Ayurvedic drugs have a two-yr expiry
TNN Jun 24, 2011, 10.34pm IST
VARANASI: The research study for the stability of ayurvedic preparations involving medicated 'ghee' (grhita) and oil (taila), conducted at the department of Rasa Shastra, BHU, has fixed the shelf-life of such preparations as a maximum of two years.
As per Anand Chaudhary, associate professor in the department and regional coordinator, Pharmacovigilance Centre for North Region, the rule 161 (B) of Drugs and Cosmetics Act, 1945 has made it mandatory to print the manufacture and expiry date of all ayurvedic, siddha and unani ( ASU) drugs from April 1, 2010 onwards. "Under no circumstances, consumers should buy these drugs after their expiry date, especially preparations of medicated ghee and oil that are manufactured two years ago," he added.
It may be mentioned here that only 'asavarishta' (herbal liquid preparation) and 'bhasma' (metallic-herbo formulations) have no expiry date and can be used even after two years of manufacturing.
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A number of ayurvedic preparations involving medicated ghee and oil, including Mahanarayana Taila with analgesic properties are used in Panchakarma procedure and most of them have a shelf-life of 18 to 24 months. "The buyers need to be aware and informed about the efficacy of the drugs with proper attention paid to the date of their manufacture and expiry," added Chaudhary.
Monday, June 27, 2011
Wednesday, June 22, 2011
Ayush dept may amend drug procurement policy for ASU drugs
Ayush dept may amend drug procurement policy for ASU drugs under NRHM
Suja Nair Shirodkar, Mumbai
Thursday, June 23, 2011, 08:00 Hrs [IST]
The Department of Ayush may amend the drug procurement policy for Ayurveda, Siddha & Unnani (ASU) drugs under the National Rural Health Mission (NRHM) to bring the private sector also under the ambit of this policy which is now restricted to the public sector units only.
In this regard, the Department of Ayush is convening a meeting with the representatives of Ayurvedic Drug Manufacturers’ Association (ADMA) on June 29. The meeting is aimed at finding a common ground and future course on this issue.
Ever since the government decided to procure ASU drugs under NRHM only from PSUs like TAMPCOL, Oushadhi, Indian Medicines Pharmaceutical Corporation Ltd. (IMPCL), etc on the insistence of department of Ayush for ensuring quality of medicines, there has been persistent demand from the ASU industry to sources drugs from private sector too.
The industry is hopeful that with this meeting, they would be able to get into some understanding with the government.
According to Chandrakanth Bhanushali, general secretary, ADMA, “I think it is important for the government and the industry to have discussion on this issue and get into a consensus that will help in benefiting the industry at large. We need to find a middle way that will help us to get out of this complicated situation.”
Earlier, the Department had mentioned that the demand made by the industry to include private sectors under the NRHM scheme cannot be considered since under the present policy, procurement of medicines for the NRHM or other public health schemes can only be done from PSU undertakings.
“We want to know why is the government so apprehensive about the private companies selling medicines under the NRHM scheme. We are surprised by the attitude of the government that rather than encouraging the small scale industry it it crippling it by bringing in such restrictions.”
ADMA has suggested that the Department of Ayush should take some proactive step for the development of the industry by amending the policy guidelines so that equal opportunity can be provided for all in the industry.
Suja Nair Shirodkar, Mumbai
Thursday, June 23, 2011, 08:00 Hrs [IST]
The Department of Ayush may amend the drug procurement policy for Ayurveda, Siddha & Unnani (ASU) drugs under the National Rural Health Mission (NRHM) to bring the private sector also under the ambit of this policy which is now restricted to the public sector units only.
In this regard, the Department of Ayush is convening a meeting with the representatives of Ayurvedic Drug Manufacturers’ Association (ADMA) on June 29. The meeting is aimed at finding a common ground and future course on this issue.
