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.
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