition of employing a qualified pharmacist in the shop.
But, the state drug department has found that most of the time, pharmacists are not present in the pharmacy shops as they are working somewhere else. This has resulted in a situation where the pharmacy shops are run by non-professionals. Just to fulfil the law criterion, the traders rope in some pharmacists on some fixed payment. There are reports that in several cases, the pharmacists come to the pharmacy shops once in a month to collect the monthly fees.
Apart from this, the state government will also intensify inspection of the existing pharmacies in the state to ensure that the pharmacy shops are manned by professional pharmacists only. As per law, drug inspectors have to inspect the pharmacy shops at least twice a year. But, this practice has become a farce as most of the inspectors are hand in glove with the traders
Friday, December 28, 2007
Sunday, December 23, 2007
December 22, 2007
The rapid growth of Indian clinical trial industry, which is expected to touch US $2 billion in 2010, should be streamlined with adequate regulation and mutual understanding with the foreign clients, say experts.
In a panel discussion on 'Multinational Clinical Trials In India - Opportunities and Challenges' at the 59the IPC conference in Varanasi, experts suggested that the drug regulator should consider adding specific guidelines for pre-clinical studies and related research works, in order to support the momentum of growth of clinical trials in the country.
The ideal approach for the Indian clinical trial industry to grow to the target of US $2 billion should have mutual understanding with the foreign clients to create a win-win situation for both the parties and to allay apprehension from the minds of Indian patients. The government should also create a panel of experts in the field, on the lines of the advisory board in US, to give adequate guidelines to the regulator on clinical trial issues, said Dr Ashok Rakhit, vice president, Clinical Pharmacology, Hoffmann-La Roche Inc, USA, who was chairing the session.
He said that there should be emphasis on patient-safety with adequate priority, so that there would be no apprehension for the patients about the tests conducted. There is an apprehension in the minds of people that the big pharma is using the third world countries as their testing ground. "We know that the rumours on this are completely baseless, but we have to take steps to clear the apprehensions from the common people," he added.
India is going to be the sought-after place for overseas pharma companies in phase III clinical trials, said Dr Susan Abu-Shakra, vice president, Clinical Development, Allegran Inc. She averred that the win-win situation in the clinical trial outsourcing sector would make the Indian patients get treated with drugs cheaply.
The availability of English-learned skilled people, availability of latest technologies and exclusive sites are some of the major strengths of Indian clinical trial sector. The delay in regulatory approvals for drug trials is one of the major difficulties faced by the clients of Indian clinical trial industry. However, the recent experience of the company, which received regulatory approval within six months, shows that the regulatory efforts are also on the way of development, said Dr Susan.
Indian companies should concentrate more on long-term studies rather than looking for quick bucks from short-term trials, commented Prof. Nicholas HG Holford, University of Auckland, New Zealand. Earlier, Dr Satish Bhatia, chief executive, Fortis Clinical Research Centre presented his views on the effects of races, the Caucasian and Indian, in clinical pharmacokinetics. Prof. Harish Padkh, director, B V Patel PERD Centre, Gujarat discussed 'polymorphism and genotype - phenotype correlation of drug response in Indian population', in the symposium.
The rapid growth of Indian clinical trial industry, which is expected to touch US $2 billion in 2010, should be streamlined with adequate regulation and mutual understanding with the foreign clients, say experts.
In a panel discussion on 'Multinational Clinical Trials In India - Opportunities and Challenges' at the 59the IPC conference in Varanasi, experts suggested that the drug regulator should consider adding specific guidelines for pre-clinical studies and related research works, in order to support the momentum of growth of clinical trials in the country.
The ideal approach for the Indian clinical trial industry to grow to the target of US $2 billion should have mutual understanding with the foreign clients to create a win-win situation for both the parties and to allay apprehension from the minds of Indian patients. The government should also create a panel of experts in the field, on the lines of the advisory board in US, to give adequate guidelines to the regulator on clinical trial issues, said Dr Ashok Rakhit, vice president, Clinical Pharmacology, Hoffmann-La Roche Inc, USA, who was chairing the session.
He said that there should be emphasis on patient-safety with adequate priority, so that there would be no apprehension for the patients about the tests conducted. There is an apprehension in the minds of people that the big pharma is using the third world countries as their testing ground. "We know that the rumours on this are completely baseless, but we have to take steps to clear the apprehensions from the common people," he added.
India is going to be the sought-after place for overseas pharma companies in phase III clinical trials, said Dr Susan Abu-Shakra, vice president, Clinical Development, Allegran Inc. She averred that the win-win situation in the clinical trial outsourcing sector would make the Indian patients get treated with drugs cheaply.
The availability of English-learned skilled people, availability of latest technologies and exclusive sites are some of the major strengths of Indian clinical trial sector. The delay in regulatory approvals for drug trials is one of the major difficulties faced by the clients of Indian clinical trial industry. However, the recent experience of the company, which received regulatory approval within six months, shows that the regulatory efforts are also on the way of development, said Dr Susan.