Ever since the government decided to procure ASU drugs under NRHM only from PSUs like TAMPCOL, Oushadhi, Indian Medicines Pharmaceutical Corporation Ltd. (IMPCL), etc on the insistence of department of Ayush for ensuring quality of medicines, there has been persistent demand from the ASU industry to sources drugs from private sector too.
The industry is hopeful that with this meeting, they would be able to get into some understanding with the government.
According to Chandrakanth Bhanushali, general secretary, ADMA, “I think it is important for the government and the industry to have discussion on this issue and get into a consensus that will help in benefiting the industry at large. We need to find a middle way that will help us to get out of this complicated situation.”
Earlier, the Department had mentioned that the demand made by the industry to include private sectors under the NRHM scheme cannot be considered since under the present policy, procurement of medicines for the NRHM or other public health schemes can only be done from PSU undertakings.
“We want to know why is the government so apprehensive about the private companies selling medicines under the NRHM scheme. We are surprised by the attitude of the government that rather than encouraging the small scale industry it it crippling it by bringing in such restrictions.”
ADMA has suggested that the Department of Ayush should take some proactive step for the development of the industry by amending the policy guidelines so that equal opportunity can be provided for all in the industry.
Sunday, June 19, 2011
Proper clinical trials must for indigenous medicine system
Proper clinical trials must for indigenous medicine system
Naveen Kumar, TNN Jun 17, 2011, 10.35pm IST
Tags:
* European Union
VARANASI: Are the new and more strict guidelines of European Union (EU), promising to keep close vigil on manufacture and sale of ayurvedic, siddha and unani (ASU) drugs a warning call for local manufacturers?
While the new and strict guidelines of EU call for proper documentation apart from long clinical assessment and trial (spanning over 10 years) of all types of drugs prepared under indigenous medicine system in different countries across the world and the practice has been made mandatory for these drugs before they are sold in EU countries from May this year.
"The EU may not be a big player as far as business of ASU drugs are concerned, but the move is a clear indication of how the western countries have started to look at the safety and efficacy of indigenous drugs, putting the health of their citizens at the forefront," said Anand Chaudhary, regional co-ordinator, Regional Pharmacovigilance Centre for Ayurveda Drugs (RPC-AD), Banaras Hindu University. "It is also a wake up call for local manufacturers to start scientific validation and proper documentation of indigenous drugs that are being developed at various centres across the country," he added. It may be mentioned here that while India is the fourth leading manufacturer of pharmaceuticals in the world comprising over 6,000 licensed drug manufacturers apart from over 60,000 brands of medicines, the pharmacovigilance is still in infancy stage in the country. Even though the country has witnessed establishment of two zonal pharmacovigilance centres apart from eight RPCs and 30 peripheral centres to bolster pharmacovigilance in the last three years, report from various centres suggesting low reporting of adverse drug reactions (ADRs) from these medicines are enough to reflect lack of awareness in this regard.
While a total of 114 cases of ADRs from ayurvedic drugs have been reported from different parts of the country in the period stretching from January 2010 to April 2011, the northern region of the country has drawn blank, failing to report even a single case of adverse drug reaction in the past 15 months. Also, as per reports of RPC-AD centre at BHU, only three cases of ADRs have been reported at the centre since its inception in 2008.
"The figure clearly reflects lack of awareness for reporting ADRs in the region and also sends strong warning and wake up call to the local manufacturers to pull their socks to promote scientific validation and initiate documentation for ASU drugs, if they are to become saleable in the world," says Chaudhary, who is also associate professor in the department of rasa shastra. He also emphasised that pharmacovigilance was basically meant to ensure post-marketing surveillance of ayurvedic products which might identify in ADR products, so that further improved version of ayurvedic product was available for the common man. "It is not meant for triggering any kind of rivalry or penalisation, but come up with safe drugs, much on the heels of the new guidelines of EU," he added.
Naveen Kumar, TNN Jun 17, 2011, 10.35pm IST
Tags:
* European Union
VARANASI: Are the new and more strict guidelines of European Union (EU), promising to keep close vigil on manufacture and sale of ayurvedic, siddha and unani (ASU) drugs a warning call for local manufacturers?
