With no exact data available on the number of Ayurveda medicine manufacturers in the state, the Kerala Ayurveda department has decided to create a database of all licences issued and names of working manufacturing units in a digital format.
In the current scenario, there is no way to find out whether all the licensees are operating or what products are manufactured by each company and if any malpractice or misuse of licence is being committed. Also, the growing number of cases of people possessing licences and never renewing them has to be identified. The digital format will be released within three months, said Dr N Vimala Anil, drugs controller for Ayurveda department in Kerala.
“The data creation will not only help the department to deal with the issues related to licence releases, but will also help regulate process of licence renewal, new product endorsement and find out the number of classical and proprietary medicines being manufactured by each company. It will also help to keep a tap on companies which are engaged in the production and sale of drugs without licences or renewals. The database will be useful for the inspecting officers to carry out their duties without any kind of hurdles”, said the DC.
According to Dr Vimala, the department will build a digital file of the entire licences issued so far and arrange it area wise, with the name of company, the date it was issued on, and the products each unit manufactures. This will help the various offices of the Ayurveda department to regulate the operations of the manufacturers and make sure renewals take place. Once the database of licences is ready, it will help the department revoke licences which have not been renewed without any reasonable explanations.
Acknowledging the need to upgrade and strengthen the technical systems in the office, the state health secretary has directed the drugs controller to hold consultations with the manufacturers’ associations, and as a result a meeting of office-bearers of Ayurveda Medicine Manufacturers Organisation of India (AMMOI) and the department officials was held at the drugs control office last week. Following it, the general secretary of AMMOI, Dr D Ramanathan held a detailed exercise of collecting database of manufacturing companies across the state. Updating the details is going on.
According to information received from the DC office, the listed licensees in the state are 1200, but working units are only 687. Out of this, 646 units have GMP licences. The number of loan licensees is 98. However, exact information about operation of the units, shifting of offices, change of addresses, non-renewals, details of products etc has to be collected after detailed inspections at the units.
Referring to the human resources, the DC said the number of drug inspectors has now been increased to 7 which is sufficient to collect materials for the database. With this, issue of licences, renewals, product endorsements etc will become easier and transparent.
After the meeting, AMMOI general secretary Dr Ramanathan submitted a memorandum to the health secretary demanding establishment of a separate drugs control directorate for Ayurveda. Briefing Pharmabiz about the conclusions arrived at the meeting, he said the facilities presently available at the three government Ayurveda colleges in the state are not sufficient for conducting clinical studies for Ayurvedic medicines. This problem may be taken into consideration by the R&D wing of ISM department, he said.
Source:Pharmabiz
In the current scenario, there is no way to find out whether all the licensees are operating or what products are manufactured by each company and if any malpractice or misuse of licence is being committed. Also, the growing number of cases of people possessing licences and never renewing them has to be identified. The digital format will be released within three months, said Dr N Vimala Anil, drugs controller for Ayurveda department in Kerala.
“The data creation will not only help the department to deal with the issues related to licence releases, but will also help regulate process of licence renewal, new product endorsement and find out the number of classical and proprietary medicines being manufactured by each company. It will also help to keep a tap on companies which are engaged in the production and sale of drugs without licences or renewals. The database will be useful for the inspecting officers to carry out their duties without any kind of hurdles”, said the DC.
According to Dr Vimala, the department will build a digital file of the entire licences issued so far and arrange it area wise, with the name of company, the date it was issued on, and the products each unit manufactures. This will help the various offices of the Ayurveda department to regulate the operations of the manufacturers and make sure renewals take place. Once the database of licences is ready, it will help the department revoke licences which have not been renewed without any reasonable explanations.
Acknowledging the need to upgrade and strengthen the technical systems in the office, the state health secretary has directed the drugs controller to hold consultations with the manufacturers’ associations, and as a result a meeting of office-bearers of Ayurveda Medicine Manufacturers Organisation of India (AMMOI) and the department officials was held at the drugs control office last week. Following it, the general secretary of AMMOI, Dr D Ramanathan held a detailed exercise of collecting database of manufacturing companies across the state. Updating the details is going on.
According to information received from the DC office, the listed licensees in the state are 1200, but working units are only 687. Out of this, 646 units have GMP licences. The number of loan licensees is 98. However, exact information about operation of the units, shifting of offices, change of addresses, non-renewals, details of products etc has to be collected after detailed inspections at the units.
Referring to the human resources, the DC said the number of drug inspectors has now been increased to 7 which is sufficient to collect materials for the database. With this, issue of licences, renewals, product endorsements etc will become easier and transparent.
After the meeting, AMMOI general secretary Dr Ramanathan submitted a memorandum to the health secretary demanding establishment of a separate drugs control directorate for Ayurveda. Briefing Pharmabiz about the conclusions arrived at the meeting, he said the facilities presently available at the three government Ayurveda colleges in the state are not sufficient for conducting clinical studies for Ayurvedic medicines. This problem may be taken into consideration by the R&D wing of ISM department, he said.
Source:Pharmabiz
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