Indian companies should concentrate more on long-term studies rather than looking for quick bucks from short-term trials, commented Prof. Nicholas HG Holford, University of Auckland, New Zealand. Earlier, Dr Satish Bhatia, chief executive, Fortis Clinical Research Centre presented his views on the effects of races, the Caucasian and Indian, in clinical pharmacokinetics. Prof. Harish Padkh, director, B V Patel PERD Centre, Gujarat discussed 'polymorphism and genotype - phenotype correlation of drug response in Indian population', in the symposium.
Friday, October 26, 2007
India's Clinical Trials Registry to cover ongoing trials too soon
The Clinical Trials Registry-India (CTRI) set up by the Indian Council of Medical Research may register all ongoing clinical trials along with prospective trials in it, it learnt. The Registry has been set up just two months ago and is well received in the industry.
After the CTRI was launched on July 20 by the National Institute of Medical Statistics NIMS, an initiative of ICMR, 12 prospective trials have been registered so far and the NIMS has been receiving a lot more enquiries.
``The response is good. We have already 100 registered users, mainly pharmaceutical companies. So far only the prospective trials, cleared by the Ethics Committee, are allowed to register. Now we will extend the spectrum to cover the ongoing trials too,'' its coordinator Dr Abha Rani Agarwal said.
The mission of the CTRI is to encourage all clinical trials conducted in India to be prospectively registered before the enrolment of the first participant and to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset. In this manner the CTRI hopes to become a WHO ICTRP ICMJE (International Council of Medical Journal Editors) compliant Primary Register for India.
It is aimed at giving all required information about a trial at a single point to the public and researchers and make trials more transparent. It also would help stop the practice of suppressing negative results of trials by companies.
A similar registry was also launched around the same time by China, the main competitor of India in the fast growing clinical trials sector. The online registry showed that it also could rope in only a dozen registrations so far.
With the ongoing trials also being included, the authorities are hoping to see a big rush of registrations and greater service for the users. The NIMS has been getting positive responses across the country after the registry was launched. They said that many features of the registry were still under development and it would be soon transformed into fully operational platform with an array of services.
According to available reports, nearly 300 clinical trials are going on in the country whereas just 120 trials were held last year. Clinical trials in India cost 50 per cent less than the average cost in the US and recruitment of patients were said to be far easier, prompting the multinationals to shift focus to India.
CTRI puts the data of on-going clinical trials in public domain, an attempt to make the clinical research more transparent and accountable in a time when India is increasingly emerging as a preferred destination for outsourcing of clinical trials. At the same time, the clinical trials arena has been one of the least regulated sector notwithstanding some guidelines in existence. The Centre is also in process of putting a policy in place for the sector.
The WHO has been encouraging the countries to create platforms for registration of all trials involving humans at the early stage of development. The International Committee of Medical Journal Editors in July 2005 made mandatory the registration of trials for publication of findings and reports in 12 leading medical journals worldwide. This triggered a sudden spurt in registration. The US Government registry receives 200 entries every week now.
After the CTRI was launched on July 20 by the National Institute of Medical Statistics NIMS, an initiative of ICMR, 12 prospective trials have been registered so far and the NIMS has been receiving a lot more enquiries.
``The response is good. We have already 100 registered users, mainly pharmaceutical companies. So far only the prospective trials, cleared by the Ethics Committee, are allowed to register. Now we will extend the spectrum to cover the ongoing trials too,'' its coordinator Dr Abha Rani Agarwal said.
The mission of the CTRI is to encourage all clinical trials conducted in India to be prospectively registered before the enrolment of the first participant and to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset. In this manner the CTRI hopes to become a WHO ICTRP ICMJE (International Council of Medical Journal Editors) compliant Primary Register for India.
It is aimed at giving all required information about a trial at a single point to the public and researchers and make trials more transparent. It also would help stop the practice of suppressing negative results of trials by companies.
A similar registry was also launched around the same time by China, the main competitor of India in the fast growing clinical trials sector. The online registry showed that it also could rope in only a dozen registrations so far.
With the ongoing trials also being included, the authorities are hoping to see a big rush of registrations and greater service for the users. The NIMS has been getting positive responses across the country after the registry was launched. They said that many features of the registry were still under development and it would be soon transformed into fully operational platform with an array of services.
According to available reports, nearly 300 clinical trials are going on in the country whereas just 120 trials were held last year. Clinical trials in India cost 50 per cent less than the average cost in the US and recruitment of patients were said to be far easier, prompting the multinationals to shift focus to India.
CTRI puts the data of on-going clinical trials in public domain, an attempt to make the clinical research more transparent and accountable in a time when India is increasingly emerging as a preferred destination for outsourcing of clinical trials. At the same time, the clinical trials arena has been one of the least regulated sector notwithstanding some guidelines in existence. The Centre is also in process of putting a policy in place for the sector.
The WHO has been encouraging the countries to create platforms for registration of all trials involving humans at the early stage of development. The International Committee of Medical Journal Editors in July 2005 made mandatory the registration of trials for publication of findings and reports in 12 leading medical journals worldwide. This triggered a sudden spurt in registration. The US Government registry receives 200 entries every week now.
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