While the new and strict guidelines of EU call for proper documentation apart from long clinical assessment and trial (spanning over 10 years) of all types of drugs prepared under indigenous medicine system in different countries across the world and the practice has been made mandatory for these drugs before they are sold in EU countries from May this year.
"The EU may not be a big player as far as business of ASU drugs are concerned, but the move is a clear indication of how the western countries have started to look at the safety and efficacy of indigenous drugs, putting the health of their citizens at the forefront," said Anand Chaudhary, regional co-ordinator, Regional Pharmacovigilance Centre for Ayurveda Drugs (RPC-AD), Banaras Hindu University. "It is also a wake up call for local manufacturers to start scientific validation and proper documentation of indigenous drugs that are being developed at various centres across the country," he added. It may be mentioned here that while India is the fourth leading manufacturer of pharmaceuticals in the world comprising over 6,000 licensed drug manufacturers apart from over 60,000 brands of medicines, the pharmacovigilance is still in infancy stage in the country. Even though the country has witnessed establishment of two zonal pharmacovigilance centres apart from eight RPCs and 30 peripheral centres to bolster pharmacovigilance in the last three years, report from various centres suggesting low reporting of adverse drug reactions (ADRs) from these medicines are enough to reflect lack of awareness in this regard.
While a total of 114 cases of ADRs from ayurvedic drugs have been reported from different parts of the country in the period stretching from January 2010 to April 2011, the northern region of the country has drawn blank, failing to report even a single case of adverse drug reaction in the past 15 months. Also, as per reports of RPC-AD centre at BHU, only three cases of ADRs have been reported at the centre since its inception in 2008.
"The figure clearly reflects lack of awareness for reporting ADRs in the region and also sends strong warning and wake up call to the local manufacturers to pull their socks to promote scientific validation and initiate documentation for ASU drugs, if they are to become saleable in the world," says Chaudhary, who is also associate professor in the department of rasa shastra. He also emphasised that pharmacovigilance was basically meant to ensure post-marketing surveillance of ayurvedic products which might identify in ADR products, so that further improved version of ayurvedic product was available for the common man. "It is not meant for triggering any kind of rivalry or penalisation, but come up with safe drugs, much on the heels of the new guidelines of EU," he added.
Monday, April 25, 2011
ASU drugs
Quacks easily get Ayush licences
April 24: Getting a licence to sell ayurvedic medicines is easier than getting one to sell allopathic drugs. Moreover, ayurvedic drugs are sold without the required information about their content, contra-indications, expiry date etc. This is only to be expected when the regulatory authorities are lax about these infringements of the law, and when the penalty is so paltry.
Dr M. Venkateshwarloo, inspecting medical officer, Ayush (ayurveda, yoga, unani, siddha and homeopathy), said that where earlier details about the Ayush drug did not have to be mentioned on the packaging, now it is compulsory. “It is mandatory to mention the composition, expiry date and contra-indications on every medicine bottle or pack. Those bottles without such informative labels may be spurious or sold by quacks and may contain heavy metals and preservatives more than the stipulated amount. If we get complaints from the public, we will take action,” said Dr Venkateshwarloo.
Stricter punishment is to come into force soon for infringements of this requirement. Currently, says the assistant director of the state Drug Control Administration, “in case of spurious Ayush drugs, the violator is let off with a few months’ imprisonment and a small fine. However, in case of allopathic drugs, depending on the nature of the offence, the punishment varies from five years’ imprisonment to life, besides a hefty fine.”
Dr B. Venkatram Reddy, drug inspector of the government department of Ayush, admits that getting a licence for Ayush drugs is easy. “To get a licence for the sale of homoeo drugs, the shop should be clean and hygienic and the technical person selling the medicines should have at least five years of experience, while following good manufacturing practices is needed to get a licence for manufacture of drugs.” An Ayush official said enforcement, regulatory and monitoring authorities need to be more active where sale of drugs is concerned.
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